Obesity & OverweightEatWell RxNCT07396805
Trial of Food Is Medicine Approaches for Obesity Treatment in Adults With Food Insecurity
A study testing BWL, VOUCHER and HOME in people with Obesity & Overweight, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- BWL, VOUCHER and HOME
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2026to 30 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21205
About this study
Official title: 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?
Read the 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.
- Conditions
- Obesity & Overweight
- Being tested
- BWL, VOUCHER, HOME
- Keywords
- obesity, weight loss, food insecurity, nutrition
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BWLBehavioural
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.
VOUCHEROther
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.
HOMEOther
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.
| Study group | Role | What they receive |
|---|---|---|
| BWL-Alone | Active comparator | Participants receive BWL-Alone Receives: Behavioral: BWL |
| BWL+Voucher | Experimental | Participants receive BWL+Voucher Receives: Behavioral: BWL; Other: VOUCHER |
| BWL+Home | Experimental | Participants receive BWL+Home Receives: Behavioral: BWL; Other: HOME |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 24 weeks
Secondary outcomes (9)
Percent initial weight loss at week 24 (BWL+VOUCHER versus BWL+HOME)
Comparison of BWL+VOUCHER versus BWL+HOME for weight loss (percent of baseline weight) at 24 weeks
Measured: Baseline to 24 weeks
Percent initial weight loss at week 52 (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 52 weeks
Measured: Baseline to 52 weeks
Percent initial weight loss at week 52 (BWL+VOUCHER versus BWL+HOME)
Comparison of BWL+VOUCHER versus BWL+HOME for weight loss (percent of baseline weight) at 52 weeks
Measured: Baseline to 52 weeks
Change from baseline to weeks 24 and 52 in SF-36 Physical Component Score
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).
Measured: Baseline to week 24 and week 52
Change from baseline to weeks 24 and 52 in SF-36 Mental Component Score
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
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)
Measured: Baseline to week 24 and week 52
Incremental cost-effectiveness per unit decrease in weight (kg)
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.
Measured: Baseline to week 24 and week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start13 Mar 2026
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Ariana Chao, PhD, CRNP, FNP-BC, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396805
- Sponsor's protocol ID
- IRB00528955
- Other IDs
- R01NR021699
- Acronym
- EatWell Rx
- Status last verified
- Mar 2026
- First submitted
- 28 Jan 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Food Is Medicine Approaches for Obesity Treatment in Adults With Food Insecurity
- ClinicalTrials.gov ID
- NCT07396805
- Acronym / sponsor ID
- EatWell Rx / IRB00528955
- Conditions
- Obesity & Overweight
- Keywords
- obesity, weight loss, food insecurity, nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 13 Mar 2026 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jul 2030 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BWL-Alone | Active comparator | Behavioral: BWLParticipants receive BWL-Alone |
| BWL+Voucher | Experimental | Behavioral: BWL, Other: VOUCHERParticipants receive BWL+Voucher |
| BWL+Home | Experimental | Behavioral: BWL, Other: HOMEParticipants receive BWL+Home |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BWLParticipants 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. | Behavioural | BWL+Home, BWL+Voucher, BWL-Alone |
| VOUCHERDuring 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. | Other | BWL+Voucher |
| HOMEDuring 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. | Other | BWL+Home |
Primary outcome
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
9 secondary outcomes
Percent initial weight loss at week 24 (BWL+VOUCHER versus BWL+HOME)
Time frame: 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
Percent initial weight loss at week 52 (BWL+VOUCHER versus BWL+HOME)
Time frame: 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
Change from baseline to weeks 24 and 52 in SF-36 Mental Component Score
Time frame: 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
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
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
Incremental cost-effectiveness per unit decrease in weight (kg)
Time frame: Baseline to week 24 and week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ariana Chao, PhD, CRNP, FNP-BC principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BWL, VOUCHER and HOME in people with Obesity & Overweight, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ariana M Chao, PhD, CRNP, FNP-BC (667-208-7078, ariana.chao@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent initial weight loss at week 24 (BWL+VOUCHER and BWL+HOME to BWL-Alone) (time frame: Baseline to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.