More Fresh Fruit and Vegetable Prescription Program for Families With Type 2 Diabetes Mellitus

NCT05138432 | Recruiting

• 1 other identifier: 1027421
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Rady Children's Hospital San Diego (RCHSD), UCSD Division of Child and Community Health and the Center for Community Health, and Northgate Gonzalez (NG) Markets will collaborate to create a Produce Prescription Program (Fruit and Vegetable Prescription Program) to be implemented in the RCHSD Diabetes Clinic. We will provide families on Medi-Cal who have a child with T2DM with a fruit and vegetable prescription (FVRx) which will enhance their ability to purchase GusNIP-eligible fresh fruits and vegetables (FV). These prescriptions will be delivered in the form of an electronic voucher that can be filled at any NG Markets throughout San Diego and Riverside counties. The goal of this program is to increase the purchase and consumption of fresh fruits and vegetables, decrease food insecurity, and improve metabolic outcomes for children with type 2 diabetes mellitus (T2DM).

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• Change in Household food security

  18-item US Household Food Security Survey Module

  Survey will be completed at baseline and 12 months

• Change in Hemoglobin A1c

  Point of care A1c

  Measured as part of the participant's routine care in the Diabetes Clinic at baseline and 12 months

Secondary Outcomes (7)

• Change in BMI z-score

  Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic

• Change in Total cholesterol

  Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic

• Change in Liver function tests

  Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic

• Change in Blood pressure

  Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic

• Change in beta carotene

  Measured at baseline and 12 months

Study Arms (2)

Intervention Group

OTHER

Monthly fruit and vegetable vouchers for 12 months, to start immediately after enrollment.

Behavioral: Fruit and Vegetable Prescription Voucher

Delayed Intervention Group

OTHER

Monthly fruit and vegetable vouchers for 12 months, to start after a 6-month waiting period.

Behavioral: Fruit and Vegetable Prescription Voucher

Interventions

Fruit and Vegetable Prescription Voucher BEHAVIORAL

Each participant will immediately (intervention group) or after a 6-month waiting period (delayed-intervention group) receive seven $15 vouchers (value $105 per month) for 12 months. Up to 4 vouchers ($60 total) can be redeemed at any one transaction for purchase of fresh fruits and vegetables, dried beans and legumes at participating Northgate Gonzalez markets. Both groups will continue to receive diabetes and nutrition education as is standard in their practice.

Delayed Intervention Group; Intervention Group

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age \< 18 years old
• Diagnosis of type 2 diabetes mellitus
• Hemoglobin A1c greater than or equal to 6.5
• Receiving care at the Rady Children's Hospital Diabetes Clinic

You may not qualify if:

• Another immediate family member living in the same household who is already recruited into the study

Sponsors & Collaborators

• University of California, San Diego: lead
• United States Department of Agriculture (USDA): collaborator
• Rady Children's Hospital, San Diego: collaborator

Study Sites (1)

Rady Children's Hospital San Diego

San Diego, California, 92123, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Fruit

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Kyung Rhee, MD, MS, MA

  University of California San Diego, Rady Children's Hospital San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kay Rhee, MD, MS, MA

CONTACT

858-576-1700; masfrescoFVRX@health.ucsd.edu

Sarah Hiller-Venegas, MPH

CONTACT

masfrescoFVRX@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Model Details: Participants upon enrollment will be randomized into two groups, either to immediately receive up to $105 per month in vouchers for 12 months (intervention group) or to receive $105 per month in incentives for 12 months after a 6-month delay (delayed-intervention group)

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: December 1, 2021
• Study Start: November 29, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)