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NCT Number: NCT07534501

'Eat Well' Produce Prescription RCT

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Durham VA Health Care System

Durham, North Carolina, 27705, United States

Location status: Recruiting

Location contact

Connor Drake, PhD

PRINCIPAL_INVESTIGATOR

Study Principal Investigator

CONTACT

[email protected]

(919) 616-6936

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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 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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Hemoglobin A1c

    Time frame: 12 months

    Change in hemoglobin A1c from baseline to 12 months

  2. Healthcare utilization

    Time frame: 12 months

    Numeric value of inpatient, outpatient and ED visits from baseline to 12 months.

  3. Enrollment in VA Nutrition/Wellness programs

    Time frame: 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Principal Investigator

CONTACT

[email protected]

(919) 616-6936

Sponsors and collaborators

Lead sponsor

Institute for Medical Research, Inc.

Other

Collaborators

  • Genentech, Inc.
  • Rockefeller Foundation

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 16, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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