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

Recruiting now · Not applicable

Conditions studied: Obesity & Overweight

In brief

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?

Key facts

Study ID

NCT07396805

Run by

Johns Hopkins University

People needed

300

Starts

2026-03-13

Expected to finish

2030-07-30

Last updated by the study team

2026-03-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Following a specialized dietary regimen (e.g., gluten-free)

Where it is running

• Johns Hopkins University — Baltimore, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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