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Not yet recruiting NCT07376044

RUSH Food is Medicine Veggie Rx - GusNIP Produce Prescription

No phase Interventional Food Insecurity Diabetes in Adults Hypertension (HTN)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Food is Medicine.
Who it may be relevant to
Registry conditions: Food Insecurity, Diabetes in Adults, Hypertension (HTN). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

GusNIP Produce Prescription Project

Overview

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

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.

Interventions

  • Behavioral Food is Medicine
    Fresh produce food prescription program designed to address food insecurity and increase intake of nutritious foods.

Primary outcome measures

  • Change in Fruit and Vegetable Intake [Time frame: 6 months, 12 months]
  • Change in Food Security Status [Time frame: 6months, 12 months]
  • Change in Healthcare Utilization and Associated Costs [Time frame: 6 months, 12 months]
  • Change in Health Outcomes Associated with Hypertension [Time frame: 6 months, 12 months]
  • Change in Health Outcome Associated with Diabetes [Time frame: 6 months, 12 months]
  • Local Economic Support [Time frame: Monthly for 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Rush University Medical Center — Chicago

Publications

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

Identifiers

NCT: NCT07376044 · 23122803 · 2025-70413-45380

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗