Actively Recruiting
A Pilot, 3-arm Randomized Controlled Trial of a Fruit and Vegetable Prescription Program for Patients With Type Two Diabetes
Led by Milton S. Hershey Medical Center · Updated on 2025-11-21
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Milton S. Hershey Medical Center
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a fruit and vegetable prescription (F&V Rx) program designed to improve diabetes management among low-income Hispanic adults with type 2 diabetes. The study aims to test how F&V prescriptions affect participation in diabetes self-management education and support (DSME/S), fruit and vegetable intake, diet quality, blood sugar control measured by hemoglobin A1c, and the program's acceptability and sustainability. This pilot randomized controlled trial addresses gaps in understanding the role of F&V prescriptions combined with DSME/S attendance in diabetes care. The study includes three groups: one receiving usual care, one receiving usual care plus four monthly F&V Rx vouchers regardless of DSME/S attendance, and one receiving usual care plus F&V Rx vouchers contingent on monthly DSME/S group attendance over 16 weeks. Participants in the intervention groups receive vouchers to purchase fruits and vegetables at local stores. The trial tests the impact of these approaches on education uptake and retention as well as health and dietary outcomes. Participants will attend study visits at the beginning and end of the 16-week period for assessments including blood samples for A1c and plasma carotenoids, dietary intake surveys, and diabetes self-management questionnaires. Researchers will monitor voucher use, DSME/S attendance, and collect feedback from both participants and care providers to evaluate program implementation. The study is conducted with cultural adaptations and community involvement to support relevance for Hispanic adults with type 2 diabetes.
CONDITIONS
Brief Title
A Fruit and Vegetable Prescription Program
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient at Penn State Health St. Joe's Medical Center
- Diagnosis of Type 2 Diabetes Mellitus for six months or longer
- A1c level is 7% (53 mmol/mol) or higher
- Low income as defined by enrollment in SNAP, uninsured, Medicaid, or food insecurity per USDA criteria
- Ability to give a blood sample
- Willing to respond to study staff contacts during the study
- Able and willing to give informed consent
- Can read and write in English or Spanish
You will not qualify if you...
- Diagnosis of Type 2 Diabetes Mellitus less than six months ago
- Participation in the Veggie Rx program in the past year
- Attendance at any diabetes self-management education and support sessions in the past year
- Pregnant women or those planning pregnancy during the study
- Uncontrolled mental illness or substance abuse, or inpatient treatment for these in past six months
- Unstable or significant medical condition in past 3 months (e.g., recent heart attack, stroke, DVT)
- A1c level less than 7%
- Inability to speak English or Spanish
- Unable to provide informed consent
- Unable to give a blood sample
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 16 weeks
Participants receive usual care and may receive fruit and vegetable prescriptions depending on their group assignment. Some participants attend diabetes self-management education and support (DSME/S) sessions to help manage their diabetes.
Monthly visits for up to 4 months
Duration - At week 16
Participants complete follow-up assessments to evaluate changes in diabetes management, fruit and vegetable intake, and related health outcomes.
1 follow-up visit
Trial Site Locations
Total: 1 location
1
Penn State Health St. Joseph Downtown Campus
Reading, Pennsylvania, United States, 19601
Actively Recruiting
Research Team
S
Susan Veldheer, DEd, RD
K
Kayla N Rutt, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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