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.