Diabetes in Adults, Food Insecurity, Hypertension (HTN)
Conditions
Keywords
Food Insecurity, Food is Medicine, Nutrition Security, Diet-related Chronic Disease, Produce Prescription
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
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
BEHAVIORALFood is Medicine
Fresh produce food prescription program designed to address food insecurity and increase intake of nutritious foods.
Sponsors
Rush University Medical Center
United States Department of Agriculture (USDA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fruit and Vegetable Intake | 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 | 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 | 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 | 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 | 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 | 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). |
Countries
United States
Contacts
CONTACTTraci Simmons, DrPHc, MPH
CONTACTJulia Bassett, PhDc, MBA
PRINCIPAL_INVESTIGATORTraci Simmons, DrPHc, MPH
Rush University Medical Center
Outcome results
None listed