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Healthy food access plus weight loss support for adults with obesity and food insecurity

Tests grocery delivery or vouchers added to weight loss support in adults with obesity.

Key facts

Who runs it
Johns Hopkins University
Where
Baltimore, United StatesSee the site
Trial code
Registry title
Trial of Food Is Medicine Approaches for Obesity Treatment in Adults With Food Insecurity
Status
Recruiting
People taking part
300 people, planned
Started
13 Mar 2026
Expected to end
30 Jul 2030
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • BWL
  • VOUCHER
  • HOME
Record updated
16 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with obesity who also struggle to get enough food. It tests healthy food support together with a weight loss programme.

Age
18 years and older
Sex
All sexes can join.
Disease stage
BMI over 30 kg/m2 and a positive result on the 10-item US Adult Food Security Survey Module (food insecurity).
Earlier treatment
No earlier obesity surgery or weight-loss device, and none planned. No weight loss of more than 5 kg (11 lb) in the last 90 days.

Main reasons for not taking part

  • Serious mental health conditions, such as active substance abuse or schizophrenia, that could put the person at risk or limit following the programme
  • Pregnant or planning pregnancy in the next year
  • Planned move from the Baltimore area in the next year
  • Recently started or changed a medicine that can cause weight change of ±5 kg (11 lb)
  • Severe food allergies or a specialized diet, such as gluten-free

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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
  • 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)

Where in United States

  • Johns Hopkins UniversityBaltimore, United StatesContact: Ariana M Chao, PhD, CRNP, FNP-BCTaking people

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

* 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?

The 3 groups in the trial

  • BWL-AloneExisting treatment, for comparison

    Participants receive BWL-Alone

    Treatment: BWL

  • BWL+VoucherTreatment being tested

    Participants receive BWL+Voucher

    Treatment: BWL and VOUCHER

  • BWL+HomeTreatment being tested

    Participants receive BWL+Home

    Treatment: BWL and HOME

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Randomized Controlled Trial of Food Is Medicine Approaches for Obesity Treatment in Adults With Food Insecurity
Plain-language title
Healthy food access plus weight loss support for adults with obesity and food insecurityGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
16 March 2026