Fresh Fruit and Vegetable Prescriptions for Type 2 Diabetes

Overseen By Sarah Hiller-Venegas, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Family member in study

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if electronic vouchers for fresh fruits and vegetables can help children with type 2 diabetes improve their health. The Fruit and Vegetable Prescription Voucher program provides these vouchers to encourage healthier eating and reduce food insecurity. Participants will receive the vouchers either immediately or after a six-month delay. Families with a child under 18 who has type 2 diabetes and is receiving treatment at Rady Children's Hospital may qualify. As an unphased trial, this study offers families a unique opportunity to contribute to research that could enhance dietary habits and health outcomes for children with type 2 diabetes.

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 prior data suggests that this Produce Prescription Program is safe for children with type 2 diabetes?

Research shows that programs providing vouchers for fruits and vegetables are safe. Many places have used these programs without encountering safety issues. Studies have found that they can improve health, such as better diabetes control and overall diet quality. Participants often experience better blood sugar levels and face fewer challenges in accessing enough food, with no negative side effects. In short, these programs are well-tolerated and beneficial for health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for type 2 diabetes, which often rely on medications like metformin or insulin therapy, the fruit and vegetable prescription voucher offers a unique approach by directly addressing dietary habits. Researchers are excited about this treatment because it promotes healthier eating patterns by providing monthly vouchers for fruits and vegetables, potentially improving blood sugar control naturally. This method empowers patients to make sustainable lifestyle changes, which could lead to better long-term health outcomes without the side effects associated with some medications.

What evidence suggests that the Fruit and Vegetable Prescription Program could be effective for type 2 diabetes?

Research shows that programs providing fruit and vegetable prescriptions can significantly aid in managing diabetes. In this trial, participants in the Intervention Group will receive monthly fruit and vegetable vouchers for 12 months immediately after enrollment. Meanwhile, those in the Delayed Intervention Group will receive the same vouchers after a 6-month waiting period. Previous studies have shown that participants from rural, low-income areas managed their diabetes better after joining such programs. Another study found that these programs improve diet quality and overall health for people with diabetes. Participants often consume more fruits and vegetables and experience less anxiety about food availability. These programs are also linked to improved heart health and overall body health. Overall, the evidence suggests that these prescriptions can be a valuable component of managing type 2 diabetes. ^{1 2 5 6 7}

Who Is on the Research Team?

Kyung Rhee, MD

Principal Investigator

University of California San Diego, Rady Children's Hospital San Diego

Are You a Good Fit for This Trial?

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

Exclusion Criteria

Another immediate family member living in the same household who is already recruited into the study

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Fruit and Vegetable Prescription Voucher

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

Monthly fruit and vegetable vouchers for 12 months, to start immediately after enrollment.

Group II: Delayed Intervention Group Experimental Treatment 1 Intervention

Monthly fruit and vegetable vouchers for 12 months, to start after a 6-month waiting period.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

United States Department of Agriculture (USDA)

Collaborator

Trials

103

Recruited

287,000+

Rady Children's Hospital, San Diego

Collaborator

Trials

42

Recruited

14,300+

Published Research Related to This Trial

The Fresh Prescription (Fresh Rx) program, which provided low-income patients with diabetes in Detroit up to $80 for purchasing fruits and vegetables, led to a significant decrease in hemoglobin A1C (HbA1c) levels from 9.64% to 9.14% over 15 weeks.

While the Fresh Rx group showed improvement in HbA1c, there were no significant changes in blood pressure or body mass index (BMI) for either the Fresh Rx or control groups, suggesting that while the program may help with blood sugar management, it may not impact weight or blood pressure in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial of a fruit and vegetable prescription program at a federally qualified health center in low income uncontrolled diabetics. Bryce, R., WolfsonBryce, JA., CohenBryce, A., et al.[2023]

The Fruit and Vegetable Prescription (FVRx) program significantly increased the consumption of dark green vegetables among participants compared to those in the Ad hoc Nutrition Education and Control groups, indicating its effectiveness in promoting healthier eating habits.

Participants in the FVRx program also showed improved food purchasing practices and financial management, suggesting that combining nutrition education with produce prescriptions can enhance food security and resource management for low-income adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Fruit and Vegetable Prescription Program With Expanded Education for Low-Income Adults. Slagel, N., Newman, T., Sanville, L., et al.[2022]

The Veggie Rx program, aimed at increasing access to fresh produce for low-income patients with obesity, hypertension, and type 2 diabetes, resulted in a statistically significant decrease in BMI among participants, with an average reduction of 0.74 kg/m2.

The study, which analyzed data from 54 participants compared to a matched control group, demonstrates the effectiveness of healthy food incentive programs in improving health outcomes for low-income populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Veggie Rx: an outcome evaluation of a healthy food incentive programme. Cavanagh, M., Jurkowski, J., Bozlak, C., et al.[2019]

The 'Prevention Produce' program, which combined fruit and vegetable prescriptions with a month-long educational curriculum, successfully increased fruit and vegetable consumption among nine families at risk of chronic disease and food insecurity.

Participants reported a greater understanding of the health benefits of produce, and the mentorship aspect of the program was positively received by both families and medical students, highlighting its potential as a model for integrating preventive health strategies in healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Prevention Produce": Integrating Medical Student Mentorship into a Fruit and Vegetable Prescription Program for At-Risk Patients. Forbes, JM., Forbes, CR., Lehman, E., et al.[2020]

Community-based fruit and vegetable prescription programs, primarily targeting low-income, non-white females, have shown significant improvements in diet quality (94% of studies), health outcomes (83%), and food security (82%), indicating their effectiveness in promoting healthier eating habits.

Despite the positive outcomes, the considerable variation in study design and measurement techniques makes it difficult to compare the effectiveness of different program methodologies, highlighting the need for more standardized and well-designed research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based fruit and vegetable prescription programs: a scoping review. Greatorex Brooks, E., McInerney, M.[2023]

A 6-month produce prescription program providing $60 monthly vouchers for fresh produce did not significantly improve glycemic control (HbA1c levels) in 252 patients with diabetes compared to 534 control participants receiving usual care.

No significant differences were found in secondary health outcomes such as blood pressure or BMI, indicating that the program did not have a measurable impact on overall health metrics during the study period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Produce Prescription Program for Patients With Diabetes: A Longitudinal Analysis of Glycemic Control. Hager, K., Shi, P., Li, Z., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9222454/

Fruit and Vegetable Prescription Program for Diabetes ... Participation in this FVRx program significantly improved diabetes control among rural, low-income participants. The grant funding supporting the program, ...

2. diabetesjournals.org diabetesjournals.org/care/article/48/10/1783/163117/Health-and-Economic-Impact-and-Cost-effectiveness

Health and Economic Impact and Cost-effectiveness of ... Produce prescription (PRx) programs have been shown to result in improved dietary quality, diabetes control, and cardiometabolic outcomes.

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.122.009520

Impact of Produce Prescriptions on Diet, Food Security ... The study found that produce prescription program participation was associated with improvements in fruit and vegetable intake, food insecurity ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2211335517301079

Participation in a farmers' market fruit and vegetable ... The findings suggest the importance of a fruit and vegetable prescription program in low-income patients with type 2 diabetes in regards to improved health ...

5. ahajournals.org ahajournals.org/doi/10.1161/JAHA.122.029215

Health and Economic Impacts of Implementing Produce ... Our model suggests that implementing produce prescriptions among US adults with diabetes and food insecurity would generate substantial health gains and be ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39217534/

Examining Food Security, Fruit and Vegetable Intake, and ... Objective: Outcomes from produce prescription (PPR) programs, an exemplar of a Food is Medicine intervention, have not been synthesized. The ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2211335521001005

A pilot randomized controlled trial of a fruit and vegetable ... 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), ...