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

NCT05138432 · University of California, San Diego

Recruiting

In plain English

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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.

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

Study design

Enrollment target: 200 participants

Allocation: randomized

Masking: none

Age groups: child, adult

Timeline

Starts: 2021-11-29

Estimated completion: 2026-06-30

Last updated: 2025-11-19

Interventions

Behavioral: Fruit and Vegetable Prescription Voucher

Primary outcomes

• Change in Household food security (Survey will be completed at baseline and 12 months)
• Change in Hemoglobin A1c (Measured as part of the participant's routine care in the Diabetes Clinic at baseline and 12 months)

Sponsor

University of California, San Diego · other

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

Contacts & investigators

ContactKay Rhee, MD, MS, MA · contact · masfrescoFVRX@health.ucsd.edu · 858-576-1700

ContactSarah Hiller-Venegas, MPH · contact · masfrescoFVRX@health.ucsd.edu

InvestigatorKyung Rhee, MD, MS, MA · principal_investigator, University of California San Diego, Rady Children's Hospital San Diego

All locations (1)

Rady Children's Hospital San DiegoRecruiting

San Diego, California, United States

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