A Fruit and Vegetable Prescription Program

NCT06107816 | Recruiting

• 2 other identifiers: 23681R01DK132077-01A1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Evaluate the impact of a F&V Rx on DSME/S uptake in low-income adults

  Defined as the number of participants who attend any 1 DSME (# attend any 1 DSME/S session/total # randomized)

  Throughout the 16 week intervention

• Evaluate the impact of a F&V Rx on DSME/S retention in low-income adults.

  Defined as % who attend \>=75% of sessions (# attend \>= 75% sessions/ # attended any 1 DSME/S session)

  Throughout the 16 week intervention

Secondary Outcomes (6)

• Evaluate the impact of a F&V Rx on A1c (% and mg/dL)

  Baseline (week 0) and follow up (week 16)

• Evaluate the impact of a F&V Rx on Diabetes Self-Management

  Baseline (week 0) and follow up (week 16)

• Evaluate the impact of a F&V Rx on Fruit and Vegetable Intake

  Baseline (week 0) and follow up (week 16)

• Evaluate the impact of a F&V Rx on Healthy Eating index-2015

  Baseline (week 0) and follow up (week 16)

• Evaluate the impact of a F&V Rx on Total plasma carotenoids (ng/mL)

  Baseline (week 0) and follow up (week 16)

Other Outcomes (3)

• Assess program implementation outcomes - Acceptability of Intervention Measure (AIM)

  Throughout the 16 week intervention and follow-up

• Assess program implementation outcomes - Intervention Appropriateness Measure (IAM)

  Throughout the 16 week intervention and follow-up

• Assess program implementation outcomes - Clinic/providers/staff - Implementation Outcomes Questionnaire (IOQ)

  Throughout the 16 week intervention and follow-up

Study Arms (3)

Usual Care Control Group

PLACEBO COMPARATOR

Will receive usual care

Behavioral: Usual Care

F&V Rx Alone Group

ACTIVE COMPARATOR

Will receive 4 monthly F\&V Rx vouchers regardless of their DSME/S attendance.

Behavioral: F&V Rx alone

F&V Rx + DSME/S Group

ACTIVE COMPARATOR

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)

Behavioral: F&V Rx plus DSME/S

Interventions

Usual Care BEHAVIORAL

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

Usual Care Control Group

F&V Rx alone BEHAVIORAL

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

F&V Rx Alone Group

F&V Rx plus DSME/S BEHAVIORAL

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

F&V Rx + DSME/S Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Penn State Health St. Joseph Downtown Campus

Reading, Pennsylvania, 19601, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Complications

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Susan Veldheer, DEd, RD

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Veldheer, DEd, RD

CONTACT

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

Kayla N Rutt, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Family and Community Medicine

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 30, 2023
• Study Start: July 26, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)