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

2177 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Eat Well for diabetes?

Research shows that programs prescribing fruits and vegetables can help people with type 2 diabetes improve their blood sugar levels and reduce weight. These programs have also been linked to better food security and improvements in mood and stress. ^{1 2 3 4 5}

Is the Eat Well Produce Benefit for Diabetes treatment safe for humans?

The studies suggest that programs promoting increased intake of fruits and vegetables, like the Eat Well Produce Benefit, are generally safe and can improve health outcomes in people with diabetes. Participants in these programs reported high satisfaction and improved dietary habits, with no safety concerns mentioned. ^{1 6 7 8 9}

How does the Eat Well treatment for diabetes differ from other treatments?

The Eat Well treatment is unique because it focuses on dietary changes, emphasizing the consumption of fruits, vegetables, nuts, and whole grains, which can improve glycemic control and reduce diabetes risk. Unlike traditional medications, this approach uses food as a form of therapy to manage diabetes. ^{4 10 11 12 13}

What is the purpose of this trial?

This trial tests if giving diabetes patients gift cards for fruits and vegetables, along with nutrition education, can improve their health. It focuses on those who struggle to afford healthy food. The goal is to see if this helps manage their diabetes better.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The impact of a produce prescription programme on healthy food purchasing and diabetes-related health outcomes. [2021]

2. England 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. [2023]

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

Impact of a Prescription Produce Program on Diabetes and Cardiovascular Risk Outcomes. [2022]

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

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

5. United States 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. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Three-year effects on dietary quality of health education: a randomized controlled trial of people with screen-detected dysglycaemia (The ADDITION study, Denmark). [2022]

7. United States 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. [2023]

8. England 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. [2021]

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

Intake of vegetables, legumes, and fruit, and risk for all-cause, cardiovascular, and cancer mortality in a European diabetic population. [2023]

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

Diet in 45- to 74-year-old individuals with diagnosed diabetes: comparison to counterparts without diabetes in a nationally representative survey (Etude Nationale Nutrition Santé 2006-2007). [2022]

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

The impact of nuts on diabetes and diabetes risk. [2019]

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

One size does not fit all: Nutrition strategies for people with diabetes. [2021]

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

Sugar-sweetened product consumption alters glucose homeostasis compared with dairy product consumption in men and women at risk of type 2 diabetes mellitus. [2023]