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Developing and Testing a New Model
to Reduce Risk for Heart Disease
and Stroke
Project Update
- May 24, 2016 -
PI: Ruth Lindquist, PhD, RN, FAAN, Professor
University of Minnesota, School of Nursing
Partner: National USA Foundation, Inc. (NUFI)
Rev./Dr. LB West, Mount Airy Baptist Church, Washington, D.C.
Conceptual Model
↑Awareness
Education
↑Activation
Ready to
change
Demonstrated
commitment
(run-in)
↑Awareness
Effort to
change
Outcomes
↑Knowledge
Improved health behaviors
“Simple 7” goals achieved
Reduced CVD risk
↓Community
CVD risk of
AA men
Goal
setting
Education Inspiration Ongoing
Feedback
“tracking”
Peer
support
Advice
Community
CVD risk
of AA men
Peer Group
vs. Education
Group
Accountability
Peer Group
Processes
Feasibility
Safety
Pot. Efficacy
Protocol &
Design
Refinements
Next Grant
Personal risk
(screening)
Follow-up
Study Aim
Aim 1. Determine the feasibility of a six-month psycho-educational peer
group intervention to reduce risk factors for CVD and stroke. Feasibility
will be assessed by the degree of completion of the four phases of the
intervention and the protocol-relevant activities including: screening for
risks; run-in of one month of weekly blood pressure checks; recruitment
of two groups of 6 men for the 6-month program at each church; delivery
of a program of counseling and behavior change; distribution and use of
activity monitors and smart phones to monitor and share activity, sleep,
and nutritional intake; engagement in mutual peer support; completion of
study measures; and achievement of short-term goals set within peer
groups for behavior change.
Intervention Model Phases
Phase I
Education
Video
Presentation
Phase II
Health
Screening
Health
activation will
be assessed
Consent and
Measures
Phase III
Blood
Pressure
Run-In
3-week Blood
pressure check
Recruit to
enroll in the 6-
month program
Phase IV
6-month small
group support,
education, and
behavioral
change
Weekly -> Bi-
weekly ->
Monthly
Phase V
Follow-up
2 month after
the end of
Phase IV
Approach
Subjects and Setting – Performance sites
Research Design
Research Progress
2Participants Enrollment (n)
Minneapolis Washington DC Total
Phase I
(Education)
5 19 24
Phase II
(Screening)
20 15 35
Phase III
(Run-In)
13 12 25
Phase IV
(Peer Group)
13 12 25
Update
• Sample (N=52): New Salem (n=24) and Mount Airy (n=28);
(1 withdrawl).
• Peer Group (N=16): (n=9) and (n=8). Individuals (N=7):
(n=3) and (n=4).
• Phase IV: Week 8 and Week 12 (136 pages of group
process transcripts to date).
Study Aim
Aim 2: To implement and revise the peer group
intervention protocol.
Study Aim
Aim 3. Determine the effect size of the peer
group intervention on outcomes of risk
reduction.
Measures
I. Primary Outcome Measures
(Life’s Simple 7)
Total
Cholesterol
Blood
Pressure
Blood
Glucose
Physical
Activity
Health diet
score
Obesity Smoking
Productivity
Primary Outcome for a Pilot Study to Reduce Risk Factors for Heart Disease and
Stroke for African American Men: American Heart Association’s Life’s Simple 7.
Using wearable fitness and mobile technologies to augment behavior change and
reduce cardiovascular (CVD) risk among African American (AA) men.
Developing, a New Model to Prevent Heart Disease and Stroke:
Challenges and Lessons Learned.
Discrepancy between Self-Report and Objective Assessments of Cardiovascular
Risk in a Pilot Study to Reduce Risks for Heart Disease and Stroke
of African American Men.
Evaluation: Church Leadership
• I think it’s going great, to see the men getting
excited about their health…to the extent their
diet is changing and they’re exercising.
• The men continue to be mega-excited. We’re
seeing physical results and they continue
supporting one another. I believe their pledge
is to continue their journey even beyond the
study.
Evaluation: Facilitator
• “My only comment at this time would be that
when we get an individual’s attention on
risks and ultimate consequences of negative
lifestyles, they pay attention and are willing
to change. In other words, the myth that
individuals are so set in their ways that they
don’t desire to change, particularly AA men,
is proving not to be true.”
Evaluation: Investigator
“It’s working!”
“There is a notable shift of engagement of
participants in the group and daily decisions
impacting their health. There is
accountability, self-responsibility, and self-
regulation. Men are examining and
discussing what they do, shouldn’t do,
should do and what they could do better”..
Preliminary Qualitative Analysis
Peer group transcripts: Men are taking personal responsibility
and integrating new information that they are discovering on
their own. They are making judgments and tailoring
information to their own needs/lifestyle/response. They are
helping each other, spreading their wisdom regarding salutary
lifestyle choices to their families and members of the church,
and making plans for long-term continuance. They are
shopping differently, packing food, and eating out less, cutting
“hidden” calories, salt, preservatives, and speaking about
“choices,” goals and “balance.” There is tremendous growth in
understanding lifestyle impact on health in the group.
Audio Recording, Transcription and Qualitative Text:
The Long Road
• “When I first started losing weight I enjoyed it. Now
all things coming down. Blood pressure is down.
Blood sugars lower.”
• “Walking is my main goal. My blood pressure looks
better. Not where I want to be. 120/80 is where I
want it to be. I know I can do better. I know that we
are closer to that 7 thing.”
Transcript text (cont.)
• “What goes in affects our entire
body…again…when we know better…we do
better.”
• “I started eating more multigrain…so that was one
thing…and because of the FitBit…I am more
conscious of that [physical activity].”
• “I ate spinach for the first time”…
Transcript text (cont.)
• “I lost 8 to 10 pounds”… “pants getting loose”…
• “When I think that I am all balanced, I eat a
salad…Thursday, I just walked away … that fried
chicken”…
• …”he was here to preserve his body... To do what
he was put on earth to do.”
• “Cuz it all works together. The way I got my mind
set up now. What I put into my body, I figure how
long it takes me to burn it off.”
Transcript text (cont.)
• … “We will be losing…getting that pressure
right…we gotta eat different”…
• “I might try that. I like chicken…I gotta try more
fish”…
• “Since we come here, I been cookin’ …I’m starting
to cook”…
• … “remove that skin first…I like the shake’n bake;
I’m trying not to eat that fried chicken.”
Transcript text (cont.)
• “Peach Cobbler…I didn’t get any of that…I asked
them not to give you any of that…some people ate
peach cobbler and the cake…I had a small portion.”
• … “My blood pressure is better when I sleep”…
• “We plan our meals…now we are planning healthy
meals…you can get a container…you can get a
portion…you can measure your meals…some
people do it…cut up their chicken for the rest of the
week”…
Transcript text (cont.): Facilitators
• “So I will give you a challenge…at least two
salads…without any type of dressing on it…2 this
week. In terms of beverages…water only” …
[coffee, black, permitted].
• “One cupcake…it usually takes me 20-30 minutes
to burn it off. I become more conscious. You want
to start monitoring. The guys are journaling…and
hopefully, next week I’m gonna cook for you all.
And it will be probably no more than 300 calories.”
Project Summary Highlights
• Screening results
• Congregational interest
• Wives/friends are helping
• Thinking about & finding new ways to be active (choosing more activity)
• Food interest/knowledge exploding (actively choosing to eat better: Cut
sodas; Cut sweets; Cut salt)
• Experimenting; making connections
• Learning from each other; active observing/modeling
• Planning ahead (eating and activity)
• 2 men needed to purchase new pants; more reporting weight loss.
• “Transportable”
Discussion & Next Steps (cont.)
Contemplated Manuscripts and Presentations
1. Primary Outcomes (feasibility and effect size)
2. The Long Road to Behavior Change (qualitative)---AHA
3. Literature review Life’s Simple 7 for AA men
4. Literature review technology use for AA men
5. Lessons Learned
6. Developing a New Model to Reduce Heart Disease and
Stroke in AA Men
Contemplated Grants
1. AHA Innovative Research Grant
2. PA-13-331 Health Promotion among Racial and Ethnic
Minority Males (R21)
Discussion/Next Steps (cont.)
• Challenges
• Facilitators
• No-cost extension
• Follow-up
• Design
• Population

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Developing and Testing a New Model to Reduce Heart Disease and Stroke

  • 1. Developing and Testing a New Model to Reduce Risk for Heart Disease and Stroke Project Update - May 24, 2016 - PI: Ruth Lindquist, PhD, RN, FAAN, Professor University of Minnesota, School of Nursing Partner: National USA Foundation, Inc. (NUFI) Rev./Dr. LB West, Mount Airy Baptist Church, Washington, D.C.
  • 2. Conceptual Model ↑Awareness Education ↑Activation Ready to change Demonstrated commitment (run-in) ↑Awareness Effort to change Outcomes ↑Knowledge Improved health behaviors “Simple 7” goals achieved Reduced CVD risk ↓Community CVD risk of AA men Goal setting Education Inspiration Ongoing Feedback “tracking” Peer support Advice Community CVD risk of AA men Peer Group vs. Education Group Accountability Peer Group Processes Feasibility Safety Pot. Efficacy Protocol & Design Refinements Next Grant Personal risk (screening) Follow-up
  • 3. Study Aim Aim 1. Determine the feasibility of a six-month psycho-educational peer group intervention to reduce risk factors for CVD and stroke. Feasibility will be assessed by the degree of completion of the four phases of the intervention and the protocol-relevant activities including: screening for risks; run-in of one month of weekly blood pressure checks; recruitment of two groups of 6 men for the 6-month program at each church; delivery of a program of counseling and behavior change; distribution and use of activity monitors and smart phones to monitor and share activity, sleep, and nutritional intake; engagement in mutual peer support; completion of study measures; and achievement of short-term goals set within peer groups for behavior change.
  • 4. Intervention Model Phases Phase I Education Video Presentation Phase II Health Screening Health activation will be assessed Consent and Measures Phase III Blood Pressure Run-In 3-week Blood pressure check Recruit to enroll in the 6- month program Phase IV 6-month small group support, education, and behavioral change Weekly -> Bi- weekly -> Monthly Phase V Follow-up 2 month after the end of Phase IV
  • 6. Subjects and Setting – Performance sites Research Design
  • 7. Research Progress 2Participants Enrollment (n) Minneapolis Washington DC Total Phase I (Education) 5 19 24 Phase II (Screening) 20 15 35 Phase III (Run-In) 13 12 25 Phase IV (Peer Group) 13 12 25
  • 8. Update • Sample (N=52): New Salem (n=24) and Mount Airy (n=28); (1 withdrawl). • Peer Group (N=16): (n=9) and (n=8). Individuals (N=7): (n=3) and (n=4). • Phase IV: Week 8 and Week 12 (136 pages of group process transcripts to date).
  • 9. Study Aim Aim 2: To implement and revise the peer group intervention protocol.
  • 10. Study Aim Aim 3. Determine the effect size of the peer group intervention on outcomes of risk reduction.
  • 11. Measures I. Primary Outcome Measures (Life’s Simple 7) Total Cholesterol Blood Pressure Blood Glucose Physical Activity Health diet score Obesity Smoking
  • 12. Productivity Primary Outcome for a Pilot Study to Reduce Risk Factors for Heart Disease and Stroke for African American Men: American Heart Association’s Life’s Simple 7. Using wearable fitness and mobile technologies to augment behavior change and reduce cardiovascular (CVD) risk among African American (AA) men. Developing, a New Model to Prevent Heart Disease and Stroke: Challenges and Lessons Learned. Discrepancy between Self-Report and Objective Assessments of Cardiovascular Risk in a Pilot Study to Reduce Risks for Heart Disease and Stroke of African American Men.
  • 13. Evaluation: Church Leadership • I think it’s going great, to see the men getting excited about their health…to the extent their diet is changing and they’re exercising. • The men continue to be mega-excited. We’re seeing physical results and they continue supporting one another. I believe their pledge is to continue their journey even beyond the study.
  • 14. Evaluation: Facilitator • “My only comment at this time would be that when we get an individual’s attention on risks and ultimate consequences of negative lifestyles, they pay attention and are willing to change. In other words, the myth that individuals are so set in their ways that they don’t desire to change, particularly AA men, is proving not to be true.”
  • 15. Evaluation: Investigator “It’s working!” “There is a notable shift of engagement of participants in the group and daily decisions impacting their health. There is accountability, self-responsibility, and self- regulation. Men are examining and discussing what they do, shouldn’t do, should do and what they could do better”..
  • 16. Preliminary Qualitative Analysis Peer group transcripts: Men are taking personal responsibility and integrating new information that they are discovering on their own. They are making judgments and tailoring information to their own needs/lifestyle/response. They are helping each other, spreading their wisdom regarding salutary lifestyle choices to their families and members of the church, and making plans for long-term continuance. They are shopping differently, packing food, and eating out less, cutting “hidden” calories, salt, preservatives, and speaking about “choices,” goals and “balance.” There is tremendous growth in understanding lifestyle impact on health in the group.
  • 17. Audio Recording, Transcription and Qualitative Text: The Long Road • “When I first started losing weight I enjoyed it. Now all things coming down. Blood pressure is down. Blood sugars lower.” • “Walking is my main goal. My blood pressure looks better. Not where I want to be. 120/80 is where I want it to be. I know I can do better. I know that we are closer to that 7 thing.”
  • 18. Transcript text (cont.) • “What goes in affects our entire body…again…when we know better…we do better.” • “I started eating more multigrain…so that was one thing…and because of the FitBit…I am more conscious of that [physical activity].” • “I ate spinach for the first time”…
  • 19. Transcript text (cont.) • “I lost 8 to 10 pounds”… “pants getting loose”… • “When I think that I am all balanced, I eat a salad…Thursday, I just walked away … that fried chicken”… • …”he was here to preserve his body... To do what he was put on earth to do.” • “Cuz it all works together. The way I got my mind set up now. What I put into my body, I figure how long it takes me to burn it off.”
  • 20. Transcript text (cont.) • … “We will be losing…getting that pressure right…we gotta eat different”… • “I might try that. I like chicken…I gotta try more fish”… • “Since we come here, I been cookin’ …I’m starting to cook”… • … “remove that skin first…I like the shake’n bake; I’m trying not to eat that fried chicken.”
  • 21. Transcript text (cont.) • “Peach Cobbler…I didn’t get any of that…I asked them not to give you any of that…some people ate peach cobbler and the cake…I had a small portion.” • … “My blood pressure is better when I sleep”… • “We plan our meals…now we are planning healthy meals…you can get a container…you can get a portion…you can measure your meals…some people do it…cut up their chicken for the rest of the week”…
  • 22. Transcript text (cont.): Facilitators • “So I will give you a challenge…at least two salads…without any type of dressing on it…2 this week. In terms of beverages…water only” … [coffee, black, permitted]. • “One cupcake…it usually takes me 20-30 minutes to burn it off. I become more conscious. You want to start monitoring. The guys are journaling…and hopefully, next week I’m gonna cook for you all. And it will be probably no more than 300 calories.”
  • 23. Project Summary Highlights • Screening results • Congregational interest • Wives/friends are helping • Thinking about & finding new ways to be active (choosing more activity) • Food interest/knowledge exploding (actively choosing to eat better: Cut sodas; Cut sweets; Cut salt) • Experimenting; making connections • Learning from each other; active observing/modeling • Planning ahead (eating and activity) • 2 men needed to purchase new pants; more reporting weight loss. • “Transportable”
  • 24. Discussion & Next Steps (cont.) Contemplated Manuscripts and Presentations 1. Primary Outcomes (feasibility and effect size) 2. The Long Road to Behavior Change (qualitative)---AHA 3. Literature review Life’s Simple 7 for AA men 4. Literature review technology use for AA men 5. Lessons Learned 6. Developing a New Model to Reduce Heart Disease and Stroke in AA Men Contemplated Grants 1. AHA Innovative Research Grant 2. PA-13-331 Health Promotion among Racial and Ethnic Minority Males (R21)
  • 25. Discussion/Next Steps (cont.) • Challenges • Facilitators • No-cost extension • Follow-up • Design • Population