A Toolbox Approach to Obesity Treatment in Urban Safety-Net Primary Care Clinics: a Pragmatic Clinical Trial.

BACKGROUND: There is a need for new strategies to improve the success of obesity treatment within the primary care setting. OBJECTIVE: To determine if patients offered low out-of-pocket cost weight management tools achieved more weight loss compared to usual care. DESIGN: Twelve-month pragmatic clinical weight loss trial with a registry-based comparator group performed in primary care clinics of an urban safety-net hospital. PARTICIPANTS: From a large clinical registry, we randomly selected 428 patients to have the opportunity to receive the intervention. INTERVENTIONS: Medical weight management tools-partial meal replacements, recreation center vouchers, pharmacotherapy, commercial weight loss program vouchers, and a group behavioral weight loss program-for $5 or $10 monthly. Patients chose their tools, could switch tools, and could add a second tool at 6 months. MAIN MEASURES: The primary outcome was the proportion of intervention-eligible patients who achieved ≥ 5% weight loss. The main secondary outcome was the proportion of on-treatment patients who achieved ≥ 5% weight loss. KEY RESULTS: Overall, 71.3% (305 of 428) had available weight measurement data/PCP visit data to observe the primary outcome. At 12 months, 23.3% (71 of 305) of intervention-eligible participants and 15.7% (415 of 2640) of registry-based comparators had achieved 5% weight loss (p < 0.001). Of the on-treatment participants, 34.5% (39 of 113) achieved 5% weight loss. Mean percentage weight loss was - 3.15% ± 6.41% for on-treatment participants and - 0.30% ± 6.10% for comparators (p < 0.001). The initially preferred tools were meal replacements, pharmacotherapy, and recreation center passes. CONCLUSIONS: Access to a variety of low out-of-pocket cost weight management tools within primary care resulted in ≥ 5% body weight loss in approximately one quarter of low-income patients with obesity. TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT01922934.

Medication costs during an 18 month clinical trial of obesity treatment among patients encountered in primary care.

BACKGROUND: Weight loss often leads to reductions in medication costs, particularly for weight-related conditions. We aimed to evaluate changes in medication costs from an 18 month study of weight loss among patients recruited from primary care. METHODS: Study participants (n = 79, average age = 56.3; 75.7 % female) with average BMI of 39.5 kg/m(2), plus one co-morbid condition of either diabetes/pre-diabetes, hypertension, abnormal cholesterol, or sleep apnea, were recruited from 2 internal medicine practices. All participants received intensive behavioral and dietary treatment during months 0-6, including subsidized access to portion-controlled foods for weight loss. From months 7-18, all participants were offered continued access to subsidized foods, and half of participants were randomly assigned to continue in-person visits ("Intensified Maintenance"), while the other half received materials by mail or e-mail ("Standard Maintenance"). Medication costs were evaluated at months 0, 6, and 18. RESULTS: Participants assigned to Intensified Maintenance maintained nearly all their lost weight, whereas those assigned to Standard Maintenance regained weight. However, no significant differences in medication costs were observed within or between groups during the 18 months of the trial. A reduction of nearly $30 per month (12.9 %) was observed among all participants from month 0 to month 6 (active weight loss phase), but this difference did not reach statistical significance. CONCLUSIONS: A behavioral intervention that led to clinically significant weight loss did not lead to statistically significant reductions in medication costs. Substantial variability in medication costs and lack of a systematic approach by the study team to reduce medications may explain the lack of effect. TRIAL REGISTRATION: The trial was registered at (NCT01220089) on September 23, 2010.