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

This study is looking at whether providing healthy food options, combined with a behavioral weight loss (BWL) program, can help adults with obesity and food insecurity lose weight. You would be eligible if you are 18 or older, have a BMI (Body Mass Index) over 30, and screen positive for food insecurity. The study wants to see if BWL combined with either grocery store gift cards (VOUCHER) or home-delivered, medically-tailored groceries (HOME) leads to more weight loss than BWL alone. The main goal is to measure the percentage of weight lost after 24 weeks. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 300 participants. You would be randomly assigned to one of three groups: BWL alone, BWL with grocery vouchers, or BWL with home-delivered groceries.
What's involved
You would receive 21 behavioral weight loss sessions over 52 weeks and attend 4 in-person assessments to measure things like weight, blood pressure, and complete questionnaires.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is measured at 24 weeks, but behavioral weight loss sessions continue for 52 weeks.

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NCT07396805

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

Recruiting
NAAges 18+InterventionalTreatment
Johns Hopkins University
~300 participants
Updated 2026-03-16 on ClinicalTrials.gov
What's tested:BWLVOUCHERHOME

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent initial weight loss at week 24 (BWL+VOUCHER and BWL+HOME to BWL-Alone)
Measured over Baseline to 24 weeks

Conditions

Obesity & Overweight

Explore related trials

Obesity

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Ariana Chao, PhD, CRNP, FNP-BC · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Ariana M Chao, PhD, CRNP, FNP-BC
[email protected]
667-208-7078
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Percent initial weight loss at week 24 (BWL+VOUCHER and BWL+HOME to BWL-Alone)Baseline to 24 weeks

    Comparison of BWL+VOUCHER and BWL+HOME to BWL-Alone for weight loss (percent of baseline weight) at 24 weeks