Recruiting

Fruit & Vegetable

Sponsor:

Milton S. Hershey Medical Center

Code:

NCT06107816

Conditions

Diabetes Mellitus

Diabetes Complications

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Usual Care

F&V Rx alone

F&V Rx plus DSME/S

Study Details

Brief 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.

Conditions

Diabetes Mellitus

Diabetes Complications

Study ID

NCT06107816

Start date

Jul 26, 2024

Status verified date

Nov, 2025

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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)

Interventions

Usual Care

Visit with a primary care provider and referral for diabetes self-management education and support (DSME/S) sessions

F&V Rx alone

Usual Care plus four F\&V prescriptions that are independent of DSME/S attendance

F&V Rx plus DSME/S

Usual Care plus four F\&V prescriptions that are dependent on DSME/S attendance

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

Central Contacts and Locations

Central contacts

Susan Veldheer, DEd, RD

717-531-5625sveldheer@pennstatehealth.psu.edu

Kayla N Rutt, MS

717-858-6204krutt1@pennstatehealth.psu.edu

Locations

Penn State Health St. Joseph Downtown Campus

Recruiting

Reading, Pennsylvania, United States, 19601

Contacts

Lisa Weaver

ljw34@psu.edu

More Information

Sponsor

Milton S. Hershey Medical Center

Last update posted

Nov 21, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Milton S. Hershey Medical Center on 2025-11-21.