Hypertension
Conditions
Keywords
Produce prescription, Hypertension, Food insecurity, Veterans
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. 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.
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.
Interventions
BEHAVIORALEat 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.
BEHAVIORALEat 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.
Sponsors
Institute for Medical Research, Inc.
Rockefeller Foundation
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic blood pressure | 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
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c | 12 months | Change in hemoglobin A1c from baseline to 12 months |
| Healthcare utilization | 12 months | Numeric value of inpatient, outpatient and ED visits from baseline to 12 months. |
| Enrollment in VA Nutrition/Wellness programs | 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. |
Countries
United States
Contacts
CONTACTStudy Principal Investigator
Outcome results
None listed