Produce Prescription Program for Type 2 Diabetes and Prediabetes

(I-PPP Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Iowa State University

Disqualifiers: Under 18, Not diabetic, others

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

Compensation: Varies

Number of Visits: Unknown

300 Participants Needed

Trial Summary

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

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

What data supports the effectiveness of the Produce Prescription Program for Type 2 Diabetes and Prediabetes treatment?

Research shows that food prescription programs, like the one in the study, can help people with diabetes improve their health by increasing their intake of fruits and vegetables and improving their ability to plan and cook healthy meals. These programs have been associated with reductions in blood sugar levels and improvements in dietary habits, which are important for managing diabetes. ^{1 2 3 4 5}

Is the Produce Prescription Program safe for humans?

The Produce Prescription Program, which provides fruits and vegetables to participants, has been shown to be safe for humans. Studies have reported high levels of patient satisfaction and improvements in health outcomes without any safety concerns. ^{1 3 6 7 8}

How is the Produce Your Path Behavioral Nutrition Intervention treatment different from other treatments for type 2 diabetes?

The Produce Your Path Behavioral Nutrition Intervention is unique because it involves a produce prescription program that provides subsidized fruits and vegetables, along with nutrition education and culinary resources, to improve diet quality and diabetes-related health outcomes. This approach focuses on increasing access to healthy foods and empowering patients with the knowledge to make healthier lifestyle choices, which is different from traditional medication-based treatments. ^{1 6 8 9 10}

What is the purpose of this trial?

The goal of this study is to understand how a Produce Prescription Program paired with a behavioral nutrition intervention affect nutrition and overall health in low-income Iowans with type 2 diabetes or pre-diabetes. Research questions include: 1. What impact does a produce prescription program paired with a behavioral nutrition intervention on nutrition security compared to the behavioral nutrition intervention alone and usual care groups? 2. What impact does a produce prescription program paired with a behavioral nutrition intervention on hemoglobin A1c, fruit and vegetables intake, food security, and related behaviors compared to the behavioral nutrition intervention alone and usual care groups? Participants of the behavioral nutrition intervention (Produce Your Path) alone will: * Watch monthly nutrition education videos about topics like planning and budgeting for groceries, reading nutrition labels, eating more fruits and vegetables, and new recipes to try * Complete a short quiz about their own goals and habits related to the topic * (Optional): Join a Facebook group to communicate with other participants about their goals, share ideas and recipes, and ask questions Participants of both the Produce Prescription and Produce Your Path Interventions will: * Complete each monthly nutrition education module and monthly quiz * (Optional): Join a Facebook group to communicate with other participants about their goals, share ideas and recipes, and ask questions * Receive $30.00 per each person in their household monthly to buy fresh fruits and vegetables Participants of the control group will: * Follow their usual care for health conditions * Complete the required data collection for the study

Eligibility Criteria

This trial is for low-income Iowans aged 18 or older who have been diagnosed with pre-diabetes or type 2 diabetes. Participants must be on Medicaid or eligible for SNAP benefits, own a smartphone, speak and understand English, and be patients at a partnering clinic. Only one person per household can join.

Inclusion Criteria

Receiving medical assistance under a state plan (Medicaid) or eligible for Supplemental Nutrition Assistance Program (SNAP) benefits

Owns a smart phone

Able to read and understand English; speaks English

Exclusion Criteria

Is not a patient at a partnering health care clinic

I am not diagnosed with pre-diabetes or diabetes.

Cannot read or understand English

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in the Produce Prescription Program and/or the Produce Your Path Behavioral Nutrition Intervention

6 months

Monthly virtual modules and quizzes

Follow-up

Participants are monitored for changes in nutrition security, hemoglobin A1c, and other health metrics

4 weeks

Treatment Details

Interventions

• Iowa Produce Prescription Program (I-PPP)
• Produce Your Path Behavioral Nutrition Intervention

Trial Overview The study tests the effects of providing $30 monthly for fresh produce (I-PPP) plus nutrition education (PYP), against just nutrition education alone or usual care. It measures changes in hemoglobin A1c levels, fruit and vegetable intake, food security, and related behaviors.

Participant Groups

Group I: PYP Alone Group Experimental Treatment 1 Intervention

The PYP Alone Group will complete the six-month behavioral nutrition intervention, but will not receive monthly incentives to redeem for fresh fruits and vegetables. PYP Alone participants will still complete the corresponding quizzes to monthly education modules. The PYP Alone participants will also have access to separate optional Facebook group to post questions, share goals and recipes, and answer prompts posted by the research team.

Group II: I-PPP+PYP Group Experimental Treatment 2 Interventions

The I-PPP+PYP participants will participate in both the Iowa Produce Prescription Program and the Produce Your Path Behavioral Nutrition Intervention. This group will complete the monthly PYP intervention modules to receive the produce prescription dollar amount, which can be redeemed at partnering retail locations on fresh fruits and vegetables. An optional Facebook group for the I-PPP+PYP participants with offer additional social support and resources for participants, who can use the Facebook page to post questions, share goals and recipes, and answer prompts posted by the research team.

Group III: Control Group Active Control 1 Intervention

This group will not receive the produce prescription incentive or behavioral intervention.

Who Is Running the Clinical Trial?

Iowa State University

Lead Sponsor

Trials

63

Recruited

145,000+

Findings from Research

The A Prescription for Healthy Living (APHL) culinary medicine curriculum led to a significant reduction in HbA1c levels among patients with diabetes, indicating improved blood sugar control, with a mean difference of -0.96% (p = 0.028).

Participants in the APHL program reported increased fruit and vegetable consumption, greater confidence in cooking healthy meals, and more frequent cooking from scratch, suggesting positive changes in dietary behaviors and self-efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Virtual Culinary Medicine Curriculum on Biometric Outcomes, Dietary Habits, and Related Psychosocial Factors among Patients with Diabetes Participating in a Food Prescription Program. Sharma, SV., McWhorter, JW., Chow, J., et al.[2022]

Nutrition and lifestyle interventions have been crucial in three major diabetes clinical trials, showing their effectiveness in preventing diabetes and reducing complications for individuals with diabetes.

Dietitians played a key role in these trials by not only implementing nutrition plans but also tailoring their approaches to individual participants, which helped improve outcomes like blood sugar control and weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research charting a course for evidence-based clinical dietetic practice in diabetes. Delahanty, LM.[2010]

A community-based diabetes prevention program successfully enrolled 213 individuals with prediabetes, achieving a high completion rate of 95%, and demonstrated significant improvements in weight, waist circumference, and physical activity after 6 months.

The program showed effective diabetes risk reduction, but future efforts are needed to enhance physician referrals and participant engagement, as well as to explore digital expansion to reach more individuals at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Evaluation of the Reach and Effectiveness of a Diabetes Prevention Behaviour Change Program Situated in a Community Site. Bean, C., Dineen, T., Locke, SR., et al.[2021]

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]

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]

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]

The Food as Medicine Program, implemented over 12 months with 20 participants, showed a slight decrease in HbA1c levels, indicating potential benefits in managing type 2 diabetes symptoms, although these changes were not statistically significant.

Participants reported improvements in diabetes self-care activities and a reduction in diabetes-related distress, suggesting that the program may enhance self-management behaviors essential for effective diabetes control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot evaluation of the Food as Medicine program for patients with type 2 diabetes. Biber, DD.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of a Virtual Culinary Medicine Curriculum on Biometric Outcomes, Dietary Habits, and Related Psychosocial Factors among Patients with Diabetes Participating in a Food Prescription Program. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Research charting a course for evidence-based clinical dietetic practice in diabetes. [2010]

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

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

4. Canada pubmed.ncbi.nlm.nih.gov

An Evaluation of the Reach and Effectiveness of a Diabetes Prevention Behaviour Change Program Situated in a Community Site. [2021]

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

Diet Quality Outcomes of a Cooperative Extension Diabetes Prevention Program. [2023]

6. 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]

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

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

8. 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]

9. England pubmed.ncbi.nlm.nih.gov

A pilot evaluation of the Food as Medicine program for patients with type 2 diabetes. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of a Lifestyle Intervention in Patients with Type 2 Diabetes: The Physical Activity and Nutrition for Diabetes in Alberta (PANDA) Trial. [2023]