Trials / Not Yet Recruiting
Not Yet RecruitingNCT07534501
'Eat Well' Produce Prescription Randomized Controlled Trial
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
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,500 (estimated)
- Sponsor
- Institute for Medical Research, Inc. · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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. 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. We 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 us 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. In this pragmatic randomized controlled trial, we 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. We 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). Our 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
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Eat Well 6-months | 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. |
| BEHAVIORAL | Eat Well 12-months | 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. |
Timeline
- Start date
- 2026-05-01
- Primary completion
- 2027-11-01
- Completion
- 2028-06-01
- First posted
- 2026-04-16
- Last updated
- 2026-04-16
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT07534501. Inclusion in this directory is not an endorsement.