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

NCT ID: NCT05138432

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-29
• Study Completion Date: 2026-06-30

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).

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group

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

Group Type: OTHER

Fruit and Vegetable Prescription Voucher

Intervention Type: 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

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

Group Type: OTHER

Fruit and Vegetable Prescription Voucher

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Agriculture (USDA)

FED

Sponsor Role: collaborator

Rady Children's Hospital, San Diego

OTHER

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Kay Rhee

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kyung Rhee, MD, MS, MA

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Rady Children's Hospital San Diego

San Diego, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kay Rhee, MD, MS, MA

Role: CONTACT

masfrescoFVRX@health.ucsd.edu

858-576-1700 ext. 858-966-5841

Sarah Hiller-Venegas, MPH

Role: CONTACT

masfrescoFVRX@health.ucsd.edu

Facility Contacts

Karen Chan

Role: primary

masfrescoFVRX@health.ucsd.edu

858-576-1700 ext. 221857

Other Identifiers

1027421

Identifier Type: -

Identifier Source: org_study_id