A Fruit and Vegetable Prescription Program

Part of paid clinical trials in Reading, Pennsylvania.

Sponsor
Milton S. Hershey Medical Center
Study ID
NCT06107816
Status
Recruiting
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Conditions

  • Diabetes Complications
  • Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Usual Care — BEHAVIORAL
    Visit with a primary care provider and referral for diabetes self-management education and support (DSME/S) sessions
  • F&V Rx alone — BEHAVIORAL
    Usual Care plus four F\&V prescriptions that are independent of DSME/S attendance
  • F&V Rx plus DSME/S — BEHAVIORAL
    Usual Care plus four F\&V prescriptions that are dependent on DSME/S attendance

Study Details

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.

Key Dates

Start date
Jul 26, 2024
Status verified
Nov 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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)

Primary Outcome Measure

Evaluate the impact of a F&V Rx on DSME/S uptake in low-income adults [ Time Frame: Throughout the 16 week intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Penn State Health St. Joseph Downtown CampusReadingPennsylvania19601

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Penn State Health St. Joseph Downtown Campus· Reading, PA

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