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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

TypeNameDescription
BEHAVIORALEat 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.
BEHAVIORALEat 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.

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.