'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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Eat Well 6-months; Behavioral: Eat Well 12-months

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.

• Study Type: Interventional
• Enrollment (Estimated): 1500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study Principal Investigator; Phone Number: (919) 616-6936; Email: Connor.Drake@va.gov

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Durham VA Health Care System
      • Contact: Study Principal Investigator; Phone Number: (919) 616-6936; Email: Connor.Drake@va.gov
      • Principal Investigator: Connor Drake, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Food Insecurity Risk
2. Hypertension AND diabetes or obesity
3. Hospitalization, ED visit, OR outpatient visit in the past 12-months
4. NC resident
5. Valid email address

Exclusion Criteria:

• Living in a nursing home or residential facility where meals are prepared

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 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.
Experimental: 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.	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.
No Intervention: Standard of Care; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin A1c	Change in hemoglobin A1c from baseline to 12 months	12 months
Healthcare utilization	Numeric value of inpatient, outpatient and ED visits from baseline to 12 months.	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.	12 months

Collaborators and Investigators

• Sponsor: Institute for Medical Research, Inc.
• Collaborators: Genentech, Inc.; Rockefeller Foundation

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: April 10, 2026
• First Submitted That Met QC Criteria: April 10, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Hypertension; Veterans; Food insecurity; Produce prescription
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: 1881008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No