A Fruit and Vegetable Prescription Program

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus; Diabetes Complications

• Registration Number: NCT06107816
• Lead Sponsor: Milton S. Hershey Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-16
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Patient at Penn State Health St. Joe's Medical Center<br><br> - Diagnosis of Type 2 Diabetes Mellitus greater than or equal to six months<br><br> - A1c level is greater than or equal to 7% (53 mmol/mol)<br><br> - Low income defined as enrolled in Supplemental Nutrition Assistance Program (SNAP),<br> is uninsured or have Medicaid, or identifying as food insecure based on USDA<br> criteria.<br><br> - Ability to give a blood sample<br><br> - Willing to respond to contacts from study staff over the study period<br><br> - Willing and able to give informed consent<br><br> - Can read and write in English or Spanish<br><br>Exclusion Criteria:<br><br> - Diagnosis of Type 2 Diabetes Mellitus less than six months<br><br> - Patients who have previously participated in the Veggie Rx program in the past year<br><br> - Patients who have attended any diabetes self-management education and support<br> (DSME/S) sessions in the past year<br><br> - Women who are pregnant or who plan to become pregnant during the study period<br><br> - Any uncontrolled mental illness or substance abuse, or inpatient treatment for these<br> in the past six months<br><br> - Any unstable or significant medical condition in the past 3 months (e.g. recent<br> heart attack, stroke, DVT)<br><br> - A1c level is less than 7%<br><br> - Does not speak English or Spanish<br><br> - Inability to provide informed consent<br><br> - Unable to give a blood sample

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the impact of a F&V Rx on DSME/S uptake in low-income adults;Evaluate the impact of a F&V Rx on DSME/S retention in low-income adults.

Secondary Outcome Measures

Name	Time	Method
Evaluate the impact of a F&V Rx on A1c (% and mg/dL);Evaluate the impact of a F&V Rx on Diabetes Self-Management;Evaluate the impact of a F&V Rx on Fruit and Vegetable Intake;Evaluate the impact of a F&V Rx on Healthy Eating index-2015;Evaluate the impact of a F&V Rx on Total plasma carotenoids (ng/mL);Evaluate the impact of a F&V Rx on Food insecurity