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NCT Number: NCT05138432

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).

Recruiting

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rady Children's Hospital San Diego

San Diego, California, 92123, United States

Location status: Recruiting

Location contact

Karen Chan

CONTACT

[email protected]

858-576-1700 ext. 221857

Kyung Rhee, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Household food security

    Time frame: Survey will be completed at baseline and 12 months

    18-item US Household Food Security Survey Module

  2. Change in Hemoglobin A1c

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

    Point of care A1c

Secondary outcomes

  1. Change in BMI z-score

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

    BMI calculated by measured height and weight and converted to BMI z-score

  2. Change in Total cholesterol

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

    Serum Total cholesterol

  3. Change in Liver function tests

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

    Serum aspartate transaminase (AST), serum alanine transaminase (ALT)

  4. Change in Blood pressure

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

    Systolic and diastolic BP

  5. Change in beta carotene

    Time frame: Measured at baseline and 12 months

    serum beta carotene levels

  6. Change in fruit and vegetable intake

    Time frame: Survey will be completed at baseline and 12 months.

    Change in child fruit and vegetable intake as measured by the DSQ

  7. Change in HDL cholesterol

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

    Serum HDL cholesterol

Study contacts

Contact information is provided by the study sponsor or research team.

Kay Rhee, MD, MS, MA

CONTACT

[email protected]

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

Sarah Hiller-Venegas, MPH

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Rady Children's Hospital, San Diego
  • United States Department of Agriculture (USDA)

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Dec 1, 2021
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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