'Eat Well' Produce Prescription Randomized Controlled Trial

NCT07534501 | Not Yet Recruiting

• 1 other identifier: 1881008
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Keywords

Produce prescription; Hypertension; Food insecurity; Veterans

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Hemoglobin A1c

  12 months

• Healthcare utilization

  12 months

• Enrollment in VA Nutrition/Wellness programs

  12 months

Study Arms (3)

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.

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.

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.

Interventions

Eat Well 6-months BEHAVIORAL

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 6-months

Eat Well 12-months BEHAVIORAL

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.

Eat Well 12-months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Food Insecurity Risk
• Hypertension AND diabetes or obesity
• Hospitalization, ED visit, OR outpatient visit in the past 12-months
• NC resident
• Valid email address

You may not qualify if:

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

Sponsors & Collaborators

• Institute for Medical Research, Inc.: lead
• Rockefeller Foundation: collaborator
• Genentech, Inc.: collaborator

Study Sites (1)

Durham VA Health Care System

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Study Principal Investigator

CONTACT

(919) 616-6936; Connor.Drake@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 16, 2026
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE

Locations

US (1)