Produce Prescription + Diabetes Prevention for Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine whether combining a Diabetes Prevention Program (DPP) with a Prescription Produce Plan (PPP) can help prevent Type 2 Diabetes. Participants will either follow the DPP, which emphasizes healthy lifestyle changes, or receive the DPP along with fresh fruits, vegetables, and cooking classes. The trial targets individuals with prediabetes who have slightly elevated blood sugar levels and a higher body weight. Participants should be comfortable with English and able to attend regular sessions over a year. As an unphased trial, this study provides a unique opportunity to contribute to innovative diabetes prevention strategies.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the treatments in this study are safe for participants. In past studies, people lost weight and lowered their cholesterol by joining similar programs. One study found no major safety issues for people with diabetes using the produce prescription program. Another study suggested that making fruits and vegetables more accessible can improve health and reduce healthcare costs. Overall, these programs have been well-received, with no major negative effects reported.12345
Why are researchers excited about this trial?
Researchers are excited about the Produce Prescription Program (PPP) within a Diabetes Prevention Program (DPP) because it offers a fresh, holistic approach to diabetes prevention. Unlike standard treatments that typically focus on medication and lifestyle advice, this program provides participants with fresh fruits and vegetables, hands-on cooking demonstrations, and tailored community support. This method not only addresses dietary habits directly but also integrates social support, which could lead to more sustainable lifestyle changes. By focusing on both nutrition and social needs, this trial aims to uncover whether a more comprehensive support system can enhance the effectiveness of traditional diabetes prevention strategies.
What evidence suggests that this trial's treatments could be effective for preventing Type 2 Diabetes?
Research has shown that the Diabetes Prevention Program (DPP) effectively reduces the risk of developing type 2 diabetes. Studies have found that participants in the DPP Lifestyle Change Program lower their risk of type 2 diabetes by 58%. This program emphasizes dietary changes and increased physical activity.
In this trial, one group of participants will receive the DPP alone, while another group will receive a combination of the DPP and a Produce Prescription Plan (PPP). The PPP provides access to fresh fruits and vegetables, potentially enhancing health outcomes. Although specific data on PPP is limited, research models suggest that produce prescriptions can lead to significant health benefits for people with diabetes and those facing food insecurity. This combination of approaches aims to encourage healthier habits and effectively reduce the risk of diabetes.678910Who Is on the Research Team?
Ana Diallo
Principal Investigator
Virginia Commonwealth University
Are You a Good Fit for This Trial?
This trial is for adults age 18 or older who are overweight (BMI of at least 25), not pregnant, have prediabetes based on recent blood tests or a doctor's diagnosis, and can speak and understand English.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants engage in a 12-month Diabetes Prevention Program (DPP) with or without the Prescription Produce Program (PPP), including lifestyle changes, cooking demonstrations, and resource referrals
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of medication adherence, wellness goals, physical activity, blood pressure, diet quality, and social needs
What Are the Treatments Tested in This Trial?
Interventions
- Diabetes Prevention Program (DPP)
- Produce Prescription Plan (PPP)
Trial Overview
The study is testing whether adding a produce prescription plan—which provides access to fruits and vegetables—to the standard Diabetes Prevention Program helps people with prediabetes improve their diet and prevent diabetes.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
The research intervention in this study is the DPP + Produce Prescription Plan (DPP+PPP). Besides receiving the DPP, the intervention group participants will receive bags of fresh fruits and vegetables, attend four cooking demonstrations, and if there are positive screens for social needs, be referred to work with a community-based wellness program to access resources.
All participants in this research study will participate in the Diabetes Prevention Program (DPP), which is a 12-month lifestyle change program incorporating the latest evidence on self-efficacy, physical activity, and healthy diet. Additionally, all participants will be screened for social needs at regular timepoints and receive a list of available resources.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Virginia Commonwealth University
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Citations
Cost-effectiveness of the National Diabetes Prevention Program
Compared with nonenrollees, each NDPP enrollee had an average reduction of $4,552 (95% CI −13,231, 2,014) in 2-year total direct medical costs.
Diabetes Prevention Program (DPP) - NIDDK
After about 3 years, the DPP showed that participants in the DPP Lifestyle Change Program lowered their chances of developing type 2 diabetes by 58 percent ...
Evidence
The Diabetes Prevention Program Outcomes Study 10-year follow-up found that individuals with a previous gestational diabetes diagnosis were 48% more likely to ...
Medicare Diabetes Prevention Program (MDPP) Expanded ...
Outcomes: By widely implementing this program among people with Medicare, the MDPP Expanded Model can improve health and decrease costs ...
The cost-effectiveness of diabetes prevention: results from the ...
Over the 10 years of combined DPP/DPPOS follow-up, diabetes incidence was reduced by 34 % in the lifestyle group and 18 % in the metformin group ...
The impact of a produce prescription programme on healthy ...
For the 353 participants with diabetes, there were no statistically significant relationships between programme utilisation and diabetes control.
Health and Economic Impacts of Implementing Produce ...
Our model suggests that implementing produce prescriptions among US adults with diabetes and food insecurity would generate substantial health gains and be ...
Impact of a Prescription Produce Program on Diabetes and ...
Fruit and vegetable prescription programs may improve diabetes outcomes by incentivizing DSME uptake and retention.
Study confirms diabetes prevention programs reduce costs ...
People who complete DPPs are one-third less likely to develop type 2 diabetes after 10 years. complete a DPP will be diagnosed with diabetes ...
What Is the National DPP? | National Diabetes Prevention ...
The Diabetes Prevention Program Outcomes Study, showed that participants were still one-third less likely to develop type 2 diabetes a decade ...
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