Clinical trial NCT05138432: More Fresh Fruit and Vegetable Prescription Program for Families with Type 2 Diabetes Mellitus
Official title: More Fresh Fruit and Vegetable Prescription Program for Families with Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: United States Department of Agriculture (USDA)
name: Rady Children's Hospital, San Diego
First posted: 2021-12-01
Enrollment: 200
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants upon enrollment will be randomized into two groups, either to immediately receive up to $105 per month in vouchers for 12 months (intervention group) or to receive $105 per month in incentives for 12 months after a 6-month delay (delayed-intervention group)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Household food security
timeFrame: Survey will be completed at baseline and 12 months
measure: Change in Hemoglobin A1c
timeFrame: Measured as part of the participant's routine care in the Diabetes Clinic at baseline and 12 months
Secondary outcomes:
measure: Change in BMI z-score
timeFrame: Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic
measure: Change in Total cholesterol
timeFrame: Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic
measure: Change in Liver function tests
timeFrame: Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic
measure: Change in Blood pressure
timeFrame: Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic
measure: Change in beta carotene
timeFrame: Measured at baseline and 12 months
measure: Change in fruit and vegetable intake
timeFrame: Survey will be completed at baseline and 12 months.
measure: Change in HDL cholesterol
timeFrame: Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital San Diego
state: California
Study officials:
affiliation: University of California San Diego, Rady Children's Hospital San Diego
name: Kyung Rhee, MD, MS, MA
role: PRINCIPAL_INVESTIGATOR
References: