RUSH Food is Medicine Veggie Rx - GusNIP Produce Prescription

NCT07376044 | Not Yet Recruiting

• 2 other identifiers: 231228032025-70413-45380
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Food Insecurity; Diabetes in Adults; Hypertension (HTN)

Keywords

Food Insecurity; Food is Medicine; Nutrition Security; Diet-related Chronic Disease; Produce Prescription

Outcome Measures

Primary Outcomes (6)

• 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.

  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

Study Arms (1)

Produce Prescription

OTHER

Receipt of fresh produce prescription boxes and produce vouchers redeemable using SNAP, alongside nutrition education and chronic disease management education.

Behavioral: Food is Medicine

Interventions

Food is Medicine BEHAVIORAL

Fresh produce food prescription program designed to address food insecurity and increase intake of nutritious foods.

Produce Prescription

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Rush University Medical Center: lead
• United States Department of Agriculture (USDA): collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

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

  BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Traci Simmons, DrPHc, MPH

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Community Health and Engagement

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 29, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)