A Randomized Controlled Trial of Food is Medicine Approaches for Obesity Treatment in Adults with Food Insecurity

Food insecurity is common among adults with obesity and is associated with less favorable outcomes in behavioral weight loss (BWL) interventions. There is a lack of evidence on treatment strategies that are effective in addressing both food insecurity and obesity. The primary objective of this proposal is to improve obesity treatment among adults with food insecurity by enhancing patients' capacity to afford and obtain nutritious foods during BWL. To achieve this objective, we will conduct a randomized controlled trial with a 3-group, parallel design that enrolls 300 adults with obesity and food insecurity. Participants will be assigned to one of three groups: BWL-Alone (n=100), BWL with food supplementation via either food vouchers (BWL+VOUCHER; n=100), or home-delivered, medically tailored groceries consistent with BWL recommendations (BWL+HOME; n=100). Food vouchers and HOME provisions will be provided for the initial 24 weeks of treatment. All groups will receive BWL treatment for 52 weeks in accordance with treatment guidelines. Assessments will occur at baseline and at weeks 12, 24 (conclusion of food supplementation), and 52 (completion of BWL treatment). Our primary aims are to assess whether BWL+VOUCHER and BWL+HOME yield greater weight loss (percentage of initial weight) at 24 weeks compared to BWL-Alone. Secondary objectives are to examine differences in percent weight loss between BWL+HOME vs BWL+VOUCHER at week 24, and to assess changes among groups from baseline to 52 weeks. Additional secondary goals are to investigate changes in health-related quality of life and self-reported and objective measures of dietary quality across treatment groups. Our exploratory aim is to conduct an economic analysis to evaluate the cost-effectiveness of each intervention. The anticipated outcome of this study is to provide evidence of feasible food support interventions applicable within healthcare systems to improve nutrition in people with obesity.