'Eat Well' Produce Prescription RCT
Purpose
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.
Condition
- Hypertension
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- 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.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
|
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. |
|
|
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. |
|
Recruiting Locations
Durham, North Carolina 27705
More Details
- Status
- Recruiting
- Sponsor
- Institute for Medical Research, Inc.
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. 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.