Recruiting

BWL & HOME, VOUCHER

Sponsor:

Johns Hopkins University

Code:

NCT07396805

Conditions

Obesity & Overweight

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BWL

VOUCHER

HOME

Study Details

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

Study ID

NCT07396805

Start date

Mar 13, 2026

Status verified date

Mar, 2026

Completion date

Jul 30, 2030

Anticipated

Primary completion date

Jun 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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)

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: BWL-Alone

Participants receive BWL-Alone

experimental: BWL+Voucher

Participants receive BWL+Voucher

experimental: BWL+Home

Participants receive BWL+Home

Interventions

BWL

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.

VOUCHER

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.

HOME

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Ariana M Chao, PhD, CRNP, FNP-BC

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

Locations

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21205

More Information

Sponsor

Johns Hopkins University

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Keywords

  • obesity
  • weight loss
  • food insecurity
  • nutrition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-03-16.