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NCT06107816Recruiting

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

Source: ClinicalTrials.gov · Last updated 21 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
120 (estimated)
First submitted
16 Oct 2023
Start date
26 Jul 2024
Primary completion date
Jul 2027
Lead sponsor
Milton S. Hershey Medical Center
NCT number
NCT06107816

What you commit to

  • Study type: Interventional
  • Planned participants: 120
  • From 26 Jul 2024 to the primary completion date, Jul 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who have previously participated in the Veggie Rx program in the past year

Other illness

  • Diagnosis of Type 2 Diabetes Mellitus less than six months
  • Patients who have attended any diabetes self-management education and support (DSME/S) sessions in the past year
  • 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)

Other

  • Women who are pregnant or who plan to become pregnant during the study period
  • A1c level is less than 7%
  • Does not speak English or Spanish
  • Inability to provide informed consent
  • Unable to give a blood sample

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Penn State Health St. Joseph Downtown Campus
Coordinator of this site? Confirm its status
ReadingUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.