RUSH Food is Medicine Veggie Rx - GusNIP Produce Prescription

GusNIP Produce Prescription Project

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:

• Does participation increase fruit and vegetable consumption for participants?
• Does participation reduce individual and household food insecurity?
• Does participation reduce healthcare utilization and associated costs?
• Does participation lead to improvements in diet-related health outcomes (e.g., hypertension, diabetes)?
• Does participation support the local economy by increasing participant spending at local food vendors?

Participants will:

• Receive 6 months home delivered produce prescription boxes
• Receive 6 months match of produce vouchers
• Receive nutrition education and participate in Chronic Disease Self-Management classes

Study Overview

• Status: Not yet recruiting
• Conditions: Food Insecurity; Diabetes in Adults; Hypertension (HTN)
• Intervention / Treatment: Behavioral: Food is Medicine

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Traci Simmons, DrPHc, MPH; Phone Number: 312-942-7013; Email: traci_e_simmons@rush.edu
• Study Contact Backup: Name: Julia Bassett, PhDc, MBA; Phone Number: 312-942-7296; Email: Julia_S_Bassett@rush.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
      • Contact: Traci Simmons, DrPHc, MPH; Phone Number: 312-942-7013; Email: traci_e_simmons@rush.edu
      • Contact: Julia Bassett, PhDc, MBA; Phone Number: 312-942-7296; Email: Julia_S_Bassett@rush.edu
      • Principal Investigator: Traci Simmons, DrPHc, MPH
      • Sub-Investigator: Julia Bassett, PhDc, MBA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults over 18 years of age
• Participants receiving medical care at Rush
• Participants with a diagnosis of hypertension and/or diabetes
• Participants with a positive screen for food insecurity
• Participants eligible for medical assistance through a state plan
• Participants eligible for benefits through the SNAP program
• Participants are member of a low-income household
• Participants willing to participate for duration of the program (12-months)
• Participants residing in service area of the referring Rush clinic

Exclusion Criteria:

• Adults unable to consent
• Individuals not yet adults - infants, children, teenagers
• Incarcerated individuals

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Produce Prescription; Receipt of fresh produce prescription boxes and produce vouchers redeemable using SNAP, alongside nutrition education and chronic disease management education.	Behavioral: Food is Medicine; Fresh produce food prescription program designed to address food insecurity and increase intake of nutritious foods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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
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

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Collaborators: United States Department of Agriculture (USDA)
• Investigators: Principal Investigator: Traci Simmons, DrPHc, MPH, Rush University Medical Center

Publications and helpful links

General Publications

• Ansell, D. A., & Lightfoot, L. E. (2021). The death gap: How inequality kills. University of Chicago Press

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: December 30, 2025
• First Submitted That Met QC Criteria: January 21, 2026
• First Posted (Actual): January 29, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Food Insecurity; Nutrition Security; Food is Medicine; Diet-related Chronic Disease; Produce Prescription
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: 23122803; 2025-70413-45380 (Other Grant/Funding Number: U.S. Department of Agriculture National Institute of Food and Agriculture)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No