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?

The goal of this clinical trial is to learn if an enhanced, culturally, socially, and structurally tailored Diabetes Prevention Program (E-DPP) can improve weight loss and related diabetes risk factors in African American adults with prediabetes living in low-income, socially vulnerable communities.

The main questions it aims to answer are:

* Does the enhanced DPP (E-DPP) lead to greater percent weight loss at 6 and 12 months compared to the standard culturally tailored DPP (S-DPP)?

* How do social determinants (e.g., food insecurity, stigma, access to resources) influence weight loss and engagement in lifestyle behaviors?

Researchers will compare a standard culturally tailored DPP (S-DPP) to an enhanced DPP (E-DPP) to see if improving access to healthy food, physical activity, and community resources increases weight loss and improves diabetes-related outcomes.

Participants will

1. Attend DPP sessions delivered in community settings (e.g., churches)

2. Receive lifestyle education focused on diet, physical activity, and weight loss

3. Engage in physical activity (including in-class exercise sessions \[E-DPP only\] and community-based options)

4. Receive support for healthy eating, including food deliveries (\[E-DPP only\]), food selection guidance, and referrals to food assistance programs

5. Receive information and support for accessing community resources for food and physical activity

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?

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?

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+