Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-31 @ 3:32 AM
Study NCT ID:
NCT05138432
Status:
RECRUITING
Last Update Posted:
2025-11-19
First Post:
2021-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
More Fresh Fruit and Vegetable Prescription Program for Families With Type 2 Diabetes Mellitus
Sponsor:
University of California, San Diego
Organization:
Study Overview
Official Title:
More Fresh Fruit and Vegetable Prescription Program for Families With Type 2 Diabetes Mellitus
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: