HypertensionNCT07534501
'Eat Well' Produce Prescription RCT
A study testing Eat Well 6-months and Eat Well 12-months in people with Hypertension, run by Institute for Medical Research, Inc. at 1 site in United States.
Trial summary
This project, conducted within the Department of Veterans Affairs Healthcare System (VHA), will study how a produce prescription (PRx) program called "Eat Well" affects Veterans' health and how often they use healthcare services. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Eat Well 6-months and Eat Well 12-months
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2026to Jun 2028
- 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
- Food Insecurity Risk
- Hypertension AND diabetes or obesity
- Hospitalization, ED visit, OR outpatient visit in the past 12-months
- NC resident
- Valid email address
Who cannot join
- Living in a nursing home or residential facility where meals are prepared
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
Durham VA Health Care System
Durham, North Carolina, 27705
Study Principal Investigator, (919) 616-6936, Connor.Drake@va.gov
Connor Drake, PhD
About this study
Official title: Assessing the Impact of Implementing the 'Eat Well' Produce Prescription for Veterans At-Risk of Food Insecurity With a Diet-Sensitive Chronic Condition: A Pragmatic Randomized Controlled Trial
This project, conducted within the Department of Veterans Affairs Healthcare System (VHA), will study how a produce prescription (PRx) program called "Eat Well" affects Veterans' health and how often they use healthcare services. About 1 in 4 Veteran households experience food insecurity (FI), which means they do not have reliable access to safe and healthy food. FI can make health worse in many ways, especially for people with conditions like diabetes that need a healthy diet. It also leads to higher healthcare costs. A PRx program, like Eat Well, helps by giving people money or vouchers to buy fruits and vegetables. This study will enroll 1,500 eligible Veterans in North Carolina who will be randomized to receive Eat Well for 6-months, Eat Well for 12-months, or the standard of care. This research will help VA learn important information about using produce prescriptions as a proven way to improve food security.
Read the detailed description
Food insecurity (FI), or the limited or uncertain availability of nutritionally adequate and safe foods, is common among Veteran households (approximately 1 in 4). FI worsens health across multiple dimensions, particularly for those with related diet-sensitive cardiometabolic conditions (e.g., diabetes) and is associated with higher healthcare costs. A produce prescription (PRx) program is an evidence-based food security intervention that reduces cost barriers to healthy food purchases by providing a regular subsidy for fruits and vegetables. PRx programs improve food security, diet, and health outcomes. This pragmatic randomized controlled trial will evaluate the impact of a PRx program called "Eat Well", which provides $100 per month subsidy via a debit card for healthy foods, on Veteran cardiometabolic health and utilization patterns. This study will enroll 1,500 eligible Veterans in North Carolina who will be randomized to receive Eat Well for 6-months, Eat Well for 12-months, or the standard of care (e.g., resources for healthy living). The primary outcome of interest is change in systolic blood pressure (from baseline to 12-months). Secondary outcomes of interest include change in hemoglobin A1c levels (from baseline to 12-months) and mean inpatient, outpatient, ED, and health promotion program visits from the beginning of the program. This research will generate crucial knowledge about the offering of PRx as an evidence-based food security intervention.
- Conditions
- Hypertension
- Being tested
- Eat Well 6-months, Eat Well 12-months
- Keywords
- Produce prescription, Hypertension, Food insecurity, Veterans
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eat Well 6-monthsBehavioural
Participants will receive $100/month of Eat Well benefits for 6- months and instructions on enrolling in existing VA programs designed to improve health self-management and nutrition education.
Eat Well 12-monthsBehavioural
Participants will receive $100/month of Eat Well benefits for 12-months and instructions on enrolling in existing VA programs designed to improve health self-management and nutrition education.
| Study group | Role | What they receive |
|---|---|---|
| Eat Well 6-months | Experimental | Participants will receive $100/month of Eat Well benefits for 6- months and instructions on enrolling in existing VA programs designed to improve health self-management and nutrition education. Receives: Behavioral: Eat Well 6-months |
| Eat Well 12-months | Experimental | Participants will receive $100/month of Eat Well benefits for 12- months and instructions on enrolling in existing VA programs designed to improve health self-management and nutrition education. Receives: Behavioral: Eat Well 12-months |
| Standard of Care | No intervention | The standard of care arm will not receive the Eat Well program with referrals to VA resources and program. They will only continue to receive standard VA health care services that they regularly engage with. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
Changes in systolic blood pressure (from baseline to 12-months) will be compared between the treatment and control groups. Primary and secondary data will be abstracted from the VA Electronic Health Record (EHR)
Measured: 12 months
Secondary outcomes (3)
Hemoglobin A1c
Change in hemoglobin A1c from baseline to 12 months
Measured: 12 months
Healthcare utilization
Numeric value of inpatient, outpatient and ED visits from baseline to 12 months.
Measured: 12 months
Enrollment in VA Nutrition/Wellness programs
Whether or not participants enrolled in specific nutrition and wellness-related programs at the VA during study timeframe. Collected by medical record and self-report.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start20 May 2026
- Primary completionNov 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Model description
- In this pragmatic randomized trial, We will randomize eligible Veterans to three study arms: "Eat Well" for 6-months, Eat Well for 12-months, or the standard of care (e.g., resources for healthy living). Our target recruitment goal is 1,500 Veterans. For Veterans randomized to Eat Well study arms, they will receive $100/month in Eat Well funds loaded onto a debit card, which can be spent on fruits, vegetables, and legumes at participating grocery store vendors across North Carolina. Participants can also shop online at Instacart. They will also be directed to self-enroll/schedule to participate in existing VA programs that support healthy eating among other health self-management activities (e.g., Whole Health programming, MOVE!, consultation with a registered dietician, and Annie SMS). All treatment arm participants will receive supportive utilization messages to increase their engagement with the program and promote benefit utilization.
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute for Medical Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Rockefeller Foundation, Genentech, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534501
- Sponsor's protocol ID
- 1881008
- Status last verified
- Jun 2026
- First submitted
- 10 Apr 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data used for the analysis will be made available by the research team upon reasonable request abiding by data sharing policies of the Veterans Health Administration.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Implementing the 'Eat Well' Produce Prescription for Veterans At-Risk of Food Insecurity With a Diet-Sensitive Chronic Condition: A Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07534501
- Acronym / sponsor ID
- 1881008
- Conditions
- Hypertension
- Keywords
- Produce prescription, Hypertension, Food insecurity, Veterans
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Institute for Medical Research, Inc.University, hospital or other
- Collaborators
- Rockefeller Foundation, Genentech, Inc.
- Study start
- 20 May 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 16 Apr 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.
This project, conducted within the Department of Veterans Affairs Healthcare System (VHA), will study how a produce prescription (PRx) program called "Eat Well" affects Veterans' health and how often they use healthcare services. About 1 in 4 Veteran households experience food insecurity (FI), which means they do not have reliable access to safe and healthy food. FI can make health worse in many ways, especially for people with conditions like diabetes that need a healthy diet. It also leads to higher healthcare costs. A PRx program, like Eat Well, helps by giving people money or vouchers to buy fruits and vegetables. This study will enroll 1,500 eligible Veterans in North Carolina who will be randomized to receive Eat Well for 6-months, Eat Well for 12-months, or the standard of care. This research will help VA learn important information about using produce prescriptions as a proven way to improve food security.
Detailed description
Food insecurity (FI), or the limited or uncertain availability of nutritionally adequate and safe foods, is common among Veteran households (approximately 1 in 4). FI worsens health across multiple dimensions, particularly for those with related diet-sensitive cardiometabolic conditions (e.g., diabetes) and is associated with higher healthcare costs. A produce prescription (PRx) program is an evidence-based food security intervention that reduces cost barriers to healthy food purchases by providing a regular subsidy for fruits and vegetables. PRx programs improve food security, diet, and health outcomes. This pragmatic randomized controlled trial will evaluate the impact of a PRx program called "Eat Well", which provides $100 per month subsidy via a debit card for healthy foods, on Veteran cardiometabolic health and utilization patterns. This study will enroll 1,500 eligible Veterans in North Carolina who will be randomized to receive Eat Well for 6-months, Eat Well for 12-months, or the standard of care (e.g., resources for healthy living). The primary outcome of interest is change in systolic blood pressure (from baseline to 12-months). Secondary outcomes of interest include change in hemoglobin A1c levels (from baseline to 12-months) and mean inpatient, outpatient, ED, and health promotion program visits from the beginning of the program. This research will generate crucial knowledge about the offering of PRx as an evidence-based food security intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- In this pragmatic randomized trial, We will randomize eligible Veterans to three study arms: "Eat Well" for 6-months, Eat Well for 12-months, or the standard of care (e.g., resources for healthy living). Our target recruitment goal is 1,500 Veterans. For Veterans randomized to Eat Well study arms, they will receive $100/month in Eat Well funds loaded onto a debit card, which can be spent on fruits, vegetables, and legumes at participating grocery store vendors across North Carolina. Participants can also shop online at Instacart. They will also be directed to self-enroll/schedule to participate in existing VA programs that support healthy eating among other health self-management activities (e.g., Whole Health programming, MOVE!, consultation with a registered dietician, and Annie SMS). All treatment arm participants will receive supportive utilization messages to increase their engagement with the program and promote benefit utilization.
| Arm | Type | Receives |
|---|---|---|
| Eat Well 6-months | Experimental | Behavioral: Eat Well 6-monthsParticipants will receive $100/month of Eat Well benefits for 6- months and instructions on enrolling in existing VA programs designed to improve health self-management and nutrition education. |
| Eat Well 12-months | Experimental | Behavioral: Eat Well 12-monthsParticipants will receive $100/month of Eat Well benefits for 12- months and instructions on enrolling in existing VA programs designed to improve health self-management and nutrition education. |
| Standard of Care | No intervention | –The standard of care arm will not receive the Eat Well program with referrals to VA resources and program. They will only continue to receive standard VA health care services that they regularly engage with. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Food Insecurity Risk
- Hypertension AND diabetes or obesity
- Hospitalization, ED visit, OR outpatient visit in the past 12-months
- NC resident
- Valid email address
Key exclusion criteria (1 listed)
- Living in a nursing home or residential facility where meals are prepared
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 |
|---|---|---|
| Eat Well 6-monthsParticipants will receive $100/month of Eat Well benefits for 6- months and instructions on enrolling in existing VA programs designed to improve health self-management and nutrition education. | Behavioural | Eat Well 6-months |
| Eat Well 12-monthsParticipants will receive $100/month of Eat Well benefits for 12-months and instructions on enrolling in existing VA programs designed to improve health self-management and nutrition education. | Behavioural | Eat Well 12-months |
Primary outcome
Systolic blood pressure
Time frame: 12 months
Changes in systolic blood pressure (from baseline to 12-months) will be compared between the treatment and control groups. Primary and secondary data will be abstracted from the VA Electronic Health Record (EHR)
3 secondary outcomes
Hemoglobin A1c
Time frame: 12 months
Healthcare utilization
Time frame: 12 months
Enrollment in VA Nutrition/Wellness programs
Time frame: 12 months
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 11 Jun 2026.
- Individual participant dataSharing planned: Yes. Deidentified data used for the analysis will be made available by the research team upon reasonable request abiding by data sharing policies of the Veterans Health Administration.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eat Well 6-months and Eat Well 12-months in people with Hypertension, run by Institute for Medical Research, Inc. 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 5 inclusion and 1 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 11 Jun 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 Study Principal Investigator ((919) 616-6936, Connor.Drake@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure (time frame: 12 months). 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 11 Jun 2026.