Eat Well Produce Benefit for Diabetes

Overseen By Susan Spratt, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a program called Eat Well can assist people with diabetes who struggle to afford healthy food. Participants will receive monthly gift cards for fruits and vegetables, along with nutrition education, to determine if these benefits improve blood sugar levels and overall heart health. Researchers will compare this group with another group that receives only educational materials. Individuals with diabetes who are part of the Duke Diabetes Registry and face food insecurity may be well-suited for this trial. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance access to nutritious food for those in need.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on diet and nutrition, so you may not need to change your medications, but it's best to confirm with the trial organizers.

What prior data suggests that the Eat Well program is safe for diabetes patients?

Research shows that the Eat Well Produce Prescription program is safe and well-received by participants. Studies have found that people are generally very satisfied with the program. Participants reported eating more fruits and vegetables, including trying new ones, without any significant negative effects.

Eat Well aims to help people improve their health by increasing their intake of fruits and vegetables. This method is not only safe but also beneficial for overall health, especially for those with diabetes or limited access to food. By providing gift cards for produce, the program seeks to make healthy eating easier.

Overall, evidence suggests that Eat Well is a safe choice for anyone looking to improve their diet and health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Eat Well Produce Prescription program for diabetes because it introduces a novel approach that focuses on enhancing patients' access to healthy foods rather than relying solely on medication. Unlike traditional diabetes treatments, which often include medications like metformin or insulin to manage blood sugar levels, this program provides participants with an $80 monthly benefit to purchase eligible produce, encouraging healthier eating habits. By integrating curated nutrition and diet information, this approach aims to empower patients with education and resources to make lifestyle changes, potentially leading to improved long-term health outcomes without the side effects associated with some medications.

What evidence suggests that the Eat Well program is effective for diabetes patients at risk of food insecurity?

Research shows that the Eat Well Produce Prescription program, which participants in this trial may receive, can improve heart and metabolic health, particularly for people with diabetes who struggle to afford food. Studies have found that financial support for buying fruits and vegetables leads to increased consumption, which can enhance health, such as better blood sugar levels. Specifically, past results suggest that participants in similar programs have better control of their HbA1c levels, a measure of long-term blood sugar management. Additionally, eating more fruits and vegetables has been linked to fewer emergency room visits, indicating better overall health. These benefits likely result from improved nutrition and making healthy eating more affordable. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for diabetes patients who struggle with getting enough food (food insecurity). They must have been active in the Duke Diabetes Registry within the past year and had at least one outpatient A1c measurement. There are no specific exclusion criteria, so a wide range of individuals facing these challenges may qualify.

Inclusion Criteria

Be active in the Duke Diabetes Registry in the past 12 months AND have had at least one outpatient A1c measurement

I am at risk of not having enough food due to financial issues or where I live.

Exclusion Criteria

N/A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an $80 monthly benefit for eligible produce for 12 months and diabetes education materials

12 months

Monthly visits (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including HbA1c measurements and ED visits

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Eat Well

Trial Overview

The 'Eat Well' program provides participants with gift/debit cards to buy fruits and vegetables plus educational nutrition materials. The study compares these participants against those only receiving education to see if there's an improvement in blood sugar control (Hb A1c levels) and fewer emergency visits up to 18 months after finishing the program.

How Is the Trial Designed?

Group I: Eat Well Experimental Treatment 1 Intervention

The experimental group will participate in the Eat Well Produce Prescription program, receiving an $80 monthly benefit for eligible produce for 12 months and diabetes education materials through email, including curated nutrition and diet information from the Diabetes Resource Page, consistent with standard of care at Duke University Health System.

Group II: Control Active Control 1 Intervention

The control group will receive usual care (including diabetes educational materials) without the prescription benefit.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

A prescription (PRx) program in rural Eastern North Carolina provided patients with type 2 diabetes weekly home deliveries of fruits and vegetables, leading to high patient satisfaction and increased consumption of produce.

The program not only improved dietary habits but also significantly enhanced glycemic control, demonstrating the effectiveness of combining food access with nutrition education and culinary resources for better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Evaluation of the Delivery-Based HEALED Produce Rx Program for Uninsured Patients With Diabetes in Rural Eastern North Carolina. Sastre, LR., Stroud, B., Smith, E., et al.[2023]

A 9-month study involving 33 patients with type 2 diabetes showed that a food education program combined with a supervised exercise regimen significantly improved dietary patterns, including increased intake of healthy fats and vegetables.

The program had a retention rate of 54%, highlighting the importance of strategies to enhance participant attendance and adherence for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of a community-based food education programme on dietary pattern in patients with type 2 diabetes: Results of a pilot randomised controlled trial in Portugal. Vasconcelos, C., Cabral, M., Ramos, E., et al.[2021]

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]

A 3-month produce prescription program for 303 predominantly Hispanic/Latino adults with or at risk of type 2 diabetes led to significant reductions in weight, waist circumference, and systolic blood pressure, indicating improved cardio-metabolic health.

Participants with higher baseline HbA1c levels experienced a notable decrease in HbA1c, alongside improvements in food security and mental health measures, suggesting that access to fresh produce can positively impact both physical and psychological well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporal changes in bio-behavioral and glycemic outcomes following a produce prescription program among predominantly Hispanic/Latino adults with or at risk of type 2 diabetes. Sato Imuro, SE., Sabharwal, A., Conneely, C., et al.[2023]

Participation in a 13-week Fresh Prescription program significantly reduced hemoglobin A1C (HbA1C) levels in patients with uncontrolled type 2 diabetes, indicating improved blood sugar control (from 9.54% to 8.83%, p = 0.001).

Despite the positive impact on HbA1C, the program did not result in significant changes in weight or blood pressure among participants, suggesting that while fruit and vegetable prescriptions can improve glycemic control, they may not affect other health metrics in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participation in a farmers' market fruit and vegetable prescription program at a federally qualified health center improves hemoglobin A1C in low income uncontrolled diabetics. Bryce, R., Guajardo, C., Ilarraza, D., et al.[2020]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39111387/

Addressing cost barriers to healthy eating with Eat Well, a ...

We seek to test the effect of a prescription produce program, 'Eat Well' on cardiometabolic health and healthcare utilization.

2.

eatwellrx.org

eatwellrx.org/s/Eat-Well-Research-Brief_Final.pdf

EAT WELL RESEARCH FINDINGS

Reinvestment Partners produce prescription program on fruit and vegetable purchasing and diabetes-related health outcomes. Research Partner ...

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clinicaltrials.gov

clinicaltrials.gov/show/NCT05896644

Eat Well Produce Benefit for Diabetes and Food Insecurity

The goal of this clinical trial is to assess the impact of participation in Eat Well for diabetes patients who are at risk of food insecurity.

4.

ahajournals.org

ahajournals.org/doi/10.1161/CIRCOUTCOMES.122.009520

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

Produce prescriptions may improve cardiometabolic health by increasing fruit and vegetable (F&V) consumption and food insecurity.

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1551714424002386?via%3Dihub

Addressing cost barriers to healthy eating with Eat Well, a ...

Patients with diabetes at risk of food insecurity face cost barriers to healthy eating and, as a result, poor health outcomes. Population health management ...

6.

cdc.gov

cdc.gov/pcd/issues/2023/22_0384.htm

Development and Evaluation of the Delivery-Based ...

The level of patient satisfaction with the program was high; the reported level of consumption of produce, including unfamiliar produce, was ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8369461/

The impact of a produce prescription programme on ...

Produce Prescription Programmes can increase healthy food purchasing among food-insecure people, which may improve chronic disease care.