Trial of Food Is Medicine Approaches for Obesity Treatment in Adults With Food Insecurity (EatWell Rx)

March 13, 2026 updated by: Johns Hopkins University

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

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?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participants will:

  • Receive 21 sessions of BWL over 52 weeks delivered 1-on-1 with a counselor
  • Visit the research team for 4 in-person assessments to assess measures like height, weight, blood pressure, pulse, complete dietary assessments, questionnaires and interviews, and evaluate skin carotenoid levels (a non-invasive measure)
  • Be randomized (like picking numbers from a hat) to BWL-Alone; BWL+VOUCHER; or BWL+HOME. Participants in BWL+VOUCHER will receive grocery store gift cards every 2 weeks for the first 24 weeks of the study. Participants in BWL+HOME will receive groceries delivered to the home every 2 weeks for the first 24 weeks of the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: BWL-Alone
Participants receive BWL-Alone
Behavioral: 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.
Experimental: BWL+Voucher
Participants receive BWL+Voucher
Behavioral: 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.
Other: 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.
Experimental: BWL+Home
Participants receive BWL+Home
Behavioral: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent initial weight loss at week 24 (BWL+VOUCHER and BWL+HOME to BWL-Alone)
Time Frame: Baseline to 24 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent initial weight loss at week 24 (BWL+VOUCHER versus BWL+HOME)
Time Frame: Baseline to 24 weeks
Comparison of BWL+VOUCHER versus BWL+HOME for weight loss (percent of baseline weight) at 24 weeks
Baseline to 24 weeks
Percent initial weight loss at week 52 (BWL+VOUCHER and BWL+HOME to BWL-Alone)
Time Frame: Baseline to 52 weeks
Comparison of BWL+VOUCHER and BWL+HOME to BWL-Alone for weight loss (percent of baseline weight) at 52 weeks
Baseline to 52 weeks
Percent initial weight loss at week 52 (BWL+VOUCHER versus BWL+HOME)
Time Frame: Baseline to 52 weeks
Comparison of BWL+VOUCHER versus BWL+HOME for weight loss (percent of baseline weight) at 52 weeks
Baseline to 52 weeks
Change from baseline to weeks 24 and 52 in SF-36 Physical Component Score
Time Frame: Baseline to week 24 and week 52
BWL-Alone, BWL+VOUCHER, and BWL+HOME in changes from baseline to weeks 24 and 52 in SF-36 Physical Component Score. Scores range from 0 (lowest) to 100 (highest/best).
Baseline to week 24 and week 52
Change from baseline to weeks 24 and 52 in SF-36 Mental Component Score
Time Frame: Baseline to week 24 and week 52
BWL-Alone, BWL+VOUCHER, and BWL+HOME in changes from baseline to weeks 24 and 52 in SF-36 Mental Component Score. Scores range from 0 (lowest) to 100 (highest/best).
Baseline to week 24 and week 52
Change from baseline to weeks 24 and 52 in total Impact of Weight on Quality of Life scale
Time Frame: Baseline to week 24 and week 52
BWL-Alone, BWL+VOUCHER, and BWL+HOME in changes from baseline to weeks 24 and 52 in total Impact of Weight on Quality of Life scale. Scores range from 0 (lowest) to 100 (highest/best).
Baseline to week 24 and week 52
Change from baseline to weeks 24 and 52 in total Healthy Eating Index score as measured using the Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool
Time Frame: Baseline to week 24 and week 52
BWL-Alone, BWL+VOUCHER, and BWL+HOME in changes from baseline to weeks 24 and 52 in total Health Eating Index score. Scores range from 0 (lowest) to 100 (highest/best which reflect the set of foods aligns with key dietary recommendations and dietary patterns published in the Dietary Guidelines).
Baseline to week 24 and week 52
Change from baseline to weeks 24 and 52 in skin carotenoid levels as measured by the Veggie Meter
Time Frame: Baseline to week 24 and week 52
BWL-Alone, BWL+VOUCHER, and BWL+HOME in changes from baseline to weeks 24 and 52 in skin carotenoid levels with scores ranging from 0 (lowest) to 800 (highest)
Baseline to week 24 and week 52
Incremental cost-effectiveness per unit decrease in weight (kg)
Time Frame: Baseline to week 24 and week 52
This measure describes the additional cost required to achieve one kilogram of weight loss with BWL+VOUCHER or BWL+HOME compared with BWL-Alone. It is calculated by dividing the difference in total costs between the two groups by the difference in average weight loss. Lower values indicate that the intervention achieves weight loss at a lower cost.
Baseline to week 24 and week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Nursing Research (NINR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ariana Chao, PhD, CRNP, FNP-BC, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 13, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00528955
  • R01NR021699 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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