Food InsecurityNCT07376044
RUSH Food is Medicine Veggie Rx - GusNIP Produce Prescription
A study testing Food is Medicine in people with Food Insecurity and Diabetes in Adults, run by Rush University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Food Insecurity, Diabetes in Adults, Hypertension (HTN)
- What is being tested?
- Food is Medicine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Adults unable to consent
- Individuals not yet adults - infants, children, teenagers
- Incarcerated individuals
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
Traci Simmons, DrPHc, MPH, 312-942-7013, traci_e_simmons@rush.edu
Julia Bassett, PhDc, MBA, 312-942-7296, Julia_S_Bassett@rush.edu
About this study
Official title: 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?
Read more
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
Read the 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.
- Conditions
- Food Insecurity, Diabetes in Adults, Hypertension (HTN)
- Being tested
- Food is Medicine
- Keywords
- Food Insecurity, Food is Medicine, Nutrition Security, Diet-related Chronic Disease, Produce Prescription
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food is MedicineBehavioural
Fresh produce food prescription program designed to address food insecurity and increase intake of nutritious foods.
| Study group | Role | What they receive |
|---|---|---|
| Produce Prescription | Other | Receipt of fresh produce prescription boxes and produce vouchers redeemable using SNAP, alongside nutrition education and chronic disease management education. Receives: Behavioral: Food is Medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Monthly for 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start30 Jun 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food InsecurityStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Responsible party
- Principal investigator, Traci Simmons, Rush University Medical Center
- Investigators
- Traci Simmons, DrPHc, MPH, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07376044
- Sponsor's protocol ID
- 23122803
- Other IDs
- 2025-70413-45380, 2025
- Status last verified
- Jun 2026
- First submitted
- 30 Dec 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Ansell, D. A., & Lightfoot, L. E. (2021). The death gap: How inequality kills. University of Chicago Press
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GusNIP Produce Prescription Project
- ClinicalTrials.gov ID
- NCT07376044
- Acronym / sponsor ID
- 23122803
- Conditions
- Food Insecurity, Diabetes in Adults, Hypertension (HTN)
- Keywords
- Food Insecurity, Food is Medicine, Nutrition Security, Diet-related Chronic Disease, Produce Prescription
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Produce Prescription | Other | Behavioral: Food is MedicineReceipt of fresh produce prescription boxes and produce vouchers redeemable using SNAP, alongside nutrition education and chronic disease management education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- Adults unable to consent
- Individuals not yet adults - infants, children, teenagers
- Incarcerated individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food is MedicineFresh produce food prescription program designed to address food insecurity and increase intake of nutritious foods. | Behavioural | Produce Prescription |
Primary outcome
Change in Fruit and Vegetable Intake
Time frame: 6 months, 12 months
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.
Change in Food Security Status
Time frame: 6months, 12 months
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.
Change in Healthcare Utilization and Associated Costs
Time frame: 6 months, 12 months
Changes in healthcare utilization including hospital, emergency department, and outpatient visits using Electronic Health Records and claims data.
Change in Health Outcomes Associated with Hypertension
Time frame: 6 months, 12 months
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.
Change in Health Outcome Associated with Diabetes
Time frame: 6 months, 12 months
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.
Local Economic Support
Time frame: Monthly for 1 year
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- BackgroundAnsell, D. A., & Lightfoot, L. E. (2021). The death gap: How inequality kills. University of Chicago Press
- Individual participant dataSharing planned: No. 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.
Related trials for Food Insecurity
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Improving Healthy Food Access in Food Insecurity Populations in Normal and Emergency Situations
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
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Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Traci Simmons, DrPHc, MPH principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food is Medicine in people with Food Insecurity and Diabetes in Adults, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Traci Simmons, DrPHc, MPH (312-942-7013, traci_e_simmons@rush.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fruit and Vegetable Intake (time frame: 6 months, 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07376044, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.