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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a Produce Prescription Program combined with nutrition education can enhance nutrition and health outcomes for low-income individuals with type 2 diabetes or prediabetes. Participants will either receive only the nutrition education (Produce Your Path Behavioral Nutrition Intervention), both the education and monthly funds to purchase fresh produce, or continue with their usual care. The trial aims to determine if these interventions improve blood sugar levels and increase fruit and vegetable intake. This study may suit adults diagnosed with prediabetes or diabetes who receive Medicaid or SNAP benefits and are patients at a partnering clinic. As an unphased trial, it offers a unique opportunity to explore innovative ways to manage diabetes through lifestyle changes.

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 prior data suggests that this Produce Prescription Program and Behavioral Nutrition Intervention are safe?

Research shows that the treatments in this study—the Iowa Produce Prescription Program and the Produce Your Path Behavioral Nutrition Intervention—are safe for participants. Studies have found that programs like the Produce Prescription, which provide fruits and vegetables to participants, are well-tolerated, with no significant reports of harm or negative effects.

The Produce Your Path Behavioral Nutrition Intervention is also considered safe. Nutritional programs help manage type 2 diabetes and are generally well-received by participants. These programs promote healthier eating habits, improving health without causing major side effects.

Both treatments in this trial aim to improve health through diet and do not pose known safety risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Produce Your Path (PYP) Behavioral Nutrition Intervention because it offers a fresh approach to managing Type 2 Diabetes and prediabetes by emphasizing nutritional education and social support rather than medication alone. Unlike standard treatments that often rely on medications like metformin or insulin, this intervention focuses on behavior change and healthy eating. Participants in the PYP program engage in educational modules and can interact in a supportive online community to share recipes and goals. Additionally, the combination of the Iowa Produce Prescription Program with PYP provides financial incentives to purchase fruits and vegetables, making healthy eating more accessible and appealing. This innovative approach could empower individuals to take control of their health through informed dietary choices.

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

Research has shown that a produce prescription program can greatly improve health for people with type 2 diabetes or pre-diabetes. In one study, participants lost weight and lowered their cholesterol after three months. Another study found that some people no longer needed medication because their blood sugar levels improved. In this trial, participants in the I-PPP+PYP Group will engage in both the Iowa Produce Prescription Program and the Produce Your Path Behavioral Nutrition Intervention. Research indicates that this combination can help manage and even reduce the risk of type 2 diabetes by increasing fruit and vegetable intake. Meanwhile, the PYP Alone Group will complete the Produce Your Path program without the produce prescription incentives. Overall, these programs show promise for improving diet and controlling blood sugar levels. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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

Cannot read or understand English

I am not diagnosed with pre-diabetes or diabetes.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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]

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 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]

Citations

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withpower.com

withpower.com/trial/produce-prescription-program-for-type-2-diabetes-and-prediabetes-330e1

Produce Prescription Program for Type 2 Diabetes and ...

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, ...

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ctv.veeva.com

ctv.veeva.com/study/iowa-produce-prescription-program

Iowa Produce Prescription Program - ClinicalTrials.Veeva

The goal of this study is to understand how a Produce Prescription Program paired with a behavioral nutrition intervention affect nutrition ...

3.

midiowahealth.org

midiowahealth.org/stories/produce-prescription-program

A Food is Medicine Approach to Health Care

Within six months of participating in the Produce Prescription Program, her glucose levels lowered to the point of no longer needing medication.

4.

iowahealthieststate.com

iowahealthieststate.com/produce-rx

Iowa Produce Prescription Program

The Iowa Produce Prescription Program (IPPP) advances health equity by transforming the healthcare system's role to increase access to affordable, nutritious ...

5.

molinahealthcare.com

molinahealthcare.com/members/common/en-US/abtmolina/compinfo/newsmed/newsarticlepage.aspx?ArticleID=1281&lob=All&type=IsNewsMediaSpecial&year=All&State=All&ArticlePageLink=abtmolina/compinfo/newsmed/newsarticlepage.aspx

Molina News

The Iowa Produce Prescription Program pilot in 2022 saw a group of nearly 200 individuals record decreases cholesterol and average blood sugar ...

6.

app.trialscreen.org

app.trialscreen.org/trials/iowa-produce-prescription-program-trial-nct06837805

Iowa Produce Prescription Program

This Interventional study is looking for people with Diabetes Mellitus Type 2, Pre-diabetes in Ames United States to take part.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11195530/

Engagement in a pilot produce prescription program ...

This study evaluates the implementation, reach, engagement, and retention of a PRx program piloted in two regions of Georgia (US) from 2020 to 2022.