NCT07396805

Trial of Food Is Medicine Approaches for Obesity Treatment in Adults With Food Insecurity

A Randomized Controlled Trial of Food Is Medicine Approaches for Obesity Treatment in Adults With Food Insecurity

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if increased access to healthy foods, combined with behavioral weight loss (BWL) interventions, results in greater weight loss for adults with obesity and food insecurity. It will also learn about changes in health-quality of life and dietary quality. The main questions it aims to answer are: * Does BWL, combined with either home-delivered, medically-tailored (HOME) groceries or grocery vouchers (VOUCHER), result in greater weight loss than BWL alone? * Is the addition of HOME to BWL more effective at supporting adults with food insecurity and obesity to lose weight when compared to BWL and VOUCHER?

Detailed description

Participants will: * Receive 21 sessions of BWL over 52 weeks delivered 1-on-1 with a counselor * Visit the research team for 4 in-person assessments to assess measures like height, weight, blood pressure, pulse, complete dietary assessments, questionnaires and interviews, and evaluate skin carotenoid levels (a non-invasive measure) * Be randomized (like picking numbers from a hat) to BWL-Alone; BWL+VOUCHER; or BWL+HOME. Participants in BWL+VOUCHER will receive grocery store gift cards every 2 weeks for the first 24 weeks of the study. Participants in BWL+HOME will receive groceries delivered to the home every 2 weeks for the first 24 weeks of the study.

Conditions

• Obesity & Overweight

Interventions

Type	Name	Description
BEHAVIORAL	BWL	Participants will receive a lifestyle modification program consisting of behavioral, physical activity, and dietary counseling delivered over 21, approximately 15 minute sessions delivered by trained interventionists. Sessions will be weekly during weeks 0-4, every other week during weeks 6-24, monthly during weeks 25-52. Treatment will be delivered remotely.
OTHER	VOUCHER	During the initial 24 weeks, participants randomized to this group will receive the BWL program along with food vouchers distributed in the form of grocery store gift cards. Gift cards worth $60 will be emailed to participants every 2 weeks after their BWL session. From weeks 24-52, participants will continue to have monthly counseling sessions.
OTHER	HOME	During the initial 24 weeks, participants assigned to this group will receive home-delivered, medically tailored groceries alongside BWL. The contents of each box will be approximately $60 ($30/week) and sent using Instacart. From weeks 24-52, participants will continue to have monthly counseling sessions.

Timeline

• Start date: 2026-03-13
• Primary completion: 2030-06-30
• Completion: 2030-07-30
• First posted: 2026-02-09
• Last updated: 2026-03-16

Locations

1 site across 1 country: United States