STUDY PROTOCOLOpen Access
Weight gain prevention among black women in
the rural community health center setting: The
Perry Foley1*, Erica Levine1, Sandy Askew1, Elaine Puleo2, Jessica Whiteley3, Bryan Batch4, Daniel Heil5, Daniel Dix1,
Veronica Lett1, Michele Lanpher1, Jade Miller1, Karen Emmons6and Gary Bennett1
Background: Nearly 60% of black women are obese. Despite their increased risk of obesity and associated chronic
diseases, black women have been underrepresented in clinical trials of weight loss interventions, particularly those
conducted in the primary care setting. Further, existing obesity treatments are less effective for this population. The
promotion of weight maintenance can be achieved at lower treatment intensity than can weight loss and holds
promise in reducing obesity-associated chronic disease risk. Weight gain prevention may also be more consistent
with the obesity-related sociocultural perspectives of black women than are traditional weight loss approaches.
Methods/Design: We conducted an 18-month randomized controlled trial (the Shape Program) of a weight gain
prevention intervention for overweight black female patients in the primary care setting. Participants include 194
premenopausal black women aged 25 to 44 years with a BMI of 25–34.9 kg/m2. Participants were randomized
either to usual care or to a 12-month intervention that consisted of: tailored obesogenic behavior change goals,
self-monitoring via interactive voice response phone calls, tailored skills training materials, 12 counseling calls with a
registered dietitian and a 12-month YMCA membership.
Participants are followed over 18 months, with study visits at baseline, 6-, 12- and 18-months. Anthropometric data,
blood pressure, fasting lipids, fasting glucose, and self-administered surveys are collected at each visit.
Accelerometer data is collected at baseline and 12-months.
At baseline, participants were an average of 35.4 years old with a mean body mass index of 30.2 kg/m2. Participants
were mostly employed and low-income. Almost half of the sample reported a diagnosis of hypertension or
prehypertension and 12% reported a diagnosis of diabetes or prediabetes. Almost one-third of participants smoked
and over 20% scored above the clinical threshold for depression.
Discussion: The Shape Program utilizes an innovative intervention approach to lower the risk of obesity and
obesity-associated chronic disease among black women in the primary care setting. The intervention was informed
by behavior change theory and aims to prevent weight gain using inexpensive mobile technologies and existing
health center resources. Baseline characteristics reflect a socioeconomically disadvantaged, high-risk population
sample in need of evidence-based treatment strategies.
Trial registration: The trial is registered with clinicaltrials.gov NCT00938535.
Keywords: Obesity, Weight, eHealth, Women’s health, Minority health, Primary care, Prevention
* Correspondence: firstname.lastname@example.org
1Duke Obesity Prevention Program, Duke Global Health Institute, 2812 Erwin
Road, Suite 403 Box 90392, Durham, NC 27705, USA
Full list of author information is available at the end of the article
© 2012 Foley et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative
Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly cited.
Foley et al. BMC Public Health 2012, 12:305
The epidemic of obesity in the U.S. shows no signs of
abating – presently, almost 70% of the adult U.S. popula-
tion is either overweight or obese . Black women are
disproportionately affected by the condition. Between
1976 and 2008, obesity among black women increased
more than 60% [2,3]. Nearly 60% of black women are
obese, a rate that is twice that of non-Hispanic white
women . Socioeconomic status and obesity are less
strongly associated in black women than in other groups.
Nevertheless, socioeconomic factors strongly pattern
exposure to obesogenic environmental factors [4,5], the
adoption of obesogenic risk behaviors , the limited
availability of weight management resources [7,8], and
the efficacy of obesity treatment strategies in the primary
care setting .
Despite their vastly increased risk of obesity and
associated chronic disease [10,11], racial/ethnic minority
and socioeconomically disadvantaged populations have
been underrepresented in clinical trials of weight
loss interventions . This is problematic because
promoting weight loss among black women is a long-
standing and vexing clinical challenge [12,13]. Evidence-
based obesity treatments are consistently less effective
and absolute weight losses are generally smaller among
black women, compared to other populations [10,11,14].
There is growing recognition that alternative clinical
treatment strategies are necessary to contend with the
challenge of obesity [14-17]. While it is undeniable that
weight loss is the optimal treatment strategy for many
obese individuals, weight gain prevention may have
considerable clinical utility among overweight and some
obese black women.
Weight gain prevention holds promise in reducing risk
associated with cardiovascular diseases (CVD), type 2
diabetes, some cancers  and perhaps premature
mortality . Weightgain prevention
particular benefits for blacks, who exhibit disproportion-
ately greater rates of adulthood weight gain [20,21] and
extreme obesity , both of which increase obesity-
associated chronic disease risk [22-24]. Relative to
whites, black women have weaker associations of
adiposity with cardiovascular risk factors [25-28] and
mortality from cardiovascular disease [29,30] and all
causes. Thus, promoting weight stability within the
overweight (BMI=25-29.9 kg/m2) and lower levels of the
Class 1 obesity ranges (BMI=30-34.9 kg/m2) might be an
appropriate chronic disease risk reduction strategy in black
women, especially prior to menopause, when weight gains
are particularly pronounced [31,32].
Additionally, we suspect that weight gain prevention
strategies may be more consistent with the sociocultural
experiences of black women, compared to traditional
weight loss approaches. While some opposing data exist,
most studies have shown that black women are more
tolerant of heavier body weights, as compared to white
women . Blacks have a greater social acceptance of
overweight, less body weight dissatisfaction, and higher
body weight ideals than do whites [12,33-40]. A number
of studies have shown that overweight blacks are less
likely to perceive themselves to be overweight, compared
to whites and Hispanics [41-43]. Perceived body image
and attractiveness are not as strongly linked with weight
in black women, compared to white women. Moreover, a
majority of blacks do not consider overweight to be
unhealthy . Given that black women’s views about
attractiveness and health are not closely associated with
their weight status, weight loss messages [44-46] – which
emphasize the importance of thinness – may have
limited effectiveness among obese women. Intervention
messages that emphasize weight gain prevention or
enhancement of one’s current shape may have greater
Given the challenges associated with promoting weight
loss among black women, particularly in the primary care
setting, alternative treatment strategies are necessary.
Weight gain prevention among overweight and Class 1
obese individuals is one such approach, one that requires
relatively low treatment intensity and might be more
consistent with the sociocultural experiences of black
women. We suspect that its lower intensity and greater
consistency with sociocultural norms may heighten
participant responsiveness, improve intervention engage-
ment, and enhance intervention outcomes among black
We conduct the Shape Program (Shape), an 18-month
randomized controlled trial of a weight gain preven-
tion intervention for overweight and Class 1 obese
(BMI: 25–34.9 kg/m2) black female patients in the
primary care setting. The primary outcome is weight
maintenance over 12 months; secondary outcomes are
change in obesity risk behaviors and obesity-related
biomarkers, as well as maintenance of outcomes
through 18-months. The primary hypothesis is that
baseline BMI levels will be maintained in participants
randomized to the intervention, while BMI levels will
increase in those assigned to usual care.
All study procedures and protocols were approved by
the Duke University Institutional Review Board and the
Piedmont Health Board of Advisors.
Shape is conducted in six CHCs operated by Piedmont
Health, a private, non-profit community health system
that operates six health centers in a seven-county service
Foley et al. BMC Public Health 2012, 12:305
Page 2 of 11
area in central North Carolina. Each Piedmont Health
center offers primary care services, with additional site-
specific services (e.g., laboratory, dentistry, pharmacy)
that address local needs. Registered dietitians based at
each health center provide WIC counseling, diabetes
education, and medical nutrition therapy. Piedmont
Health has a patient population of nearly 40,000 with
over 123,900 medical/dental visits in 2010. Patients are
predominately racial/ethnic minority (77%), 98% are
<200% of the federal poverty level, and most are either
uninsured, underinsured, or hold public insurance (59%
uninsured, 31% Medicaid/Medicare).
Participants include 194 premenopausal black women,
aged 25 to 44 years, with a BMI of 25-34.9 kg/m2.
Additional inclusion criteria are: at least one visit to a
Piedmont Health center in the prior 24 months, North
Carolina residency, and the ability to read and write in
English. Exclusion criteria include: current pregnancy,
being≤12 months postpartum, a history of myocardial
infarction or stroke in the prior two years, and profound
cognitive, developmental or psychiatric disorders.
Participant screening and recruitment
Recruitment of participants occurred between September
2009 and February 2011. Piedmont Health staff used
electronic medical record (EMR) data to generate lists of
potentially eligible patients from each health center. Study
staff abstracted patients’ heights and weights from paper
medical charts to assess BMI eligibility (25–34.9 kg/m2).
Potential participants were sent invitation letters
(signed by the respective health center medical director
and the study principal investigator) and study brochures
via postal mail. Patients could opt out of the study by
calling the toll-free number provided in the recruitment
letter. No patients opted out of the recruitment process.
After one week, study staff called potentially eligible
patients to invite participation, perform an initial eligibility
assessment, and schedule a screening evaluation visit.
Randomization occurred at the baseline visit, using a
computer-based algorithm that was triggered after parti-
cipants completed the baseline questionnaire battery.
equally (1:1) across treatment arms. We assigned partici-
pants to one of two research assistants and participants
randomized to the intervention arm were randomly
assigned to one of two interventionists. The intervention
design precluded blinding either patients or interven-
tionists to treatment assignment.
The study is designed to detect a difference of 1.03 kg/m2
in BMI at the 0.05 alpha level and 80% statistical power
using a two-tailed test for differences. We increased the
target sample size to account for examination of effect
modifiers and mediators.
Usual care participants received the current standard of
care offered by their primary care providers. In addition,
usual care participants received semi-annual newsletters
from our study team over the 12-month project period.
These newsletters covered topics (e.g., finances, the
environment) that were relevant to women in the target
age group but did not relate to weight, nutrition, or
Weight maintenance intervention
Social Cognitive Theory (SCT) [49,50] informed the inter-
vention’s design. From SCT, self-efficacy was selected as
the primary psychosocial mediator. There is strong and
consistent evidence that self-efficacy is positively asso-
ciated with weight loss intentions, initiation, and mainten-
ance [51-53]. The intervention was designed to target each
of the four factors that Bandura identified as influencing
self-efficacy:  mastery experiences, social modeling,
social persuasion, and somatic and emotional reactions.
Social Cognitive Theory also indicates that behavior change
can be facilitated through a number of self-regulatory
processes that were built into the intervention, including
self-monitoring [55,56], goal setting [53,57], and social
support . The intervention was designed to support
these self-regulatory processes, which should further
The intervention contained five components (Table 1):
1) obesogenic behavior change goals; 2) self-monitoring
via interactive voice response (IVR) phone calls; 3) tailored
skills training materials; 4) 12 interpersonal counseling
calls; and 5) a 12-monthYMCA membership.
Behavior change goals
The intervention utilized the interactive obesity treatment
approach (iOTA), which creates an energy deficit sufficient
to produce weight change through the modification of
routine obesogenic lifestyle behaviors [59,60]. Participants
were assigned 3 behavior change goals from the iOTA
library using an algorithm that considers a participant’s
need for change, self-efficacy, readiness, and the goal’s
intended caloric deficit. The iOTA goal library contains
over 21 obesogenic behavior change goals (e.g., five or
Foley et al. BMC Public Health 2012, 12:305
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more fruits and vegetables/day, no fast food, no sugar
sweetened beverages, walking 7,000 steps/day) that were
selected based on their: 1) empirical support; 2) population
relevance; 3) ease of self-monitoring; and 4) concreteness.
Participants were assigned new goals at months two and
four to maintain motivation and facilitate goal mastery.
At the beginning of each new goal assignment (every
two months), participants received printed personalized
feedback reports that detailed results of the previous goal
assignments as well as provided tailored prescriptions for
Behavior change strategies
We recommended that participants self-monitor their
iOTA behavior change goals daily using paper tracking
logs. Participants were given pedometers to facilitate
daily monitoring of physical activity. Participants relayed
the self-monitoring data recorded on their tracking logs
to the study team during weekly interactive voice
response (IVR) calls. Interactive voice response calls allow
one to interact with a computer system using a telephone
by typing on the keypad or via speech. Participants
received weekly IVR calls throughout the 12-month inter-
vention. Self-monitoring data collected via IVR were
visible to coaches to inform counseling activities during
monthly coaching calls.
After self-monitoring data was collected, tailored feedback
was immediately provided through IVR. Feedback messages
successes, and/or offered motivational strategies. Short skills
training tips were also provided.
Shape utilized telephonic technologies for several
reasons. First, IVR helps to overcome the literacy/numeracy
barriers associated with detailed paper records. These
systems have high reach [61,62], as mobile phone penetra-
tion is very high in the target population. In contrast to
web-based approaches, telephony is easily accessible, low-
cost, quickly used, and requires no expert knowledge.
Finally, IVR is inexpensive to develop, simple to tailor and
Skills training materials
A major point of innovation in the Shape design is that,
unlike traditional weight loss strategies, our approach
suggests that participants maintain their current weight
(and shape). This approach inherently embraces long-
held social norms and aesthetic values. The interven-
tion’s focus resulted from qualitative pilot work designed
to assess the acceptability of print materials and to test
Shape print materials were tailored at several levels.
Participants received skills training content that corre-
sponded to their behavior change goals. At baseline visits,
participants were provided with a set of tailored interven-
tion materials to be utilized over the first two months of
the intervention. For example, individualized “Shape
Tracking Logs” included tailored narratives based on each
participant’s unique set of goals. Additional materials were
sent via postal mail every two months. We sent cycle-
specific materials every two months in order to keep parti-
cipants focused on the goals of current assignment and to
heighten feelings of novelty and connection with the
program. Participants also received quarterly newsletters
with additional skills training information (e.g., appropriate
portion sizes, food shopping tips, healthy recipes).
Telephone counseling calls
Each month, 20-minute counseling calls were delivered by
Piedmont Health registered dietitians (“coaches”) trained
in motivational interviewing principles . The coach
calls were designed to enhance self-efficacy by guiding
participants through identification of barriers to behavior
change and resulting ambivalence towards change efforts.
They also provided skills training and helped participants
utilize goal-setting as a problem solving strategy.
Coaches used a web application that presented each
session’s call script, allowed for note taking, and provided
access to participant self-monitoring data. The system
recorded calls and automatically stored process data
(e.g., date/time, call disposition, duration). Prior to the
monthly counseling calls, coaches reviewed the participant
self-monitored IVR goal tracking data that was held on the
centralized data management system. The coaches used
this data to guide discussions of participant progress
towards assigned goals and to discuss readiness for behavior
change and barriers to change. Data from the coaching calls
were stored on the secure study server with all other study
data for monitoring and data collection purposes.
Shape coaches participated in a 2-day training session
at baseline and received biannual refresher trainings.
Shape staff monitored IVR data for completeness and
Table 1 Intervention design
Component Type of contact Frequency of contacts (over 12-month period)
Self-monitoring with tailored feedbackPrinted tracking logs
Tailored skills trainingPrinted materials22/year
Interpersonal counseling Coaching calls from Registered Dietician1/month
Physical activityYMCA membership 12-month membership
Foley et al. BMC Public Health 2012, 12:305
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reviewed 5% of coaching calls for adherence to protocol.
Weekly supervision with the intervention coordinator
ensured appropriate delivery of the coaching component
of the intervention.
Participants in the target population have limited options
for safe and affordable physical activity. We addressed
this barrier and promoted participant motivation for
physical activity by providing intervention participants
with 12-month memberships to local YMCAs.
At the screening visit, research assistants oriented
participants to the study, gathered informed consent,
and collected anthropometric data to confirm BMI
eligibility. The anthropometric and blood data collection
activities were conducted at baseline and again at study
follow-up visits at 6, 12, and 18 months.
Participants changed into hospital gowns and their body
heights were measured to the nearest 0.1 cm using a
calibrated wall-mounted stadiometer (Seca 214)  and
body weights were measured to the nearest 0.1 kg using
a portable electronic scale (Seca Model 876) . Waist
circumference was measured to the nearest 0.1 cm using
a vinyl, retractable tape measure (AccuFitness MyoTape)
where circumference was measured horizontally from
the highest point of the iliac crest at minimal respiration.
The Omron HEM 907XL, a microprocessor controlled,
noninvasive device that automatically measures systolic
pressure, diastolic pressure, and pulse rate for adults, was
used to measure blood pressure three times at 1-minute
intervals after five minutes of quiet sitting. Participants were
advised not to smoke or to consume any caffeine within 30
minutes of their study visits.
Participants were instructed to fast for at least eight
hours prior to their study visits. Each participant had a
fasting glucose and lipid panel analyzed using fingerstick
blood specimens collected in 40μl capillary tubes
(Cholestech LDX; Cholestech Corporation, Hayward,
All participants (Intervention and Usual Care) wore
accelerometers (Actical; Philips Respironics, Inc., Bend,
OR USA) on their non-dominant wrists  to provide
estimates of free-living physical activity before baseline
and after 12-month visits. Participants were instructed to
wear the monitors continuously until their return visits
approximately 14 days later. Upon its return, the activity
monitor was removed from the wrist and data was
downloaded to a computer and visually screened for
compliance and collection errors. Complete files were
defined as those in which the monitor had been worn
for ≥10 days (i.e., complete compliance).
Activity monitor files were first transformed from 15-sec
to 1-min epochs and then “smoothed” using a protocol
validated for wrist monitoring of physical activity in
overweight and obese adults . Next, the resulting data
were transformed into units of activity energy expenditure
(AEE; kcals/kg/min) using a 2R calibration algorithm 
and then summarized into outcome variables that included
time (T; mins/week) and activity energy expenditure (AEE;
kcals/week) engaged in light (TLand AEEL, respectively)
and moderate-vigorous (TMV and AEEMV, respectively)
activity intensities. The cut point used to distinguish light
from moderate intensity activities was 0.0385 kcals/kg/min,
which is the same value defined previously for overweight
and obese adults . Finally, both TMV and AEEMV
variables were summarized in activity bouts of 1 and 10
minutes. These data-screening and processing procedures
were consistent with those recently recommended for use
with accelerometry-based physical activity data .
Participants complete self-report surveys at baseline
and 6-, 12-, and 18-month follow-up. Surveys are
administered via computer using an online survey tool
(www.surveygizmo.com). Demographic variables collected
at baseline include age, race/ethnicity, marital status, occu-
pational status, educational attainment, income, and co-
We used validated measures to assess a range of rele-
vant constructs, including:
Body image The 14-item Figure Rating Scale (FRS) is
designed to assess current and past body size as well as
attractiveness of body figure drawings .
Quality of life The 5-item EuroQol instrument (EQ-5D)
assesses mobility, self-care, usual activities, pain/discomfort,
and anxiety/depression. The EuroQol visual analog scale
(EQ-VAS) is similar to a health thermometer and is
designed to assess self-rated health quality of life [71,72].
Medical history Twelve items measure general health
and previous diagnosis and perceived risk of diabetes
and high blood pressure.
Physical activity Four items are used to assess current
stage of change in relation to physical activity. A 6-item
scale from the Behavioral Risk Factor Surveillance Sys-
tem (BRFSS) is designed to assess the amount and fre-
quency of moderate and vigorous activity [73,74].
Foley et al. BMC Public Health 2012, 12:305
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Tobacco use Three items assess current smoking beha-
viors and previous quit attempts. This measure is derived
from the National Health Interview Survey (NHIS) .
Sleep behavior The Medical Outcomes Study (MOS)
Sleep is a 12-item measure designed to assess minutes to
fall asleep, total hours of sleep each night, and difficulties
with sleep. The questionnaire assesses six dimensions:
sleep disturbance, sleep adequacy, daytime somnolence,
snoring, short of breath, and quantity of sleep .
Self-efficacy for exercise Self-efficacy for exercise is
measured using five items that assess confidence in
ability to exercise when tired, in a bad mood, don’t have
time, on vacation, or when it is raining/snowing .
Genetic causal beliefs An 8-item scale is designed to
assess perceptions of risk for obesity, diabetes, and heart
disease (i.e., genetic or behavioral lifestyle habits) [78,79].
Dietary restraint The Three Factor Eating Question-
naire is designed to assess different dimensions of eating
behavior. For the current study, we used the 18-item
revised version (TFEQ-R18) to measure three domains:
Cognitive Restraint (6 items), Uncontrolled Eating (9
items), and Emotional Eating (3 items) [80,81].
Social support A 19-item subscale from the Medical
Outcomes Study (MOS-SSS) assesses availability of social
support. Four subscales are used: emotional/informa-
tional, tangible, affectionate, and positive social inter-
Perceived weight A 12-item scale is designed to assess
perceptions of past, current, and future weight, self-
perceived weight class (i.e., underweight, average weight,
overweight), and body satisfaction.
Negative life events A 16-item questionnaire measures
frequency of stressful life events .
Depression The 8-item Patient Health Questionnaire
(PHQ-8) is designed to assess the presence of depressive
Health literacy A 3-item questionnaire is used to screen
for limited health literacy .
environment questions include items adapted from the
Neighborhood Environment Walkability Scale (NEWS)
on perceptions of the built environment, land use mix,
and community support for physical activity .
Food security An adaptation of the USDA Household
Food Security Scale (6 items) is designed to assess
household food security (money for food, food afford-
ability, skipped meals) [87-89].
Racial identity The 8-item Centrality subscale of the
Multidimensional Inventory of Black Identity (MIBI) is used
to measure African-American or black racial identity .
Absenteeism and presenteeism The 11 items from the
World Health Organization Health and Work Perform-
ance Questionnaire (HPQ)-Short Form assess number
of hours worked, expected hours of work, missed work,
total hours of work over the past 4 weeks, and perceived
job performance [91,92].
Shape will be evaluated using the RE-AIM planning and
evaluation framework  (Table 2). The RE-AIM
framework addresses five issues related to both internal
and external validity by comprehensively evaluating the
success of interventions on issues key for translation
from research to practice and dissemination: 1) Reach
and representativeness of individuals who participate;
2) Effectiveness/Efficacy of the intervention on the
primary outcomes at the individual level; 3) Adoption
at the organizational/CHC level; 4) Implementation
measured at the CHC provider/staff level; and 5)
Maintenance at both the individual participant and
A total of 194 black female patients were randomized to
treatment arms. Five participants became ineligible after
randomization due to pregnancy or diagnosis of cancer.
At baseline (Table 3), participants were an average of
35.4 (SD=5.5) years old with an average BMI of 30.2
(SD=2.6) kg/m2. Participants were mostly employed
(70.4%) and low-income – 73.5% had an annual house-
hold income≤$29,999 and one-third lived beneath the
federal poverty threshold. Participants were supporting
an average of 3.2 (SD=1.3) persons with their household
income. Most participants (72.5%) did not live with
partners in the household. One-third of the sample had a
high school diploma, GED or less and only 7% had
returned an average of 15.1 days after initial placement.
Complete baseline accelerometer data was collected for
87.6% of the participants (n=170). Nearly a third (31.6%)
of participants met the federal guideline of≥150 minutes
of 10-minute bouts of physical activity each week. Parti-
cipants averaged 166.9 (SD=265.5) minutes a week of
moderate physical activity in 10-minute bouts and no
Foley et al. BMC Public Health 2012, 12:305
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(0.0) minutes a week of vigorous activity in 10-minute
Almost half (46.0%) of the sample reported a diagno-
sisof hypertension orprehypertension
reported a diagnosis of diabetes or prediabetes. Almost
one-third of participants smoked and over one-fifth
scored above the PHQ clinical threshold for depression.
Mean blood pressure measurements were: SBP=123.2
(SD=14.8)/DBP=80.6 (SD=11.0). Mean lipid levels
were optimal or close to optimal.
Despite the recent plateau of the obesity epidemic in the
U.S. adult population , black women still have dramat-
ically higher obesity risk compared to other groups.
Given evidence suggesting that overweight (and Class 1
obesity) is less health damaging for black women
compared to other racial/ethnic groups, maintaining
weight status among black women in the BMI≤35 kg/m2
range may hold promise as an alternative obesity treatment
strategy. Strategies are needed that can prevent weight gain
for women in the BMI≤35 kg/m2range, those who might
benefit most from weight gain prevention approaches.
Fortunately, weight gain prevention can be accomplished at
lower treatment intensity than can weight loss . A major
advantage for this population is that weight gain prevention
builds upon existing weight-related sociocultural norms
among black women instead of challenging them. In stark
contrast to the focus of weight loss interventions, Shape’s
content focused on “maintaining shapes” and “showing off
curves” in order to validate sociocultural norms about body
image and to reinforce self-affirming weight maintenance
Furthermore, Shape was designed for primary care
practice – a particularly meaningful setting for addressing
the obesity epidemic and one in which relatively few
weight-related trials are conducted. More specifically,
the intervention was developed for implementation in
community health centers, critical primary care delivery
systems for our nation’s most medically vulnerable popula-
tions. Indeed, the baseline characteristics of the Shape
sample reflect a group that is at extremely high risk for
obesity and obesity-associated chronic disease. The sample
was composed of largely rural, black women who are
unmarried, supporting several family members, and strug-
gling to make ends meet. About half of the sample was
diagnosed with hypertension or prehypertension. Partici-
pants demonstrated elevated levels of moderate physical
activity (that was likely due primarily to occupational
pursuits) and no vigorous activity, which suggests little
intentional exercise. Many women (over 20%) in our
sample were above the clinical threshold for depression.
Together, this group is one at extremely high disease risk
and, yet, one for which we have few evidence-based inter-
Although Shape is a novel approach executed in an
understudied population, we are encouraged by our
Table 2 RE-AIM Measures
Domain Description Measure Data source(s)
Reach Degree to which target
population is reached by
1. % Eligible population contacted
2. % Who respond to contact
3. % Who participate/are excluded
4. Representativeness of study sample
to target population
1-4. Study database
1–4. PHS EHR
Efficacy Improvement in study
1. Change in weight and secondary
1. In-person measurement
Adoption Potential organizational
1. Patient intervention satisfaction
1. Survey (12 mo)
Implementation Degree to which intervention
is implemented as intended
1. Interventionist adherence to
2. Participant adherence to intervention
1. Study database
1. Process measures including:
supervisor review of coach call
recordings, of # attempted
and completed coach calls, of timing
and accuracy of mailed materials
1. Patient survey (baseline, 6, 12 mo)
2. # attempted and completed coach
and IVR calls
2. # participant YMCA visits
1. Patient survey (18 mo)
1. PHS EHR
1. Study database
1. Staff time diaries
2. Financial statements
MaintenanceCan program outcomes be
sustained over time?
1. Weight change at 18 months
Cost How much does intervention
1. Cost of staff time (coach
and research staff) devoted to conducting
2. Cost of intervention delivery: print
materials, technology costs, YMCA memberships
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Table 3 Baseline characteristics of the Shape Program analytic sample (n=189)
Variable N (percent)
Black or African American 189 (100.0)
More than 1 race11 (5.8)
Less than high school graduate19 (10.0)
High school graduate or GED45 (23.8)
Some college or vocational/trade school83 (43.9)
Associate degree26 (13.8)
College graduate or post graduate degree13 (6.9)
Unknown 3 (1.6)
Annual household income
Under $10,000 - $29,999139 (73.5)
$30,000 - $39,99924 (12.7)
Over $40,00024 (12.7)
Unknown 2 (1.1)
People supported by this income: mean (SD)3.2 (1.3)
Living under U.S. Census poverty threshold62 (33.3)
Widowed, divorced, separated44 (23.3)
Never married78 (41.3)
Not married or living with partner15 (7.9)
Yes 133 (70.4)
No 53 (28.0)
Unknown 3 (1.6)
Current smoker58 (30.7)
Self-reported history of:
Diabetes or prediabetes23 (12.2)
Hypertension or prehypertension87 (46.0)
Meeting U.S Federal guidelines for physical activity using accelerometers49 (31.6)
Depression score: mean (SD)
Depression score ≥ 10
Age (yrs)35.4 (5.5)
Waist circumference (cm) 97.8 (8.2)
Blood pressure: systolic (mmHg)123.2 (14.8)
Blood pressure: diastolic (mmHg) 80.6 (11.0)
Triglycerides (mg/dL)102.2 (47.5)
LDL (mg/dL)107.4 (34.2)
HDL (mg/dL)53.8 (16.1)
Total cholesterol (mg/dL)179.2 (37.3)
Fasting glucose (mg/dL)105.1 (44.3)
Foley et al. BMC Public Health 2012, 12:305
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initial success with recruitment and retention. To
optimize participant recruitment and retention, the study
team employed several strategies designed to accommo-
date the busy lives of study participants, most of whom
work, are socioeconomically disadvantaged, and are
solely responsible for children in the household. Study
visits were offered in a number of locations convenient
to participants, including in the Piedmont Health
centers, at all times of day on weekdays and weekends.
Participants who notified the study team about transporta-
tion difficulties were offered home visits and taxi vouchers
for evaluation visits.
The research team worked closely and collaboratively
with Piedmont Health partners on Shape design and
implementation issues. The research team designed
recruitment and data collection activities to be minimally
burdensome on health center practices, while harnessing
the strengths of the Piedmont Health system. Financial
mechanisms were negotiated that adequately reimbursed
Piedmont Health for its involvement and for the staff
time of its registered dietitians, who functioned as study
coaches. These types of strategies are crucial in ensuring
that CHC-based research benefits patients without
overburdening already-strained clinical operations.
In conclusion, black women are disproportionally
affected by the epidemic of obesity and, consequently,
the risk of comorbidities associated with being obese. In
previous trials, low-income black women have not been
as well represented as other groups; when included, their
weight loss outcomes have been suboptimal. Shape was
designed to take an innovative approach to managing
obesity and its health consequences among black women
by integrating behavior change theory, building upon an
understanding of sociocultural norms and utilizing
health information technologies. In these ways, Shape
was designed to be responsive to calls for interventions
that have dissemination potential in real world practice
settings. Such considerations are particularly pressing for
socioeconomically disadvantaged populations given their
dramatically increased risk of obesity and obesity-
associated chronic diseases and the limited availability of
obesity treatment options.
CVD: Cardiovascular disease; CHC: Community health center; EMR: Electronic
medical record; SCT: Social cognitive theory; iOTA: Interactive obesity
treatment approach; IVR: Interactive voice response; AEE: Activity energy
expenditure; T: Time; FRS: Figure rating scale; BRFSS: Behavioral risk factor
surveillance system; NHIS: National health interview survey; MOS: Medical
outcomes study; PHQ: Patient health questionnaire; MIBI: Multidimensional
inventory of black identity.
The authors declare that they have no competing interests.
This trial is funded by grant R01DK078798. Dr. Emmons was supported by
K05CA124415 and Dr. Bennett was supported by K22CA126992. We express
deep gratitude to the administration and staff of Piedmont Health for their
continued collaboration and participation in the Shape Program. In particular,
we would like to thank Brian Toomey, MSW, Tom Wroth, MD, MPH, Heather
Miranda, RD, LDN, Marni Holder, RN, FNP-BC, Ashley Brewer, RD, LDN, Greg
Wheatley, MPH, RD, LDN, Kristen Norton, MA, RD, LDN, Marianne Ratcliffe,
MHA and staff at the PHS health centers for their support. We are grateful to
Martha Zorn, MS at the University of Massachusetts-Amherst for her
assistance with data analysis and to Lisa Englert for her assistance with
manuscript preparation. Lastly, we would like to especially thank the women
participating in Shape.
1Duke Obesity Prevention Program, Duke Global Health Institute, 2812 Erwin
Road, Suite 403 Box 90392, Durham, NC 27705, USA.2School of Public Health
and Health Sciences, University of Massachusetts Amherst, 425 Arnold House
715 North Pleasant Street, Amherst, MA 01003-9304, USA.3College of
Nursing and Health Sciences, University of Massachusetts Boston, 100
Morrissey Boulevard, Boston, MA 02125, USA.4Division of Endocrinology,
Metabolism and Nutrition, Duke University Medical Center, 200 Trent Drive,
Duke South Orange Zone DUMC, Box 3031, Durham, NC 27710, USA.
5Department of Health & Human Development, Montana State University,
H&PE Complex, Hoseaus Room 121, Bozeman, MT 59717, USA.6Dana-Farber
Cancer Institute, 450 Brookline Avenue, LW601, Boston, MA 02215, USA.
PF managed study design and execution and drafted the manuscript for
publication. EL and JW coordinated intervention design. BB consulted on
data safety and execution of the study. DH consulted on the accelerometer
data collection protocols and analyzed accelerometer data. EP and SA
participated in study design and conducted statistical analysis. DD, VL, ML
and JM conducted primary data collection and participated in study design.
KE participated in study conceptualization and design. GB conceived of the
study, acquired study funding, participated in study design and coordination
and drafted the manuscript for publication. All authors read and approved
the final manuscript.
DD is now with Quintiles Transnational in Durham, NC and VL is now with
the School of Social Work at the University of North Carolina, Chapel Hill, NC.
Received: 10 April 2012 Accepted: 26 April 2012
Published: 26 April 2012
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Cite this article as: Foley et al.: Weight gain prevention among black
women in the rural community health center setting: The Shape
Program. BMC Public Health 2012 12:305.
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