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A Fruit and Vegetable Prescription Program
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.
Conditions:
🦠 Diabetes Mellitus 🦠 Diabetes Complications
🗓️ Study Start (Actual) July 2024
🗓️ Primary Completion (Estimated) June 2026
✅ Study Completion (Estimated) June 2027
👥 Enrollment (Estimated) 120
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Reading, Pennsylvania, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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 Criteria:

    • * 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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 16 October 2023
  • First Submitted that Met QC Criteria 24 October 2023
  • First Posted 30 October 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 9 July 2024
  • Last Update Posted 10 July 2024
  • Last Verified July 2024