F&V Vouchers for Type 2 Diabetes
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on dietary changes rather than medication adjustments.
What data supports the effectiveness of the treatment F&V Rx for Type 2 Diabetes?
Is the Fruit and Vegetable Prescription Program safe for humans?
The Fruit and Vegetable Prescription Program, which provides vouchers for fresh produce, has been studied in various settings and has not shown any safety concerns. It aims to improve access to fruits and vegetables, and while it focuses on health benefits, no adverse effects have been reported in the studies available.14678
How is the F&V Rx treatment for Type 2 Diabetes different from other treatments?
The F&V Rx treatment is unique because it involves providing vouchers for fruits and vegetables to improve diet quality and health outcomes, particularly for food-insecure populations. Unlike traditional medications, this approach focuses on dietary changes and may include educational and social support components to encourage long-term health improvements.126910
What is the purpose of this trial?
Dietary intake of fruits and vegetables (F\&V) is a cornerstone for the treatment of type 2 diabetes, however less than 16% of Hispanic adults consume the recommended number of servings each day. F\&V prescription (F\&V Rx) programs are embedded into clinical settings and provide patients with vouchers to purchase F\&V at local retailers. The proposed study aims to test the effects of a F\&V Rx on diabetes self-management education and support (DSME/S) uptake and retention, dietary intake of F\&V and diet quality, glucose control (hemoglobin A1c), and program implementation outcomes.
Research Team
Susan Veldheer, DEd, RD
Principal Investigator
Penn State College of Medicine
Eligibility Criteria
This trial is for low-income individuals with Type 2 Diabetes Mellitus who have had the condition for at least six months and an A1c level of 7% or higher. Participants must be able to give blood samples, respond to study contacts, consent to participate, and read/write in English or Spanish. Pregnant women, those with recent significant medical conditions, uncontrolled mental illness/substance abuse, or previous DSME/S sessions are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive monthly F&V Rx vouchers, with some groups requiring DSME/S attendance for additional vouchers
Follow-up
Participants are monitored for changes in A1c, dietary intake, and program implementation outcomes
Treatment Details
Interventions
- F&V Rx alone
- F&V Rx plus DSME/S
F&V Rx alone is already approved in United States for the following indications:
- Type 2 Diabetes Management
- Diabetes Prevention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Milton S. Hershey Medical Center
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator