Behavioral treatment for weight gain prevention among black women in primary care practice: a randomized clinical trial.

IMPORTANCE Few weight loss treatments produce clinically meaningful weight loss outcomes among black women, particularly in the primary care setting. New weight management strategies are necessary for this population. Weight gain prevention might be an effective treatment option, with particular benefits for overweight and class 1 obese black women. OBJECTIVE To compare changes in weight and cardiometabolic risk during a 12-month period among black women randomized to a primary care-based behavioral weight gain prevention intervention, relative to usual care. DESIGN, SETTING, AND PARTICIPANTS Two-arm randomized clinical trial (the Shape Program). We recruited patients from a 6-site community health center system. We randomized 194 overweight and class 1 obese (body mass index [calculated as weight in kilograms divided by height in meters squared], 25-34.9) premenopausal black women aged 25 to 44 years. Enrollment began on December 7, 2009; 12- and 18-month assessments were completed in February and October 2, 2012. INTERVENTIONS The medium-intensity intervention included tailored behavior change goals, weekly self-monitoring via interactive voice response, monthly counseling calls, tailored skills training materials, and a gym membership. MAIN OUTCOMES AND MEASURES Twelve-month change in weight and body mass index and maintenance of change at 18 months. RESULTS Participants had a mean age of 35.4 years, a mean weight of 81.1 kg, and a mean body mass index of 30.2 at baseline. Most were socioeconomically disadvantaged (79.7% with educational level less than a college degree; 74.3% reporting annual income <$30,000). The 12-month weight change was larger among intervention participants (mean [SD], -1.0 [0.5] kg), relative to usual care (0.5 [0.5] kg; mean difference, -1.4 kg [95% CI, -2.8 to -0.1 kg]; P = .04). At month 12, 62% of intervention participants were at or below their baseline weights compared with 45% of usual-care participants (P = .03). By 18 months, intervention participants maintained significantly larger changes in weight (mean difference, -1.7 kg; 95% CI, -3.3 to -0.2 kg). CONCLUSIONS AND RELEVANCE A medium-intensity primary care-based behavioral intervention demonstrated efficacy for weight gain prevention among socioeconomically disadvantaged black women. A "maintain, don't gain" approach might be a useful alternative treatment for reducing obesity-associated disease risk among some premenopausal black women. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00938535.