More Fresh Fruit and Vegetable Prescription Program for Families With Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fruit and Vegetable Prescription Voucher
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
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
Sites / Locations
- Rady Children's Hospital San DiegoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Intervention Group
Delayed Intervention Group
Arm Description
Monthly fruit and vegetable vouchers for 12 months, to start immediately after enrollment.
Monthly fruit and vegetable vouchers for 12 months, to start after a 6-month waiting period.
Outcomes
Primary Outcome Measures
Change in Household food security
18-item US Household Food Security Survey Module
Change in Hemoglobin A1c
Point of care A1c
Secondary Outcome Measures
Change in BMI z-score
BMI calculated by measured height and weight and converted to BMI z-score
Change in Total cholesterol
Serum Total cholesterol
Change in Liver function tests
Serum aspartate transaminase (AST), serum alanine transaminase (ALT)
Change in Blood pressure
Systolic and diastolic BP
Change in beta carotene
serum beta carotene levels
Change in fruit and vegetable intake
Change in child fruit and vegetable intake as measured by the DSQ
Change in HDL cholesterol
Serum HDL cholesterol
Full Information
NCT ID
NCT05138432
First Posted
November 8, 2021
Last Updated
August 30, 2023
Sponsor
University of California, San Diego
Collaborators
United States Department of Agriculture (USDA), Rady Children's Hospital, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT05138432
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2021 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
United States Department of Agriculture (USDA), Rady Children's Hospital, San Diego
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Other
Arm Description
Monthly fruit and vegetable vouchers for 12 months, to start immediately after enrollment.
Arm Title
Delayed Intervention Group
Arm Type
Other
Arm Description
Monthly fruit and vegetable vouchers for 12 months, to start after a 6-month waiting period.
Intervention Type
Behavioral
Intervention Name(s)
Fruit and Vegetable Prescription Voucher
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Household food security
Description
18-item US Household Food Security Survey Module
Time Frame
Survey will be completed at baseline and 12 months
Title
Change in Hemoglobin A1c
Description
Point of care A1c
Time Frame
Measured as part of the participant's routine care in the Diabetes Clinic at baseline and 12 months
Secondary Outcome Measure Information:
Title
Change in BMI z-score
Description
BMI calculated by measured height and weight and converted to BMI z-score
Time Frame
Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic
Title
Change in Total cholesterol
Description
Serum Total cholesterol
Time Frame
Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic
Title
Change in Liver function tests
Description
Serum aspartate transaminase (AST), serum alanine transaminase (ALT)
Time Frame
Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic
Title
Change in Blood pressure
Description
Systolic and diastolic BP
Time Frame
Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic
Title
Change in beta carotene
Description
serum beta carotene levels
Time Frame
Measured at baseline and 12 months
Title
Change in fruit and vegetable intake
Description
Change in child fruit and vegetable intake as measured by the DSQ
Time Frame
Survey will be completed at baseline and 12 months.
Title
Change in HDL cholesterol
Description
Serum HDL cholesterol
Time Frame
Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Chan
Phone
858-576-1700
Ext
221857
Email
masfrescoFVRX@health.ucsd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung Rhee, MD
Organizational Affiliation
University of California San Diego, Rady Children's Hospital San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rady Children's Hospital San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Chan
Phone
858-576-1700
Ext
221857
Email
masfrescoFVRX@health.ucsd.edu
First Name & Middle Initial & Last Name & Degree
Kyung Rhee, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
More Fresh Fruit and Vegetable Prescription Program for Families With Type 2 Diabetes Mellitus
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