Fresh Fruit and Vegetable Prescriptions for Type 2 Diabetes
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, San Diego
Disqualifiers: Family member in study
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?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).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems to focus on providing fresh fruits and vegetables to improve health outcomes.
What data supports the effectiveness of the treatment Fruit and Vegetable Prescription Program for Type 2 Diabetes?
Research shows that fruit and vegetable prescription programs can help improve health outcomes by increasing access to fresh produce. In one study, participants with diabetes who received produce prescriptions saw a significant decrease in their blood sugar levels (HbA1c), suggesting these programs may help manage diabetes.
12345Is the Fruit and Vegetable Prescription Program safe for humans?
The Fruit and Vegetable Prescription Program, which provides access to fresh produce, has been studied in various settings and has not shown any safety concerns for participants. It is generally considered safe as it involves increasing the consumption of fruits and vegetables, which are part of a healthy diet.
12345How does the Fresh Fruit and Vegetable Prescription treatment for Type 2 Diabetes differ from other treatments?
The Fresh Fruit and Vegetable Prescription treatment is unique because it focuses on providing financial incentives to increase access to fresh produce, aiming to improve diet quality and glycemic control in low-income patients with Type 2 Diabetes. Unlike traditional medications, this approach addresses dietary habits and food security, which are crucial for managing diabetes.
12356Eligibility Criteria
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.Inclusion Criteria
Your hemoglobin A1c level is 6.5 or higher.
I am under 18 years old.
Receiving care at the Rady Children's Hospital Diabetes Clinic
+1 more
Exclusion Criteria
Another immediate family member living in the same household who is already recruited into the study
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Assessment
Baseline assessments including laboratory studies and physiologic assessments
1 visit
1 visit (in-person)
Intervention
Participants receive monthly fruit and vegetable vouchers for 12 months
12 months
Monthly visits (in-person or virtual)
Delayed Intervention
Participants receive monthly fruit and vegetable vouchers after a 6-month delay
12 months
Monthly visits (in-person or virtual)
Follow-up
Participants are monitored for changes in metabolic outcomes and food security
6 months
Every 6 months (in-person or virtual)
Participant Groups
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.
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 Clinic Near You
Research Locations NearbySelect from list below to view details:
Rady Children's Hospital San DiegoSan Diego, CA
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Who Is Running the Clinical Trial?
University of California, San DiegoLead Sponsor
United States Department of Agriculture (USDA)Collaborator
Rady Children's Hospital, San DiegoCollaborator
References
"Prevention Produce": Integrating Medical Student Mentorship into a Fruit and Vegetable Prescription Program for At-Risk Patients. [2020]Fruit and vegetable prescription (FVRx) programs provide increased access to produce to food-insecure, at-risk populations, yet many lack the educational and social components to support long-term disease prevention.
A pilot randomized controlled trial of a fruit and vegetable prescription program at a federally qualified health center in low income uncontrolled diabetics. [2023]Eating a healthy diet is important for managing diabetes. Although there are high rates of diabetes in low-income urban areas, these patients often have limited access to fruits and vegetables. The 15-week Fresh Prescription (Fresh Rx) program was designed to improve access and consumption of fruits and vegetables among low-income patients with diabetes in Detroit, MI. The purpose of this study was to evaluate the effects of a fruit and vegetable prescription program on changes in hemoglobin A1C (HbA1C), blood pressure (BP), and body mass index (BMI) in patients with diabetes in a randomized controlled trial at a federally qualified health center (FQHC). Patients randomized to the Fresh Rx group (n = 56) were allotted up to $80 ($10 for up to eight weeks) for purchase of produce from a farmers market based at the FQHC. The control group (n = 56) received standard treatment plus information on community resources to improve health. Outcomes were compared at baseline and within three months of program completion. There were no significant between-group differences for any of the outcomes at program completion (p > .05); however, there was a small effect size for HbA1c (partial η2 = 0.02). Within the Fresh Rx group, HbA1c significantly decreased from 9.64% to 9.14% (p = 0.006). However, no changes were noted within the control group (9.38 to 9.41%, p = 0.89). BMI and BP did not change from pre- to post-study in either group (p > .05). Results from this study offer preliminary evidence that produce prescription programs may reduce HbA1C in low-income patients with diabetes.
Community-based fruit and vegetable prescription programs: a scoping review. [2023]Identify and categorise different models of community-based fruit and vegetable prescription programs, to determine variation in terms of methodology, target population characteristics, and outcomes measured. Applying the scoping review methodology, ten electronic databases were utilised to identify community-based fruit and vegetable incentive programs. Results were evaluated by two independent reviewers, using Covidence software. All full-text reviews were completed and documented using the PRISMA-ScR guidelines. Search results were stored and reviewed within the Covidence software. Thirty full-text articles were utilised from the 40 206 identified in the search. Target populations were predominantly female, non-white, and low-income. Considerable heterogeneity was found in both study design and quality. Fruit and vegetable vouchers were utilised in 63 % (n 19) of the studies. Prescriptions were primarily provided by community health centres (47 %; n 14) or NGOs (307 %; n 9) and could be redeemed at farmers' markets (40 %; n 12) or grocery stores (27 %; n 8). When measured, diet quality significantly improved in 94 % (n 16), health outcomes significantly improved in 83 % (n 10), and food security status improved in 82 % (n 10) of studies. Providing financial incentives to offset the cost of fresh fruits and vegetables can increase consumption, improve health outcomes, and improve food security status. The majority of studies showed significant improvements in at least one outcome, demonstrating the effectiveness of community-based fruit and vegetable prescription programs. However, the diversity of measurement techniques and heterogeneity of design, dosage, and duration impeded meaningful comparisons. Further well-designed studies are warranted to compare the magnitude of effects among different program methodologies.
Effects of a Fruit and Vegetable Prescription Program With Expanded Education for Low-Income Adults. [2022]Fruit and Vegetable Prescription (FVRx) Programs combine produce prescriptions and nutrition education to reduce fruit and vegetable consumption barriers and promote health among low-income patient populations. This study examined whether a multi-level FVRx intervention model with intensive education improves dietary behaviors, food security, and health outcomes over single-level interventions alone. A 6-month nonrandomized, parallel, controlled trial was conducted with one intervention, FVRx (n = 31) and two comparison groups, Ad hoc Nutrition Education (n = 13) and Control (n = 16). The FVRx group received produce prescriptions (US$1/day/household member) redeemable at a farmer's market, two SNAP-Ed programs, one financial literacy program, and monthly health screenings. The Nutrition Education (NE) group participated in one SNAP-Ed program, and the Control group received safety-net clinic care only. Surveys assessed dietary intake, food security, food purchasing practices, and financial and food resource management. Pre-post clinical biomarkers (blood lipid and hemoglobin A1c) and monthly biometrics (anthropometrics and blood pressure) were measured. Descriptive analysis and one-way analysis of variance (ANOVA) were conducted. Compared with comparison groups, FVRx participants significantly increased the frequency of consuming dark green vegetables, FVRx (0.36 ± 0.72); NE (0.14 ± 0.33); Control (-0.09 ± 0.19) cups/day (p < .05). FVRx participants significantly improved multiple healthful food purchasing practices, and the ability to afford more utilities (FVRx (33%); NE (0%); Control (10%); p < .05). Limited changes were observed in food security and clinical biomarker outcomes between groups. Combining expanded nutrition and financial literacy education with produce prescriptions improves low-income adults' financial and food resources, preference, knowledge, purchase, and consumption of locally grown vegetables over single-level interventions.
Veggie Rx: an outcome evaluation of a healthy food incentive programme. [2019]One challenge to healthy nutrition, especially among low-income individuals, is access to and consumption of fresh fruits and vegetables. To address this problem, Veggie Rx, a healthy food incentive programme, was established within a community clinic to increase access to fresh produce for low-income patients diagnosed with obesity, hypertension and/or type 2 diabetes. The current research aimed to evaluate Veggie Rx programme effectiveness.
Evaluation of a Produce Prescription Program for Patients With Diabetes: A Longitudinal Analysis of Glycemic Control. [2023]Produce prescriptions have shown promise in improving diabetes care, although most studies have used small samples or lacked controls. Our objective was to evaluate the impacts of a produce prescription program on glycemic control for patients with diabetes.