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

NCT07396805 | Recruiting DMC

• 2 other identifiers: IRB00528955R01NR021699
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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?

Conditions

Obesity & Overweight

Keywords

obesity; weight loss; food insecurity; nutrition

Outcome Measures

Primary Outcomes (1)

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

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

  Baseline to 24 weeks

Secondary Outcomes (9)

• 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

Study Arms (3)

BWL-Alone

ACTIVE COMPARATOR

Participants receive BWL-Alone

Behavioral: BWL

BWL+Voucher

EXPERIMENTAL

Participants receive BWL+Voucher

Behavioral: BWL; Other: VOUCHER

BWL+Home

EXPERIMENTAL

Participants receive BWL+Home

Behavioral: BWL; Other: HOME

Interventions

BWL BEHAVIORAL

Participants will receive a lifestyle modification program consisting of behavioral, physical activity, and dietary counseling delivered over 21, approximately 15 minute sessions delivered by trained interventionists. Sessions will be weekly during weeks 0-4, every other week during weeks 6-24, monthly during weeks 25-52. Treatment will be delivered remotely.

BWL+Home; BWL+Voucher; BWL-Alone

VOUCHER OTHER

During the initial 24 weeks, participants randomized to this group will receive the BWL program along with food vouchers distributed in the form of grocery store gift cards. Gift cards worth $60 will be emailed to participants every 2 weeks after their BWL session. From weeks 24-52, participants will continue to have monthly counseling sessions.

BWL+Voucher

HOME OTHER

During the initial 24 weeks, participants assigned to this group will receive home-delivered, medically tailored groceries alongside BWL. The contents of each box will be approximately $60 ($30/week) and sent using Instacart. From weeks 24-52, participants will continue to have monthly counseling sessions.

BWL+Home

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Ariana Chao, PhD, CRNP, FNP-BC

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ariana M Chao, PhD, CRNP, FNP-BC

CONTACT

667-208-7078; ariana.chao@jhu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 9, 2026
• Study Start: March 13, 2026
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): July 30, 2030
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

US (1)