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Fresh Fruit and Vegetable Prescriptions for Type 2 Diabetes

N/A
Recruiting
Led By Kyung Rhee, MD, MS, MA
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age < 18 years old
Diagnosis of type 2 diabetes mellitus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at baseline and 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will provide families with a child who has type 2 diabetes with a prescription for fruits and vegetables. The prescription will come in the form of a voucher that can be used at any Northgate Gonzalez 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.

Who is the study for?
This trial is for families with children under 18 who have type 2 diabetes, are treated at Rady Children's Hospital Diabetes Clinic, and have a Hemoglobin A1c of 6.5 or higher. It excludes households that already have a family member in the study.
What is being tested?
The trial tests a Fruit and Vegetable Prescription Program where families get electronic vouchers to buy fresh produce at Northgate Gonzalez Markets, aiming to improve diet and health outcomes in kids with type 2 diabetes.
What are the potential side effects?
There are no direct medical side effects from participating in this program as it involves dietary changes by increasing fruit and vegetable intake rather than medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am under 18 years old.
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I have been diagnosed with type 2 diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at baseline and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Hemoglobin A1c
Change in Household food security
Secondary study objectives
Change in BMI z-score
Change in Blood pressure
Change in HDL cholesterol
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Intervention GroupExperimental Treatment1 Intervention
Monthly fruit and vegetable vouchers for 12 months, to start immediately after enrollment.
Group II: Delayed Intervention GroupExperimental Treatment1 Intervention
Monthly fruit and vegetable vouchers for 12 months, to start after a 6-month waiting period.

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,180 Previous Clinical Trials
1,574,847 Total Patients Enrolled
United States Department of Agriculture (USDA)FED
100 Previous Clinical Trials
286,479 Total Patients Enrolled
Rady Children's Hospital, San DiegoOTHER
41 Previous Clinical Trials
14,033 Total Patients Enrolled

Media Library

Intervention Group Clinical Trial Eligibility Overview. Trial Name: NCT05138432 — N/A
Type 2 Diabetes Research Study Groups: Intervention Group, Delayed Intervention Group
Type 2 Diabetes Clinical Trial 2023: Intervention Group Highlights & Side Effects. Trial Name: NCT05138432 — N/A
Intervention Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT05138432 — N/A
~40 spots leftby Aug 2025
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