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?

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.

Is 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. ^{1 2 3 4 5}

How 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. ^{1 2 4 5 6}

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. ^{1 2 3 4 5}

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 '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]

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]

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]

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]

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. United States pubmed.ncbi.nlm.nih.gov

"Prevention Produce": Integrating Medical Student Mentorship into a Fruit and Vegetable Prescription Program for At-Risk Patients. [2020]

2. United States 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Community-based fruit and vegetable prescription programs: a scoping review. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of a Fruit and Vegetable Prescription Program With Expanded Education for Low-Income Adults. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Veggie Rx: an outcome evaluation of a healthy food incentive programme. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a Produce Prescription Program for Patients With Diabetes: A Longitudinal Analysis of Glycemic Control. [2023]