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

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).

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Fruit and Vegetable Prescription Voucher

Detailed Description

Participants upon enrollment will be randomized into two groups, either to immediately receive nutrition incentive vouchers for 12 months (intervention group) or to receive nutrition incentive vouchers for 12 months after a 6-month delay (delayed-intervention group). To evaluate the implementation and outcomes of this program, we will collect fruit and vegetable prescription (FVRx) voucher data in addition to standardized laboratory studies, (hemoglobin A1c (HbA1c), total cholesterol, HDL cholesterol and liver function tests (LFTs)) and physiologic assessments (height, weight) at the child's follow-up appointments through the Diabetes Clinic. These markers will be evaluated at baseline, 6-, 12- and 18-months. Additionally, we will ask participants to complete online or phone surveys including the Dietary Screener Questionnaire (DSQ) for youth and parents and the 18-item US Household Food Security Survey Module every 6 months.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kay Rhee, MD, MS, MA; Phone Number: 858-966-5841 858-576-1700; Email: masfrescoFVRX@health.ucsd.edu
• Study Contact Backup: Name: Sarah Hiller-Venegas, MPH; Email: masfrescoFVRX@health.ucsd.edu

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Recruiting
      • Rady Children's Hospital San Diego
      • Contact: Karen Chan; Phone Number: 221857 858-576-1700; Email: masfrescoFVRX@health.ucsd.edu
      • Principal Investigator: Kyung Rhee, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention Group; Monthly fruit and vegetable vouchers for 12 months, to start immediately after enrollment.	Behavioral: Fruit and Vegetable Prescription Voucher; 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.
Other: Delayed Intervention Group; Monthly fruit and vegetable vouchers for 12 months, to start after a 6-month waiting period.	Behavioral: Fruit and Vegetable Prescription Voucher; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in BMI z-score	BMI calculated by measured height and weight and converted to 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	Serum 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	Serum aspartate transaminase (AST), serum alanine transaminase (ALT)	Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic
Change in Blood pressure	Systolic and diastolic BP	Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic
Change in beta carotene	serum beta carotene levels	Measured at baseline and 12 months
Change in fruit and vegetable intake	Change in child fruit and vegetable intake as measured by the DSQ	Survey will be completed at baseline and 12 months.
Change in HDL cholesterol	Serum HDL cholesterol	Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: United States Department of Agriculture (USDA); Rady Children's Hospital, San Diego
• Investigators: Principal Investigator: Kyung Rhee, MD, MS, MA, University of California San Diego, Rady Children's Hospital San Diego

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: November 8, 2021
• First Submitted That Met QC Criteria: November 18, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Estimated): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Fruit
• Other Study ID Numbers: 1027421

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No