RUSH Food is Medicine Veggie Rx - GusNIP Produce Prescription
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRush University Medical Center
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Adults unable to consent
Individuals not yet adults - infants, children, teenagers
Incarcerated individuals
Trial design
Design model
Single group
Treatments tested in this trial
Food is Medicine
BehavioralFresh produce food prescription program designed to address food insecurity and increase intake of nutritious foods.
Treatment groups
400 Participants
are divided into 1 treatment groupGroup A: Produce PrescriptionOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
6 months, 12 months2
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.
Time frame
6months, 12 months3
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.
Time frame
6 months, 12 months4
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.
Time frame
6 months, 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Rush University Medical Center
Lead sponsor
United States Department of Agriculture (USDA)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: