PIIS2212267214015895

RESEARCH
Original Research
The Effectiveness of Two Community-Based
Weight Loss Strategies among Obese,
Low-Income US Latinos
Lisa Goldman Rosas, MPH, PhD; Sreedevi Thiyagarajan, MS; Benjamin Alan Goldstein, MPH, PhD; Rebecca Lucia Drieling, MPH, MMQ;
Priscilla Padilla Romero, MPH, MPP; Jun Ma, MD, PhD; Veronica Yank, MD; Randall Scott Stafford, MD, PhD
ARTICLE INFORMATION
Article history:
Accepted 23 September 2014
Available online 8 January 2015
Keywords:
Weight loss
Obesity
Randomized Controlled Trial
Hispanic Americans
Community Health Workers
Supplementary materials:
Table 1 is available online at www.andjrnl.org
2212-2672/Copyright ª 2015 by the Academy of
Nutrition and Dietetics.
http://dx.doi.org/10.1016/j.jand.2014.10.020
ABSTRACT
Background Latino immigrants have high rates of obesity and face barriers to weight loss.
Objective To evaluate the effectiveness of a case-management (CM) intervention with
and without community health workers (CHWs) for weight loss.
Design This was a 2-year, randomized controlled trial comparing two interventions
with each other and with usual care (UC).
Participants/setting Eligible participants included Latinos with a body mass index of
30 to 60 and one or more heart disease risk factors. The 207 participants recruited
during 2009-2010 had a mean age of 47 years and were mostly women (77%). At 24
months, 86% of the sample was assessed.
Intervention The CMþCHW (n¼82) and CM (n¼84) interventions were compared with
each other and with UC (n¼41). Both included an intensive 12-month phase followed by
12 months of maintenance. The CMþCHW group received home visits.
Main outcome measures Weight change at 24 months.
Statistical analyses Generalized estimating equations using intent-to-treat.
Results At 6 months, mean weight loss in the CMþCHW arm was À2.1 kg (95% CI À2.8
to À1.3) or À2% of baseline weight (95% CI À1% to À2%) compared with À1.6 kg (95% CI
À2.4 to À0.7; % weight change, À2%, À1%, and À3%) in CM and À0.9 kg (95% CI À1.8 to
0.1; % weight change, À1%, 0%, and À2%) in UC. By 12 and 24 months, differences
narrowed and CMþCHW was no longer statistically distinct. Men achieved greater
weight loss than women in all groups at each time point (P<0.05). At 6 months, men in
the CMþCHW arm lost more weight (À4.4 kg; 95% CI À6.0 to À2.7) compared with UC
(À0.4 kg; 95% CI À2.4 to 1.5), but by 12 and 24 months differences were not significant.
Conclusions This study demonstrated that incorporation of CHWs may help promote
initial weight loss, especially among men, but not weight maintenance. Additional
strategies to address social and environmental influences may be needed for Latino
immigrant populations.
J Acad Nutr Diet. 2015;115:537-550.
T
HE 51 MILLION LATINOS IN THE UNITED STATES ARE
disproportionately represented among Americans
with a high body mass index (BMI), with 79% at
least overweight and 39% obese.1
The high preva-
lence of obesity is a critical public health issue due to high
costs associated with treating obesity-related diseases2
such as type 2 diabetes mellitus and coronary heart dis-
ease. As the largest and fastest growing US minority
group,3
efforts to address obesity in US Latinos should
include effective strategies tailored to this population. Un-
fortunately, effective strategies for weight loss in Latinos
have yet to be developed and rigorously tested.
Modest weight reductions (5% to 10% of initial weight) are
sufficient to reduce the incidence of type 2 diabetes and the
risk of coronary heart disease events.4
The US Preventive
Services Task Force recommends individually adapted
behavioral interventions to achieve and maintain such
weight loss. Intensive (ie, 12 to 26 sessions per year) case
management models that integrate lifestyle interventions
and multiple risk factor reduction appear to be effective.5
The
Diabetes Prevention Program (DPP) study demonstrated that
a case management-based intensive lifestyle intervention
was effective in reducing the occurrence of type 2 diabetes
and facilitating weight loss among adults at high risk for
progression to type 2 diabetes.6
Evidence for the effective-
ness of these interventions among Latinos is limited7-9
and
there is a vital need to evaluate intensive lifestyle in-
terventions in this population.
Latinos face social and environmental barriers to weight
loss that are not adequately addressed by existing behavioral
interventions. Latinos are more likely to live in poverty, lack
health insurance, have limited opportunities for physical
activity, and experience food insecurity compared with their
non-Latino white peers.10-12
Latino immigrants may face
ª 2015 by the Academy of Nutrition and Dietetics. JOURNAL OF THE ACADEMY OF NUTRITION AND DIETETICS 537

additional barriers related to acculturation, language,13
and
immigration status. Community health workers (CHWs) have
been shown to be particularly effective for other health issues
among Latinos.14
This strategy may be well suited to over-
coming the social, cultural, and environmental barriers to
weight loss, but has not been rigorously tested for this
purpose.
The Vivamos Activos Fair Oaks (VAFO) clinical trial was
designed to evaluate the effect of intensive lifestyle in-
terventions for weight loss in Latino immigrants and to
determine whether CHWs provide additional benefits.
A community-based program, VAFO tested a health educator
case management approach to weight loss with and without
added CHW support. Primary (weight loss) and secondary
(cardiovascular risk factors) outcomes were compared for the
two lifestyle interventions to each other and to a usual care
group over 24 months of follow-up. Longer than most pub-
lished weight loss trials, a 2-year follow-up allows for sepa-
rating shorter-term active weight loss from longer-term
maintenance of behavior change. An additional aim was to
investigate sex differences inweight loss and maintenance. We
hypothesized that the case management with CHW augmen-
tation would produce greater weight loss in Latino immigrants
compared with case management alone and usual care.
METHODS
Recruitment and Participants
VAFO was developed as a community-based randomized
controlled trial comparing two weight loss interventions to
each other and to a usual care control group. The study design
and methods have been published previously.15
Eligible par-
ticipants were recruited from the Fair Oaks Clinic between
September 2009 and October 2010. The Fair Oaks Clinic, a
satellite community health centerof the San Mateo County, CA,
health system (SMMC), is the primary health care provider for
North Fair Oaks, a 14,700-person, low-income, and largely
Latino (73%) unincorporated neighborhood.16
Spanish-
speaking male and female patients using the clinic and
residing in the neighborhood were eligible to participate if
they had a BMI of 30 to 60 and one or more coronary heart
disease risk factors (eg, systolic blood pressure 130 to 200 mm
Hg, diastolic blood pressure 80 to 105 mm Hg, total cholesterol
>180 mg/dL [4.65 mmol/L], low-density lipoprotein choles-
terol >120 mg/dL [3.10 mmol/L], high-density lipoprotein
cholesterol <40 mg/dL [1.03 mmol/L] for men and <50 mg/dL
[1.29 mmol/L] for women, triglycerides >150 mg/dL [1.70
mmol/L], gylcated hemoglobin 6.0% to 11.5%, fasting plasma
glucose 95 to 400 mg/dL [5.27 to 22.20 mmol/L], or diagnosis of
type 2 diabetes). Patients unwilling to attempt weight loss;
those with serious, unstable medical conditions or other cir-
cumstances that would inhibit engagement in the intervention
or retention over the 2 years of follow-up (ie, uncontrolled
psychiatric disorders, advanced heart failure, uncontrolled
substance abuse, pregnant, planned move, or refusal of home
visits) were excluded from the study. Of 427 individuals who
were screened, 387 (91%) were eligible, and 207 (53%) con-
sented to participate (see the Figure). Individuals were iden-
tified for screening by provider referral, medical record review,
and through outreach in the clinic and the community.
Institutional review boards of both Stanford University and
SMMC approved study procedures and materials and all
participants provided written informed consent. The trial is
registered with ClinicalTrials.gov (identifier: NCT01242683).
The trial was conducted in compliance with the Health
Insurance Portability and Accountability Act and was over-
seen by a Data Safety and Monitoring Board composed of
researchers with relevant expertise, but without ties to the
study investigators and lacking conflicts of interest. Adverse
events were classified as to seriousness, relationship to the
study, and whether they were expected. All serious events
(largely hospitalizations) were urgently reviewed by the
principal investigator, including an assessment of possible
relationship to the study protocol.
Randomization and Blinding
Separate blocks based on the permutations of sex, BMI (30 to
34.9, 35 to 39.9, or >40), and type 2 diabetes status (yes or
no) were used to allocate participants to one of three study
arms: usual care (UC), case management (CM), or case
management plus CHW support (CMþCHW). To maximize
the proportion of participants receiving an active interven-
tion and the statistical power available to compare the two
active interventions, 40% were randomized to CM, 40% to
CMþCHW, and 20% to UC. A biostatistician performed all
randomizations. Randomization resulted in the following
allocation: CMþCHW (n¼82), CM (n¼84), and UC (n¼41).
The total sample size was based on achieving a statistical
power of 80% for detecting a 4.5% difference in weight loss
from baseline (eg, À2.5% weight loss in CM vs þ2.0% weight
gain in UC) based on a two-tailed P value of 0.05 accounting
for the three pertinent statistical contrasts (CM vs CMþCHW,
CM vs UC, and CMþCHW vs UC).15
A 2.5% weight loss
translates to approximately 5 lb weight loss for a 200-lb
person. Data collection staff was blinded to treatment
assignment.
Interventions
The CM and CMþCHW interventions originated from the
DPP.6
The investigators’ previous Heart to Heart trial,17
based
in San Mateo County and including the Fair Oaks Clinic, was
key to the tailoring of a weight-loss interventions to the
organizational needs of SMMC and the sociocultural realities
of the population. As in DPP and Heart to Heart trial,
the interventions employed Social Cognitive Theory and
the Transtheoretical Model of Behavior Change.18,19
Key
interventional approaches in the case-management inter-
vention included motivational interviewing, building self-
management, and goal-setting skills, providing hands-on
cooking and physical activity demonstrations, fostering self-
efficacy, leveraging group-based social support, identifying
community resources, and coordinating with primary care
providers. Additional CHW approaches integrated with CM
activities included building broad skills for navigating an
obesogenic environment, fostering family support, enhancing
participant success in food negotiations, mapping out
neighborhood walking routes, and engaging participants in a
modified photovoice activity. The modified photovoice
activity engaged participants to take pictures of their food
and physical activity and then the CHW used the pictures as
triggers for goal setting and problem solving. Significant
community engagement preceded our pilot testing of our
adaptations of the previous interventions for the local
RESEARCH
538 JOURNAL OF THE ACADEMY OF NUTRITION AND DIETETICS April 2015 Volume 115 Number 4

neighborhood. Intervention fidelity was ensured through
in-depth staff training, weekly staff debriefing sessions, and
an external evaluation. Interventionists for the CM and CHW
components were all bilingual and bicultural and underwent
approximately 100 hours of training before implementation,
which included facilitation observation with feedback.
Weekly debriefing sessions with interventionists enabled
staff to continuously evaluate and provide feedback on
intervention fidelity. Consistency and quality of intervention
delivery was assessed by an external evaluator using a
structured observation form. Intervention fidelity was further
ensured through high continuity of interventionists over the
study period with three group session facilitators, one case
manager, and one community health worker.
The CM and CMþCHW interventions included an intensive
phase for the first 12 months (with even greater initial
intensity) followed by a 12-month maintenance phase. The
CM intervention included 12 groups sessions and four indi-
vidual sessions in the intensive phase with three group ses-
sions and one individual session in the maintenance phase.
Randomized participants were grouped into cohorts to
attend group sessions sequentially together. The time from
randomization to the first group session varied and ranged
from immediately following randomization to 3 months
following randomization. In a minority of cases, a participant
joined an existing cohort if it worked for his or her schedule
and only one session had been missed. Participants were
encouraged to attend group sessions in their assigned cohort;
however, they were able to attend any available group ses-
sion. The session topics have been published previously.15
Each group session lasted approximately 2 hours and
included nutrition and physical activity components, activ-
ities to promote goal setting and social support, and tools to
improve implementation of skills taught in the classes. The
Figure. Participant flow diagrams for the Vivamos Activos Fair Oaks Study (N¼207).
RESEARCH
April 2015 Volume 115 Number 4 JOURNAL OF THE ACADEMY OF NUTRITION AND DIETETICS 539

Table 2. Baseline demographic and clinical characteristics of randomized participants in Vivamos Activos Fair Oaks study
(N¼207), by randomized arm
Characteristic
All
(N[207)
CMa
(n[84)
CMDCHWb
(n[82)
UCc
(n[41) P valued
ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒn (%)ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ!
Sex
Male 48 (23.2) 20 (23.8) 19 (23.2) 9 (22.0) 0.97
Female 159 (76.8) 64 (76.2) 63 (76.8) 32 (78.0)
Schooling
Eighth grade or less 140 (67.6) 59 (70.2) 50 (61.0) 31 (75.6) 0.45
Some high school 24 (11.6) 10 (11.9) 10 (12.2) 4 (9.8)
High school graduate or more 43 (20.8) 15 (17.9) 22 (26.8) 6 (14.6)
Employment status
Employed 97 (46.9) 38 (45.2) 38 (46.3) 21 (51.2) 0.87
Unemployed 21 (10.1) 7 (8.3) 10 (12.2) 4 (9.8)
Not working 89 (43.0) 39 (46.4) 34 (41.5) 16 (39)
Annual income ($)
<10,000 58 (28.0) 25 (29.8) 22 (26.8) 11 (26.8)
10,000-20,000 92 (44.4) 39 (46.4) 34 (41.5) 19 (46.3) 0.84
>20,000 56 (27.1) 19 (22.6) 26 (31.7) 11 (26.8)
Country of birth
Mexico 159 (76.8) 62 (75.6) 66 (78.6) 31 (75.6) 0.88
Othere
48 (23.2) 20 (24.4) 18 (21.4) 10 (24.4)
Diabetes mellitus type 2 89 (43.0) 37 (44.0) 34 (41.5) 18 (43.9) 0.94
Depressed (CESDf
>9) 65 (31.4) 30 (35.7) 26 (31.7) 9 (22.0) 0.30
Obesity-related impairmentg
Mild 116 (56.0) 54 (64.3) 39 (47.6) 23 (56.1) 0.17
Moderate 30 (14.5) 10 (11.9) 12 (14.6) 8 (19.5)
Severe 61 (29.5) 20 (23.8) 31 (37.8) 10 (24.4)
Self-perceived healthh
Very good 22 (10.6) 6 (7.1) 11 (13.4) 5 (12.2) 0.03*
Good 85 (41.1) 30 (35.7) 42 (51.2) 13 (31.7)
Fair 79 (38.2) 42 (50.0) 20 (24.4) 17 (41.5)
Poor 21 (10.1) 6 (7.1) 9 (11) 6 (14.6)
Food Securityi
Food secure 101 (48.8) 42 (50.0) 42 (51.2) 17 (41.5) 0.33
Low food security 80 (38.6) 32 (38.1) 27 (32.9) 21 (51.2)
Very low food security 26 (12.6) 10 (11.9) 13 (15.9) 3 (7.3)
ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒmeanÆstandard deviationƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ!
Years in United States 16.5Æ9.7 17.2Æ10.9 16.0Æ9.5 15.9Æ7.1 0.69
Age (y) 47.1Æ11.1 47.9Æ11.9 46.0Æ10.7 47.6Æ10.5 0.50
Clinical characteristics
Body mass index 35.6Æ5.3 36.0Æ5.7 35.5Æ5.1 34.9Æ4.4 0.50
Weight (lb) 196.8Æ35.8 196.8Æ35.1 196.8Æ35.1 195.4Æ33.4 0.95
(continued on next page)
RESEARCH

Transtheoretical Model of Behavior Change was presented to
participants as a framework to understand the long-term
nature of the behavior change process. Take-home items
included items such as pedometers, exercise compact discs,
and free weights. The individual sessions generally lasted at
least 30 minutes and focused on individualized goal setting
based on the patient’s stage of behavior change, problem
solving, and medical and social service referrals. Participants
randomized to CMþCHW received the CM intervention plus
five CHW home visits during the intensive phase and two
CHW home visits during the maintenance phase. Home visits
were semistructured to allow the CHW to facilitate behavior
changes relevant to the participant and his/her household,
family, and neighborhood. All participants continued to
receive standard medical care throughout the study. Usual
care consisted of routine primary care follow-ups with
potential for referral to lifestyle counseling within a special-
ized diabetes clinic located within the clinic. The control
group was offered a modified case management intervention
at the completion of their 24-month follow-up.
Outcome Measures
Trained, bilingual, and bicultural research assistants who
were blinded to participant assignment collected anthropo-
metric, clinical, behavioral, and sociodemographic informa-
tion at baseline and follow-up assessment visits. The primary
outcome was change in BMI from baseline to 24 months with
assessments at 6 and 12 months to differentiate active weight
loss from weight maintenance. Results are presented as
change in weight in kilograms and BMI. Weight was
measured at each assessment visit in duplicate using a
Detecto scale, whereas height was measured in duplicate
using a wall-mounted stadiometer at baseline only. Partici-
pants’ anthropometric measures were assessed without their
shoes and coats.
Secondary outcomes included change in obesity-related
cardiovascular risk factors at 6, 12, and 24 months. Obesity-
related cardiovascular risk factors included waist circumfer-
ence, systolic blood pressure, diastolic blood pressure, fasting
blood glucose, glycated hemoglobin, total cholesterol, high-
density lipoprotein cholesterol, low-density lipoprotein
cholesterol, triglycerides, and C-reactive protein. Waist
circumference was averaged from two measurements at the
iliac crest at each in-clinic visit. Blood pressure was measured
via automated Welch Allyn Spot Vital Signs LXi following the
study protocol at each in-clinic visit. Lipids, glucose, glycated
hemoglobin, and C-reactive protein were measured in a
fasting blood sample.
Additional information collected only at baseline included
sex, date and place of birth, time in the United States, years of
schooling, English and Spanish fluency and literacy, language
preferences, and family composition. Other measures collected
Table 2. Baseline demographic and clinical characteristics of randomized participants in Vivamos Activos Fair Oaks study
(N¼207), by randomized arm (continued)
Characteristic
All
(N[207)
CMa
(n[84)
CMDCHWb
(n[82)
UCc
(n[41) P valued
ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒmeanÆstandard deviationƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ!
Height (cm) 62.3Æ3.1 62.0Æ3.2 62.5Æ3.0 62.6Æ3.1 0.49
Systolic blood pressure (mm Hg) 115.2Æ13.0 114.5Æ13.0 114.8Æ12.7 117.2Æ13.9 0.52
Diastolic blood pressure (mm Hg) 73.6Æ7.6 73.0Æ7.6 74.1Æ7.2 73.8Æ8.6 0.66
LDL cholesterol (mg/dL)j
104.9Æ34.9 100.6Æ30.8 107.8Æ39.2 107.8Æ33.5 0.36
HDL cholesterol (mg/dL)j
45.6Æ10.8 44.3Æ12.7 47.2Æ9.4 44.9Æ8.9 0.22
Triglycerides (mg/dL)k
164.3Æ99.5 175.4Æ127.5 147.1Æ70.1 176.2Æ79.6 0.13
Total cholesterol (mg/dL)j
181.6Æ42.0 178.5Æ38.7 181.6Æ46 188.0Æ40.4 0.50
Fasting glucose (mg/dL)l
113.4Æ33.3 116.6Æ37.5 111.9Æ31.7 110.0Æ26.5 0.51
Glycated hemglobin (%) 6.5Æ1.4 6.5Æ1.3 6.4Æ1.6 6.4Æ1.3 0.89
C-reactive protein (mg/L)m
0.7Æ0.5 0.6Æ0.3 0.8Æ0.6 0.6Æ0.3 0.14
a
CM¼case management arm.
b
CMþCHW¼case management plus community health worker arm.
c
UC¼usual care control arm.
d
Fisher exact P value because some of the cell values are <5.
e
Other includes El Salvador (n¼19, 39%), Guatemala (n¼14, 29%), other Central and South American countries (Argentina, Brazil, Columbia, Honduras, Nicaragua, Peru, and Uruguay), and
Puerto Rico (n¼1).
f
CESD¼Center for Epidemiologic Studies Depression Scale e Iowa 11Â4.
g
Obesity-Related Problem Scale.
h
Self-Rated Health item from National Health Interview Survey.
i
Six-Item Short Form of the US Department of Agriculture Food Security Survey Module (Spanish).
j
To convert mg/dL cholesterol to mmol/L, multiply mg/dL by 0.026. To convert mmol/L cholesterol to mg/dL, multipy mmol/L by 38.6. Cholesterol of 193 mg/dL¼5.00 mmol/L.
k
To convert mg/dL triglyceride to mmol/L, multiply mg/dL by 0.0113. To convert mmol/L triglyceride to mg/dL, multiply mmol/L by 88.6. Triglyceride of 159 mg/dL¼1.80 mmol/L.
l
To convert mg/dL glucose to mmol/L, multiply mg/dL by 0.0555. To convert mmol/L glucose to mg/dL, multiply mmol/L by 18.0. Glucose of 108 mg/dL¼6.0 mmol/L.
m
To convert mg/L C-reactive protein to nmol/L, multiply 9.524. To convert nmol/L C-reactive protein to mg/L, multiply nmol/L by 0.105. C-reactive protein of 5.5 mg/L¼52.38 nmol/L.
*Significant at P<0.05.
RESEARCH

Table 3. Estimated mean changes in clinical outcomes over 24 months in the intention-to-treat population of Vivamos Activos
Fair Oaks study using generalized estimating equations and multiple imputation to account for missing data (n¼207)
Change in
outcome
measures CMa
(n[84) CMDCHWb
(n[82) UCc
(n[41)
P Value
CM
vs UC
CMD CHW
vs UC
CMD CHW
vs CM
ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒmean (95% CI)ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ!
Weight (kg)
6 mo À1.6 (À2.4 to À0.7) À2.1 (À2.8 to À1.3) À0.9 (À1.9 to 0.1) 0.28 0.05 0.65
24 mo À1.0 (À2.4 to 1.0) À1.0 (À2.4 to 0.4) À0.6 (À2.8 to 1.5) 0.78 0.76 0.98
Body mass index
24 mo À0.4 (À1.0 to 0.2) À0.4 (À0.9 to 0.2) À0.2 (À1.1 to 0.7) 0.67 0.72 0.93
Percentage weight change
6 mo À0.02 (À0.02 to À0.01) À0.02 (À0.03 to À0.01) À0.01 (À0.02 to 0) 0.50 0.24 0.54
12 mo À0.01 (À0.03 to 0) À0.02 (À0.04 to À0.01) À0.01 (À0.03 to 0.01) 0.96 0.92 0.95
24 mo À0.01 (À0.02 to 0.01) À0.02 (À0.03 to 0) 0 (À0.03 to 0.02) 0.92 0.72 0.76
Waist circumference
6 mo À0.7 (À1.3 to À0.2) À0.6 (À1 to À0.2) 0.0 (À0.7 to 0.7) 0.11 0.14 0.89
12 mo À1.5 (À2.2 to À0.8) À0.6 (À1.4 to 0.2) À1.3 (À2.2 to À0.4) 0.76 0.26 0.36
Systolic blood
pressure
6 mo À0.1 (À2.9 to 2.7) À1.8 (À4.2 to 0.6) À2.2 (À6.4 to 2) 0.41 0.87 0.71
12 mo À2.2 (À5.1 to 0.6) À1.3 (À4.3 to 1.6) À3.0 (À7.8 to 1.7) 0.77 0.57 0.86
24 mo 0.6 (À2.3 to 3.5) 0.5 (À2.9 to 3.8) À0.2 (À4.3 to 3.8) 0.74 0.79 0.98
Diastolic blood
pressure
6 mo À0.1 (À1.5 to 1.3) À0.2 (À1.6 to 1.2) 0.3 (À1.9 to 2.6) 0.73 0.72 0.98
12 mo À0.6 (À2.3 to 1.1) 0.3 (À1.7 to 2.2) À1.3 (À4.1 to 1.5) 0.62 0.40 0.78
24 mo 1.2 (À0.5 to 2.9) 0.9 (À0.9 to 2.7) À0.2 (À2.2 to 1.8) 0.33 0.46 0.90
Total cholesterol
6 mo 1.7 (À4.6 to 7.9) À0.6 (À10.2 to 9.1) 2.8 (À7.6 to 13.2) 0.86 0.64 0.85
12 mo 1.8 (À5.2 to 8.8) 8.7 (1.2 to 16.2) 1.5 (À9.3 to 12.3) 0.96 0.30 0.55
24 mo 7.0 (À1.8 to 15.8) 10.8 (0.7 to 20.8) 5.6 (À4.5 to 15.6) 0.82 0.48 0.76
Fasting blood glucose
6 mo 0.7 (À5.9 to 7.2) 0.4 (À5.4 to 6.2) 4.0 (À3.7 to 11.7) 0.52 0.47 0.98
12 mo À1.6 (À9.8 to 6.7) À2.9 (À8.8 to 3.0) 6.3 (À1.5 to 14.1) 0.18 0.07 0.88
24 mo 2.7 (À8.5 to 13.9) À1.9 (À11.9 to 8.2) 4.6 (À6.3 to 15.5) 0.81 0.34 0.72
Glycated hemoglobin
6 mo 0.0 (À0.1 to 0.2) À0.2 (À0.4 to 0.0) À0.1 (À0.3 to 0.1) 0.30 0.50 0.33
12 mo 0.0 (À0.2 to 0.2) À0.2 (À0.5 to 0.0) À0.1 (À0.5 to 0.3) 0.57 0.73 0.61
24 mo À0.1 (À0.3 to 0.2) À0.3 (À0.6 to À0.1) À0.3 (À0.5 to 0.0) 0.19 0.75 0.33
RESEARCH

at each assessment visit from the participants included
depression screening,20
obesity-related problems,21
food
security,22
self-rated health, dietary practices, physical activity
level, and neighborhood resource use. A 7-day pedometer
record was also collected in conjunction with these visits.
Statistical Analysis
All analyses were pre-specified as per the research protocol.
The primary outcome of weight change and secondary out-
comes of cardiovascular risk factors were compared at 6, 12,
and 24 months after randomization among study arms.
Generalized estimating equations were used for primary and
secondary outcomes as intent-to-treat. Generalized esti-
mating equations accounts for the correlation of repeated
measures on individuals over time and produces marginal
estimates of population-level changes relevant for public
health recommendations.23
The effect is captured by a
treatment-time interaction term. An exchangeable correlation
structure and used robust variance estimation was assumed.
Three contrasts were tested: UC vs CM, UC vs CMþCHW,
and CM vs CMþCHW for primary and secondary outcomes.
Holm’s method24
was used to account for the three
comparisons of the primary outcome at 24 months using an
adjusted P value of 0.02. The significance level for secondary
outcomes was set at P<0.05. Potential effect modification by
sex as our first a priori subgroup was investigated by
including cross products of treatment group with sex in
models. All analyses were conducted using SAS (version 9.3,
SAS Institute, Inc).
The protocol allowed for retrieving weights from electronic
medical records; however, no data were available within
3 months of the expected visit date. Because Missing
Completely at Random was not expected, multiple imputa-
tion was performed for missing data under the assumption of
Missing at Random. Missing data were imputed using the
joint modeling approach implemented in PROC MIANALYZE
in SAS version 9.3, with 5 imputations of the data and use
Rubin’s method for variance estimates.25
Because this was a
sensitivity analysis, the same analyses were repeated using a
last observation carried forward approach.
RESULTS
Body weight was collected from 207 participants (100%) at
baseline, followed by 190 (91.8%) at 6 months, 171 (82.6%) at
Table 3. Estimated mean changes in clinical outcomes over 24 months in the intention-to-treat population of Vivamos Activos
Fair Oaks study using generalized estimating equations and multiple imputation to account for missing data (n¼207) (continued)
Change in
outcome
measures CMa
(n[84) CMDCHWb
(n[82) UCc
(n[41)
P Value
CM
vs UC
CMD CHW
vs UC
CMD CHW
vs CM
ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒmean (95% CI)ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ!
High-density
lipoprotein
cholesterol
6 mo À1.4 (À3.3 to 0.5) À0.4 (À1.8 to 1.1) 0.0 (À1.6 to 1.6) 0.29 0.76 0.61
12 mo 0.6 (À1.9 to 3.1) 1.6 (À0.8 to 4.0) 1.7 (À1.2 to 4.5) 0.59 0.98 0.75
24 mo À0.2 (À3.7 to 3.3) 0.3 (À3.2 to 3.8) 1.4 (À1.4 to 4.3) 0.46 0.62 0.89
Low-density
lipoprotein
cholesterol
6 mo 16.3 (À6.4 to 39) 5.5 (À5.6 to 16.6) 12.9 (0.6 to 25.3) 0.79 0.39 0.54
12 mo 2.9 (À2.9 to 8.7) 4.0 (À2.6 to 10.7) 1.9 (À7.3 to 11.1) 0.86 0.72 0.91
24 mo 5.8 (À1.3 to 12.8) 4.8 (À3.8 to 13.4) 4.0 (À6.5 to 14.4) 0.77 0.91 0.93
Trigylcerides
6 mo À7.4 (À30.5 to 15.7) À3.2 (À19.4 to 13.0) À17.2 (À38.1 to 3.7) 0.53 0.29 0.87
12 mo À12.3 (À37.2 to 12.6) 1.5 (À14.0 to 17.0) À19.0 (À40.8 to 2.8) 0.69 0.13 0.58
24 mo 5.0 (À25.5 to 35.5) 15.1 (À14.4 to 44.6) À1.3 (À36.8 to 34.2) 0.79 0.48 0.80
C-reactive proteind
At 12 mo 0.1 (0.0 to 0.2) 0.0 (À0.2 to 0.2) 0.2 (À0.1 to 0.5) 0.51 0.35 0.54
At 24 mo 0.1 (0.0 to 0.3) 0.0 (À0.2 to 0.1) 0.3 (0.0 to 0.7) 0.32 0.07 0.12
a
b
c
d
Not measured at 6 mo.
RESEARCH

Table 4. Estimated mean changes in clinical outcomes over 24 months in the intention-to-treat population of Vivamos Activos Fair
Oaks study (N¼207) using generalized estimating equations and multiple imputation to account for missing data
Change in
outcome
measures CMa
(n[84) CMDCHWb
(n[82) UCc
(n[41)
P Value
CM
vs UC
CMD CHW
vs UC
CMD CHW
vs CM
Weight
Male
6 mo À5.2 (À8.6 to À1.8) À9.6 (À13.3 to À5.9) À0.9 (À5.2 to 3.4) 0.12 <0.01** 0.37
24 mo À4.3 (À8.7 to 0.0) À4.5 (À9.7 to 0.8) À4.4 (À11.9 to 3.1) 0.99 0.99 0.99
Female
12 mo À2.8 (À5.7 to 0.2) À3.1 (À5.6 to À0.5) À0.5 (À4.1 to 3.1) 0.32 0.25 0.94
24 mo À1.4 (À5.2 to 2.3) À1.5 (À5.4 to 2.3) À0.5 (À6.3 to 5.4) 0.78 0.74 0.98
Body mass index
Male
6 mo 0.9 (À1.4 to À0.3) 1.6 (À2.2 to À1) 0.1 (À0.8 to 0.6) 0.09 <0.01** 0.36
12 mo 0.6 (À1.2 to À0.1) 1.2 (À2 to À0.5) 0.8 (À2 to 0.4) 0.79 0.53 0.62
24 mo 0.7 (À1.4 to 0) 0.7 (À1.6 to 0.1) 0.6 (À1.8 to 0.5) 0.90 0.91 0.99
Female
6 mo 0.6 (À1 to À0.1) 0.5 (À0.9 to À0.2) 0.4 (À0.9 to 0) 0.64 0.64 0.99
12 mo 0.5 (À1.1 to 0) 0.6 (À1 to À0.1) 0.1 (À0.8 to 0.6) 0.29 0.27 0.98
24 mo 0.3 (À1 to 0.4) 0.3 (À1 to 0.4) 0.1 (À1.1 to 1) 0.70 0.74 0.97
Percentage weight
change (%)
Male
6 mo À0.03 (À0.04 to À0.01) À0.05 (À0.06 to À0.03) 0 (À0.02 to 0.02) 0.19 0.02* 0.05
Female
6 mo À0.01 (À0.02 to 0) À0.01 (À0.02 to 0) À0.01 (À0.02 to 0) 0.87 0.83 0.46
12 mo À0.01 (À0.03 to 0) À0.02 (À0.03 to 0) À0.01 (À0.02 to 0.01) 0.63 0.56 0.44
24 mo À0.01 (À0.03 to 0) À0.02 (À0.03 to 0) À0.01 (À0.02 to 0.01) 0.85 0.80 0.47
Waist circumference
Male
6 mo À0.7 (À1.6 to 0.2) À1.4 (À2.2 to À0.7) 0.2 (À1.0 to 1.5) 0.25 0.02* 0.54
24 mo À1.2 (À2.3 to 0.0) À0.9 (À2.2 to 0.4) À1.7 (À3.2 to À0.3) 0.55 0.38 0.88
Female
6 mo À0.7 (À1.4 to À0.1) À0.4 (À0.9 to 0.1) 0.0 (À0.9 to 0.8) 0.19 0.52 0.69
24 mo À1.5 (À2.3 to À0.7) À0.7 (À1.6 to 0.1) À0.5 (À1.6 to 0.7) 0.15 0.67 0.54
RESEARCH

Oaks study (N¼207) using generalized estimating equations and multiple imputation to account for missing data (continued)
Change in
outcome
measures CMa
(n[84) CMDCHWb
(n[82) UCc
(n[41)
P Value
CM
vs UC
CMD CHW
vs UC
CMD CHW
vs CM
Systolic blood
pressure
Male
6 mo 0.8 (À4.4 to 6.0) À5.3 (À10.4 to À0.1) 2.0 (À10.1 to 14.1) 0.86 0.29 0.63
12 mo À0.4 (À6.4 to 5.7) À4.1 (À9.6 to 1.5) 2.4 (À9.5 to 14.4) 0.68 0.33 0.77
24 mo 3.0 (À2.3 to 8.3) À6.1 (À13.2 to 1.1) 0.2 (À9.2 to 9.6) 0.61 0.30 0.38
Female
6 mo À0.5 (À3.8 to 2.8) À0.7 (À3.4 to 1.9) À3.4 (À7.2 to 0.5) 0.26 0.27 0.96
12 mo À2.9 (À6.1 to 0.3) À0.5 (À4.1 to 3.1) À4.6 (À9.5 to 0.3) 0.54 0.20 0.66
24 mo À0.2 (À3.6 to 3.2) 2.5 (À1.0 to 6.0) À0.4 (À4.8 to 4.1) 0.96 0.32 0.59
Diastolic blood
pressure
Male
6 mo 0.2 (À2.8 to 3.2) À2.6 (À5.5 to 0.3) 3.5 (À2.6 to 9.6) 0.33 0.08 0.67
12 mo À0.5 (À4.0 to 3.1) À1.7 (À4.2 to 0.8) 0.1 (À4.3 to 4.4) 0.85 0.50 0.79
24 mo 3.0 (0.2 to 5.8) À1.7 (À4.8 to 1.3) 0.2 (À4.4 to 4.8) 0.33 0.49 0.35
Female
6 mo À0.2 (À1.8 to 1.4) 0.5 (À1.1 to 2.2) À0.6 (À2.8 to 1.6) 0.79 0.43 0.76
12 mo À0.6 (À2.5 to 1.4) 0.9 (À1.5 to 3.2) À1.7 (À5.0 to 1.6) 0.52 0.22 0.68
24 mo 0.6 (À1.4 to 2.6) 1.7 (À0.4 to 3.7) À0.3 (À2.5 to 1.9) 0.55 0.21 0.68
Total cholesterol
Male
6 mo 6.3 (À3.1 to 15.7) À11.6 (À39.1 to 15.8) À3.4 (À34.6 to 27.8) 0.56 0.69 0.60
12 mo 13.3 (0.0 to 26.7) 7.4 (À7.2 to 22.0) 10.9 (À8.1 to 29.8) 0.83 0.78 0.77
24 mo 19.1 (0.7 to 37.5) À0.1 (À26.3 to 26.1) 20.9 (1.6 to 40.2) 0.89 0.19 0.43
Female
6 mo 0.2 (À7.5 to 7.9) 2.9 (À6.2 to 11.9) 4.6 (À5.3 to 14.5) 0.48 0.80 0.81
12 mo À1.8 (À9.8 to 6.1) 9.2 (1.1 to 17.3) À1.1 (À13.6 to 11.3) 0.92 0.19 0.42
24 mo 3.2 (À6.6 to 13.0) 14.1 (3.8 to 24.4) 1.2 (À10.3 to 12.7) 0.79 0.11 0.42
Fasting blood glucose
Male
6 mo 1.3 (À13.5 to 16.1) À1.7 (À14.7 to 11.3) 2.6 (À25.2 to 30.5) 0.94 0.79 0.92
12 mo 0.4 (À10.5 to 11.4) À9.7 (À25.3 to 5.8) 19.0 (1.2 to 36.8) 0.08 0.02* 0.60
24 mo À5.3 (À22.8 to 12.2) À7.4 (À28.2 to 13.3) 18.0 (À13.1 to 49.1) 0.21 0.18 0.95
Female
6 mo 0.2 (À6.8 to 7.1) 1.0 (À5.4 to 7.5) 4.4 (À1.9 to 10.7) 0.36 0.45 0.91
12 mo À2.5 (À12.8 to 7.8) À0.9 (À7.4 to 5.7) 2.7 (À5.2 to 10.6) 0.44 0.48 0.86
24 mo 4.9 (À8.4 to 18.1) À0.2 (À10.4 to 9.9) 0.8 (À9.5 to 11.2) 0.63 0.87 0.69
RESEARCH

Change in
outcome
measures CMa
(n[84) CMDCHWb
(n[82) UCc
(n[41)
P Value
CM
vs UC
CMD CHW
vs UC
CMD CHW
vs CM
Glycated
hemoglobin
Male
At 6 mo 0.1 (À0.2 to 0.4) À0.3 (À0.6 to 0.0) À0.1 (À0.8 to 0.5) 0.51 0.64 0.54
At 12 mo 0.4 (0.0 to 0.8) À0.2 (À0.6 to 0.3) 0.3 (À0.1 to 0.7) 0.81 0.13 0.28
Female
At 12 mo À0.1 (À0.4 to 0.1) À0.2 (À0.5 to 0.1) À0.2 (À0.7 to 0.2) 0.65 0.94 0.84
At 24 mo À0.1 (À0.4 to 0.1) À0.3 (À0.6 to 0.1) À0.3 (À0.6 to À0.1) 0.29 0.80 0.67
High-density
lipoprotein
cholesterol
Male
At 6 mo À1.9 (À5.7 to 1.8) 1.2 (À1.0 to 3.3) À0.9 (À3.3 to 1.4) 0.64 0.20 0.26
Female
At 6 mo À1.2 (À3.4 to 1.0) À0.8 (À2.5 to 0.9) 0.2 (À1.8 to 2.2) 0.33 0.43 0.86
At 12 mo 0.9 (À2.0 to 3.8) 1.4 (À1.6 to 4.4) 2.4 (À0.7 to 5.5) 0.49 0.65 0.89
At 24 mo 0.0 (À4.3 to 4.3) 0.2 (À4.0 to 4.4) 2.2 (À0.9 to 5.3) 0.37 0.47 0.95
Low-density
lipoprotein
cholesterol
Male
At 6 mo 6.4 (À1.0 to 13.8) À12.3 (À42.5 to 18.0) 1.4 (À29.2 to 31.9) 0.75 0.52 0.56
At 12 mo 11.6 (0.8 to 22.4) 5.6 (À7.0 to 18.2) À1.6 (À31.5 to 28.4) 0.42 0.67 0.85
At 24 mo 17.4 (6.0 to 28.7) À7.6 (À27.6 to 12.4) 9.7 (À10.3 to 29.6) 0.50 0.25 0.25
Female
At 6 mo 19.3 (À10.3 to 48.8) 10.9 (0.8 to 21.0) 16.2 (2.4 to 30.0) 0.85 0.54 0.68
At 12 mo 0.1 (À6.5 to 6.7) 3.6 (À4.3 to 11.4) 2.9 (À5.8 to 11.5) 0.62 0.91 0.72
At 24 mo 2.0 (À6.1 to 10.2) 8.5 (0.0 to 17.1) 2.4 (À9.4 to 14.2) 0.96 0.42 0.62
Triglycerides
Male
At 24 mo 12.4 (À30.5 to 55.2) 25.0 (À51.5 to 101.5) 51.9 (À44 to 147.9) 0.46 0.68 0.90
RESEARCH

12 months, and 177 (85.5%) at 24 months. Participants who
were lost to follow-up had significantly higher low-density
lipoprotein and total cholesterol levels (P¼0.01) compared
with those who completed the study protocol (Table 1;
available online at www.andjrnl.org).
Study Participants
At baseline, participants had a mean age of 47.1Æ11.1, a BMI of
35.6Æ5.3, and a weight of 89.2Æ16.2 kg (196.8Æ35.8 lb), 23%
were men, and all were Latino (Table 2). Participants had
been in the United States an average of 16.3Æ9.9 years, were
low income with 48% reporting an annual income <$20,000,
and had low educational attainment (74% less than high
school). Forty-three percent of participants had a type 2 dia-
betes diagnosis at baseline. A level of depressive symptoms
indicating possible depression was reported by 31% of par-
ticipants (Center for Epidemiologic Studies Depression Scale
score !9) and about half (51%) were classified as being food
insecure. Whereas 41% of participants reported their current
health at baseline to be good (41%), fair or poor health status
was common (48%). Moderate to severe obesity-related
impairments were reported by 44% of participants.
Intervention Participation and Follow-Up
The median number of group CM sessions attended was 12
(interquartile range¼6 to 14) in the CM arm and 10.5 (inter-
quartile range¼4 to 14) in the CMþCHW arm out of 16
possible. Group Sessions 1 through 4 were well attended
with 76% to 84% participation. Fewer participants attended
Sessions 5 through 8 (64% to 70%) and Sessions 9 through
12 (57% to 61%). The mean attendance rate for the 3 main-
tenance sessions (Sessions 13 through 15) was 33%. Of the 4
planned individual CM sessions, 96% completed one, 92%
completed two, 90% completed three, and 82% completed
four sessions. Of CMþCHW participants, 71% completed all
seven possible home visits.
Among the 207 participants, weight measurements were
available on 197 (95%) at 6 months, 173 (84%) at 12 months,
and 181 (87%) at 24 months. An intensive effort was made to
locate participants for the 24-month follow-up who had
previously been lost to follow-up. By study arm, 24-month
weight measurements were available for 89% of the CM
participants, 84% of CMþCHW, and 90% of UC. There was no
difference in loss to follow-up by sex. Whereas follow-up of
24 months was planned, mean follow-up duration was
25.7Æ2.6 months among completers (n¼181). The final
follow-up visit was completed during October 2012.
Weight Loss
In the initial 6 month intensive intervention period weight
loss in the CMþCHW arm was significantly greater at À2.1 kg
(95% CI À2.8 to À1.3) compared with À0.9 kg in UC (95%
CI À1.9 to 0.1; P¼0.05), although it did not differ from À1.6 kg
in CM (95% CI À2.4 to À0.7; P¼0.65) (Table 3). At 12 months,
mean changes from baseline were À1.9 kg (95% CI À2.9
to À0.9) in the CMþCHW group (P¼0.21 vs UC and P¼0.76 vs
CM), À1.4 kg (95% CI À2.4 to À0.3) in the CM group (P¼0.49
vs UC), and À0.7 kg (95% CI À2.2 to 0.8) in the UC arm. Both
intervention groups experienced further recidivism by
24 months with mean changes of À1.0 kg (95% CI À2.4 to 0.4)
Change in
outcome
measures CMa
(n[84) CMDCHWb
(n[82) UCc
(n[41)
P Value
CM
vs UC
CMD CHW
vs UC
CMD CHW
vs CM
Female
At 6 mo À11.3 (À40.6 to 17.9) À2.5 (À22.1 to 17.0) À14.2 (À37.1 to 8.6) 0.88 0.44 0.76
At 24 mo 3.2 (À35.9 to 42.3) 12.3 (À19.0 to 43.7) À16.3 (À51.3 to 18.7) 0.47 0.24 0.83
C-reactive proteind
Male
At 24 mo 0.0 (À0.2 to 0.3) À0.3 (À0.6 to 0.0) 0.1 (À0.2 to 0.4) 0.59 0.06 0.05
Female
At 12 mo 0.1 (À0.1 to 0.2) 0.0 (À0.2 to 0.3) 0.2 (À0.1 to 0.6) 0.42 0.35 0.70
At 24 mo 0.2 (0.0 to 0.3) 0.0 (À0.1 to 0.2) 0.4 (À0.1 to 0.8) 0.38 0.17 0.36
a
b
c
d
Not measured at 6 mo.
**Significant at P<0.01.
RESEARCH

in the CMþCHW group (P¼0.76 vs UC and P¼0.98 vs CM)
and À1.0 kg (95% CI À2.4 to 0.5) in the CM group (P¼0.78 vs
UC). Mean weight loss at 24 months in the UC arm was À0.6
kg (95% CI À2.8 to 1.5). Similar results were obtained when
BMI was analyzed as the outcome (Table 3). These results
held in sensitivity analyses.
Sex Differences
There were significant differences by treatment arm accord-
ing to sex (P<0.05), with men achieving greater weight loss
than women in all groups at each time point (Table 4). The
mean weight loss for men at 6 months in CMþCHW was À4.4
kg (95% CI À6.0 to À2.7) (P<0.01 vs UC and P¼0.37 vs CM), in
CM was À2.4 kg (95% CI À3.9 to À0.8) (P¼0.12 vs UC) and in
UC was À0.4 kg (95% CI À2.4 to 1.5). In contrast, mean weight
loss for women at 6 months in CMþCHW was À1.4 kg (95%
CI À2.2 to À0.5) (P¼0.57 vs UC and P¼0.96 vs CM), in CM
was À1.3 kg (95% CI À2.4 to À0.3) (P¼0.65 vs UC), and in UC
was À1.0 kg (95% CI À2.1 to 0.1). Both sexes regained weight
by 24 months and the two intervention arms did not signif-
icantly differ from UC. The same results were obtained when
BMI was analyzed as the outcome (Table 3).
Changes in Secondary Outcomes. Secondary clinical
outcomes, including waist circumference, blood pressure,
lipid levels, and indicators of glucose tolerance did not
significantly differ between active treatment arms or
compared with UC control at 6, 12, or 24 months (Table 3).
Among men, those in CMþCHW achieved a greater reduction
in waist circumference at 6 months and fasting blood glucose
level at 12 months compared with UC and systolic and dia-
stolic blood pressure, low-density lipoprotein cholesterol,
and C-reactive protein compared with CM at 24 months
(P 0.05) (Table 4).
Adverse Events
Overall, 11 hospitalizations (five in CMþCHW, five in CM, and
one in UC) and 69 visits to the emergency room (29 in
CMþCHW, 23 in CM, and 17 in UC) occurred over the 24
months of the study. None of the events were determined to
be related to the study. Although adverse events in the UC
arm were lower, there were fewer participants in this arm
(n¼41) compared with CM (n¼84) and CMþCHW (n¼82).
One UC participant and one CM participant became pregnant
during the course of the study; their data were included in
the analysis in accordance with an intent-to-treat approach.
There were no deaths.
DISCUSSION
Using a design with strong internal and external validity,
VAFO showed that two interventions aimed at facilitating
long-term weight loss among obese low-income Latino
immigrants with one or more CHD risk factors were no more
effective than usual care over 2 years. Although statistically
significant weight loss was observed at the end of the
6-month initial intensive intervention period, especially in
male participants, this finding was likely not clinically sig-
nificant. In addition, the interventions were unsuccessful at
preventing weight regain during the final 18 months of the
trial. These findings suggest some promise of the VAFO
approach, specifically the intervention that included both
case management and CHW support for early adoption of
weight-loss behaviors, while indicating the need for more
effective weight maintenance strategies.
Low-income Latino immigrants have been underrepre-
sented in primary care-based weight loss trials despite their
high risk for obesity-related comorbidities and socioeco-
nomic and environmental disadvantage.26
Racial/ethnic mi-
norities demonstrate poorer weight loss outcomes compared
with non-Latino whites in trials with at least 12 months of
follow-up.7
Trials with 24 months of follow-up among racial/
ethnic minorities have been rare.7,27
The Be Fit, Be Well trial
(N¼365) was designed to test the effectiveness of a primary-
care based lifestyle intervention in a racial/ethnic minority
(71% African American, 13% Hispanic) population of obese
adults on one or more antihypertensive medications over 24
months.28
At 24 months, intervention participants lost 1.53
kg, which was greater than the weight loss in VAFO of 0.9 kg
in the CM arm and 1.0 kg in the CMþCHW arm. The VAFO
population was of similar income level but lower educational
level compared with Be Fit, Be Well. Education level may be
an indicator for other socioeconomic factors that possibly
played a role in the intervention effectiveness; more than
two-thirds (68%) of participants in VAFO had an eighth-grade
education or less.
The mean weight loss was greatest in the CMþCHW arm at
each time point, although the difference was only significant
at 6 months. A recent trial of a community-based translation
of the DPP incorporating CHWs (n¼301) demonstrated
12-month weight loss of 7.1 kg compared with 1.4 kg among
controls. The study participants were primarily non-Latino
whites (74%) with greater than a high school education
(80%),29
making it difficult to compare with VAFO results.
Still, given the low cost of incorporating a CHW approach,
and the results from this trial, using CHWs to promote life-
style changes may be beneficial, particularly in low-income
populations.
VAFO demonstrated success in recruiting and retaining a
sample with nearly one-quarter men (23%) and they
appeared to respond more favorably to both interventions in
comparison to women. Ethnic minority men make up <2% of
participants in US weight loss trials.30
The limited evidence
suggests mixed results with men doing better in some trials
and women in others.30
It is possible that culturally specific
gender roles contributed to the differential effect within this
low-income Latino immigrant population. Compared with
Latina women, it may be easier for Latino men to make diet
and activity pattern changes that affect the rest of the family.
Other potential explanations include the higher income and
education among men than women and their greater level of
physical activity. Given the limited existing evidence on the
effectiveness of lifestyle interventions among racial/ethnic
minority men, future trials focusing on men may provide
particularly useful information.
VAFO participants may have faced medical and psychoso-
cial barriers to weight loss. A significant proportion of par-
ticipants had a diagnosis of diabetes (43%) at baseline, which
may have made it difficult for them to lose weight. These
participants’ mean glycated hemoglobin level was 7.2%Æ1.6%,
suggestive of tight glucose control through medications such
as sulfonylureas and insulin, which are associated with
weight gain. Approximately one-third of participants were
taking at least one of these medications at baseline.
RESEARCH

Participants also faced significant psychosocial barriers,
including depression, fair to poor perceived health, food
insecurity, and lack of perceived neighborhood safety. Inte-
gration of additional or higher intensity strategies that
address psychosocial and environmental barriers to weight
loss may be needed. Promising strategies identified by
intervention staff included the inclusion of additional family
members, direct provision of mental health services, and
enhanced resources for healthful eating and physical activity.
Modest weight loss was observed among participants in
the UC group (À0.6 at 24 months). Other weight loss studies
have reported weight loss among control participants.31
Because we recruited participants from a clinical setting, it
is possible that the “usual care” of the control group involved
primary care treatments to which many low-income Hispanic
populations do not have access given low rates of health care
insurance coverage in this population.
The VAFO trial had several strengths supporting the in-
ternal and external validity of the design, such as a focus on a
high-risk minority population; 87% 24-month follow-up; and
evidence-based, innovative, and practical intervention stra-
tegies integrated into a primary care clinic. Nevertheless,
several considerations and limitations affect the interpreta-
tion of our study results. The participants were significantly
more socioeconomically vulnerable than participants in
comparable trials.28,32,33
In addition to low income and ed-
ucation, all VAFO participants were foreign-born with the
exception of one participant from Puerto Rico. Although in-
quiries about immigration status were avoided, it is likely
that undocumented participants faced barriers to weight loss
resources and experienced additional life stressors. For
example, undocumented participants could not access the
Supplemental Nutrition Assistance Program despite their low
incomes. In addition, participants may have been adversely
affected by the economic recession that took place during the
time the trial was conducted. Due to the socioeconomic
vulnerability of the VAFO participants and the recession, the
results may not be generalizable to other Latino populations
or to nonrecession time periods. Intervention participation
may have presented additional limitations to the trial. As in
other lifestyle intervention trials, all participants did not
attend all planned intervention activities (one-on-one case
management, groups sessions, and home visits). This limited
our ability to test whether the planned intervention had the
intended effect. Nevertheless, the percentage of participants
attending each activity was within the expected range. In
addition, although the group cohort design of the study was
intended to foster social support among group members,
participants were often unable to attend assigned groups.
This limited the benefits of the social support aspect of the
study design.
CONCLUSIONS
Case management alone and in combination with a CHW
were no more effective than usual care at achieving and
maintaining weight loss over 24 months. The intensive,
initial 6-month interventions appeared promising and may
reflect the ability to facilitate some active adoption of
behavior change, particularly among men. Additional
research is needed to identify more effective strategies to
address the psychosocial and environmental barriers for
weight loss and maintenance among low-income Latino
immigrants.
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AUTHOR INFORMATION
L. G. Rosas is research director and instructor of medicine, R. S. Stafford is a professor of medicine, Program on Prevention Outcomes and
Practices, Stanford Prevention Research Center, and B. A. Goldstein is an instructor of medicine and a senior biostatistician, Quantitative Sciences
Unit, Department of Medicine, all at Stanford University, Palo Alto, CA. S. Thiyagarajan is a project manager, Abbott, Alameda, CA; at the time of
the study, she was a data analyst/manager, Program on Prevention Outcomes and Practices, Stanford Prevention Research Center, Stanford
University, Palo Alto, CA. R. L. Drieling is a doctoral degree student, Department of Epidemiology, School of Public Health, University of
Washington, Seattle, and National Cancer Institute Biobehavioral Cancer Prevention and Control Program Afﬁliate, Fred Hutchinson Cancer
Research Center, Seattle, WA; at the time of the study, she was research director, Program on Prevention Outcomes and Practices, Stanford
Prevention Research Center, Stanford University, Palo Alto, CA. P. P. Romero is a study coordinator and case manager, Fair Oaks Clinic of San
Mateo Medical Center, Redwood City, CA. J. Ma is an associate scientist, Palo Alto Medical Foundation Research Institute, Palo Alto, CA, and a
consulting assistant professor, Stanford Prevention Research Center, School of Medicine, Stanford University, Palo Alto, CA. V. Yank is an
instructor of medicine, General Medical Disciplines, Stanford School of Medicine, Stanford University, Palo Alto, CA; at the time of the study, she
was a joint fellow at the Stanford Prevention Research Center and the Palo Alto Medical Foundation Research Institute, Palo Alto, CA.
Address correspondence to: Lisa Goldman Rosas, MPH, PhD, Program on Prevention Outcomes and Practices, Stanford Prevention Research
Center, 1070 Arastradero Rd, Suite 100, Palo Alto, CA 94304. E-mail: lgrosas@stanford.edu
STATEMENT OF POTENTIAL CONFLICT OF INTEREST
No potential conﬂict of interest was reported by the authors.
FUNDING/SUPPORT
This study was funded by National Heart, Lung, and Blood Institute grant no. R01 HL089448, and the REDCap data management tools were
supported by the National Institutes of Health (grant no. UL1 RR025744).
ACKNOWLEDGEMENTS
The authors thank Gloria Flores-Garcia, Jeannette Quintana, Jonathan Messinger, Wes Alles, PhD, Jeanette Aviles, MD, Christopher Gardner, PhD,
William Haskell, PhD, Abby King, PhD, Marcia Stefanick, PhD, and Marilyn Winkleby, PhD, MPH, for providing expert guidance on project
development. The authors also thank Ernesto Ceja, Rosa Gill, Elidia Contreras, and Gabriela Spencer for services as intervention staff; Oralia
Espinoza, Alexis Fields, Olivia Tigre, Jessica Ng Luna, Sophia Colombari Figueroa, Angeles Ramans, and Ulysses Rosas for data collection and
research support; Dave Ahn, PhD, for data management; the Data and Safety Monitoring Board (Douglas Bauer, PhD [chair], Bud Gerstman, PhD,
and David Han [executive secretary; formerly Sandra Bravo); El Concilio of San Mateo County and the San Mateo Medical Center for collaboration
and support; and to the patients and their families for contribution to the research.
RESEARCH

Table 1. Comparison of participants in the Vivamos Activos Fair Oaks study (N¼207) who completed the study protocol
compared with those who were lost to follow-up by 24 months
Participant characteristic Completed Lost to Follow-Up P value
ƒƒƒƒƒƒƒƒƒƒƒƒƒn (%)ƒƒƒƒƒƒƒƒƒƒƒƒƒ!
Group 0.55
UCa
37 (21) 4 (13)
CMb
72 (41) 12 (40)
CMþCHWc
68 (38) 14 (47)
Male sex 41 (23) 7 (23) 1.00
Schooling 0.27
Eighth grade or less 93 (53) 20 (67)
Some high school 37 (27) 7 (23)
High school or more 47 (21) 3 (10)
Employment status 0.67
Employed 85 (48) 12 (40)
Unemployed 17 (10) 4 (13)
Not working 75 (42) 14 (47)
Annual income ($) 0.75
<10,000 48 (27) 10 (33)
10,000-20,000 50 (45) 13 (43)
>20,000 50 (28) 7 (23)
Country of birth 0.23
Mexico 139 (79) 20 (67)
Other 38 (21) 10 (33)
Diabetes mellitus type 2 79 (47) 7 (26) 0.07
Depressed (CESDd
>9) 54 (31) 11 (37) 0.50
Obesity-related impairmente
0.55
Mild 99 (56) 17 (57)
Moderate 24 (14) 6 (20)
Severe 54 (31) 7 (23)
Self-perceived healthf
0.30
Very good 20 (11) 2 (7)
Good 68 (38) 17 (57)
Fair 70 (40) 9 (30)
Poor 19 (11) 2 (7)
Food securityg
0.90
Food secure 86 (49) 15 (50)
Low food security 68 (38) 12 (40)
Very low food security 23 (13) 3 (10)
ƒƒƒƒƒƒmeanÆstandard deviationƒƒƒƒƒƒ!
Age (y) 47.3Æ11.0 49.0Æ12.1 0.46
Years in United States 16.4Æ9.5 17.7Æ10.3 0.51
Clinical characteristics
Body mass index 35.5Æ5.4 35.9Æ4.0 0.66
RESEARCH
April 2015 Volume 115 Number 4 JOURNAL OF THE ACADEMY OF NUTRITION AND DIETETICS 550.e1

Table 1. Comparison of participants in the Vivamos Activos Fair Oaks study (N¼207) who completed the study protocol
compared with those who were lost to follow-up by 24 months (continued)
Participant characteristic Completed Lost to Follow-Up P value
ƒƒƒƒƒƒmeanÆstandard deviationƒƒƒƒƒƒ!
Weight (lb) 196.4Æ36.5 199.7Æ31.6 0.61
Height (cm) 62.3Æ3.0 62.5Æ3.7 0.80
Systolic blood pressure (mm Hg) 116Æ1.0 116Æ0.9 0.31
Diastolic blood pressure (mm Hg) 74Æ0.3 747Æ0.3 0.24
Low-density lipoprotein cholesterol (mg/dL)h
103Æ36 117Æ2 0.01*
High-density lipoprotein cholesterol (mg/dL)h
46Æ11 46Æ11 0.99
Triglycerides (mg/dL)i
164Æ103 164Æ77 0.96
Total cholesterol (mg/dL)h
179Æ74 195Æ74 0.01*
Fasting glucose (mg/dL)j
113Æ32 114Æ38 0.92
Glycated hemoglobin (%) 6.5Æ1.3 6.4Æ1.8 0.91
C-reactive protein (mg/dL)k
0.69Æ0.48 0.63Æ0.35 0.57
a
b
c
d
CESD¼Center for Epidemiologic Studies Depression ScaleeIowa 11Â4.
e
Obesity-Related Problem Scale.
f
Self-Rated Health item from National Health Interview Survey.
g
Six-Item Short Form of the US Department of Agriculture Food Security Survey Module (Spanish).
h
To convert mg/dL cholesterol to mmol/L, multiply mg/dL by 0.026. To convert mmol/L cholesterol to mg/dL, multipy mmol/L by 38.6. Cholesterol of 193 mg/dL¼5.00 mmol/L.
i
To convert mg/dL triglyceride to mmol/L, multiply mg/dL by 0.0113. To convert mmol/L triglyceride to mg/dL, multiply mmol/L by 88.6. Triglyceride of 159 mg/dL¼1.80 mmol/L.
j
To convert mg/dL glucose to mmol/L, multiply mg/dL by 0.0555. To convert mmol/L glucose to mg/dL, multiply mmol/L by 18.0. Glucose of 108 mg/dL¼6.0 mmol/L.
k
To convert mg/L C-reactive protein to nmol/L, multiply 9.524. To convert nmol/L C-reactive protein to mg/L, multiply nmol/L by 0.105. C-reactive protein of 5.5 mg/L¼52.38 nmol/L.
RESEARCH
550.e2 JOURNAL OF THE ACADEMY OF NUTRITION AND DIETETICS April 2015 Volume 115 Number 4

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