A Pilot, 3-arm Randomized Controlled Trial of a Fruit and Vegetable Prescription Program for Patients With Type Two Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient at Penn State Health St. Joe's Medical Center

• Diagnosis of Type 2 Diabetes Mellitus greater than or equal to six months

• A1c level is greater than or equal to 7% (53 mmol/mol)

• Low income defined as enrolled in Supplemental Nutrition Assistance Program (SNAP), is uninsured or have Medicaid, or identifying as food insecure based on USDA criteria.

• Ability to give a blood sample

• Willing to respond to contacts from study staff over the study period

• Willing and able to give informed consent

• Can read and write in English or Spanish

Locations
United States
Pennsylvania
Penn State Health St. Joseph Downtown Campus
RECRUITING
Reading
Contact Information
Primary
Susan Veldheer, DEd, RD
sveldheer@pennstatehealth.psu.edu
717-531-5625
Backup
Kayla N Rutt, MS
krutt1@pennstatehealth.psu.edu
717-858-6204
Time Frame
Start Date: 2024-07-26
Estimated Completion Date: 2027-07
Participants
Target number of participants: 120
Treatments
Placebo_comparator: Usual Care Control Group
Will receive usual care
Active_comparator: F&V Rx Alone Group
Will receive 4 monthly F\&V Rx vouchers regardless of their DSME/S attendance.
Active_comparator: F&V Rx + DSME/S Group
Will receive monthly F\&V Rx vouchers starting at the first group session and they will receive additional F\&V Rx vouchers only when they attend a monthly DSME/S group (up to 4 total)
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Milton S. Hershey Medical Center

This content was sourced from clinicaltrials.gov