Enhanced Diabetes Prevention Program for Prediabetes

JE
JE
Overseen ByJannette E Berkley-Patton, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Missouri, Kansas City
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special diabetes prevention program can help African American adults with prediabetes in low-income communities lose weight and reduce their risk of developing diabetes. It compares a standard program to an enhanced version, the Enhanced Diabetes Prevention Program (E-DPP), which includes additional support such as food deliveries and access to community resources. Participants will attend sessions on healthy eating and physical activity. Those who are prediabetic and involved in a participating church's community services might be a good fit. As an unphased trial, this study allows participants to contribute to important research that could lead to better community health solutions.

Will I have to stop taking my current medications?

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.

What prior data suggests that this enhanced Diabetes Prevention Program is safe?

Research has shown that the Diabetes Prevention Program (DPP) is generally safe and easy for most people to follow. Studies have found that the lifestyle changes in the DPP can significantly lower the risk of developing type 2 diabetes. Participants in the DPP's lifestyle change program reduced their chances of developing diabetes by 58% over about three years.

No major safety issues have been reported with these programs. They emphasize lifestyle changes like improved diet and exercise, which are typically low-risk activities. The goal is to enhance habits, which is generally safe for most people.

The Enhanced Diabetes Prevention Program (E-DPP) provides additional support, such as digital tools and community assistance, to facilitate adherence to the program without introducing any known risks.

Overall, evidence suggests that these programs are safe and effective for individuals with prediabetes.12345

Why are researchers excited about this trial?

The Enhanced Diabetes Prevention Program (E-DPP) is unique because it integrates digital tools and culturally tailored supports with the standard CDC PreventT2 curriculum. Unlike traditional programs that rely solely on in-person coaching, E-DPP offers tailored text messages with DPP content and resource links, enhancing accessibility and personalization. Additionally, this program includes in-class healthy food distribution and culturally specific physical activity sessions, making it a holistic approach to sustained behavior change. Researchers are excited about E-DPP as it addresses diabetes disparities and offers a more comprehensive support system for individuals with prediabetes, potentially improving outcomes over standard methods.

What evidence suggests that this trial's programs could be effective for prediabetes?

Research has shown that programs aimed at preventing diabetes can significantly lower the risk of developing type 2 diabetes. For instance, lifestyle programs like the Diabetes Prevention Program (DPP) can reduce the risk by about 58%. These programs emphasize healthier eating and increased physical activity. One study found that people who completed a DPP were 35% less likely to develop diabetes. In this trial, participants will be randomized to receive either the Standard Diabetes Prevention Program (S-DPP) or the Enhanced Diabetes Prevention Program (E-DPP). The E-DPP includes additional community support, which might lead to greater weight loss and improved health outcomes related to diabetes.12367

Who Is on the Research Team?

JE

Jenifer E Jenifer, PhD

Principal Investigator

University of Missouri, Kansas City

Are You a Good Fit for This Trial?

This trial is for African American adults, age 18 or older, with prediabetes who are members or users of participating churches in low-income communities. People can't join if they are pregnant, breastfeeding, unable to do light exercise, don't speak English, live with another participant from a different church, or have very high blood pressure without doctor approval.

Inclusion Criteria

I am 18 years old or older.
I am prediabetic based on my blood sugar levels or diabetes risk factors.
Members of a participating church or user of a participating church's outreach services

Exclusion Criteria

Individuals who are pregnant, breastfeeding or planning to become pregnant in the next year
Individuals who are not able to engage in low-impact physical activity
Individuals who do not speak English
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants attend DPP sessions, receive lifestyle education, engage in physical activity, and receive support for healthy eating and accessing community resources

12 months
22 sessions (in-person)

Follow-up

Participants are monitored for weight loss, dietary intake, physical activity, and use of community resources

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Enhanced Diabetes Prevention Program (E-DPP)

Trial Overview

The study compares two versions of the Diabetes Prevention Program: a standard culturally tailored program and an enhanced version that adds food deliveries and more physical activity support. Both focus on healthy eating and exercise to help prevent diabetes.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Enhanced Diabetes Prevention Program (E-DPP)Experimental Treatment1 Intervention
Group II: Standard Diabetes Prevention Program (S-DPP)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Missouri, Kansas City

Lead Sponsor

Trials
73
Recruited
34,600+

Children's Mercy Hospital Kansas City

Collaborator

Trials
261
Recruited
941,000+

University of Massachusetts, Amherst

Collaborator

Trials
83
Recruited
3,474,000+

San Diego State University

Collaborator

Trials
182
Recruited
119,000+

University of Kansas

Collaborator

Trials
157
Recruited
332,000+

Citations

NIDDK's Journey Into the Prevention of Type 2 Diabetes and ...

After mean 2.8 years, ILS reduced diabetes risk by 58% and metformin by 31%, leading to study termination ahead of schedule due to demonstrated ...

Nationwide Effectiveness and Efficiency of the National ... - PMC

At a national level, the study by Zhuo and colleagues projected that the National DPP will prevent 888,500 cases of diabetes within 25 years of ...

Diabetes Prevention Programs: Effectiveness and Value

1 The Diabetes Prevention Program Trial (DPP Trial) demonstrated that the incidence of type 2 diabetes could be reduced using intensive diet and lifestyle ...

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

It also found that successful completion of the National DPP lifestyle change program reduced progression to diabetes for these individuals by 35%. To access ...

The Lancet Diabetes & Endocrinology

The large initial intervention effects seen in the DPP trial were followed by sustained reductions in cumulative diabetes incidence for 21 years. Intervention ...

Evaluation of a Digital Diabetes Prevention Program ...

Our study examined a digitally delivered DPP that removed some barriers to access and increased participation for low-income patients.