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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-70413-45380 | Other Grant/Funding Number | U.S. Department of Agriculture National Institute of Food and Agriculture |
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| Name | Class |
|---|---|
| United States Department of Agriculture (USDA) | FED |
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The goal of this clinical trial is to assess nutrition incentives and produce vouchers to measure the impacts of food insecurity-related chronic health conditions in adults with hypertension and/or diabetes. The main questions it aims to answer are:
Participants will:
The clinical trial will serve up to 400 participants over the GusNIP Produce Prescription project. The primary outcome measure one is to strengthen food systems access and improve participant level dietary health quality through increased fruit and vegetable consumption; reduce overall individual and household level food insecurity; reduce healthcare use and associated costs; and support local economies through local food procurement. Rush participants with or at risk of diabetes and/or hypertension who screen positive for food insecurity and meet the requirements to participate in a Produce Prescription project are referred to the Veggie Rx program for one year participation. Vouchers for up to $40 dollars match can be used concurrently with SNAP EBT benefits at a local grocer, the project's SNAP firm partner. Data will measure improvements in fruit and vegetable consumption, food security status, diet quality, knowledge and behaviors, self-efficacy, healthcare utilization and associated costs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Produce Prescription | Other | Receipt of fresh produce prescription boxes and produce vouchers redeemable using SNAP, alongside nutrition education and chronic disease management education. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food is Medicine | Behavioral | Fresh produce food prescription program designed to address food insecurity and increase intake of nutritious foods. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Fruit and Vegetable Intake | Mean change in daily servings of fruits and vegetables (FV) determined by self-reported data using 10-item Dietary Screener Questionnaire (DSQ). The 10-item DSQ scale collects intake frequency of FV including the quantity (i.e., amount) and variety (i.e., kinds) through retrospective observance of the past 30-days. Scale values range from decreased, stayed the same, increased, or does not apply, with increased FV intake correlating with improved intake, and decreased correlating with less intake. A higher score means a better outcome. | 6 months, 12 months |
| Change in Food Security Status | Individual and household level food security as measured using the United States Department of Agriculture 10-item United States Adult Food Security Module. Measured on a scale of severity from high to low food security, including high food security, marginal food security, low food security and very low food security with very low food security meaning a worse outcome. | 6months, 12 months |
| Change in Healthcare Utilization and Associated Costs | Changes in healthcare utilization including hospital, emergency department, and outpatient visits using Electronic Health Records and claims data. | 6 months, 12 months |
| Change in Health Outcomes Associated with Hypertension | Changes in hypertension clinical biomarkers through Electronic Health Records, self-reported pre and post assessments for chronic disease self-management classes. Measured by 10 mm Hg reduction in systolic BP for participants with uncontrolled hypertension, as targeted by the intervention. | 6 months, 12 months |
| Change in Health Outcome Associated with Diabetes | Changes in diabetes clinical biomarkers through Electronic Health Records, self-reported pre and post assessments for chronic disease self-management classes. Measured by changes in hemoglobin A1c (HbA1c), as targeted by the intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Traci Simmons, DrPHc, MPH | Contact | 312-942-7013 | traci_e_simmons@rush.edu | |
| Julia Bassett, PhDc, MBA | Contact | 312-942-7296 | Julia_S_Bassett@rush.edu |
| Name | Affiliation | Role |
|---|---|---|
| Traci Simmons, DrPHc, MPH | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Ansell, D. A., & Lightfoot, L. E. (2021). The death gap: How inequality kills. University of Chicago Press |
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IPD may not be shared to protect participant confidentiality, and PHI. Should individual data be requested, the investigators will de-identify data. Data sharing mechanisms should be in place for inquiries regarding IPD.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 6 months, 12 months |
| Local Economic Support | Change in participant spending through use of produce vouchers at local food vendors using Supplemental Nutrition Assistance Program/Electronic Benefits Transfer leads to local economic support. Measured by point of sale dollar value of produce voucher, dollar value of Supplemental Nutrition Assistance Program purchase (Electronic Benefits Transfer sales). | Monthly for 1 year |