NCT07396805
Recruiting
Not Applicable
A Randomized Controlled Trial of Food Is Medicine Approaches for Obesity Treatment in Adults With Food Insecurity
Johns Hopkins University1 site in 1 country300 target enrollmentStarted: March 13, 2026Last updated:
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Johns Hopkins University
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Percent initial weight loss at week 24 (BWL+VOUCHER and BWL+HOME to BWL-Alone)
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •BMI\>30 kg/m2
- •Screening positive for food insecurity using the well-validated, 10-item US Adult Food Security Survey Module.
- •Age 18 years and older
- •Completion of baseline assessments
- •Ability to engage in physical activity (i.e., can walk at least 2 blocks without stopping for rest)
- •Willing and able to provide pictures of food receipts to study team (or mail receipts to study team)
- •Willing and able to provide written informed consent and participate in all study activities
- •Female participants of child-bearing potential must agree in writing to use an approved method of contraception during the study
Exclusion Criteria
- •Significant psychiatric conditions (e.g., active substance abuse, schizophrenia) that may pose a risk to the participant during intervention, cause a change in weight, or limit ability to adhere to the program's behavioral recommendations
- •Pregnant or planning pregnancy in the next year
- •Planned move from the Baltimore area in the next year
- •Recently began a course of or changed the dosage of medication that can cause significant weight change (±5 kg)
- •Previous or planned obesity treatment with surgery or a weight-loss device
- •Weight loss of \>5 kg in the previous 90 days
- •Household member already participating in study due to potential contamination effects
- •Lack of stable residence and ability to store and prepare food
- •Lack of telephone
- •Severe food allergies
Arms & Interventions
BWL-Alone
Active Comparator
Participants receive BWL-Alone
Intervention: BWL (Behavioral)
BWL+Voucher
Experimental
Participants receive BWL+Voucher
Intervention: BWL (Behavioral)
BWL+Voucher
Experimental
Participants receive BWL+Voucher
Intervention: VOUCHER (Other)
BWL+Home
Experimental
Participants receive BWL+Home
Intervention: BWL (Behavioral)
BWL+Home
Experimental
Participants receive BWL+Home
Intervention: HOME (Other)
Outcomes
Primary Outcomes
Percent initial weight loss at week 24 (BWL+VOUCHER and BWL+HOME to BWL-Alone)
Time Frame: Baseline to 24 weeks
Comparison of BWL+VOUCHER and BWL+HOME to BWL-Alone for weight loss (percent of baseline weight) at 24 weeks
Secondary Outcomes
- Percent initial weight loss at week 24 (BWL+VOUCHER versus BWL+HOME)(Baseline to 24 weeks)
- Percent initial weight loss at week 52 (BWL+VOUCHER and BWL+HOME to BWL-Alone)(Baseline to 52 weeks)
- Percent initial weight loss at week 52 (BWL+VOUCHER versus BWL+HOME)(Baseline to 52 weeks)
- Change from baseline to weeks 24 and 52 in SF-36 Physical Component Score(Baseline to week 24 and week 52)
- Change from baseline to weeks 24 and 52 in SF-36 Mental Component Score(Baseline to week 24 and week 52)
- Change from baseline to weeks 24 and 52 in total Impact of Weight on Quality of Life scale(Baseline to week 24 and week 52)
- Change from baseline to weeks 24 and 52 in total Healthy Eating Index score as measured using the Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool(Baseline to week 24 and week 52)
- Change from baseline to weeks 24 and 52 in skin carotenoid levels as measured by the Veggie Meter(Baseline to week 24 and week 52)
- Incremental cost-effectiveness per unit decrease in weight (kg)(Baseline to week 24 and week 52)
Investigators
Study Sites (1)
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