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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Fruit and Vegetable Prescription Voucher


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention Group<br>Monthly fruit and vegetable vouchers for 12 months, to start immediately after enrollment. | Behavioral: Fruit and Vegetable Prescription Voucher<br>* 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.<br>|
| Other: Delayed Intervention Group<br>Monthly fruit and vegetable vouchers for 12 months, to start after a 6-month waiting period. | Behavioral: Fruit and Vegetable Prescription Voucher<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Household food security | 18-item US Household Food Security Survey Module | Survey will be completed at baseline and 12 months | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Change in beta carotene | serum beta carotene levels | Measured at baseline and 12 months | 
| 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. | 
| 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 |