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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05138432
• Other study ID #: 1027421
• Status: Recruiting
• Phase: N/A
• Start date: November 29, 2021
• Est. completion date: August 31, 2025

Study information

• Verified date: August 2023
• Source: University of California, San Diego
• Contact: Karen Chan
• Phone: 858-576-1700
• Email: masfrescoFVRX[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Rady Children's Hospital San Diego	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	Rady Children's Hospital, San Diego, United States Department of Agriculture (USDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Household food security	18-item US Household Food Security Survey Module	Survey will be completed at baseline and 12 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in beta carotene	serum beta carotene levels	Measured at baseline and 12 months
Secondary	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.
Secondary	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