A Fruit and Vegetable Prescription Program
A Pilot, 3-arm Randomized Controlled Trial of a Fruit and Vegetable Prescription Program for Patients With Type Two Diabetes
Milton S. Hershey Medical Center
120 participants
Jul 26, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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
Exclusion Criteria10
- Diagnosis of Type 2 Diabetes Mellitus less than six months
- Patients who have previously participated in the Veggie Rx program in the past year
- Patients who have attended any diabetes self-management education and support (DSME/S) sessions in the past year
- Women who are pregnant or who plan to become pregnant during the study period
- Any uncontrolled mental illness or substance abuse, or inpatient treatment for these in the past six months
- Any unstable or significant medical condition in the past 3 months (e.g. recent heart attack, stroke, DVT)
- A1c level is less than 7%
- Does not speak English or Spanish
- Inability to provide informed consent
- Unable to give a blood sample
Interventions
Visit with a primary care provider and referral for diabetes self-management education and support (DSME/S) sessions
Usual Care plus four F\&V prescriptions that are independent of DSME/S attendance
Usual Care plus four F\&V prescriptions that are dependent on DSME/S attendance
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06107816