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.