NCT07396805Recruiting
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
Source: ClinicalTrials.gov · Last updated 16 Mar 2026
Brief summary (registry, in English)
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?
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 28 Jan 2026
- Start date
- 13 Mar 2026
- Primary completion date
- 30 Jun 2030
- Lead sponsor
- Johns Hopkins University
- Diseases
- Obesity
- NCT number
- NCT07396805
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 13 Mar 2026 to the primary completion date, 30 Jun 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
- Severe food allergies
Other
- Pregnant or planning pregnancy in the next year
- Planned move from the Baltimore area in the next year
- 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
- Following a specialized dietary regimen (e.g., gluten-free)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.