Produce Prescription for Type 2 Diabetes

(GARDEN-CARDIO Trial)

SA
Overseen BySyed Ahmad, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: West Virginia University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if monthly vouchers for fruits and vegetables, combined with dietary education, can help people with type 2 diabetes manage their blood sugar. Participants will split into two groups, each experiencing both normal diabetes care and the produce voucher program at different times. Researchers will track changes in blood sugar levels, diet quality, and other health factors. People with type 2 diabetes who struggle to control blood sugar (HbA1c above 8%) and face food insecurity may be well-suited for this study. As an unphased trial, this study provides a unique opportunity to explore innovative ways to improve diabetes management and diet quality.

What prior data suggests that this produce prescription intervention is safe for people with type 2 diabetes?

Research shows that programs providing vouchers for fruits and vegetables are generally safe and well-received. Studies have found that these programs help people with type 2 diabetes eat more fruits and vegetables and improve their health without causing serious side effects.

For instance, one study found that using these vouchers lowered blood sugar levels in people with diabetes, indicating the program's benefits and safety. Another study demonstrated that these programs improve participants' access to food and enhance overall health.

In summary, research supports that giving monthly vouchers for fruits and vegetables is a safe way to help manage diabetes and improve diet.12345

Why are researchers excited about this trial?

Researchers are excited about the Produce Prescription for Type 2 Diabetes because it offers a fresh approach by integrating fruit and vegetable vouchers with dietary education. Unlike standard treatments that often rely on medication to control blood sugar levels, this method emphasizes nutritional changes that may improve overall health. By potentially increasing access to healthy foods and promoting better dietary habits, this approach could offer a sustainable and empowering way to manage diabetes.

What evidence suggests that this trial's treatments could be effective for type 2 diabetes?

Research has shown that programs providing vouchers for fruits and vegetables can improve diet and health for individuals with type 2 diabetes. In this trial, participants will be randomized into two groups: one group will receive the produce prescription intervention, which includes fruit and vegetable vouchers and standardized dietary education, for 5 months before switching to usual care. The other group will begin with usual care for 5 months before switching to the produce prescription intervention. One study found that using these vouchers significantly reduced A1c levels, which measure blood sugar control. Another study found that these programs help individuals consume more fruits and vegetables, manage blood sugar, and reduce waist size. Additionally, providing vouchers increased vegetable intake and improved food security, meaning individuals had better access to healthy foods. These findings suggest that access to fresh produce can help individuals manage their diabetes more effectively.24678

Who Is on the Research Team?

GS

George Sokos, DO, FACC

Principal Investigator

West Virginia University Heart and Vascular Institute

Are You a Good Fit for This Trial?

This trial is for adults with type 2 diabetes who get care at WVU clinics and recently had high blood sugar (HbA1c above 8%). Participants should also have trouble affording enough healthy food. They must be willing to join the study and follow its procedures.

Inclusion Criteria

Must have had a clinic visit within the past 6 months
Positive screening for food insecurity based on the USDA 6-item food security survey
Able and willing to provide written informed consent
See 3 more

Exclusion Criteria

Severe cognitive impairment
I have chronic pancreatitis.
I have been diagnosed with pancreatic cancer.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment Phase 1

Participants receive either produce vouchers and dietary education or usual diabetes care for 5 months

5 months
Monthly visits (in-person or virtual)

Treatment Phase 2

Participants crossover to the alternate treatment: either produce vouchers and dietary education or usual diabetes care for 5 months

5 months
Monthly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Produce Gift Card and Dietary Education

Trial Overview

The study compares two approaches: giving monthly $100 vouchers for fruits and vegetables plus dietary education, versus usual diabetes care. Each participant will try both methods during the study in a random order over a total of 10 months.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Usual Care to Produce Gift CardExperimental Treatment2 Interventions
Group II: Produce Gift Card to Usual CareExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

West Virginia University

Lead Sponsor

Trials
192
Recruited
64,700+

Citations

Voucher for Healthy Foods and Diabetes Control - PMC

A voucher intended to improve access to healthy foods did not improve diabetes control in this trial where recipients reported more vegetable ...

Predictors of Voucher Redemption in Produce Prescription ...

Produce (fruit and vegetable) prescription programs can improve diet and health outcomes of people with type 2 diabetes, yet voucher redemption ...

Experiences of people with diabetes receiving a voucher for ...

The experiences shared by the study participants suggest that a monthly voucher for healthy foods may improve well-being by providing freedom to ...

Proof in produce: Voucher program may help diabetes ...

“We also found that voucher redemption was significantly related to a decrease in A1c, which suggests that the vouchers paired with nutrition ...

THE IMPACT OF A FRUIT AND VEGETABLE FARMERS ...

The Farmers' Market Voucher program successfully increased FV consumption and had a positive effect on blood glucose and waist circumference.

Examining Food Security, Fruit and Vegetable Intake ... - PMC

The objective of this study was to conduct a systematic review to examine the impact of PPR programs on food security, fruit and vegetable (FV) intake, PPR ...

Impact of a Prescription Produce Program on Diabetes and ...

Fruit and vegetable prescription programs may improve diabetes outcomes by incentivizing DSME uptake and retention.

Impact of Produce Prescriptions on Diet, Food Security ...

Produce prescriptions may play a role in improving cardiometabolic health by increasing fruit and vegetable consumption and food security.