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give original forum with a minimum of 250 words and respond
to both students separately with a minimum of 100 words each
First page Original forum with references
Swcond page Michael response with references
Third page Joshua response with references
Original Forum
For this week's discussion, think about the best location for
your e-portfolio. Do you want to use an existing social media
platform, or create your own? Do you want to post a blog, or
create a website? What period do you want your e-portfolio to
be available for viewing? Will the public be able to access your
site, or will access be restricted? Be constructive in content and
tone. Highlight your thoughts in an action pla
Student Response
Micheal
The best way to showcase my e-portfolio would be through my
LinkedIn profile. I am not heavily engaged in social media, and
I generally like to keep my online activity consolidated. I have
briefly considered creating a blog or website in the past, and
this will remain an option for me in the future. A key reason
that I favor LinkedIn at this point is that I can build my profile
incrementally and adjust it over time based on my developing
interests.
As I am still learning how best to utilize LinkedIn, I would most
likely start small with my e-portfolio. As far as duration is
concerned, I would plan to post it under my profile indefinitely.
However, I would limit access depending on my level of
satisfaction with the product. Peer feedback will help me to
understand how I can make my e-portfolio a more coherent,
cohesive, and complete product. Once a sufficient level of
feedback is received and adjustments are made, I may choose to
make the product available to anyone with a LinkedIn profile.
A tentative action plan for making my e-portfolio publicly
available would be as follows. First, I would integrate
instructor/peer feedback into the artifacts and overall e-
portfolio. Second, I would post the e-portfolio onto my
LinkedIn account with access generally restricted. Third, I
would seek out additional feedback from individuals with
experience in the career fields in which I would like to apply
the associated skillsets. After integrating this feedback, I would
make the e-portfolio publicly accessible on LinkedIn. This
would enable me to actively refer LinkedIn connections to my
work and have it passively available to recruiters as well.
I know that sometimes products posted to social media can get
tucked away out of sight and out of mind after the initial
posting. What are some good ways to promote projects like e-
portfolios on social media to keep them in the spotlight?
Joshua
For the last 2-years I have been using LinkedIn as my e-
Porfolio. I have had some interesting discussions with various
people about why I use it to show my work but that is about as
far as it has gone. I have not recognized any potential employer
interested in my writings on LinkedIn. But the purpose of me
posting on LinkedIn is to get my writing to post first if someone
does a google search on me. I don’t want some random thing
about me to pop up as the first thing.
As for the future of using LinkedIn or another platform so show
my work, I doubt I will use anything at all. I feel the stuff I
posted six months ago is no longer a representation of the
quality of work I do or the development of my communication
skills. If I do post on social media, I think the only thing I
would have in mind is to make my writing pop first on a google
search that way the searcher gets to find some of the best
writing I can post publicly.
The further away I get from finishing my degree the more I
think I will focus on creating a website as a portfolio of my
work. The work on my website would be a place where I would
sell the book I wrote along with other various articles of
opinion and interest. I do want to work on a second book, but
this time it will be a word search puzzle book.
KINE-5300 Research Methods in Kinesiology
Fall 2022
Final Written Proposal (90 total pts)
Student Presenter:
_________________________________________
Title of Project:
_________________________________________
Instructor Assessment Score (0 = lowest; 10 = highest)
Title:
concise and descriptive 0 2 4 6 8 10
Introduction/Literature Review (already completed but now
must be
condensed to ~2 pages):
introduce content, explain how it relates to information
discussed in
lecture, provide necessary background information, define key
terms
0 2 4 6 8 10
Aims and Hypotheses (already completed; 1/4 page):
clearly state study purpose and hypothesis 0 2 4 6 8 10
Experimental Approach (already completed; 2 pages):
detailed explanation of study design, define
groups/treatments/conditions, describe key
methods/measurements
and how they work, define primary outcome variables as they
relate to
the study hypothesis
0 2 4 6 8 10
Statistical Approach (already completed; 1/2-1 page):
detailed explanation of analytical approach and its
appropriateness for
the experimental design, describe experimental controls,
describe the
determination of statistical significance or effect size, describe
appropriateness of power analyses and sample size estimates
0 2 4 6 8 10
Project Timeline (already completed; 1/2 page):
describe major goals of the study; goals are broken down into
appropriate increments, with a logical timeline for the success
of the
project
0 2 4 6 8 10
References:
inclusion of references, appropriate use of citations, consistent
formatting, quality of articles (must be scientific)
0 2 4 6 8 10
Writing
consistent font and spacing, no spelling or grammatical errors,
use of
pictures/figures (no walls of text)
0 2 4 6 8 10
Overall Quality:
clear presentation, well organized, proper material included (no
excess
information), knowledge of material, appropriate citation of
references
0 2 4 6 8 10
Total:
ADDITIONAL FEEDBACK:
Annotated Bibliography
The research that I intend to propose is a new tool to estimate
energy deficiency in
women. The following bibliography gives relevant evidence of
variables related to and
altered by low energy availability.
De Souza, M. J., Miller, B. E., Loucks, A. B., Luciano, A. A.,
Pescatello, L. S., Campbell,
C. G., & Lasley, B. L. (1998). High frequency of luteal phase
deficiency and anovulation
in recreational women runners: blunted elevation in follicle-
stimulating hormone
observed during luteal-follicular transition. The Journal of
Clinical Endocrinology &
Metabolism, 83(12), 4220-4232.
Recreational runners and sedentary women with regular
menstrual cycles were
tested for hormone secretion and energy expenditure and intake.
Luteal phase deficiency
(LPD) and anovulation was frequently observed in runners, both
conditions showing low
progesterone excretion. In LPD, follicular phase was longer and
luteal phase was shorter,
and increase of FSH secretion was lower, compared to sedentary
group. Runners also had
lower E1C secretion during follicular phase. Anovulatory
women had the lowest energy
intake and the greatest daily energy expenditure, therefore the
lowest energy balance.
This relationship between menstrual dysfunction and low energy
intake could indicate
that the variables used in this study could be part of a tool to
assess energy deficiency.
De Souza, M. J., Toombs, R. J., Scheid, J. L., O'Donnell, E.,
West, S. L., & Williams, N.
I. (2010). High prevalence of subtle and severe menstrual
disturbances in exercising
women: confirmation using daily hormone measures. Human
reproduction, 25(2), 491-
503.
The prevalence of amenorrhoeic and oligomenorrheic women in
exercising and
sedentary group was assessed. Exercising anovulatory,
oligomenorrheic and
amenorrhoeic women tended to have lower gynecological age
compared to sedentary and
exercising ovulatory women, and to exercising women with
luteal phase defects. In the
sedentary group, most women were eumenorrheic and there
were no anovulatory women,
whereas in the exercising group more than half of the subjects
were anovulatory or had
luteal phase defects. This group also had lower progesterone
excretion. By giving
evidence that exercising women are more likely to have
menstrual disturbances, this study
supports the idea that assessing energy deficiency should
include menstrual cycle data.
Gibbs, J. C., Nattiv, A., Barrack, M. T., Williams, N. I., Rauh,
M. J., Nichols, J. F., & De
Souza, M. J. (2014). Low bone density risk is higher in
exercising women with multiple
triad risk factors. Medicine and science in sports and exercise,
46(1), 167-176.
The association between Female Athlete Triad risk factors and
low bone mineral
density (BMD) was investigated in exercising women. Subjects
with low BMD had lower
weight, body mass index, fat mass, lean body mass and fat-free
mass, had their menarche
later, and exercised more than women with normal BMD. The
percentage of women with
low BMD was higher among the subjects who had more risk
factors for the Triad. In
addition to a later menarche, which could indicate menstrual
disturbances, this study
includes bone health as a variable related to energy deficiency.
Melin, A., Tornberg, Å. B., Skouby, S., Faber, J., Ritz, C.,
Sjödin, A., & Sundgot-Borgen,
J. (2014). The LEAF questionnaire: a screening tool for the
identification of female
athletes at risk for the female athlete triad. British journal of
sports medicine, 48(7), 540-
545.
The study presents the Low Energy Availability in Females
Questionnaire (LEAF-
Q). The tool was developed to easily identify subjects with low
energy availability,
reproductive disorders, and bone health, based on questions
about menstrual function, use
of contraceptive methods, injuries, and gastrointestinal
function. It was validated with
clinical verification of energy expenditure, energy intake, blood
pressure,
hypothyroidism, reproductive function, and bone health, as well
as with an eating
disorders/disordered eating questionnaire. The questionnaire
presented in this study is the
tool currently used to estimate low energy availability in
women, however this variable
is less accurate than energy deficiency. Therefore, analyzing
this study is relevant for
understanding the LEAF-Q’s weaknesses and strengths, in order
to develop a more
precise tool.
Williams, N. I., Mallinson, R. J., & De Souza, M. J. (2019).
Rationale and study design
of an intervention of increased energy intake in women with
exercise-associated
menstrual disturbances to improve menstrual function and bone
health: The REFUEL
study. Contemporary clinical trials communications, 14,
100325.
This article presents the study design of a randomized
controlled trial that
attempted to treat conditions associated with the Female Athlete
Triad with increased
energy intake instead of hormonal contraceptives for 12 months.
Changes in diet might
be a good alternative for women going through menstrual
disturbances probably
associated with low energy availability. Bone health would
likely need to be investigated
for a period longer than 12 months. The outcomes of this study
can improve the
understanding of menstrual disturbances and bone health in
exercising women and how
it is related to diet alone. In other words, how they are or not a
direct outcome of energy
deficiency and how reversible they can be.
Strock, N. C., Koltun, K. J., Southmayd, E. A., Williams, N. I.,
& De Souza, M. J. (2020).
Indices of resting metabolic rate accurately reflect energy
deficiency in exercising
women. International journal of sport nutrition and exercise
metabolism, 30(1), 14-24.
The RMRratio was tested as a predictor of indicators of the
Female Athlete Triad
and energy deficiency (ED) in women who were eumenorrheic,
amenorrhoeic and with
subclinical menstrual dysfunction. Equations used were Harris -
Benedict, DXA,
Cunningham-1980 and Cunningham-1991. RMRratio was
correlated with TT3
concentration, and it had reliable sensitivity and specificity for
ED, especially the
Cunningham-1991 and DXA. The RMRratio could be either
used as a variable to validate
a tool to assess energy deficiency, or it could be mathematically
improved for the same
purpose.
Strock, N. C., Koltun, K. J., Mallinson, R. J., Williams, N. I., &
De Souza, M. J. (2020).
Characterizing the resting metabolic rate ratio in ovulatory
exercising women over 12
months. Scandinavian journal of medicine & science in sports,
30(8), 1337-1347.
The RMRratio was tested as a predictor of TT3 longitudinally
in healthy women. In
five tests throughout a year, RMRratio was consistent and
showed good sensitivity and
specificity for all RMR predictive equations: Harris-Benedict,
DXA, Cunningham-1980,
and Cunningham-1991. As the above-cited study, this ratio
could be improved or used as
a tool. In addition, associations of the RMRratio with other
energy deficiency-related
variables can be investigated to improve the efficacy in
estimating energy deficiency.
Strock, N. C., De Souza, M. J., & Williams, N. I. (2020). Eating
behaviours related to
psychological stress are associated with functional
hypothalamic amenorrhoea in
exercising women. Journal of Sports Sciences, 38(21), 2396-
2406.
Metabolic and psychological characteristics were compared
between exercising
women with and without functional hypothalamic amenorrhoea
(FHA). Subjects with
FHA had lower blood concentration levels of T3, T4, leptin, and
PYY, and greater
cognitive restraint, drive for thinness, and need for social
approval. Therefore, FHA
exercising women had evidence of greater energy deficiency,
even with similar energy
availability. The physiological and psychological variables in
this study, which indicate
energy deficiency, could be used to validate and to develop a
tool to assess energy
deficiency.
Barrack, M., Fredericson, M., Dizon, F., Tenforde, A., Kim, B.,
Kraus, E., Kussman, A.,
Singh, S., & Nattiv, A. (2021). Dietary Supplement Use
According to Sex and Triad Risk
Factors in Collegiate Endurance Runners. The Journal of
Strength & Conditioning
Research, 35(2), 404-410.
Supplement intake was assessed in male and female collegiate
runners. Most
athletes reported taking dietary supplements. Calcium and iron
intake was higher in
women than in men. Calcium and vitamin D intake was
associated with low bone mineral
density, and it was higher in subjects who had already had bone
stress injury. Supplement
intake is easily obtained as a variable and it could be an
indicator of energy deficiency
and low bone health.
De Souza, M. J., Mallinson, R. J., Strock, N. C., Koltun, K. J.,
Olmsted, M. P., Ricker, E.
A., Scheid, J. L., Allaway, H. C., Mallinson, D. J., Don, P. K.,
& Williams, N. I. (2021).
Randomised controlled trial of the effects of increased energy
intake on menstrual
recovery in exercising women with menstrual disturbances: the
‘REFUEL’ study. Human
Reproduction, 36(8), 2285-2297.
This study showed some of the results of the randomized
controlled trial that was
referred to above (Williams et al., 2019). Oligomenorrhoeic and
amenorrhoeic women in
the study group (i.e. who were having increased energy intake)
were more likely to
experience menses than the control group for the 12 months of
study. In addition, 64% of
the study group had their menstrual function improved, which
was observed in 19% of
control group. The results show the relevance of understanding
and estimating energy
deficiency, which can lead to menstrual dysfunction, and which
can probably be treated
without the prescription of hormones.
BREATHING PATTERNS TO MINIMIZE
CARDIOVASCULAR DISEASE RISK IN DEPRESSION
TOP 10 CAUSES OF
DEATH IN THE U.S.
2018
(Kochanek et al., 2019)
HOW DO WE MEASURE CVD RISK?
Traditional Risk Factors Nontraditional Risk Factors
Endothelial dysfunction
Stress
Garcia et al., 2016
HOW DO WE MEASURE CVD RISK?
Traditional Risk Factors Nontraditional Risk Factors
Endothelial dysfunction
Stress
Garcia et al., 2016
DEPRESSION
WORK $
17.3 million American adults Leading cause of
disability worldwide
$120.5 billion
economic burden
1 out of 3 are resistant to
current treatment practices
(NIH, 2019; WHO, 2017; Hasin et al., 2018; Rush & Jain, 2018)
HOW DO WE MEASURE CVD RISK?
Traditional Risk Factors Nontraditional Risk Factors
Endothelial dysfunction
Stress
Garcia et al., 2016
HOW DO WE MEASURE CVD RISK?
Traditional Risk Factors Nontraditional Risk Factors
Endothelial dysfunction
Stress
Garcia et al., 2016
SHORT TERM ASSESSMENT OF CVD RISK
Sympathetic nervous
system activity
Blood Pressure
Heart Rate
BLOOD PRESSURE REACTIVITY AND SURVIVAL RATES
Systolic Blood Pressure Diastolic Blood Pressure
Carroll, et al., 2012
HOW DO WE LOWER BLOOD PRESSURE?
Device guided slow breathing Mindful Meditation
Sympathetic nervous
system activity
Blood Pressure
HYPOTHESIS
reactivity during the cold pressor test while
practicing device-guided slow breathing or mindful meditation
attenuations in cardiovascular reactivity during mindful
meditation compared to device guided slow breathing
METHODS
RECRUITMENT
Inclusion criteria
-35 years old
Exclusion criteria
ing brain or CV system function
25 young adults with depressive symptoms
EXPERIMENTAL APPROACH
Screening
Informed Consent
BP, HR, Temp & Blood Draw
Body Composition
Health History
MINI Interview
Technique Familiarization
Experimental Day 1
Device guided slow
breathing
Experimental Day 2
Device guided slow
breathing
Experimental Day 2
Mindful meditation
Experimental Day 1
Mindful meditation
Randomized
24 hrs
24 hrs
Figure 1. Schematic of the experimental visit. Abbreviations:
electrocardiogram (ECG), blood pressure (BP), muscle
sympathetic nerve activity
(MSNA), heart rate (HR), cold pressor test (CPT), slow
breathing (SB).
Experimental Visit
VARIABLES
Independent Variables
Dependent Variables
eats)
STATISTICAL ANALYSIS
Power analysis Project analysis
-test
-parametric test
shown as Means ± SD
(Fonkoue et al., 2018; Park et al., 2014; Scalco et al., 2009)
-power
PT and CPT+intervention
ANTICIPATED FINDINGS AND INTERPRETATION
Anticipated Findings
frequency during the cold pressor test while
practicing device-guided slow breathing or mindful
meditation
attenuations in MSNA burst frequency during
mindful meditation compared to device guided slow
breathing
Interpretation
cardiovascular reactivity during stressful situations
for depressed young adults
risk in those with depression
REFERENCES
y, A.T., Der, G., Hunt, K., Benzeval, M. &
Phillips, A.C. (2012). Increased blood pressure reactions to
acute mental stress are associated with 16-
year cardiovascular disease mortality. Psychophysiology, 49,
1444-1448. DOI: 10.1111/j.1469-8986.2012.01463.x
Li, Y., DaCosta, D., Rothbaum, B.O., Park, J. (2018). Acute
effects of device-guided slow breathing on
sympathetic nerve activity and baroreflex sensitivity in
posttraumatic stress disorder. Am J Physiol Heart Circ Physiol,
315, H141-H149.
doi:10.1152/ajpheart.00098.2018
J.E. (2016). Cardiovascular Disease in Women. Circulation
Research, 118(8), 1273-1293.
https://doi.org/10.1161/CIRCRESAHA.116.307547
W.J., Stohl, M., Grant, B.F. (2018). Epidemiology of Adult
DSM-5 Major Depressive Disorder and Its Specifiers
in the United States. Journal of the American Medical
Association Psychiatry, 75(4), 336-346. DOI:
10.1001/jamapsychiatry.2017.4602
Deaths: Final data for 2017. National Vital Statistics Reports,
68(9), 1-77.
https://www.cdc.gov/nchs/data/nvsr/nvsr68/nvsr68_09-508.pdf
-Wu, S. (2014). Mindfulness
meditation lowers muscle sympathetic nerve activity and blood
pressure in African-American males with
chronic kidney disease. American journal of physiology.
Regulatory, integrative and comparative physiology, 307(1),
R93–R101.
https://doi.org/10.1152/ajpregu.00558.2013
STAR*D Trial. Handb Exp Pharmacol, 250, 51-99. doi:
10.1007/164_2018_153
Azul, J.B., Pullenayegum, E.M., Scalco, M.Z., Kuniyoshi, F.H.,
Wajngarten, M., Negrao, C.E., Lotufo-Neto, F.
(2009). Muscle sympathetic nervous activity in depressed
patients before and after treatment with sertraline. Journal of
Hypertension, 27(12), 2429-2436. doi:
10.1097/HJH.0b013e3283310ece
health estimates, 2017.
https://doi.org/10.1161/CIRCRESAHA.116.307547
https://www.cdc.gov/nchs/data/nvsr/nvsr68/nvsr68_09-508.pdf
https://doi.org/10.1152/ajpregu.00558.2013
QUESTIONS?
Female Energy Deficiency Questionnaire – FED-Q:
Development and Validation
Ana Carla Chierighini Salamunes
Advisor: Dr Mary Jane De Souza
Introduction to the Problem
Exercising women
Risk of energy deficiency
Risk of Female Athlete Triad
How to detect energy deficiency?
Key background
Energy availability (EA):
(DEI-EEE)/kg FFM/day
Low EA: < 30 kcal/kg FFM/day
Energy deficiency (ED):
Triiodothyronine < 80 ng/dL
Resting metabolic rate ratio < 0.9 (Strock et al., 2020a)
Higher sensitivity to change than EA (Strock et al., 2020b)
Female athlete triad (De Souza et al., 2014)
Menstrual dysfunction
Impaired growth
Low bone mineral density
Key background
for clinical/large scale use is needed
Low Energy Availability in Females – LEAF-Q (Melin et al.,
2014)
Validated to detect risk of developing the Triad
Did not detect differences in EA
Did not account for EEE
value (Rogers et al., 2021)
Specific aims and hypotheses
The aim of this study is to develop and validate the Female
Energy Deficiency Questionnaire (FED-Q), a tool to assess
energy deficiency in exercising women.
H0: A questionnaire that screens for the presence of menstrual
dysfunction, impaired bone health, exercise level, dietary
habits, and eating disorders and disordered eating is not an
accurate predictor of energy deficiency in exercising women.
H1: Energy deficiency (ED) in exercising women can be
predicted with 90% sensitivity by the Female Energy Deficiency
Questionnaire – FED-Q, a questionnaire that screens for: the
presence of menstrual dysfunction; impaired bone health;
exercise level; dietary habits; and eating disorders and
disordered eating.
H2: The total score in the FED-Q will correlate with resting
metabolic rate ratio and total triiodothyronine concentration.
H3: The specific scores for menstrual dysfunction and bone
health will be associated and correlated, respectively, with
menstrual status and bone mineral density.
General study design
Questionnaire:
Feasibility
Reliability
Validity:
TT3
RMRratio
Menstrual status
Bone mineral density
Dietary energy intake
Exercise energy expenditure
Sensitivity and specificity: low TT3 and RMRratio
Subjects
Inclusion criteria:
Women 18-35 years old
Minimum 150 min of exercise/week in the last 12 months
Athlete or non-athlete
Good health, free of chronic diseases
Exclusion criteria:
Pregnant or lactating
Hormonal contraceptives or medication that can alter calcium
metabolism
Recovering from bone injury
Recruitment:
Flyers, emails, Study Finder, laboratory website
Methods
Questionnaire development and validation (Boparai et al., 2018;
Tsang et al., 2017):
Menstrual status, bone health, exercise level, dietary habits, and
disordered eating/eating disorders
Self-administered, ~20 close ended questions, Likert scale or
yes/no answers
Demographics: age, height, weight, and age of menarche
Methods
First draft:
~60 items
Feasibility: pilot-testing in ~30 subjects
Modifications
Content validity: expert committee CVI
Modifications: final draft
Scoring system
Data collection
Expert committee discussion
Modifications
Construct validity and reliability
methods
First visit
FED-Q, RMR, DXA, TT3, urine
8-10 days interval
Wearable exercise monitor, nutrition logs, urine collection
Second visit
FED-Q, exercise and nutrition data, urine samples
Reliability
Data of first and second visits
Construct validity
FED-Q of first visit and physiological data
Stability
Correlation coefficient of first and second visit
Internal consistency
Split-half method
Analytical approach
Content validity
Expert committee
Content Validity Index (CVI)
Construct validity
Normal distribution/ transformation
Pearson’s correlation or
Spearman’s rho with physiological data
Reliability
I-CVI and S-CVIAve
Sensitivity and specificity, and T-test or Mann-Whitey test
Stability: test-retest method, correlation
Internal consistency: split-half method, correlation
Sample size calculations
Questionnaire:
-item questionnaire
n=132
95% confidence interval, standard deviation of 11.6 ng/dL TT3,
margin of error of 2 ng/dL
n=165, with drop-out rate of 20%
n=195, of which 30 subjects in pilot testing
Timeline and Milestones for Success
Anticipated Results
FED-Q: feasible, reliable, and repeatable survey to assess ED in
exercising women
Cut-off point will predict low TT3 and/or low RMRratio with
90% sensitivity
FED-Q will be a tool that is accessible, rapid, simple to use,
and easy to interpret
Potential Pitfalls and Alternative Approaches to Consider
Concerns referring to feasibility, reliability, and/or validity
on or
investigation of a different tool
references
De Souza, M. J., Miller, B. E., Loucks, A. B., Luciano, A. A.,
Pescatello, L. S., Campbell, C. G., & Lasley, B. L. (1998). High
frequency of luteal phase deficiency and anovulation in
recreational women runners: blunted elevation in follicle-
stimulating hormone observed during luteal-follicular
transition. The Journal of Clinical Endocrinology &
Metabolism, 83(12), 4220-4232.
De Souza, M. J., Nattiv, A., Joy, E., Misra, M., Williams, N. I.,
Mallinson, R. J., Gibbs, J.C., Olmsted, M., Goolsby, M.,
Matheson, G. (2014). 2014 Female Athlete Triad Coalition
Consensus Statement on treatment and return to play of the
female athlete triad: 1st International Conference held in San
Francisco, California, May 2012 and 2nd International
Conference held in Indianapolis, Indiana, May 2013. British
journal of sports medicine, 48(4), 289-289.
De Souza, M. J., Toombs, R. J., Scheid, J. L., O'Donnell, E.,
West, S. L., & Williams, N. I. (2010). High prevalence of subtle
and severe menstrual disturbances in exercising women:
confirmation using daily hormone measures. Human
reproduction, 25(2), 491-503.
Melin, A., Tornberg, Å. B., Skouby, S., Faber, J., Ritz, C.,
Sjödin, A., & Sundgot-Borgen, J. (2014). The LEAF
questionnaire: a screening tool for the identification of female
athletes at risk for the female athlete triad. British journal of
sports medicine, 48(7), 540-545.
Rogers, M. A., Drew, M. K., Appaneal, R., Lovell, G., Lundy,
B., Hughes, D., Vlahovich, N., Waddington, G., Burke, L. M.
(2021). The Utility of the Low Energy Availability in Females
Questionnaire to Detect Markers Consistent With Low Energy
Availability-Related Conditions in a Mixed-Sport Cohort.
International Journal of Sport Nutrition and Exercise
Metabolism, 31(5), 427-437.
Sim, A., & Burns, S. F. (2021). questionnaires as measures for
low energy availability (LEA) and relative energy deficiency in
sport (RED-S) in athletes. Journal of Eating Disorders, 9(1), 1-
13.
Strock, N. C., De Souza, M. J., & Williams, N. I. (2020b).
Eating behaviours related to psychological stress are associated
with functional hypothalamic amenorrhoea in exercising
women. Journal of Sports Sciences, 38(21), 2396-2406.
Strock, N. C., Koltun, K. J., Mallinson, R. J., Williams, N. I., &
De Souza, M. J. (2020a). Characterizing the resting metabolic
rate ratio in ovulatory exercising women over 12 months.
Scandinavian journal of medicine & science in sports, 30(8),
1337-1347.
Tsang, S., Royse, C. F., & Terkawi, A. S. (2017). Guidelines for
developing, translating, and validating a questionnaire in
perioperative and pain medicine. Saudi journal of anaesthesia,
11(Suppl 1), S80.
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KINE-5300 Research Methods in Kinesiology
Fall 2022
Oral Proposal (80 total pts)
Student Presenter:
_________________________________________
Title of Article:
_________________________________________
Instructor Assessment Score (0 = lowest; 5 = highest)
Significance:
introduce content, explain how it relates to information
discussed in
lecture, provide necessary background information, define key
terms
0 2 4 6 8 10
Aims:
clearly state study purpose and hypothesis 0 2 4 6 8 10
Experimental Approach:
detailed explanation of study design, define
groups/treatments/conditions, describe key
methods/measurements
and how they work, define primary outcome variables as they
relate to
the study hypothesis
0 2 4 6 8 10
Statistical Approach:
detailed explanation of analytical approach and its
appropriateness for
the experimental design, describe experimental controls,
describe the
determination of statistical significance or effect size, describe
appropriateness of power analyses and sample size estimates
0 2 4 6 8 10
Project Timeline:
describe major goals of the study; goals are broken down into
appropriate increments, with a logical timeline for the success
of the
project
0 2 4 6 8 10
Slides:
consistent font and spacing, no spelling or grammatical errors,
use of
pictures/figures (no walls of text)
0 2 4 6 8 10
Presentation:
clear presentation, did not overly rely on notes or read verbatim
from
slides, well organized, proper material included (no excess
information), knowledge of material, speaks loudly and clearly,
confidence, flow and consistency between sections, answered
questions completely
0 2 4 6 8 10
Questions:
Student clearly addresses questions about the project and all
aspects
both scientifically and about the approach; student answers
questions
respectfully
0 2 4 6 8 10
Total:
ADDITIONAL FEEDBACK:
1. Female Energy Deficiency Questionnaire – FED-Q:
Development and Validation
2. ABSTRACT
Low energy availability in exercising women may cause
menstrual dysfunction and growth impairment, which
can result in low bone mineral density. A reliable a feasible tool
for clinical assessment of energy deficiency
is needed. This study aims to develop and validate the Female
Energy Deficiency Questionnaire (FED-Q). It
is anticipated to have approximately 20 items screening for
menstrual dysfunction, bone health, exercise
level, energy intake, eating disorders and disordered eating, as
well as body mass index, and age. Feasibility
will be assessed with a pilot study, followed by content
validation with the analysis of experts in the field.
Modifications will be made in the first draft for subsequent
application in a larger cohort. Construct validity will
be measured by correlation coefficients, sensitivity, and
specificity in detecting energy deficiency, defined as
low serum triiodothyronine and low resting metabolic rate ratio.
Reliability will be measured in a test-retest
method, which will be used to analyzed stability, and with
correlation coefficients in a split-half method, for
internal consistency. The FED-Q is expected to accurately
predict the risk of energy deficiency in exercising
women, allowing physicians, dietitians, nutritionists, athletic
trainers, and coaches to easily screen their
patients and athletes, hence avoiding persistent energy
deficiency and related health impairment.
3. INTRODUCTION
Estimating energy deficiency is essential to assess the risk of
developing the female athlete triad,
which consists of menstrual dysfunction and impaired bone
health caused by low energy availability (EA) (De
Souza et al., 2014). A fast, feasible, and reliable tool for
clinical use is yet to be designed. The aim of this
study is to develop and validate the Female Energy Deficiency
Questionnaire (FED-Q), a tool to assess
energy deficiency (ED) in exercising women. We hypothesize
that ED can be predicted with 90% sensitivity
by the Female Energy Deficiency Questionnaire – FED-Q, a
survey that screens for: the presence of
menstrual dysfunction; impaired bone health; exercise level;
dietary habits; and eating disorders and
disordered eating. Secondary hypotheses are: 1. the total score
in the FED-Q will correlate with resting
metabolic rate ratio (RMRratio) and total triiodothyronine
concentration; 2. the specific scores for menstrual
dysfunction and bone health will be associated and correlated,
respectively, with menstrual status and bone
mineral density. Our null hypothesis is: a questionnaire that
screens for the presence of menstrual
dysfunction, impaired bone health, exercise level, dietary
habits, and eating disorders and disordered eating
is not an accurate predictor of energy deficiency in exercising
women.
4. REVIEW OF THE LITERATURE
Low EA and ED can be caused by high exercise energy
expenditure that is not sufficiently
compensated with energy intake. EA is calculated as the
difference between exercise energy expenditur e
and dietary energy intake per kilograms of fat-free mass per day
([EEE-DEI]/kg FFM/day). Low EA is defined
as EA < 30 kcal/kg FFM/day. Persons with low EA are likely to
be energy deficient, a common condition
among female athletes and non-athlete exercising women. There
is no gold-standard for the assessment of
ED, but serum triiodothyronine (TT3 <80 ng/dL) and resting
metabolic rate ratio (RMRratio =
RMRmeasured/RMRpredicted <0.9) have been used as
parameters of ED (Strock et al., 2020a; Strock et al., 2020b;
De Souza et al., 2014).
When an individual is energy deficient, their organism does not
have enough fuel for all basic
physiological needs, and the systems that are most important to
survival are prioritized. Reproduction is one
of the first functions to be impaired because of low EA/ED (De
Souza et al., 2014). Previous studies have
reported high prevalence of menstrual dysfunction in exercising
women, which was higher than that observed
in sedentary women (De Souza et al., 2010; De Souza et al.,
1998). One study comparing active and
sedentary females found that more than 50% of the participants
in the exercising group were anovulatory,
condition not observed in any of the subjects in the sedentary
group (De Souza et al., 2010). In addition,
anovulatory exercising women have been reported to have lower
energy intake compared to both active and
sedentary eumenorrheic women, evidencing the relationship
between inadequate fueling and menstrual
dysfunction (De Souza et al., 1998).
Growth is also impaired in women with low EA, which, in more
severe cases, may impact bone mineral
density (BMD). Compared to women with normal BMD, females
with low BMD were reported to exercise
more and to have lower body fat percentage and fat mass. Age
of menarche was found to be higher, which
could be indicative of delayed menarche and menstrual
dysfunction (Gibbs et al., 2014). Menstrual
dysfunction and impaired bone health as consequences of low
EA are the components of the Female Athlete
Triad (Triad), which can include more severe cases with low
BMD and eating disorders or disordered eating
(De Souza et al., 2014).
As low EA and ED are the main cause for the impaired health
outcomes, early and precise detection
of low EA/ED risk is needed. Measurements of EEE and DEI –
used to calculate EA – depend on self-reported
data and depend on predictive equations, hence assessing EA is
less accurate than measuring ED. In a
study comparing exercising women with and without functional
hypothalamic amenorrhea, the first group was
found to have lower ED, but similar EA, indicating that the
measures used to assess ED are more sensitive
to altered metabolic function than EA (Strock et al., 2020c).
However, for clinical assessments, examining
TT3 and RMRratio may not be feasible methods, in terms of
cost, time, and access. Blood serum analyses and
the use of a metabolic analyzer are not rapid measures and may
not be easily accessed by all physicians,
dietitians, nutritionists, or athletic trainers.
Aiming to provide sports and health care professionals with an
appropriate tool, studies presented
different questionnaires that attempted to estimate low EA.
While some of them were developed specifically
for this purpose, other surveys that were tested are intended for
screening different conditions that could be
related to EA and the Triad. These are related to eating
disorders, dietary habits, and body image. Of all
available questionnaires, only a few have gone through a
complete validation process and only one has been
validated for use with adult female athletes (Sim & Burns,
2021).
To our knowledge, the Low Energy Availability in Females
Questionnaire (LEAF-Q), proposed by
Melin et al. (2014) is currently the only validated survey to
estimate low energy availability in female athletes.
Even though it seems to be a promising tool, the LEAF-Q has
several limitations. A cut-off value (score ≥ 8)
was used to determine if a participant was at risk of developing
the Triad. The LEAF-Q was considered to
have accurate sensitivity if it had detected any of the three
Triad-related outcomes – low EA, menstrual
dysfunction, and impaired bone health –, therefore neither ED
nor low EA were considered strictly necessary
to correctly identify a positive case. This raises concerns,
because positive cases of low BMD or menstrual
dysfunction do not necessarily mean that those were caused by
low EA. More importantly, there were no
significant differences in EA between groups above and below
the cut-off point, meaning that the LEAF-Q
can lead to concerning misinterpretations. In addition, the study
of Rogers et al. (Rogers et al., 2021) showed
that the LEAF-Q has a high sensitivity, but a very low
specificity in the assessment of risk of Triad outcomes,
therefore very low positive predictive values. The authors also
found the score not to be related to RMRratio,
indicating that it is likely inappropriate for assessing EA or ED.
Given the evidence in literature, it has been observed that there
are no clinically reliable and valid
tools to assess ED in exercising women. A questionnaire with
the purpose of assessing low EA and/or ED
must assess menstrual status, dietary habits, exercise level, and
bone health. For better accuracy, validation
should be assessed with correlations not only with EA, but
mainly with RMRratio and serum TT3.
5. METHODS
a. Subject Characteristics
Subjects will be women from 18 to 35 years old who have
exercised at least 150 min per week in the
last 12 months. Both athletes and non-athletes will be included.
Participants must be in good health and free
of chronic diseases. Participants will be excluded if they are
pregnant, lactating, taking hormonal
contraceptives, taking medication that could alter calcium
metabolism, or if they are recovering from bone
injury at the time of the study. Participants will be recruited via
flyers, emails, Study Finder, and the laboratory
website.
b. General study design
A questionnaire to assess ED in exercising women will be
developed. An expert committee will be
formed to discuss the first draft of the survey. It will be pilot-
tested in a small group of exercising women,
when feasibility will be assessed. The expert committee will
perform a second analysis, which will establish
content validity. For reliability and construct validity, a larger
group of exercising women will respond the
questionnaire. The validation will be performed by correlating
the final scores of the FED-Q with TT3, RMRratio,
menstrual status, BMD z-score, DEI, and EEE. Sensitivity and
specificity of predicting low TT3 and RMRratio
will be assessed. Reliability will be separated into stability and
internal consistency analyses.
c. Specific study methods
The study will follow previously described steps of
questionnaire development and validation (Boparai
et al., 2018; Tsang et al., 2017) specified as follows.
Approximately sixty questions will be formulated aiming
to assess menstrual status, bone health, exercise level, dietary
habits, and disordered eating/eating
disorders, of which approximately 20 items are expected to
remain in the final draft of the questionnaire. The
FED-Q will be designed to be a self-administered tool
containing close ended questions, with either Likert
scale or yes/no answers. Demographics such as age, height,
weight, and body mass index will be assessed
as well. A committee of three to ten experts in the field of
EA/ED/Triad will be formed to have a primary
discussion about the suitability of the FED-Q in assessing ED.
Following their comments on the first draft,
modifications will be made in the items.
Subsequently, the FED-Q will be pilot-tested for feasibility in a
group of thirty subjects. Immediately
after the participant has responded the questionnaire, a member
of the research team will read out the items
to the subject, aiming to verify if the questions were clear and if
they could be easily interpreted, as expected.
Respondents’ opinion on specific questions may be asked by the
interviewers. Based on the observations in
the pilot testing, new adjustments in the FED-Q will be
addressed. After modifications, content validity will be
assessed. The expert committee will be again invited to analyze
the extent to which the FED-Q comprises
most of the dimensions of EA and ED in exercising women. In
this step, each expert will evaluate the items
without consulting others’ opinion. The Content Validity Index
(CVI) will be used to measure the relevance of
each item in the FED-Q (Boparai et al., 2018; Polit & Beck,
2006). This analysis is detailed in the Data
Analytical Approach section. Other modifications may be
addressed to the draft, after calculating the CVI.
Following the three rounds of modifications, scores will be
attributed to each item. Responses that
are not attributed to risk of ED will not add any points to the
overall score, whereas those that might indicate
risk of ED will add at least one point to the final score. Higher
scores will be attributed to the items that,
according to the literature and to expert opinion, are more
critical indicators of ED.
The final draft of the FED-Q will be tested in a second group
of exercising women for construct
validity, followed by a reliability assessment, summarized in
Figure 1. Two visits will be required. For construct
validity, several measurements will be taken from the study
group. In the first visit, RMR will be assessed
with a ventilated hood system of indirect calorimetry
(SensorMedics Vmax Series, Yorba Linda, CA) for
subsequent estimation of the RMRratio (Cunningham 1991
equation and DXA ratio) (Strock et al., 2020a),
body composition and BMD will be assessed with a Hologic
QDR4500W DXA scanner (Hologic, Bedford,
MA), and blood draws will be taken to assess TT3. On the first
seven consecutive days between the first and
the second visit, participants will complete nutrition logs and
monitor exercise with a wearable device. Data
will be used to calculate DEI (Nutrition Pro Software), EEE,
energy balance (energy intake – energy
expenditure), and EA ([EEE-DEI]/kg FFM/day). Starting on the
first visit, urine samples of two consecutive
menstrual cycles will be collected and provided by the
participants to measure Ed1 and PdG excretion for an
estimation of menstrual status. Construct validity will be
assessed with statistical tests of correlation and
association between the questions and the specific
measurements that they are intended to measure, and
mainly with the correlation of the total score with TT3 and
RMRratio. A cut-off value will be set as predictor of
ED (TT3 < 80 ng/dL and/or RMRratio < 0.9), and sensitivity
and specificity will be assessed.
Eight to ten days following the first visit, subjects will come to
the laboratory for the second visit, when
they will provide the research staff with the exercise monitors
and nutrition logs, and a second part of the
urine samples. In this occasion, they will respond the FED-Q
one more time. Reliability will be attested in
terms of stability and internal consistency. Stability will be
measured using a test-retest method. The
responses given to the FED-Q will be compared. Little
variability is expected between the two time points.
Internal consistency will be measured with a split-half method.
Details of this analysis are provided in the
Data Analytical Approach section. The remaining urine samples
will be delivered to the research team by the
end of the first and second months of collection.
Figure 1. Summarized data collection for the assessment of
construct validity and reliability of the Female Energy
Deficiency Questionnaire.
d. Data analytical approach, including details about your
statistical model, assumptions
Validity and reliability assessments will require different
statistical analyses, specified below.
Content validity
The expert committee will be instructed to use the Content
Validity Index (CVI). They will be asked to
classify each item of the FED-Q from one to four points, in a
Likert-type scale, where one means the item is
irrelevant to assess ED; two, somewhat relevant; three, quite
relevant; and four, highly relevant. The CVI for
items (I-CVI) will be calculated as the percentage of experts
who consider an item as relevant. i.e., if they
award an item with minimum three points in the Likert scale.
Items with an I-CVI of at least 80% will be
considered acceptable. Inappropriate items will be reviewed or
excluded (Boparai et al., 2018; Polit & Beck,
2006). The average CVI for scales (S-CVI/Ave) will be
calculated as the average of all I-CVIs, which is also
expected to result in a minimum of 80% (Polit & Beck, 2006).
Construct validity
Data of TT3, RMRratio, BMD, body composition, EA, energy
balance, and FED-Q score will be tested
for normal distribution. In case of not normally distributed, data
will be log-transformed. If normal distributions
are found, parametric tests will be used, otherwise non-
parametric statistics will be applied. Pearson’s
correlation coefficient or Spearman’s rho will be used to verify
if the FED-Q score is correlated with TT3 and
RMRratio, aiming to validate the questionnaire. Correlations
will also be used to test if specific questions and
items are related to the data that they are expected to screen for
– BMD, menstrual dysfunction, exercise
level, and DEI. Of the total score, a cut-off point will be
determined as indicator of risk of ED, which will be
used to classify participants as either at risk of having ED or
not. Sensitivity and specificity in predicting ED
(TT3 < 80 ng/dL and/or RMRratio < 0.9) will be assessed, and
all variables will be compared between groups
with Student’s T test or Mann-Whitney test.
First visit
FED-Q, RMR, DXA, TT3, urine
Second visit
FED-Q, exercise and nutrition
data, urine samples
Reliability
Data of first and second visits
Stability
Correlation coefficient of first
and second visit
Internal
consistency
Split-half method
Construct validity
FED-Q of first visit and
physiological data
8-10 days
interval
Wearable exercise monitor,
nutrition logs, urine collection
Reliability
Stability of the FED-Q will be tested as the correlation
coefficients between the scores of the first and
the second visit. The split-half method will be used to measure
internal consistency: the questionnaire will be
divided into two halves with equivalent number of questions of
each domain – DEI, menstrual dysfunction,
exercise level, bone health, and eating disorders. A correlation
coefficient will indicate if the questionnaire is
consistent in screening for the same conditions (Tsang et al.,
2017).
e. Detailed sample size calculations
Literature provides several different sample size requirements
to validate a questionnaire. The lowest
acceptable value seems to be 5:1, or 5 respondents for each
item. Since the FED-Q is expected to have
approximately 20 items, a minimum sample size would be of
100 exercising women (Tsang et al., 2017).
Another approach is to calculate the sample size based on the
expected confidence level and margin
of error, as follows (Ott & Longnecker, 2015):
� =
�!
"
. �"
�"
where n is the sample size, Z is the z-score for a confidence
level of α/2, σ is the expected standard
deviation, and ε is the margin of error.
Considering a 95% confidence interval with an average standard
deviation of 11.6 ng/dL for TT3 in
similar populations (Strock et al., 2020a; 2020b; 2020c), and an
acceptable margin of error of 2 ng/dL, the
minimum sample size for the phase of validation is 132
exercising women. Applying a drop-out rate of 20%,
the minimum sample size is 165. In addition to the 30 subjects
in the pilot-testing phase, our sample size will
be of 195 exercising women.
f. Timeline
Figure 2 indicates the timeline of all necessary phases for the
completion of the study. Pilot testing is
expected to be finished by April 2022, allowing for analysis by
the experts to be finished in the first week of
June, and data collection to start in July. Data analysis will start
after all subjects have completed the first
visit and will be concluded by December 2022. A first draft of
the research will be presented in February 2023,
followed by a final version in March.
Figure 2. Research phases and timeline
6. Anticipated Results and Interpretation
The FED-Q is expected to be a feasible, reliable, repeatable,
and valid survey to assess ED in
exercising women. A minimum score, yet to be determined, is
expected to predict low TT3 and/or low RMRratio
with at least 90% sensitivity and 80% specificity. In addition,
scores on menstrual status and bone health will
be good indicators of menstrual dysfunction and low BMD. The
FED-Q will be a tool that is accessible, rapid,
simple to use, and easy to interpret. Its use will be intended for
physicians, dietitians, nutritionists, coaches,
athletic trainers, and other health care professionals, as well as
researchers, as a reliable measurement of
ED.
7. Potential Pitfalls, Alternative Explanations, and
Consideration of Alternate Approaches
There can be unexpected outcomes in any of the steps of
development and validation of the FED-Q.
If inconsistencies are observed during either the feasibility,
reliability, or the validity steps, the tool will have
to be re-evaluated. If the inconsistencies are specific to certain
items, these will have to be thoroughly
analyzed, and possibly replaced or removed. If major problems
occur, such as the questionnaire itself not
seeming reliable, going back to the first step of development
(question framing) might be needed, which
might even raise questions on whether it is possible to assess
ED by means of a questionnaire. If it is
concluded that the FED-Q is not a reliable, repeatable, and valid
tool, other clinical approaches will have to
be investigated and developed to be used for ED assessment in
exercising women.
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and validate a questionnaire: a guide. Current
clinical pharmacology, 13(4), 210-215.
De Souza, M. J., Miller, B. E., Loucks, A. B., Luciano, A. A.,
Pescatello, L. S., Campbell, C. G., & Lasley, B.
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Sjödin, A., & Sundgot-Borgen, J. (2014). The LEAF
questionnaire: a screening tool for the identification of female
athletes at risk for the female athlete triad.
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Strock, N. C., Koltun, K. J., Mallinson, R. J., Williams, N. I., &
De Souza, M. J. (2020b). Characterizing the
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Breathing Patterns to Minimize Cardiovascular Disease Risk in
Major Depressive Disorder
Introduction
Cardiovascular disease (CVD) is the leading cause of death
within the United States (Kochanek et al., 2019). Importantly,
there is strong epidemiological and experimental evidence to
suggest those with a large-magnitude of stressor-evoked
cardiovascular reactions (i.e. heart rate, blood pressure) are at
an elevated risk for CVD (Carroll, Ginty et al., 2012;
Carroll, Phillips et al., 2011; Allen et al., 1997).
Epidemiological studies have also linked major depressive
disorder
(MDD) to CVD and all-cause mortality, independent of
socioeconomic status and traditional CVD risk factors (Kozela
et
al., 2016). Depression is linked to autonomic dysfunction,
specifically sympathetic overactivity (Scalco et al., 2009;
Koschke et al., 2009), which contributes to the development of
hypertension, heart failure, arrhythmias, and
atherosclerosis (Grassi et al., 2004; Erami et al., 2002).
Furthermore, MDD is the leading cause of disability worldwide
(WHO, 2017) with an economic burden of $210.5 billion in the
United States in 2010 (Hasin et al., 2018) and at least one
third of patients are resistant to current treatment practices
(Rush & Jain, 2018). Altogether, these findings warrant the
discovery of novel therapies targeting autonomic function in
depressed adults.
Device-guided slow breathing (DGSB) has emerged as a
potential therapy to lower blood pressure and sympathetic
nervous system activity in disorders characterized by
sympathetic overactivity (Oneda et al., 2010; Fonkoue, Marvar
et
al., 2018). Although DGSB is effective at acutely lowering
blood pressure and muscle sympathetic nerve activity (MSNA),
long-term cardiovascular benefits may not be seen (Fonkoue,
Yingtian et al., 2020) due to a lack of psychobehavioral
effects of the therapy. Alternatively, mindful-based meditation
results in similar breathing patterns (<10 breaths/min) as
DGSB (Peng et al., 2003) while encouraging the individual to
be present in the moment and to acknowledge and accept
their thoughts without judgement. Indeed, mindful meditation
has been shown decrease in anxiety, depression, blood
pressure and MSNA in young adults and those with disorders
characterized by sympathetic overactivity (Bell, 2015; Park
et al., 2014). Furthermore, mindful meditation may target brain
processing alterations present within depression (Fales
et al., 2008) resulting in greater reductions of cardiovascular
reactivity compared to device-guided slow breathing during
stress-evoking situations.
Given these findings, we hypothesize that depressed young
adults will show attenuated cardiovascular reactivity during
a stress-evoking situation while practicing device-guided slow
breathing or mindful meditation. Furthermore, depressed
young adults will show greater attenuations in cardiovascular
reactivity during mindful meditation compared to device-
guided slow breathing.
Methods
The proposed study will evaluate the effects of 15 minutes of
device-guided slow breathing and 15 minutes of mindful
meditation (MM) (independent variables) on respiratory rate
(breaths/min), MSNA burst frequency (bursts/min) and
incidence (bursts/100 heart beats), blood pressure (mmHg), and
heart rate (beats/min) (dependent variables) during the
cold pressor test (CPT). The primary outcome of this project is
MSNA burst frequency (bursts/min).
A total of 25 young adults (18-35 years old) with depressive
symptoms will be recruited for this study. Participants will
be recruited from the University of Texas at Arlington and the
surrounding area through the use of flyers, email, social
media, class presentations, and radio ads. Inclusion criteria
consists of those 18-35 years old and confirmation of
depressive symptoms with a diagnostic interview. Exclusion
criteria consists of a mental illness aside from depression,
any use of depression mediation, active suicidal/homicidal
intent, active alcohol or drug dependence, an eating disorder,
use of medication that could alter how the brain or
cardiovascular system functions, cardiovascular, kidney, lung or
metabolic disease, tobacco use, pregnancy, or amenorrhea
(women).
Sample size was calculated a priori using G-power. MSNA
measurement in young adults with MDD has not been studied
to our knowledge; therefore, due to the similarities between
posttraumatic stress disorder (PTSD) and MDD, MSNA
values were estimated from studies involving young adults with
PTSD (Fonkoue, Marvar et al., 2018). Estimates of MSNA
values during the DGSB+CPT and MM+CPT conditions were
derived from both previous studies of MSNA recordings
during both breathing patterns, and clinically significant MSNA
values (Park et al., 2014; Fonkoue, Marvar et al., 2018).
Means were estimated as the change score between a cold-
pressor test and the DGSB+CPT condition, and the change
score between a cold-pressor test and the MM+CPT condition.
Accounting for a 70% success rate on peroneal nerve
innervation and MSNA recording, a total of 25 subjects are
needed to detect a 3 burst/min difference between DGSP
and MM conditions with 80% power and an alpha level of 0.05.
Experimental Approach
Participants will arrive to the laboratory for one screening visit
and two experimental visits. Each participant will be
randomly allocated to the device-guided slow breathing or
mindful meditation intervention for Experimental Day 1 using
a random number generator. Each participant will participate in
the opposite intervention for Experimental Day 2, and
each experimental visit will be separated by at least 24 hours.
Participants will be instructed to avoid exercise and
alcohol consumption for 24 hours prior to the experimental
visits, and abstain from food and caffeine 12 hours prior to
the experimental visits.
The screening visit will consist of basic health assessments and
take about one hour. First, height weight, 7-site skinfold
(body fat percent), blood pressure, heart rate and temperature
will be taken. Then, the participant will complete a
medical health history form to confirm the absence of any
exclusion criteria. Women will also complete a urine
pregnancy test to confirm absence of pregnancy. Last, the MINI
international neuropsychiatric interview will be
administered by a trained research member to determine the
presence of depressive symptoms and absence of other
mental illnesses. Lastly, a blood draw will be taken for
assessment of a complete metabolic panel, lipid profile, and
hemoglobin A1c.
Both experimental visits are identical with only the intervention
(device-guided slow breathing vs mindful meditation)
during the cold pressor test varying. All participants will arrive
to the laboratory in the morning having avoided exercise,
alcohol, food, and caffeine as outlined above. After using the
restroom, participants will lay supine and be instrumented
with a tungsten microneurography electrode in the peroneal
nerve for MSNA, the Finapres for beat-to-beat blood
pressure, electrocardiograph electrodes for continuous heart rate
and sinoatrial rhythms, and a respiratory belt to
measure respiration rate. After instrumentation, 15 minutes of
baseline MSNA, BP, HR, and respiration data will be
collected. Following baseline, a “baseline” cold pressor test will
be performed for 2 minutes to obtain baseline
cardiovascular reactivity. Next, there will be 15 minutes of rest
to ensure MSNA, BP, and HR return to resting levels.
Lastly, participants will perform 15 minutes of device-guided
slow breathing or guided mindful meditation. During the
last 2 minutes of device guided slow breathing and mindful
meditation, the participant will perform another CPT.
Participants will be asked to measure their perceived stress on a
scale of 1-10, with 1 being “not stressed at all”, to 10
being the “most stressed they’ve ever been”, after each CPT.
MSNA, blood pressure, heart rate, respiratory rate, and
ECG will be collected for the duration of the visit. A study
schematic of the experimental visit can be found below in
Figure 1.
Figure 1. Schematic of the experimental visit. Abbreviations:
electrocardiogram (ECG), blood pressure (BP), muscle
sympathetic nerve activity
(MSNA), heart rate (HR), cold pressor test (CPT), slow
breathing (SB).
7-site skinfold is a validated measure of total body fat
percentage. The method consists of gathering subcutaneous fat
into a “pinch” and measuring the thickness (mm) of the pinch
with calipers across 7 standardized sites of the body
(chest, triceps, subscapular, superiliac, thigh, midaxillary, and
abdominal). Each site is measured 2-3 times in a rotating
fashion. The measures are then inserted into an algorithm
established by the American College of Sports Medicine to
produce a body fat percentage. Since the reliability of this
method is dependent upon the individual performing the
measure, one trained research personnel will complete the body
composition portion of the experiment for all subjects.
The MINI international neuropsychiatric interview is a short,
structured interview (~15 minutes) with 16 modules
assessing DSM-IV and ICD-10 psychiatric disorders. It has
been validated in many clinical populations including those
with MDD (Fantino & Moore, 2009; Sheehan et al., 1998). The
MINI will be administered by a research team member
who has received extensive training in the administration of this
interview by a psychiatrist. The results from the MINI
will be used to document MDD severity and determine
depressive symptoms for the purpose of this study.
A small amount of blood (~10 mL or ~2 teaspoons) will be
drawn by a certified phlebotomist at the end of the screening
visit. The blood specimens will then be sent to LabCorp to
assess a complete metabolic panel (glucose, BUN, Chloride,
Calcium, Albumin, Bilirubin, AST, Potassium, Alkaline
Phosphatase, Sodium, Protein, Creatinine, BUN/Creatinine
Ratio,
Globulin, A/G ratio), lipid panel (total cholesterol,
triglycerides, HDL cholesterol, Cholesterol/HDL ratio, LDL
cholesterol,
VLDL cholesterol), and hemoglobin A1c. All blood test results
will be provided to the participant.
Microneurography allows for the direct recording of efferent
sympathetic nervous system activity in humans. Multiunit
postganglionic MSNA will be recorded using standard
techniques described within previous literature (Sundlof &
Wallin,
1978; Vallbo et al., 1979). A wand-like device is used for
external electrical stimulation to track the anatomy of the
peroneal nerve. An active tungsten microelectrode and
grounding reference electrode are inserted through the skin into
the peroneal nerve and surround tissue, respectively, to directly
measure sympathetic activity. The nerve signal will be
amplified (70,000-fold), bandpass filtered (700-2,000 Hz),
rectified, and integrated (time constant 0.1s) using a nerve
traffic analyzer. Nerve signal of MSNA will be confirmed by
lack of increase in afferent activity during light stroking of the
skin and a confirmed increase in efferent burst frequency and
spontaneous cardiac synchronous efferent bursts during
voluntary end-expiratory apnea.
The cold pressor test is an acute stress-evoking situation that
accesses cardiovascular disease risk by measuring the
amplitude of cardiovascular reactivity during the two minutes
that the participants hand is submerged in the ice w ater.
Carroll et al. (2012) showed the greater the amplitude of
cardiovascular reactivity to an acute stressor, the lower the
survival rates over the span of 20 years. Beat-to-beat blood
pressure derived from finger plethysmography, continuous
ECG derived heart rate, and MSNA activity will be recorded as
cardiovascular reactivity for the duration of the cold
pressor test. The greatest change in MSNA burst frequency,
heart rate, and blood pressure from baseline measures will
be used for data analysis. Water temperature will be between 0
and 4 degrees Celsius at the time of hand submersion.
Device-guided slow breathing will be completed using the
RESPeRATE system set to a respiration rate of 8 breaths/min
for 15 minutes. Participants will be equipped with headphones
in which the RESPeRATE system will instruct the
Experimental Visit
participant to inhale and exhale at a time interval congruous
with 8 breaths/min. Respiration rate, blood pressure, heart
rate, and MSNA will be recorded for the last 5 minutes of the
intervention to ensure compliance and evaluate its
cardiovascular effects. The cold pressor test will be employed
during the last 2 minutes of device-guided slow breathing
to assess its effects on cardiovascular reactivity. Data used for
analysis will be derived similarly to the “baseline” cold
pressor test. The change score between the “baseline” cold
pressor test and the cold pressor test + device-guided slow
breathing will be used for data comparisons.
Mindful meditation will be completed using a pre-recorded 15-
minute video. Participants will be equipped with
headphones in which the mindful meditation video will instruct
the participant to focus on sensations in the present
moment while accepting their thoughts without judgement.
Similar to the device-guided slow breathing intervention,
respiration rate, blood pressure, heart rate, and MSNA will be
recorded for the last 5 minutes of the intervention to
ensure compliance and evaluate its cardiovascular effects. The
cold pressor test will be employed during the last 2
minutes of mindful meditation to assess its effects on
cardiovascular reactivity. Data used for analysis will be derived
similarly to the “baseline” cold pressor test. The change score
between the “baseline” cold pressor test and the cold
pressor test + mindful meditation will be used for data
comparisons.
Scientific rigor will be upheld by implementing a series of
practices in this within-subject design. First, random allocation
of participants into interventions for Experimental Day 1
eliminates an “order effect”. MSNA is the gold-standard for
measuring sympathetic nervous system activity as it is a direct
measure of the sympathetic nervous system activity via
the peroneal nerve. Beat-to-beat blood pressure via finger
plethysmography is a validated and reliable measure (Schutte
et al., 2004). In addition to its validity and reliability, the
Finapres will be re-calibrated to two brachial artery pressures
before each recording period ensuring appropriate calibration
before recording data. Data analysts will be blinded as to
which intervention group the data contains. Statistical analyses
and sample size has been chosen a priori. Since
participants are not able to be blinded as to which treatment
they are receiving, this awareness is an inherit bias that
will be acknowledged within the study findings.
Statistical Analyses
A sample size of 19 will detect a 3 bursts/min difference in
MSNA burst frequency with 80% power and a significance
level of 0.05. An additional 6 subjects will be recruited for a
total sample size of 25 subjects to account for the 70%
success rate of obtaining an MSNA reading.
The statistical approach for data analysis will use a matched
pairs t-test to assess differences in the change score of
MSNA burst frequency from the “baseline” CPT and CPT paired
with each breathing intervention. Matched pairs t-tests
will also be used for comparing differences in change scores of
respiratory rate, heart rate, blood pressure, and MSNA
burst incidence. Data distributions will be assessed for
symmetry; if distributions of variables are not symmetrical, then
data will be compared using non-parametric statistical tests.
Data will be reported as means ± standard deviation and
significance will be set at an alpha of 0.05. Lastly, data will be
presented as both change scores and absolute values for
transparency.
Anticipated Findings and Interpretation
We anticipate that depressed young adults will have attenua ted
MSNA burst frequency during the cold pressor test
while practicing device-guided slow breathing or mindful
meditation compared to the cold pressor test without a
breathing or meditation intervention. Further, depressed young
adults will show greater attenuations in MSNA burst
frequency during mindful meditation compared to device-guided
slow breathing.
Regardless of the experimental outcomes, information gained
from this study is essential to understanding increased
cardiovascular disease risk and neurovascular dysfunction in
adults with major depressive disorder. MDD is a pervasive
disease in which 2/3 of its population is currently treatment
resistant. If the anticipated findings within this study are
confirmed, then mindful meditation may be useful to decrease
cardiovascular reactivity during stressful situations for
depressed young adults. These attenuations in cardiovascular
reactivity may establish mindful meditation as a useful
therapy to reduce CVD risk in those with depression, especially
in those that are treatment resistant.
Protection of Human Subjects Document
Inclusion Criteria
Inclusion criteria consists of those 18-35 years old and
confirmation of depressive symptoms with a diagnostic
interview.
Exclusion Criteria
Exclusion criteria consists of a mental illness aside from
depression, any use of depression mediation, active
suicidal/homicidal intent, active alcohol or drug dependence, an
eating disorder, use of medication that could alter how
the brain or cardiovascular system functions, cardiovascular,
kidney, lung or metabolic disease, tobacco use, pregnancy,
or amenorrhea (women).
Those with any illnesses related to cardiovascular disease (i.e.
high blood pressure, heart disease, or heart arrhythmias),
history of frostbite, history of seizures, or history of Reynaud’s
phenomenon are contraindicated for cold pressor test.
Number of Subjects
A total of 25 subjects will be recruited for this study. Sample
size was calculated a priori using G-power. MSNA
measurement in young adults with MDD has not been studied to
our knowledge; therefore, due to the similarities
between posttraumatic stress disorder (PTSD) and MDD, MSNA
values were estimated from studies involving young
adults with PTSD (Fonkoue, Marvar et al., 2018). Estimates of
MSNA values during the DGSB+CPT and MM+CPT
conditions were derived from both previous studies of MSNA
recordings during both breathing patterns, and clinically
significant MSNA values (Park et al., 2014; Fonkoue, Marvar et
al., 2018). Means were estimated as the change score
between a cold-pressor test and the DGSB+CPT condition, and
the change score between a cold-pressor test and the
MM+CPT condition. Accounting for a 70% success rate on
peroneal nerve innervation and MSNA recording, a total of 25
subjects are needed to detect a 3 burst/min difference between
DGSP and MM conditions with 80% power and an alpha
level of 0.05.
The recruitment of 25 subjects ensures adequate power for
scientific data analysis while minimizing unnecessary and
excessive recruitment. This prevents putting participants at
unnecessary, although minimal, risk.
Recruitment
Participants will be recruited from the University of Texas at
Arlington and the surrounding area through the use of
flyers, email, social media, class presentations, and radio ads.
Participation within the study is voluntary and participants
are able to withdraw at any point. All information collected
during recruitment will be confidential and discarded after
their participation in the research study.
Compensation and costs
Participants will be compensated $25 per experimental visit for
a total of $50 if both experimental visits are completed.
This compensation amount adequately compensates for their
time at a rate of about $15 /hour which is slightly higher
than an hourly rate of a part-time job. The screening and
experimental visits will be of no costs to participants, and
participants will receive a copy of all laboratory results.
Risks to subjects
Microneurography: Microneurography is an accepted and safe
research technique. The use of the wand-like device for
external electrical stimulation to assess nerve anatomic tracking
may cause minor discomfort. An active microelectrode
and a grounding reference electrode will be inserted into the
skin. There may be mild discomfort when the fine wire
needle is inserted through the skin; however, the needle is very
small. Brief sensations of pins and needles and/or
cramping are likely to be felt during the nerve search. This
needle will be left in place for the duration of the
experimental visit (approximately 1.5 hours). There is also a
small risk of infection at the site where the fine wire needle
is inserted. While unlikely, there’s a risk of nerve damage from
the procedure.
Mini-International Neuropsychiatric Interview (M.I.N.I.): The
MINI has been validated in many clinical populations
including those with MDD. The MINI is a short, structured
clinical interview (~15 minutes) that is used as a tool to
identify people who may have particular experiences or forms
of psychological distress useful for the purposes of this
study. Subjects may feel uncomfortable about answering the
questions. They are reminded that they may decline to
answer the questions and leave the study at any time. Some
subjects may be disturbed if the test recommends their
inclusion in the depression group. They are reminded that the
test is not intended to be a diagnosis or healthcare
recommendation.
Blood draw: There is a small risk of infection at the site where
the needle is inserted. There may be some bruising and
mild discomfort at the site where blood was drawn.
Electrocardiogram: We attach three electrodes to the subject’s
chest and attach electrode wires to a standard ECG
machine. There have been no adverse effects from this measure.
Participants may be shy with having the electrodes
placed on their chest. The tape from the electrodes may
temporarily redden or irritate the skin. Sensitivity to the tape is
unlikely to produce long-term effects.
Cold pressor test: The participants hand is placed in ice water
(0-4 degrees Celsius) for 2 minutes. Their hand is likely to
feel cold during the time it’s submerged. It’s unlikely to have
any long-lasting effects from this test. The participant is
reminded they may stop the test at any time.
Medical Screening: This includes a typical medical exam (blood
sample, height, weight, 7-site skinfold, blood pressure,
heart rate) and medical health history performed by research
personnel. Subjects may be uncomfortable with giving
medical information or being measured. They will be reminded
that their participation is voluntary and they may decline
any measures.
7-Site Skinfold: 7 sites on the body are pinched and measured
with calipers twice. The pinch may cause minor
discomfort for 1-2 seconds and redness. Participants may be shy
about having sites pinched and adipose tissue
measured.
Blood Pressure: Blood pressure is measured in accordance to
the American Heart Association guidelines. During the
short time the cuff is inflated, the participants arm may feel
numb or tingly. The finapres finger cuff may cause their
finger to become number or tingly over time. The cuff can be
moved to a different finger to minimize this feeling.
Confidentiality: There is a risk of loss of confidentiality if the
subjects information or identity is obtained by someone
other than the investigators, but precautions will be taken to
prevent this from happening. The confidentiality of
electronic data created by the participant or researchers will be
maintained to the degree permitted by the technology
used. Absolute confidentiality cannot be guaranteed.
Strategies to minimize risks
Microneurography: The microneurography procedure will be
immediately discontinued if the subject experiences
excessive discomfort. The nerve search will be limited to 45
minutes as the risk of symptoms during or after
microneurography are minimized when the search is not over 60
minutes; therefore, the nerve search will never be over
60 minutes.
Mini-International Neuropsychiatric Interview (M.I.N.I.):
Participants are reminded that they may decline to answer the
questions and leave the study at any time. We remind
participants that the test is not intended to be a diagnosis or
healthcare recommendation. A protocol is implemented to
adequately respond to those who are in distress by creating
walk-in appointments with the Counseling and Psychological
Services at the University of Texas at Arlington. Lastly, a list
of local mental healthcare providers will be provided to all
participants in the study, regardless of their MINI results.
Blood Draw: Participants may decline a blood draw. All blood
draws will be completed by phlebotomy certified
personnel. Sterile supplies and techniques are used to minimize
infection risks, and participants will be in a semi-
recumbent position when blood is drawn.
Electrocardiogram: Electrocardiogram leads are carefully
removed after the experiment. The test is conducted
professionally and privately, and the participant may request
that the research personnel performing the test be of the
same gender.
Cold Pressor Test: The cold pressor test will be immediately
discontinued if the subject experiences excessive
discomfort. The participant’s hand is dried and warmed
immediately after the end of the test.
Medical Screening: All medical information will be collected in
a private and professional manner, and participants may
decline to answer questions or participate in measures. Research
personnel will ensure subjects meet all inclusion and
exclusion criteria to minimize risk to participants. The
participant may request someone of the same gender to conduct
parts of the screening.
7-Site Skinfold: The measurement will be taken efficiently to
minimize the amount of time the participant is “pinched”.
The participant may decline the 7-site skinfold measure, or
request someone of the same gender to conduct the
measure.
Blood Pressure: The measurement will be taken efficiently to
minimize that amount of time the cuff is inflated on the
arm. Finapres finger cuffs will be alternated between two
fingers every 20 minutes to give the other finger a rest.
Confidentiality: All paper and electronic data collected from
this study will be stored in the investigator’s lab for at least
three years after the end of this research. Participants will be
provided with a unique subject code identifier that does
not contain any personal information. All measures will be
labeled with this unique code identifier. Paper data collected
from this study is stored in a locked file cabinet behind two
locked entrances, and only research personnel will have
access to the data. Additionally, we have obtained a Certificate
of Confidentiality from the National Institutes of Health.
With this certificate, we can’t be forced by a court order or
subpoena to disclose information that could identify the
participant in any civil, criminal, administrative, legislative or
other proceeding.
Possibility for coercion or undue influence
Participants will be compensated $25 per experimental visit for
a total of $50 if both experimental visits are completed.
This amount adequately compensates for their time at a rate of
about $15 /hour which is slightly higher than an hourly
rate of a part-time job without coercion or undue influence.
EH&S considerations
All research personnel are up to date on trainings in Biomedical
Human Subjects Research (CITI), Good Clinical Practice
(CITI), Bloodborne Pathogens, Biosafety Level 2, and Hazard
Communication and Waste Management. All materials used
for blood draws and blood processing will be immediately and
properly disposed of in biohazard reciprocal bins. All
research personnel involved with the blood draw and blood
processing will be dressed in long pants, closed toed shoes,
lab coat, and latex gloves. Needles involved with the blood
draw and microneurography measures will be disposed of
within sharps disposal containers.
Direct benefits to subjects
Participants will receive financial compensation and the medical
screening provides information about their physical
well-being. They receive a complete metabolic panel, lipid
panel, and hemoglobin A1c levels in addition to their blood
pressure and heart rate. This is important health information to
use as a “baseline” measure for participants, or the
knowledge of high blood pressure and cholesterol levels is
important as they contribute to many health problems.
Participants are also educated on the connection between MDD
and CVD, and whether mindful meditation or slow
breathing will be beneficial techniques to use for their own
physical or mental health.
Overall benefits
Overall, this project will provide direct benefits to the subjects,
undergraduate and graduate students, and will
contribute to the field of neurovascular dysfunction in regards
to those with major depressive disorder. Further, the
study may provide insight into alternative therapies for reducing
cardiovascular disease risk in those with MDD. In
regards to undergraduate and graduate students, the study
provides valuable experience, education, and partial
fulfillment of degree-work at the University of Texas at
Arlington.
Subject Privacy
All subject data will remain anonymous as all measures will be
labeled with a random, unique code identifier assigned to
them. All information collected during recruitment will be
confidential and discarded after their participation in the
research study. Participants are able to decline any measures or
not answer questions regarding their medical or mental
health history. Participants are also able to request that a
research member of the same gender perform measures at
the screening or experimental visits.
Confidentiality and Data Security
There is a risk of loss of confidentiality if the subjects
information or identity is obtained by someone other than the
investigators, but precautions will be taken to prevent this from
happening. The confidentiality of electronic data
created by the participant or researchers will be maintained to
the degree permitted by the technology used. Absolute
confidentiality cannot be guaranteed. All paper and electronic
data collected from this study will be stored in the
investigator’s lab for at least three years after the end of this
research. Participants will be provided with a unique
subject code identifier that does not contain any personal
information; therefore, all data collected will be deidentified.
All measures will be labeled with this unique code identifier.
Paper data collected from this study is stored in a locked
file cabinet behind two locked entrances, and only advised
research personnel will have access to the data. Additionally,
we have obtained a Certificate of Confidentiality from the
National Institutes of Health. With this certificate, we can’t be
forced by a court order or subpoena to disclose information that
could identify the participant in any civil, criminal,
administrative, legislative or other proceeding.
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give original forum with a minimum of 250 words and respond to bot

  • 1. give original forum with a minimum of 250 words and respond to both students separately with a minimum of 100 words each First page Original forum with references Swcond page Michael response with references Third page Joshua response with references Original Forum For this week's discussion, think about the best location for your e-portfolio. Do you want to use an existing social media platform, or create your own? Do you want to post a blog, or create a website? What period do you want your e-portfolio to be available for viewing? Will the public be able to access your site, or will access be restricted? Be constructive in content and tone. Highlight your thoughts in an action pla Student Response Micheal The best way to showcase my e-portfolio would be through my LinkedIn profile. I am not heavily engaged in social media, and I generally like to keep my online activity consolidated. I have briefly considered creating a blog or website in the past, and this will remain an option for me in the future. A key reason that I favor LinkedIn at this point is that I can build my profile incrementally and adjust it over time based on my developing interests. As I am still learning how best to utilize LinkedIn, I would most likely start small with my e-portfolio. As far as duration is concerned, I would plan to post it under my profile indefinitely. However, I would limit access depending on my level of satisfaction with the product. Peer feedback will help me to understand how I can make my e-portfolio a more coherent,
  • 2. cohesive, and complete product. Once a sufficient level of feedback is received and adjustments are made, I may choose to make the product available to anyone with a LinkedIn profile. A tentative action plan for making my e-portfolio publicly available would be as follows. First, I would integrate instructor/peer feedback into the artifacts and overall e- portfolio. Second, I would post the e-portfolio onto my LinkedIn account with access generally restricted. Third, I would seek out additional feedback from individuals with experience in the career fields in which I would like to apply the associated skillsets. After integrating this feedback, I would make the e-portfolio publicly accessible on LinkedIn. This would enable me to actively refer LinkedIn connections to my work and have it passively available to recruiters as well. I know that sometimes products posted to social media can get tucked away out of sight and out of mind after the initial posting. What are some good ways to promote projects like e- portfolios on social media to keep them in the spotlight? Joshua For the last 2-years I have been using LinkedIn as my e- Porfolio. I have had some interesting discussions with various people about why I use it to show my work but that is about as far as it has gone. I have not recognized any potential employer interested in my writings on LinkedIn. But the purpose of me posting on LinkedIn is to get my writing to post first if someone does a google search on me. I don’t want some random thing about me to pop up as the first thing. As for the future of using LinkedIn or another platform so show my work, I doubt I will use anything at all. I feel the stuff I posted six months ago is no longer a representation of the quality of work I do or the development of my communication skills. If I do post on social media, I think the only thing I would have in mind is to make my writing pop first on a google search that way the searcher gets to find some of the best
  • 3. writing I can post publicly. The further away I get from finishing my degree the more I think I will focus on creating a website as a portfolio of my work. The work on my website would be a place where I would sell the book I wrote along with other various articles of opinion and interest. I do want to work on a second book, but this time it will be a word search puzzle book. KINE-5300 Research Methods in Kinesiology Fall 2022 Final Written Proposal (90 total pts) Student Presenter: _________________________________________ Title of Project: _________________________________________ Instructor Assessment Score (0 = lowest; 10 = highest) Title: concise and descriptive 0 2 4 6 8 10 Introduction/Literature Review (already completed but now must be condensed to ~2 pages): introduce content, explain how it relates to information discussed in lecture, provide necessary background information, define key terms 0 2 4 6 8 10 Aims and Hypotheses (already completed; 1/4 page):
  • 4. clearly state study purpose and hypothesis 0 2 4 6 8 10 Experimental Approach (already completed; 2 pages): detailed explanation of study design, define groups/treatments/conditions, describe key methods/measurements and how they work, define primary outcome variables as they relate to the study hypothesis 0 2 4 6 8 10 Statistical Approach (already completed; 1/2-1 page): detailed explanation of analytical approach and its appropriateness for the experimental design, describe experimental controls, describe the determination of statistical significance or effect size, describe appropriateness of power analyses and sample size estimates 0 2 4 6 8 10 Project Timeline (already completed; 1/2 page): describe major goals of the study; goals are broken down into appropriate increments, with a logical timeline for the success of the project 0 2 4 6 8 10 References: inclusion of references, appropriate use of citations, consistent formatting, quality of articles (must be scientific) 0 2 4 6 8 10
  • 5. Writing consistent font and spacing, no spelling or grammatical errors, use of pictures/figures (no walls of text) 0 2 4 6 8 10 Overall Quality: clear presentation, well organized, proper material included (no excess information), knowledge of material, appropriate citation of references 0 2 4 6 8 10 Total: ADDITIONAL FEEDBACK: Annotated Bibliography The research that I intend to propose is a new tool to estimate energy deficiency in women. The following bibliography gives relevant evidence of variables related to and altered by low energy availability.
  • 6. De Souza, M. J., Miller, B. E., Loucks, A. B., Luciano, A. A., Pescatello, L. S., Campbell, C. G., & Lasley, B. L. (1998). High frequency of luteal phase deficiency and anovulation in recreational women runners: blunted elevation in follicle- stimulating hormone observed during luteal-follicular transition. The Journal of Clinical Endocrinology & Metabolism, 83(12), 4220-4232. Recreational runners and sedentary women with regular menstrual cycles were tested for hormone secretion and energy expenditure and intake. Luteal phase deficiency (LPD) and anovulation was frequently observed in runners, both conditions showing low progesterone excretion. In LPD, follicular phase was longer and luteal phase was shorter, and increase of FSH secretion was lower, compared to sedentary group. Runners also had lower E1C secretion during follicular phase. Anovulatory women had the lowest energy intake and the greatest daily energy expenditure, therefore the lowest energy balance. This relationship between menstrual dysfunction and low energy
  • 7. intake could indicate that the variables used in this study could be part of a tool to assess energy deficiency. De Souza, M. J., Toombs, R. J., Scheid, J. L., O'Donnell, E., West, S. L., & Williams, N. I. (2010). High prevalence of subtle and severe menstrual disturbances in exercising women: confirmation using daily hormone measures. Human reproduction, 25(2), 491- 503. The prevalence of amenorrhoeic and oligomenorrheic women in exercising and sedentary group was assessed. Exercising anovulatory, oligomenorrheic and amenorrhoeic women tended to have lower gynecological age compared to sedentary and exercising ovulatory women, and to exercising women with luteal phase defects. In the sedentary group, most women were eumenorrheic and there were no anovulatory women, whereas in the exercising group more than half of the subjects were anovulatory or had
  • 8. luteal phase defects. This group also had lower progesterone excretion. By giving evidence that exercising women are more likely to have menstrual disturbances, this study supports the idea that assessing energy deficiency should include menstrual cycle data. Gibbs, J. C., Nattiv, A., Barrack, M. T., Williams, N. I., Rauh, M. J., Nichols, J. F., & De Souza, M. J. (2014). Low bone density risk is higher in exercising women with multiple triad risk factors. Medicine and science in sports and exercise, 46(1), 167-176. The association between Female Athlete Triad risk factors and low bone mineral density (BMD) was investigated in exercising women. Subjects with low BMD had lower weight, body mass index, fat mass, lean body mass and fat-free mass, had their menarche later, and exercised more than women with normal BMD. The percentage of women with low BMD was higher among the subjects who had more risk factors for the Triad. In addition to a later menarche, which could indicate menstrual
  • 9. disturbances, this study includes bone health as a variable related to energy deficiency. Melin, A., Tornberg, Å. B., Skouby, S., Faber, J., Ritz, C., Sjödin, A., & Sundgot-Borgen, J. (2014). The LEAF questionnaire: a screening tool for the identification of female athletes at risk for the female athlete triad. British journal of sports medicine, 48(7), 540- 545. The study presents the Low Energy Availability in Females Questionnaire (LEAF- Q). The tool was developed to easily identify subjects with low energy availability, reproductive disorders, and bone health, based on questions about menstrual function, use of contraceptive methods, injuries, and gastrointestinal function. It was validated with clinical verification of energy expenditure, energy intake, blood pressure, hypothyroidism, reproductive function, and bone health, as well as with an eating
  • 10. disorders/disordered eating questionnaire. The questionnaire presented in this study is the tool currently used to estimate low energy availability in women, however this variable is less accurate than energy deficiency. Therefore, analyzing this study is relevant for understanding the LEAF-Q’s weaknesses and strengths, in order to develop a more precise tool. Williams, N. I., Mallinson, R. J., & De Souza, M. J. (2019). Rationale and study design of an intervention of increased energy intake in women with exercise-associated menstrual disturbances to improve menstrual function and bone health: The REFUEL study. Contemporary clinical trials communications, 14, 100325. This article presents the study design of a randomized controlled trial that attempted to treat conditions associated with the Female Athlete Triad with increased energy intake instead of hormonal contraceptives for 12 months. Changes in diet might
  • 11. be a good alternative for women going through menstrual disturbances probably associated with low energy availability. Bone health would likely need to be investigated for a period longer than 12 months. The outcomes of this study can improve the understanding of menstrual disturbances and bone health in exercising women and how it is related to diet alone. In other words, how they are or not a direct outcome of energy deficiency and how reversible they can be. Strock, N. C., Koltun, K. J., Southmayd, E. A., Williams, N. I., & De Souza, M. J. (2020). Indices of resting metabolic rate accurately reflect energy deficiency in exercising women. International journal of sport nutrition and exercise metabolism, 30(1), 14-24. The RMRratio was tested as a predictor of indicators of the Female Athlete Triad and energy deficiency (ED) in women who were eumenorrheic, amenorrhoeic and with subclinical menstrual dysfunction. Equations used were Harris -
  • 12. Benedict, DXA, Cunningham-1980 and Cunningham-1991. RMRratio was correlated with TT3 concentration, and it had reliable sensitivity and specificity for ED, especially the Cunningham-1991 and DXA. The RMRratio could be either used as a variable to validate a tool to assess energy deficiency, or it could be mathematically improved for the same purpose. Strock, N. C., Koltun, K. J., Mallinson, R. J., Williams, N. I., & De Souza, M. J. (2020). Characterizing the resting metabolic rate ratio in ovulatory exercising women over 12 months. Scandinavian journal of medicine & science in sports, 30(8), 1337-1347. The RMRratio was tested as a predictor of TT3 longitudinally in healthy women. In five tests throughout a year, RMRratio was consistent and showed good sensitivity and specificity for all RMR predictive equations: Harris-Benedict, DXA, Cunningham-1980, and Cunningham-1991. As the above-cited study, this ratio
  • 13. could be improved or used as a tool. In addition, associations of the RMRratio with other energy deficiency-related variables can be investigated to improve the efficacy in estimating energy deficiency. Strock, N. C., De Souza, M. J., & Williams, N. I. (2020). Eating behaviours related to psychological stress are associated with functional hypothalamic amenorrhoea in exercising women. Journal of Sports Sciences, 38(21), 2396- 2406. Metabolic and psychological characteristics were compared between exercising women with and without functional hypothalamic amenorrhoea (FHA). Subjects with FHA had lower blood concentration levels of T3, T4, leptin, and PYY, and greater cognitive restraint, drive for thinness, and need for social approval. Therefore, FHA exercising women had evidence of greater energy deficiency, even with similar energy
  • 14. availability. The physiological and psychological variables in this study, which indicate energy deficiency, could be used to validate and to develop a tool to assess energy deficiency. Barrack, M., Fredericson, M., Dizon, F., Tenforde, A., Kim, B., Kraus, E., Kussman, A., Singh, S., & Nattiv, A. (2021). Dietary Supplement Use According to Sex and Triad Risk Factors in Collegiate Endurance Runners. The Journal of Strength & Conditioning Research, 35(2), 404-410. Supplement intake was assessed in male and female collegiate runners. Most athletes reported taking dietary supplements. Calcium and iron intake was higher in women than in men. Calcium and vitamin D intake was associated with low bone mineral density, and it was higher in subjects who had already had bone stress injury. Supplement intake is easily obtained as a variable and it could be an indicator of energy deficiency and low bone health.
  • 15. De Souza, M. J., Mallinson, R. J., Strock, N. C., Koltun, K. J., Olmsted, M. P., Ricker, E. A., Scheid, J. L., Allaway, H. C., Mallinson, D. J., Don, P. K., & Williams, N. I. (2021). Randomised controlled trial of the effects of increased energy intake on menstrual recovery in exercising women with menstrual disturbances: the ‘REFUEL’ study. Human Reproduction, 36(8), 2285-2297. This study showed some of the results of the randomized controlled trial that was referred to above (Williams et al., 2019). Oligomenorrhoeic and amenorrhoeic women in the study group (i.e. who were having increased energy intake) were more likely to experience menses than the control group for the 12 months of study. In addition, 64% of the study group had their menstrual function improved, which was observed in 19% of control group. The results show the relevance of understanding and estimating energy
  • 16. deficiency, which can lead to menstrual dysfunction, and which can probably be treated without the prescription of hormones. BREATHING PATTERNS TO MINIMIZE CARDIOVASCULAR DISEASE RISK IN DEPRESSION TOP 10 CAUSES OF DEATH IN THE U.S. 2018 (Kochanek et al., 2019) HOW DO WE MEASURE CVD RISK? Traditional Risk Factors Nontraditional Risk Factors Endothelial dysfunction Stress Garcia et al., 2016
  • 17. HOW DO WE MEASURE CVD RISK? Traditional Risk Factors Nontraditional Risk Factors Endothelial dysfunction Stress Garcia et al., 2016 DEPRESSION WORK $ 17.3 million American adults Leading cause of disability worldwide $120.5 billion economic burden 1 out of 3 are resistant to current treatment practices (NIH, 2019; WHO, 2017; Hasin et al., 2018; Rush & Jain, 2018) HOW DO WE MEASURE CVD RISK? Traditional Risk Factors Nontraditional Risk Factors
  • 18. Endothelial dysfunction Stress Garcia et al., 2016 HOW DO WE MEASURE CVD RISK? Traditional Risk Factors Nontraditional Risk Factors Endothelial dysfunction Stress Garcia et al., 2016 SHORT TERM ASSESSMENT OF CVD RISK Sympathetic nervous system activity Blood Pressure Heart Rate BLOOD PRESSURE REACTIVITY AND SURVIVAL RATES Systolic Blood Pressure Diastolic Blood Pressure
  • 19. Carroll, et al., 2012 HOW DO WE LOWER BLOOD PRESSURE? Device guided slow breathing Mindful Meditation Sympathetic nervous system activity Blood Pressure HYPOTHESIS reactivity during the cold pressor test while practicing device-guided slow breathing or mindful meditation attenuations in cardiovascular reactivity during mindful meditation compared to device guided slow breathing METHODS RECRUITMENT Inclusion criteria
  • 20. -35 years old Exclusion criteria ing brain or CV system function 25 young adults with depressive symptoms EXPERIMENTAL APPROACH Screening Informed Consent BP, HR, Temp & Blood Draw
  • 21. Body Composition Health History MINI Interview Technique Familiarization Experimental Day 1 Device guided slow breathing Experimental Day 2 Device guided slow breathing Experimental Day 2 Mindful meditation Experimental Day 1 Mindful meditation Randomized 24 hrs 24 hrs
  • 22. Figure 1. Schematic of the experimental visit. Abbreviations: electrocardiogram (ECG), blood pressure (BP), muscle sympathetic nerve activity (MSNA), heart rate (HR), cold pressor test (CPT), slow breathing (SB). Experimental Visit VARIABLES Independent Variables Dependent Variables eats)
  • 23. STATISTICAL ANALYSIS Power analysis Project analysis -test -parametric test shown as Means ± SD (Fonkoue et al., 2018; Park et al., 2014; Scalco et al., 2009) -power PT and CPT+intervention
  • 24. ANTICIPATED FINDINGS AND INTERPRETATION Anticipated Findings frequency during the cold pressor test while practicing device-guided slow breathing or mindful meditation attenuations in MSNA burst frequency during mindful meditation compared to device guided slow breathing Interpretation cardiovascular reactivity during stressful situations for depressed young adults
  • 25. risk in those with depression REFERENCES y, A.T., Der, G., Hunt, K., Benzeval, M. & Phillips, A.C. (2012). Increased blood pressure reactions to acute mental stress are associated with 16- year cardiovascular disease mortality. Psychophysiology, 49, 1444-1448. DOI: 10.1111/j.1469-8986.2012.01463.x Li, Y., DaCosta, D., Rothbaum, B.O., Park, J. (2018). Acute effects of device-guided slow breathing on sympathetic nerve activity and baroreflex sensitivity in posttraumatic stress disorder. Am J Physiol Heart Circ Physiol, 315, H141-H149. doi:10.1152/ajpheart.00098.2018 J.E. (2016). Cardiovascular Disease in Women. Circulation Research, 118(8), 1273-1293. https://doi.org/10.1161/CIRCRESAHA.116.307547 W.J., Stohl, M., Grant, B.F. (2018). Epidemiology of Adult DSM-5 Major Depressive Disorder and Its Specifiers in the United States. Journal of the American Medical Association Psychiatry, 75(4), 336-346. DOI: 10.1001/jamapsychiatry.2017.4602 Deaths: Final data for 2017. National Vital Statistics Reports,
  • 26. 68(9), 1-77. https://www.cdc.gov/nchs/data/nvsr/nvsr68/nvsr68_09-508.pdf -Wu, S. (2014). Mindfulness meditation lowers muscle sympathetic nerve activity and blood pressure in African-American males with chronic kidney disease. American journal of physiology. Regulatory, integrative and comparative physiology, 307(1), R93–R101. https://doi.org/10.1152/ajpregu.00558.2013 STAR*D Trial. Handb Exp Pharmacol, 250, 51-99. doi: 10.1007/164_2018_153 Azul, J.B., Pullenayegum, E.M., Scalco, M.Z., Kuniyoshi, F.H., Wajngarten, M., Negrao, C.E., Lotufo-Neto, F. (2009). Muscle sympathetic nervous activity in depressed patients before and after treatment with sertraline. Journal of Hypertension, 27(12), 2429-2436. doi: 10.1097/HJH.0b013e3283310ece health estimates, 2017. https://doi.org/10.1161/CIRCRESAHA.116.307547 https://www.cdc.gov/nchs/data/nvsr/nvsr68/nvsr68_09-508.pdf https://doi.org/10.1152/ajpregu.00558.2013 QUESTIONS?
  • 27. Female Energy Deficiency Questionnaire – FED-Q: Development and Validation Ana Carla Chierighini Salamunes Advisor: Dr Mary Jane De Souza Introduction to the Problem Exercising women Risk of energy deficiency Risk of Female Athlete Triad How to detect energy deficiency? Key background Energy availability (EA): (DEI-EEE)/kg FFM/day Low EA: < 30 kcal/kg FFM/day Energy deficiency (ED): Triiodothyronine < 80 ng/dL Resting metabolic rate ratio < 0.9 (Strock et al., 2020a) Higher sensitivity to change than EA (Strock et al., 2020b) Female athlete triad (De Souza et al., 2014) Menstrual dysfunction Impaired growth Low bone mineral density
  • 28. Key background for clinical/large scale use is needed Low Energy Availability in Females – LEAF-Q (Melin et al., 2014) Validated to detect risk of developing the Triad Did not detect differences in EA Did not account for EEE value (Rogers et al., 2021) Specific aims and hypotheses The aim of this study is to develop and validate the Female Energy Deficiency Questionnaire (FED-Q), a tool to assess energy deficiency in exercising women. H0: A questionnaire that screens for the presence of menstrual dysfunction, impaired bone health, exercise level, dietary habits, and eating disorders and disordered eating is not an accurate predictor of energy deficiency in exercising women. H1: Energy deficiency (ED) in exercising women can be predicted with 90% sensitivity by the Female Energy Deficiency Questionnaire – FED-Q, a questionnaire that screens for: the presence of menstrual dysfunction; impaired bone health; exercise level; dietary habits; and eating disorders and disordered eating. H2: The total score in the FED-Q will correlate with resting metabolic rate ratio and total triiodothyronine concentration. H3: The specific scores for menstrual dysfunction and bone health will be associated and correlated, respectively, with menstrual status and bone mineral density. General study design
  • 29. Questionnaire: Feasibility Reliability Validity: TT3 RMRratio Menstrual status Bone mineral density Dietary energy intake Exercise energy expenditure Sensitivity and specificity: low TT3 and RMRratio Subjects Inclusion criteria: Women 18-35 years old Minimum 150 min of exercise/week in the last 12 months Athlete or non-athlete Good health, free of chronic diseases Exclusion criteria: Pregnant or lactating Hormonal contraceptives or medication that can alter calcium metabolism Recovering from bone injury Recruitment: Flyers, emails, Study Finder, laboratory website Methods Questionnaire development and validation (Boparai et al., 2018; Tsang et al., 2017): Menstrual status, bone health, exercise level, dietary habits, and disordered eating/eating disorders Self-administered, ~20 close ended questions, Likert scale or yes/no answers Demographics: age, height, weight, and age of menarche
  • 30. Methods First draft: ~60 items Feasibility: pilot-testing in ~30 subjects Modifications Content validity: expert committee CVI Modifications: final draft Scoring system Data collection Expert committee discussion Modifications Construct validity and reliability
  • 31. methods First visit FED-Q, RMR, DXA, TT3, urine 8-10 days interval Wearable exercise monitor, nutrition logs, urine collection Second visit FED-Q, exercise and nutrition data, urine samples Reliability Data of first and second visits Construct validity FED-Q of first visit and physiological data Stability Correlation coefficient of first and second visit Internal consistency Split-half method Analytical approach Content validity Expert committee Content Validity Index (CVI)
  • 32. Construct validity Normal distribution/ transformation Pearson’s correlation or Spearman’s rho with physiological data Reliability I-CVI and S-CVIAve Sensitivity and specificity, and T-test or Mann-Whitey test Stability: test-retest method, correlation Internal consistency: split-half method, correlation Sample size calculations Questionnaire: -item questionnaire n=132 95% confidence interval, standard deviation of 11.6 ng/dL TT3, margin of error of 2 ng/dL n=165, with drop-out rate of 20%
  • 33. n=195, of which 30 subjects in pilot testing Timeline and Milestones for Success Anticipated Results FED-Q: feasible, reliable, and repeatable survey to assess ED in exercising women Cut-off point will predict low TT3 and/or low RMRratio with 90% sensitivity FED-Q will be a tool that is accessible, rapid, simple to use, and easy to interpret Potential Pitfalls and Alternative Approaches to Consider Concerns referring to feasibility, reliability, and/or validity on or investigation of a different tool references De Souza, M. J., Miller, B. E., Loucks, A. B., Luciano, A. A., Pescatello, L. S., Campbell, C. G., & Lasley, B. L. (1998). High frequency of luteal phase deficiency and anovulation in recreational women runners: blunted elevation in follicle- stimulating hormone observed during luteal-follicular transition. The Journal of Clinical Endocrinology & Metabolism, 83(12), 4220-4232. De Souza, M. J., Nattiv, A., Joy, E., Misra, M., Williams, N. I.,
  • 34. Mallinson, R. J., Gibbs, J.C., Olmsted, M., Goolsby, M., Matheson, G. (2014). 2014 Female Athlete Triad Coalition Consensus Statement on treatment and return to play of the female athlete triad: 1st International Conference held in San Francisco, California, May 2012 and 2nd International Conference held in Indianapolis, Indiana, May 2013. British journal of sports medicine, 48(4), 289-289. De Souza, M. J., Toombs, R. J., Scheid, J. L., O'Donnell, E., West, S. L., & Williams, N. I. (2010). High prevalence of subtle and severe menstrual disturbances in exercising women: confirmation using daily hormone measures. Human reproduction, 25(2), 491-503. Melin, A., Tornberg, Å. B., Skouby, S., Faber, J., Ritz, C., Sjödin, A., & Sundgot-Borgen, J. (2014). The LEAF questionnaire: a screening tool for the identification of female athletes at risk for the female athlete triad. British journal of sports medicine, 48(7), 540-545. Rogers, M. A., Drew, M. K., Appaneal, R., Lovell, G., Lundy, B., Hughes, D., Vlahovich, N., Waddington, G., Burke, L. M. (2021). The Utility of the Low Energy Availability in Females Questionnaire to Detect Markers Consistent With Low Energy Availability-Related Conditions in a Mixed-Sport Cohort. International Journal of Sport Nutrition and Exercise Metabolism, 31(5), 427-437. Sim, A., & Burns, S. F. (2021). questionnaires as measures for low energy availability (LEA) and relative energy deficiency in sport (RED-S) in athletes. Journal of Eating Disorders, 9(1), 1- 13. Strock, N. C., De Souza, M. J., & Williams, N. I. (2020b). Eating behaviours related to psychological stress are associated with functional hypothalamic amenorrhoea in exercising women. Journal of Sports Sciences, 38(21), 2396-2406. Strock, N. C., Koltun, K. J., Mallinson, R. J., Williams, N. I., & De Souza, M. J. (2020a). Characterizing the resting metabolic rate ratio in ovulatory exercising women over 12 months. Scandinavian journal of medicine & science in sports, 30(8),
  • 35. 1337-1347. Tsang, S., Royse, C. F., & Terkawi, A. S. (2017). Guidelines for developing, translating, and validating a questionnaire in perioperative and pain medicine. Saudi journal of anaesthesia, 11(Suppl 1), S80. image2.png image3.png KINE-5300 Research Methods in Kinesiology Fall 2022 Oral Proposal (80 total pts) Student Presenter: _________________________________________ Title of Article: _________________________________________ Instructor Assessment Score (0 = lowest; 5 = highest) Significance: introduce content, explain how it relates to information discussed in lecture, provide necessary background information, define key terms 0 2 4 6 8 10 Aims: clearly state study purpose and hypothesis 0 2 4 6 8 10 Experimental Approach:
  • 36. detailed explanation of study design, define groups/treatments/conditions, describe key methods/measurements and how they work, define primary outcome variables as they relate to the study hypothesis 0 2 4 6 8 10 Statistical Approach: detailed explanation of analytical approach and its appropriateness for the experimental design, describe experimental controls, describe the determination of statistical significance or effect size, describe appropriateness of power analyses and sample size estimates 0 2 4 6 8 10 Project Timeline: describe major goals of the study; goals are broken down into appropriate increments, with a logical timeline for the success of the project 0 2 4 6 8 10 Slides: consistent font and spacing, no spelling or grammatical errors, use of pictures/figures (no walls of text) 0 2 4 6 8 10 Presentation: clear presentation, did not overly rely on notes or read verbatim
  • 37. from slides, well organized, proper material included (no excess information), knowledge of material, speaks loudly and clearly, confidence, flow and consistency between sections, answered questions completely 0 2 4 6 8 10 Questions: Student clearly addresses questions about the project and all aspects both scientifically and about the approach; student answers questions respectfully 0 2 4 6 8 10 Total: ADDITIONAL FEEDBACK: 1. Female Energy Deficiency Questionnaire – FED-Q: Development and Validation 2. ABSTRACT Low energy availability in exercising women may cause menstrual dysfunction and growth impairment, which
  • 38. can result in low bone mineral density. A reliable a feasible tool for clinical assessment of energy deficiency is needed. This study aims to develop and validate the Female Energy Deficiency Questionnaire (FED-Q). It is anticipated to have approximately 20 items screening for menstrual dysfunction, bone health, exercise level, energy intake, eating disorders and disordered eating, as well as body mass index, and age. Feasibility will be assessed with a pilot study, followed by content validation with the analysis of experts in the field. Modifications will be made in the first draft for subsequent application in a larger cohort. Construct validity will be measured by correlation coefficients, sensitivity, and specificity in detecting energy deficiency, defined as low serum triiodothyronine and low resting metabolic rate ratio. Reliability will be measured in a test-retest method, which will be used to analyzed stability, and with correlation coefficients in a split-half method, for internal consistency. The FED-Q is expected to accurately predict the risk of energy deficiency in exercising women, allowing physicians, dietitians, nutritionists, athletic trainers, and coaches to easily screen their patients and athletes, hence avoiding persistent energy deficiency and related health impairment. 3. INTRODUCTION Estimating energy deficiency is essential to assess the risk of developing the female athlete triad, which consists of menstrual dysfunction and impaired bone health caused by low energy availability (EA) (De Souza et al., 2014). A fast, feasible, and reliable tool for clinical use is yet to be designed. The aim of this study is to develop and validate the Female Energy Deficiency
  • 39. Questionnaire (FED-Q), a tool to assess energy deficiency (ED) in exercising women. We hypothesize that ED can be predicted with 90% sensitivity by the Female Energy Deficiency Questionnaire – FED-Q, a survey that screens for: the presence of menstrual dysfunction; impaired bone health; exercise level; dietary habits; and eating disorders and disordered eating. Secondary hypotheses are: 1. the total score in the FED-Q will correlate with resting metabolic rate ratio (RMRratio) and total triiodothyronine concentration; 2. the specific scores for menstrual dysfunction and bone health will be associated and correlated, respectively, with menstrual status and bone mineral density. Our null hypothesis is: a questionnaire that screens for the presence of menstrual dysfunction, impaired bone health, exercise level, dietary habits, and eating disorders and disordered eating is not an accurate predictor of energy deficiency in exercising women. 4. REVIEW OF THE LITERATURE Low EA and ED can be caused by high exercise energy expenditure that is not sufficiently compensated with energy intake. EA is calculated as the difference between exercise energy expenditur e and dietary energy intake per kilograms of fat-free mass per day ([EEE-DEI]/kg FFM/day). Low EA is defined as EA < 30 kcal/kg FFM/day. Persons with low EA are likely to be energy deficient, a common condition among female athletes and non-athlete exercising women. There is no gold-standard for the assessment of ED, but serum triiodothyronine (TT3 <80 ng/dL) and resting metabolic rate ratio (RMRratio =
  • 40. RMRmeasured/RMRpredicted <0.9) have been used as parameters of ED (Strock et al., 2020a; Strock et al., 2020b; De Souza et al., 2014). When an individual is energy deficient, their organism does not have enough fuel for all basic physiological needs, and the systems that are most important to survival are prioritized. Reproduction is one of the first functions to be impaired because of low EA/ED (De Souza et al., 2014). Previous studies have reported high prevalence of menstrual dysfunction in exercising women, which was higher than that observed in sedentary women (De Souza et al., 2010; De Souza et al., 1998). One study comparing active and sedentary females found that more than 50% of the participants in the exercising group were anovulatory, condition not observed in any of the subjects in the sedentary group (De Souza et al., 2010). In addition, anovulatory exercising women have been reported to have lower energy intake compared to both active and sedentary eumenorrheic women, evidencing the relationship between inadequate fueling and menstrual dysfunction (De Souza et al., 1998). Growth is also impaired in women with low EA, which, in more severe cases, may impact bone mineral density (BMD). Compared to women with normal BMD, females with low BMD were reported to exercise more and to have lower body fat percentage and fat mass. Age of menarche was found to be higher, which could be indicative of delayed menarche and menstrual dysfunction (Gibbs et al., 2014). Menstrual dysfunction and impaired bone health as consequences of low EA are the components of the Female Athlete
  • 41. Triad (Triad), which can include more severe cases with low BMD and eating disorders or disordered eating (De Souza et al., 2014). As low EA and ED are the main cause for the impaired health outcomes, early and precise detection of low EA/ED risk is needed. Measurements of EEE and DEI – used to calculate EA – depend on self-reported data and depend on predictive equations, hence assessing EA is less accurate than measuring ED. In a study comparing exercising women with and without functional hypothalamic amenorrhea, the first group was found to have lower ED, but similar EA, indicating that the measures used to assess ED are more sensitive to altered metabolic function than EA (Strock et al., 2020c). However, for clinical assessments, examining TT3 and RMRratio may not be feasible methods, in terms of cost, time, and access. Blood serum analyses and the use of a metabolic analyzer are not rapid measures and may not be easily accessed by all physicians, dietitians, nutritionists, or athletic trainers. Aiming to provide sports and health care professionals with an appropriate tool, studies presented different questionnaires that attempted to estimate low EA. While some of them were developed specifically for this purpose, other surveys that were tested are intended for screening different conditions that could be related to EA and the Triad. These are related to eating disorders, dietary habits, and body image. Of all available questionnaires, only a few have gone through a complete validation process and only one has been validated for use with adult female athletes (Sim & Burns, 2021). To our knowledge, the Low Energy Availability in Females
  • 42. Questionnaire (LEAF-Q), proposed by Melin et al. (2014) is currently the only validated survey to estimate low energy availability in female athletes. Even though it seems to be a promising tool, the LEAF-Q has several limitations. A cut-off value (score ≥ 8) was used to determine if a participant was at risk of developing the Triad. The LEAF-Q was considered to have accurate sensitivity if it had detected any of the three Triad-related outcomes – low EA, menstrual dysfunction, and impaired bone health –, therefore neither ED nor low EA were considered strictly necessary to correctly identify a positive case. This raises concerns, because positive cases of low BMD or menstrual dysfunction do not necessarily mean that those were caused by low EA. More importantly, there were no significant differences in EA between groups above and below the cut-off point, meaning that the LEAF-Q can lead to concerning misinterpretations. In addition, the study of Rogers et al. (Rogers et al., 2021) showed that the LEAF-Q has a high sensitivity, but a very low specificity in the assessment of risk of Triad outcomes, therefore very low positive predictive values. The authors also found the score not to be related to RMRratio, indicating that it is likely inappropriate for assessing EA or ED. Given the evidence in literature, it has been observed that there are no clinically reliable and valid tools to assess ED in exercising women. A questionnaire with the purpose of assessing low EA and/or ED must assess menstrual status, dietary habits, exercise level, and bone health. For better accuracy, validation should be assessed with correlations not only with EA, but mainly with RMRratio and serum TT3. 5. METHODS
  • 43. a. Subject Characteristics Subjects will be women from 18 to 35 years old who have exercised at least 150 min per week in the last 12 months. Both athletes and non-athletes will be included. Participants must be in good health and free of chronic diseases. Participants will be excluded if they are pregnant, lactating, taking hormonal contraceptives, taking medication that could alter calcium metabolism, or if they are recovering from bone injury at the time of the study. Participants will be recruited via flyers, emails, Study Finder, and the laboratory website. b. General study design A questionnaire to assess ED in exercising women will be developed. An expert committee will be formed to discuss the first draft of the survey. It will be pilot- tested in a small group of exercising women, when feasibility will be assessed. The expert committee will perform a second analysis, which will establish content validity. For reliability and construct validity, a larger group of exercising women will respond the questionnaire. The validation will be performed by correlating the final scores of the FED-Q with TT3, RMRratio, menstrual status, BMD z-score, DEI, and EEE. Sensitivity and specificity of predicting low TT3 and RMRratio
  • 44. will be assessed. Reliability will be separated into stability and internal consistency analyses. c. Specific study methods The study will follow previously described steps of questionnaire development and validation (Boparai et al., 2018; Tsang et al., 2017) specified as follows. Approximately sixty questions will be formulated aiming to assess menstrual status, bone health, exercise level, dietary habits, and disordered eating/eating disorders, of which approximately 20 items are expected to remain in the final draft of the questionnaire. The FED-Q will be designed to be a self-administered tool containing close ended questions, with either Likert scale or yes/no answers. Demographics such as age, height, weight, and body mass index will be assessed as well. A committee of three to ten experts in the field of EA/ED/Triad will be formed to have a primary discussion about the suitability of the FED-Q in assessing ED. Following their comments on the first draft, modifications will be made in the items. Subsequently, the FED-Q will be pilot-tested for feasibility in a group of thirty subjects. Immediately after the participant has responded the questionnaire, a member of the research team will read out the items to the subject, aiming to verify if the questions were clear and if they could be easily interpreted, as expected. Respondents’ opinion on specific questions may be asked by the interviewers. Based on the observations in the pilot testing, new adjustments in the FED-Q will be addressed. After modifications, content validity will be assessed. The expert committee will be again invited to analyze
  • 45. the extent to which the FED-Q comprises most of the dimensions of EA and ED in exercising women. In this step, each expert will evaluate the items without consulting others’ opinion. The Content Validity Index (CVI) will be used to measure the relevance of each item in the FED-Q (Boparai et al., 2018; Polit & Beck, 2006). This analysis is detailed in the Data Analytical Approach section. Other modifications may be addressed to the draft, after calculating the CVI. Following the three rounds of modifications, scores will be attributed to each item. Responses that are not attributed to risk of ED will not add any points to the overall score, whereas those that might indicate risk of ED will add at least one point to the final score. Higher scores will be attributed to the items that, according to the literature and to expert opinion, are more critical indicators of ED. The final draft of the FED-Q will be tested in a second group of exercising women for construct validity, followed by a reliability assessment, summarized in Figure 1. Two visits will be required. For construct validity, several measurements will be taken from the study group. In the first visit, RMR will be assessed with a ventilated hood system of indirect calorimetry (SensorMedics Vmax Series, Yorba Linda, CA) for subsequent estimation of the RMRratio (Cunningham 1991 equation and DXA ratio) (Strock et al., 2020a), body composition and BMD will be assessed with a Hologic QDR4500W DXA scanner (Hologic, Bedford, MA), and blood draws will be taken to assess TT3. On the first seven consecutive days between the first and the second visit, participants will complete nutrition logs and monitor exercise with a wearable device. Data will be used to calculate DEI (Nutrition Pro Software), EEE,
  • 46. energy balance (energy intake – energy expenditure), and EA ([EEE-DEI]/kg FFM/day). Starting on the first visit, urine samples of two consecutive menstrual cycles will be collected and provided by the participants to measure Ed1 and PdG excretion for an estimation of menstrual status. Construct validity will be assessed with statistical tests of correlation and association between the questions and the specific measurements that they are intended to measure, and mainly with the correlation of the total score with TT3 and RMRratio. A cut-off value will be set as predictor of ED (TT3 < 80 ng/dL and/or RMRratio < 0.9), and sensitivity and specificity will be assessed. Eight to ten days following the first visit, subjects will come to the laboratory for the second visit, when they will provide the research staff with the exercise monitors and nutrition logs, and a second part of the urine samples. In this occasion, they will respond the FED-Q one more time. Reliability will be attested in terms of stability and internal consistency. Stability will be measured using a test-retest method. The responses given to the FED-Q will be compared. Little variability is expected between the two time points. Internal consistency will be measured with a split-half method. Details of this analysis are provided in the Data Analytical Approach section. The remaining urine samples will be delivered to the research team by the end of the first and second months of collection.
  • 47. Figure 1. Summarized data collection for the assessment of construct validity and reliability of the Female Energy Deficiency Questionnaire. d. Data analytical approach, including details about your statistical model, assumptions Validity and reliability assessments will require different statistical analyses, specified below. Content validity The expert committee will be instructed to use the Content Validity Index (CVI). They will be asked to classify each item of the FED-Q from one to four points, in a Likert-type scale, where one means the item is irrelevant to assess ED; two, somewhat relevant; three, quite relevant; and four, highly relevant. The CVI for items (I-CVI) will be calculated as the percentage of experts who consider an item as relevant. i.e., if they award an item with minimum three points in the Likert scale. Items with an I-CVI of at least 80% will be considered acceptable. Inappropriate items will be reviewed or excluded (Boparai et al., 2018; Polit & Beck, 2006). The average CVI for scales (S-CVI/Ave) will be calculated as the average of all I-CVIs, which is also expected to result in a minimum of 80% (Polit & Beck, 2006).
  • 48. Construct validity Data of TT3, RMRratio, BMD, body composition, EA, energy balance, and FED-Q score will be tested for normal distribution. In case of not normally distributed, data will be log-transformed. If normal distributions are found, parametric tests will be used, otherwise non- parametric statistics will be applied. Pearson’s correlation coefficient or Spearman’s rho will be used to verify if the FED-Q score is correlated with TT3 and RMRratio, aiming to validate the questionnaire. Correlations will also be used to test if specific questions and items are related to the data that they are expected to screen for – BMD, menstrual dysfunction, exercise level, and DEI. Of the total score, a cut-off point will be determined as indicator of risk of ED, which will be used to classify participants as either at risk of having ED or not. Sensitivity and specificity in predicting ED (TT3 < 80 ng/dL and/or RMRratio < 0.9) will be assessed, and all variables will be compared between groups with Student’s T test or Mann-Whitney test. First visit FED-Q, RMR, DXA, TT3, urine Second visit FED-Q, exercise and nutrition data, urine samples Reliability Data of first and second visits
  • 49. Stability Correlation coefficient of first and second visit Internal consistency Split-half method Construct validity FED-Q of first visit and physiological data 8-10 days interval Wearable exercise monitor, nutrition logs, urine collection Reliability Stability of the FED-Q will be tested as the correlation coefficients between the scores of the first and the second visit. The split-half method will be used to measure internal consistency: the questionnaire will be divided into two halves with equivalent number of questions of each domain – DEI, menstrual dysfunction, exercise level, bone health, and eating disorders. A correlation coefficient will indicate if the questionnaire is consistent in screening for the same conditions (Tsang et al.,
  • 50. 2017). e. Detailed sample size calculations Literature provides several different sample size requirements to validate a questionnaire. The lowest acceptable value seems to be 5:1, or 5 respondents for each item. Since the FED-Q is expected to have approximately 20 items, a minimum sample size would be of 100 exercising women (Tsang et al., 2017). Another approach is to calculate the sample size based on the expected confidence level and margin of error, as follows (Ott & Longnecker, 2015): � = �! " . �" �" where n is the sample size, Z is the z-score for a confidence level of α/2, σ is the expected standard deviation, and ε is the margin of error. Considering a 95% confidence interval with an average standard deviation of 11.6 ng/dL for TT3 in similar populations (Strock et al., 2020a; 2020b; 2020c), and an acceptable margin of error of 2 ng/dL, the
  • 51. minimum sample size for the phase of validation is 132 exercising women. Applying a drop-out rate of 20%, the minimum sample size is 165. In addition to the 30 subjects in the pilot-testing phase, our sample size will be of 195 exercising women. f. Timeline Figure 2 indicates the timeline of all necessary phases for the completion of the study. Pilot testing is expected to be finished by April 2022, allowing for analysis by the experts to be finished in the first week of June, and data collection to start in July. Data analysis will start after all subjects have completed the first visit and will be concluded by December 2022. A first draft of the research will be presented in February 2023, followed by a final version in March. Figure 2. Research phases and timeline 6. Anticipated Results and Interpretation The FED-Q is expected to be a feasible, reliable, repeatable, and valid survey to assess ED in exercising women. A minimum score, yet to be determined, is expected to predict low TT3 and/or low RMRratio with at least 90% sensitivity and 80% specificity. In addition, scores on menstrual status and bone health will
  • 52. be good indicators of menstrual dysfunction and low BMD. The FED-Q will be a tool that is accessible, rapid, simple to use, and easy to interpret. Its use will be intended for physicians, dietitians, nutritionists, coaches, athletic trainers, and other health care professionals, as well as researchers, as a reliable measurement of ED. 7. Potential Pitfalls, Alternative Explanations, and Consideration of Alternate Approaches There can be unexpected outcomes in any of the steps of development and validation of the FED-Q. If inconsistencies are observed during either the feasibility, reliability, or the validity steps, the tool will have to be re-evaluated. If the inconsistencies are specific to certain items, these will have to be thoroughly analyzed, and possibly replaced or removed. If major problems occur, such as the questionnaire itself not seeming reliable, going back to the first step of development (question framing) might be needed, which might even raise questions on whether it is possible to assess ED by means of a questionnaire. If it is concluded that the FED-Q is not a reliable, repeatable, and valid tool, other clinical approaches will have to be investigated and developed to be used for ED assessment in exercising women. REFERENCES
  • 53. Boparai, J. K., Singh, S., & Kathuria, P. (2018). How to design and validate a questionnaire: a guide. Current clinical pharmacology, 13(4), 210-215. De Souza, M. J., Miller, B. E., Loucks, A. B., Luciano, A. A., Pescatello, L. S., Campbell, C. G., & Lasley, B. L. (1998). High frequency of luteal phase deficiency and anovulation in recreational women runners: blunted elevation in follicle-stimulating hormone observed during luteal-follicular transition. The Journal of Clinical Endocrinology & Metabolism, 83(12), 4220-4232. De Souza, M. J., Nattiv, A., Joy, E., Misra, M., Williams, N. I., Mallinson, R. J., Gibbs, J.C., Olmsted, M., Goolsby, M., Matheson, G. (2014). 2014 Female Athlete Triad Coalition Consensus Statement on treatment and return to play of the female athlete triad: 1st International Conference held in San Francisco, California, May 2012 and 2nd International Conference held in Indianapolis, Indiana, May 2013. British journal of sports medicine, 48(4), 289-289. De Souza, M. J., Toombs, R. J., Scheid, J. L., O'Donnell, E., West, S. L., & Williams, N. I. (2010). High prevalence of subtle and severe menstrual disturbances in exercising women: confirmation using daily hormone measures. Human reproduction, 25(2), 491-503. Gibbs, J. C., Nattiv, A., Barrack, M. T., Williams, N. I., Rauh, M. J., Nichols, J. F., & De Souza, M. J. (2014). Low bone density risk is higher in exercising women with multiple triad risk factors. Medicine and science in sports and exercise, 46(1), 167-176.
  • 54. Melin, A., Tornberg, Å. B., Skouby, S., Faber, J., Ritz, C., Sjödin, A., & Sundgot-Borgen, J. (2014). The LEAF questionnaire: a screening tool for the identification of female athletes at risk for the female athlete triad. British journal of sports medicine, 48(7), 540-545. Ott, R. L., & Longnecker, M. T. (2015). An introduction to statistical methods and data analysis. Cengage Learning. Polit, D. F., & Beck, C. T. (2006). The content validity index: are you sure you know what's being reported? Critique and recommendations. Research in nursing & health, 29(5), 489-497. Rogers, M. A., Drew, M. K., Appaneal, R., Lovell, G., Lundy, B., Hughes, D., Vlahovich, N., Waddington, G., Burke, L. M. (2021). The Utility of the Low Energy Availability in Females Questionnaire to Detect Markers Consistent With Low Energy Availability-Related Conditions in a Mixed-Sport Cohort. International Journal of Sport Nutrition and Exercise Metabolism, 31(5), 427-437. Sim, A., & Burns, S. F. (2021). questionnaires as measures for low energy availability (LEA) and relative energy deficiency in sport (RED-S) in athletes. Journal of Eating Disorders, 9(1), 1-13. Strock, N. C., De Souza, M. J., & Williams, N. I. (2020c). Eating behaviours related to psychological stress are associated with functional hypothalamic amenorrhoea in exercising women. Journal of Sports Sciences, 38(21), 2396-2406.
  • 55. Strock, N. C., Koltun, K. J., Mallinson, R. J., Williams, N. I., & De Souza, M. J. (2020b). Characterizing the resting metabolic rate ratio in ovulatory exercising women over 12 months. Scandinavian journal of medicine & science in sports, 30(8), 1337-1347. Strock, N. C., Koltun, K. J., Southmayd, E. A., Williams, N. I., & De Souza, M. J. (2020a). Indices of resting metabolic rate accurately reflect energy deficiency in exercising women. International journal of sport nutrition and exercise metabolism, 30(1), 14-24. Tsang, S., Royse, C. F., & Terkawi, A. S. (2017). Guidelines for developing, translating, and validating a questionnaire in perioperative and pain medicine. Saudi journal of anaesthesia, 11(Suppl 1), S80. Breathing Patterns to Minimize Cardiovascular Disease Risk in Major Depressive Disorder Introduction Cardiovascular disease (CVD) is the leading cause of death within the United States (Kochanek et al., 2019). Importantly, there is strong epidemiological and experimental evidence to suggest those with a large-magnitude of stressor-evoked cardiovascular reactions (i.e. heart rate, blood pressure) are at an elevated risk for CVD (Carroll, Ginty et al., 2012;
  • 56. Carroll, Phillips et al., 2011; Allen et al., 1997). Epidemiological studies have also linked major depressive disorder (MDD) to CVD and all-cause mortality, independent of socioeconomic status and traditional CVD risk factors (Kozela et al., 2016). Depression is linked to autonomic dysfunction, specifically sympathetic overactivity (Scalco et al., 2009; Koschke et al., 2009), which contributes to the development of hypertension, heart failure, arrhythmias, and atherosclerosis (Grassi et al., 2004; Erami et al., 2002). Furthermore, MDD is the leading cause of disability worldwide (WHO, 2017) with an economic burden of $210.5 billion in the United States in 2010 (Hasin et al., 2018) and at least one third of patients are resistant to current treatment practices (Rush & Jain, 2018). Altogether, these findings warrant the discovery of novel therapies targeting autonomic function in depressed adults. Device-guided slow breathing (DGSB) has emerged as a potential therapy to lower blood pressure and sympathetic nervous system activity in disorders characterized by sympathetic overactivity (Oneda et al., 2010; Fonkoue, Marvar et al., 2018). Although DGSB is effective at acutely lowering blood pressure and muscle sympathetic nerve activity (MSNA),
  • 57. long-term cardiovascular benefits may not be seen (Fonkoue, Yingtian et al., 2020) due to a lack of psychobehavioral effects of the therapy. Alternatively, mindful-based meditation results in similar breathing patterns (<10 breaths/min) as DGSB (Peng et al., 2003) while encouraging the individual to be present in the moment and to acknowledge and accept their thoughts without judgement. Indeed, mindful meditation has been shown decrease in anxiety, depression, blood pressure and MSNA in young adults and those with disorders characterized by sympathetic overactivity (Bell, 2015; Park et al., 2014). Furthermore, mindful meditation may target brain processing alterations present within depression (Fales et al., 2008) resulting in greater reductions of cardiovascular reactivity compared to device-guided slow breathing during stress-evoking situations. Given these findings, we hypothesize that depressed young adults will show attenuated cardiovascular reactivity during a stress-evoking situation while practicing device-guided slow breathing or mindful meditation. Furthermore, depressed young adults will show greater attenuations in cardiovascular reactivity during mindful meditation compared to device- guided slow breathing. Methods
  • 58. The proposed study will evaluate the effects of 15 minutes of device-guided slow breathing and 15 minutes of mindful meditation (MM) (independent variables) on respiratory rate (breaths/min), MSNA burst frequency (bursts/min) and incidence (bursts/100 heart beats), blood pressure (mmHg), and heart rate (beats/min) (dependent variables) during the cold pressor test (CPT). The primary outcome of this project is MSNA burst frequency (bursts/min). A total of 25 young adults (18-35 years old) with depressive symptoms will be recruited for this study. Participants will be recruited from the University of Texas at Arlington and the surrounding area through the use of flyers, email, social media, class presentations, and radio ads. Inclusion criteria consists of those 18-35 years old and confirmation of depressive symptoms with a diagnostic interview. Exclusion criteria consists of a mental illness aside from depression, any use of depression mediation, active suicidal/homicidal intent, active alcohol or drug dependence, an eating disorder, use of medication that could alter how the brain or cardiovascular system functions, cardiovascular, kidney, lung or metabolic disease, tobacco use, pregnancy, or amenorrhea (women). Sample size was calculated a priori using G-power. MSNA
  • 59. measurement in young adults with MDD has not been studied to our knowledge; therefore, due to the similarities between posttraumatic stress disorder (PTSD) and MDD, MSNA values were estimated from studies involving young adults with PTSD (Fonkoue, Marvar et al., 2018). Estimates of MSNA values during the DGSB+CPT and MM+CPT conditions were derived from both previous studies of MSNA recordings during both breathing patterns, and clinically significant MSNA values (Park et al., 2014; Fonkoue, Marvar et al., 2018). Means were estimated as the change score between a cold- pressor test and the DGSB+CPT condition, and the change score between a cold-pressor test and the MM+CPT condition. Accounting for a 70% success rate on peroneal nerve innervation and MSNA recording, a total of 25 subjects are needed to detect a 3 burst/min difference between DGSP and MM conditions with 80% power and an alpha level of 0.05. Experimental Approach Participants will arrive to the laboratory for one screening visit and two experimental visits. Each participant will be randomly allocated to the device-guided slow breathing or mindful meditation intervention for Experimental Day 1 using a random number generator. Each participant will participate in the opposite intervention for Experimental Day 2, and
  • 60. each experimental visit will be separated by at least 24 hours. Participants will be instructed to avoid exercise and alcohol consumption for 24 hours prior to the experimental visits, and abstain from food and caffeine 12 hours prior to the experimental visits. The screening visit will consist of basic health assessments and take about one hour. First, height weight, 7-site skinfold (body fat percent), blood pressure, heart rate and temperature will be taken. Then, the participant will complete a medical health history form to confirm the absence of any exclusion criteria. Women will also complete a urine pregnancy test to confirm absence of pregnancy. Last, the MINI international neuropsychiatric interview will be administered by a trained research member to determine the presence of depressive symptoms and absence of other mental illnesses. Lastly, a blood draw will be taken for assessment of a complete metabolic panel, lipid profile, and hemoglobin A1c. Both experimental visits are identical with only the intervention (device-guided slow breathing vs mindful meditation) during the cold pressor test varying. All participants will arrive to the laboratory in the morning having avoided exercise, alcohol, food, and caffeine as outlined above. After using the restroom, participants will lay supine and be instrumented
  • 61. with a tungsten microneurography electrode in the peroneal nerve for MSNA, the Finapres for beat-to-beat blood pressure, electrocardiograph electrodes for continuous heart rate and sinoatrial rhythms, and a respiratory belt to measure respiration rate. After instrumentation, 15 minutes of baseline MSNA, BP, HR, and respiration data will be collected. Following baseline, a “baseline” cold pressor test will be performed for 2 minutes to obtain baseline cardiovascular reactivity. Next, there will be 15 minutes of rest to ensure MSNA, BP, and HR return to resting levels. Lastly, participants will perform 15 minutes of device-guided slow breathing or guided mindful meditation. During the last 2 minutes of device guided slow breathing and mindful meditation, the participant will perform another CPT. Participants will be asked to measure their perceived stress on a scale of 1-10, with 1 being “not stressed at all”, to 10 being the “most stressed they’ve ever been”, after each CPT. MSNA, blood pressure, heart rate, respiratory rate, and ECG will be collected for the duration of the visit. A study schematic of the experimental visit can be found below in Figure 1. Figure 1. Schematic of the experimental visit. Abbreviations:
  • 62. electrocardiogram (ECG), blood pressure (BP), muscle sympathetic nerve activity (MSNA), heart rate (HR), cold pressor test (CPT), slow breathing (SB). 7-site skinfold is a validated measure of total body fat percentage. The method consists of gathering subcutaneous fat into a “pinch” and measuring the thickness (mm) of the pinch with calipers across 7 standardized sites of the body (chest, triceps, subscapular, superiliac, thigh, midaxillary, and abdominal). Each site is measured 2-3 times in a rotating fashion. The measures are then inserted into an algorithm established by the American College of Sports Medicine to produce a body fat percentage. Since the reliability of this method is dependent upon the individual performing the measure, one trained research personnel will complete the body composition portion of the experiment for all subjects. The MINI international neuropsychiatric interview is a short, structured interview (~15 minutes) with 16 modules assessing DSM-IV and ICD-10 psychiatric disorders. It has been validated in many clinical populations including those with MDD (Fantino & Moore, 2009; Sheehan et al., 1998). The MINI will be administered by a research team member who has received extensive training in the administration of this interview by a psychiatrist. The results from the MINI
  • 63. will be used to document MDD severity and determine depressive symptoms for the purpose of this study. A small amount of blood (~10 mL or ~2 teaspoons) will be drawn by a certified phlebotomist at the end of the screening visit. The blood specimens will then be sent to LabCorp to assess a complete metabolic panel (glucose, BUN, Chloride, Calcium, Albumin, Bilirubin, AST, Potassium, Alkaline Phosphatase, Sodium, Protein, Creatinine, BUN/Creatinine Ratio, Globulin, A/G ratio), lipid panel (total cholesterol, triglycerides, HDL cholesterol, Cholesterol/HDL ratio, LDL cholesterol, VLDL cholesterol), and hemoglobin A1c. All blood test results will be provided to the participant. Microneurography allows for the direct recording of efferent sympathetic nervous system activity in humans. Multiunit postganglionic MSNA will be recorded using standard techniques described within previous literature (Sundlof & Wallin, 1978; Vallbo et al., 1979). A wand-like device is used for external electrical stimulation to track the anatomy of the peroneal nerve. An active tungsten microelectrode and grounding reference electrode are inserted through the skin into the peroneal nerve and surround tissue, respectively, to directly measure sympathetic activity. The nerve signal will be
  • 64. amplified (70,000-fold), bandpass filtered (700-2,000 Hz), rectified, and integrated (time constant 0.1s) using a nerve traffic analyzer. Nerve signal of MSNA will be confirmed by lack of increase in afferent activity during light stroking of the skin and a confirmed increase in efferent burst frequency and spontaneous cardiac synchronous efferent bursts during voluntary end-expiratory apnea. The cold pressor test is an acute stress-evoking situation that accesses cardiovascular disease risk by measuring the amplitude of cardiovascular reactivity during the two minutes that the participants hand is submerged in the ice w ater. Carroll et al. (2012) showed the greater the amplitude of cardiovascular reactivity to an acute stressor, the lower the survival rates over the span of 20 years. Beat-to-beat blood pressure derived from finger plethysmography, continuous ECG derived heart rate, and MSNA activity will be recorded as cardiovascular reactivity for the duration of the cold pressor test. The greatest change in MSNA burst frequency, heart rate, and blood pressure from baseline measures will be used for data analysis. Water temperature will be between 0 and 4 degrees Celsius at the time of hand submersion. Device-guided slow breathing will be completed using the RESPeRATE system set to a respiration rate of 8 breaths/min for 15 minutes. Participants will be equipped with headphones
  • 65. in which the RESPeRATE system will instruct the Experimental Visit participant to inhale and exhale at a time interval congruous with 8 breaths/min. Respiration rate, blood pressure, heart rate, and MSNA will be recorded for the last 5 minutes of the intervention to ensure compliance and evaluate its cardiovascular effects. The cold pressor test will be employed during the last 2 minutes of device-guided slow breathing to assess its effects on cardiovascular reactivity. Data used for analysis will be derived similarly to the “baseline” cold pressor test. The change score between the “baseline” cold pressor test and the cold pressor test + device-guided slow breathing will be used for data comparisons. Mindful meditation will be completed using a pre-recorded 15- minute video. Participants will be equipped with headphones in which the mindful meditation video will instruct the participant to focus on sensations in the present moment while accepting their thoughts without judgement. Similar to the device-guided slow breathing intervention, respiration rate, blood pressure, heart rate, and MSNA will be recorded for the last 5 minutes of the intervention to ensure compliance and evaluate its cardiovascular effects. The
  • 66. cold pressor test will be employed during the last 2 minutes of mindful meditation to assess its effects on cardiovascular reactivity. Data used for analysis will be derived similarly to the “baseline” cold pressor test. The change score between the “baseline” cold pressor test and the cold pressor test + mindful meditation will be used for data comparisons. Scientific rigor will be upheld by implementing a series of practices in this within-subject design. First, random allocation of participants into interventions for Experimental Day 1 eliminates an “order effect”. MSNA is the gold-standard for measuring sympathetic nervous system activity as it is a direct measure of the sympathetic nervous system activity via the peroneal nerve. Beat-to-beat blood pressure via finger plethysmography is a validated and reliable measure (Schutte et al., 2004). In addition to its validity and reliability, the Finapres will be re-calibrated to two brachial artery pressures before each recording period ensuring appropriate calibration before recording data. Data analysts will be blinded as to which intervention group the data contains. Statistical analyses and sample size has been chosen a priori. Since participants are not able to be blinded as to which treatment they are receiving, this awareness is an inherit bias that will be acknowledged within the study findings.
  • 67. Statistical Analyses A sample size of 19 will detect a 3 bursts/min difference in MSNA burst frequency with 80% power and a significance level of 0.05. An additional 6 subjects will be recruited for a total sample size of 25 subjects to account for the 70% success rate of obtaining an MSNA reading. The statistical approach for data analysis will use a matched pairs t-test to assess differences in the change score of MSNA burst frequency from the “baseline” CPT and CPT paired with each breathing intervention. Matched pairs t-tests will also be used for comparing differences in change scores of respiratory rate, heart rate, blood pressure, and MSNA burst incidence. Data distributions will be assessed for symmetry; if distributions of variables are not symmetrical, then data will be compared using non-parametric statistical tests. Data will be reported as means ± standard deviation and significance will be set at an alpha of 0.05. Lastly, data will be presented as both change scores and absolute values for transparency. Anticipated Findings and Interpretation We anticipate that depressed young adults will have attenua ted MSNA burst frequency during the cold pressor test
  • 68. while practicing device-guided slow breathing or mindful meditation compared to the cold pressor test without a breathing or meditation intervention. Further, depressed young adults will show greater attenuations in MSNA burst frequency during mindful meditation compared to device-guided slow breathing. Regardless of the experimental outcomes, information gained from this study is essential to understanding increased cardiovascular disease risk and neurovascular dysfunction in adults with major depressive disorder. MDD is a pervasive disease in which 2/3 of its population is currently treatment resistant. If the anticipated findings within this study are confirmed, then mindful meditation may be useful to decrease cardiovascular reactivity during stressful situations for depressed young adults. These attenuations in cardiovascular reactivity may establish mindful meditation as a useful therapy to reduce CVD risk in those with depression, especially in those that are treatment resistant. Protection of Human Subjects Document Inclusion Criteria Inclusion criteria consists of those 18-35 years old and
  • 69. confirmation of depressive symptoms with a diagnostic interview. Exclusion Criteria Exclusion criteria consists of a mental illness aside from depression, any use of depression mediation, active suicidal/homicidal intent, active alcohol or drug dependence, an eating disorder, use of medication that could alter how the brain or cardiovascular system functions, cardiovascular, kidney, lung or metabolic disease, tobacco use, pregnancy, or amenorrhea (women). Those with any illnesses related to cardiovascular disease (i.e. high blood pressure, heart disease, or heart arrhythmias), history of frostbite, history of seizures, or history of Reynaud’s phenomenon are contraindicated for cold pressor test. Number of Subjects A total of 25 subjects will be recruited for this study. Sample size was calculated a priori using G-power. MSNA measurement in young adults with MDD has not been studied to our knowledge; therefore, due to the similarities between posttraumatic stress disorder (PTSD) and MDD, MSNA values were estimated from studies involving young adults with PTSD (Fonkoue, Marvar et al., 2018). Estimates of MSNA values during the DGSB+CPT and MM+CPT
  • 70. conditions were derived from both previous studies of MSNA recordings during both breathing patterns, and clinically significant MSNA values (Park et al., 2014; Fonkoue, Marvar et al., 2018). Means were estimated as the change score between a cold-pressor test and the DGSB+CPT condition, and the change score between a cold-pressor test and the MM+CPT condition. Accounting for a 70% success rate on peroneal nerve innervation and MSNA recording, a total of 25 subjects are needed to detect a 3 burst/min difference between DGSP and MM conditions with 80% power and an alpha level of 0.05. The recruitment of 25 subjects ensures adequate power for scientific data analysis while minimizing unnecessary and excessive recruitment. This prevents putting participants at unnecessary, although minimal, risk. Recruitment Participants will be recruited from the University of Texas at Arlington and the surrounding area through the use of flyers, email, social media, class presentations, and radio ads. Participation within the study is voluntary and participants are able to withdraw at any point. All information collected during recruitment will be confidential and discarded after their participation in the research study.
  • 71. Compensation and costs Participants will be compensated $25 per experimental visit for a total of $50 if both experimental visits are completed. This compensation amount adequately compensates for their time at a rate of about $15 /hour which is slightly higher than an hourly rate of a part-time job. The screening and experimental visits will be of no costs to participants, and participants will receive a copy of all laboratory results. Risks to subjects Microneurography: Microneurography is an accepted and safe research technique. The use of the wand-like device for external electrical stimulation to assess nerve anatomic tracking may cause minor discomfort. An active microelectrode and a grounding reference electrode will be inserted into the skin. There may be mild discomfort when the fine wire needle is inserted through the skin; however, the needle is very small. Brief sensations of pins and needles and/or cramping are likely to be felt during the nerve search. This needle will be left in place for the duration of the experimental visit (approximately 1.5 hours). There is also a small risk of infection at the site where the fine wire needle is inserted. While unlikely, there’s a risk of nerve damage from
  • 72. the procedure. Mini-International Neuropsychiatric Interview (M.I.N.I.): The MINI has been validated in many clinical populations including those with MDD. The MINI is a short, structured clinical interview (~15 minutes) that is used as a tool to identify people who may have particular experiences or forms of psychological distress useful for the purposes of this study. Subjects may feel uncomfortable about answering the questions. They are reminded that they may decline to answer the questions and leave the study at any time. Some subjects may be disturbed if the test recommends their inclusion in the depression group. They are reminded that the test is not intended to be a diagnosis or healthcare recommendation. Blood draw: There is a small risk of infection at the site where the needle is inserted. There may be some bruising and mild discomfort at the site where blood was drawn. Electrocardiogram: We attach three electrodes to the subject’s chest and attach electrode wires to a standard ECG machine. There have been no adverse effects from this measure. Participants may be shy with having the electrodes placed on their chest. The tape from the electrodes may temporarily redden or irritate the skin. Sensitivity to the tape is
  • 73. unlikely to produce long-term effects. Cold pressor test: The participants hand is placed in ice water (0-4 degrees Celsius) for 2 minutes. Their hand is likely to feel cold during the time it’s submerged. It’s unlikely to have any long-lasting effects from this test. The participant is reminded they may stop the test at any time. Medical Screening: This includes a typical medical exam (blood sample, height, weight, 7-site skinfold, blood pressure, heart rate) and medical health history performed by research personnel. Subjects may be uncomfortable with giving medical information or being measured. They will be reminded that their participation is voluntary and they may decline any measures. 7-Site Skinfold: 7 sites on the body are pinched and measured with calipers twice. The pinch may cause minor discomfort for 1-2 seconds and redness. Participants may be shy about having sites pinched and adipose tissue measured. Blood Pressure: Blood pressure is measured in accordance to the American Heart Association guidelines. During the short time the cuff is inflated, the participants arm may feel numb or tingly. The finapres finger cuff may cause their finger to become number or tingly over time. The cuff can be
  • 74. moved to a different finger to minimize this feeling. Confidentiality: There is a risk of loss of confidentiality if the subjects information or identity is obtained by someone other than the investigators, but precautions will be taken to prevent this from happening. The confidentiality of electronic data created by the participant or researchers will be maintained to the degree permitted by the technology used. Absolute confidentiality cannot be guaranteed. Strategies to minimize risks Microneurography: The microneurography procedure will be immediately discontinued if the subject experiences excessive discomfort. The nerve search will be limited to 45 minutes as the risk of symptoms during or after microneurography are minimized when the search is not over 60 minutes; therefore, the nerve search will never be over 60 minutes. Mini-International Neuropsychiatric Interview (M.I.N.I.): Participants are reminded that they may decline to answer the questions and leave the study at any time. We remind participants that the test is not intended to be a diagnosis or healthcare recommendation. A protocol is implemented to adequately respond to those who are in distress by creating
  • 75. walk-in appointments with the Counseling and Psychological Services at the University of Texas at Arlington. Lastly, a list of local mental healthcare providers will be provided to all participants in the study, regardless of their MINI results. Blood Draw: Participants may decline a blood draw. All blood draws will be completed by phlebotomy certified personnel. Sterile supplies and techniques are used to minimize infection risks, and participants will be in a semi- recumbent position when blood is drawn. Electrocardiogram: Electrocardiogram leads are carefully removed after the experiment. The test is conducted professionally and privately, and the participant may request that the research personnel performing the test be of the same gender. Cold Pressor Test: The cold pressor test will be immediately discontinued if the subject experiences excessive discomfort. The participant’s hand is dried and warmed immediately after the end of the test. Medical Screening: All medical information will be collected in a private and professional manner, and participants may decline to answer questions or participate in measures. Research personnel will ensure subjects meet all inclusion and exclusion criteria to minimize risk to participants. The
  • 76. participant may request someone of the same gender to conduct parts of the screening. 7-Site Skinfold: The measurement will be taken efficiently to minimize the amount of time the participant is “pinched”. The participant may decline the 7-site skinfold measure, or request someone of the same gender to conduct the measure. Blood Pressure: The measurement will be taken efficiently to minimize that amount of time the cuff is inflated on the arm. Finapres finger cuffs will be alternated between two fingers every 20 minutes to give the other finger a rest. Confidentiality: All paper and electronic data collected from this study will be stored in the investigator’s lab for at least three years after the end of this research. Participants will be provided with a unique subject code identifier that does not contain any personal information. All measures will be labeled with this unique code identifier. Paper data collected from this study is stored in a locked file cabinet behind two locked entrances, and only research personnel will have access to the data. Additionally, we have obtained a Certificate of Confidentiality from the National Institutes of Health. With this certificate, we can’t be forced by a court order or subpoena to disclose information that could identify the
  • 77. participant in any civil, criminal, administrative, legislative or other proceeding. Possibility for coercion or undue influence Participants will be compensated $25 per experimental visit for a total of $50 if both experimental visits are completed. This amount adequately compensates for their time at a rate of about $15 /hour which is slightly higher than an hourly rate of a part-time job without coercion or undue influence. EH&S considerations All research personnel are up to date on trainings in Biomedical Human Subjects Research (CITI), Good Clinical Practice (CITI), Bloodborne Pathogens, Biosafety Level 2, and Hazard Communication and Waste Management. All materials used for blood draws and blood processing will be immediately and properly disposed of in biohazard reciprocal bins. All research personnel involved with the blood draw and blood processing will be dressed in long pants, closed toed shoes, lab coat, and latex gloves. Needles involved with the blood draw and microneurography measures will be disposed of within sharps disposal containers. Direct benefits to subjects
  • 78. Participants will receive financial compensation and the medical screening provides information about their physical well-being. They receive a complete metabolic panel, lipid panel, and hemoglobin A1c levels in addition to their blood pressure and heart rate. This is important health information to use as a “baseline” measure for participants, or the knowledge of high blood pressure and cholesterol levels is important as they contribute to many health problems. Participants are also educated on the connection between MDD and CVD, and whether mindful meditation or slow breathing will be beneficial techniques to use for their own physical or mental health. Overall benefits Overall, this project will provide direct benefits to the subjects, undergraduate and graduate students, and will contribute to the field of neurovascular dysfunction in regards to those with major depressive disorder. Further, the study may provide insight into alternative therapies for reducing cardiovascular disease risk in those with MDD. In regards to undergraduate and graduate students, the study provides valuable experience, education, and partial fulfillment of degree-work at the University of Texas at Arlington. Subject Privacy
  • 79. All subject data will remain anonymous as all measures will be labeled with a random, unique code identifier assigned to them. All information collected during recruitment will be confidential and discarded after their participation in the research study. Participants are able to decline any measures or not answer questions regarding their medical or mental health history. Participants are also able to request that a research member of the same gender perform measures at the screening or experimental visits. Confidentiality and Data Security There is a risk of loss of confidentiality if the subjects information or identity is obtained by someone other than the investigators, but precautions will be taken to prevent this from happening. The confidentiality of electronic data created by the participant or researchers will be maintained to the degree permitted by the technology used. Absolute confidentiality cannot be guaranteed. All paper and electronic data collected from this study will be stored in the investigator’s lab for at least three years after the end of this research. Participants will be provided with a unique subject code identifier that does not contain any personal information; therefore, all data collected will be deidentified. All measures will be labeled with this unique code identifier.
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