Men-Tailored DPP for Prediabetes

(Power-Up Trial)

Overseen By Eric N Gil

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Albert Einstein College of Medicine

Disqualifiers: Physical limitations, Consent issues, Language barriers

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

Compensation: Varies

Number of Visits: 22

301 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to address the risk of diabetes among men by creating a Diabetes Prevention Program (DPP) tailored to men.

Research Team

Earle Chambers, MD MS

Principal Investigator

Albert Einstein College of Medicine

Eligibility Criteria

This trial is for men who are at least 18 years old with a recent HbA1c level between 5.7%-6.4% or a Diabetes Risk Score of 5 or higher, and a BMI of 25 or more. It's not for those unable to attend group sessions in person, give consent by phone, or complete surveys in English/Spanish.

Inclusion Criteria

Your body mass index (BMI) is 25 or higher based on your recent weight and height measurements.

My latest HbA1c is between 5.7% and 6.4%, or my diabetes risk score is 5 or higher.

Exclusion Criteria

Unable to provide informed consent by telephone

I cannot or do not want to attend group sessions in person.

I cannot or do not want to complete surveys in English or Spanish.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Core Phase

Participants attend at least 16 classes over the first 6 months focusing on food choices, physical activity, and managing stress

6 months

16 classes (in-person or virtual)

Maintenance Phase

Participants attend 6 additional classes over the next 6 months to maintain lifestyle changes

6 months

6 classes (in-person or virtual)

Follow-up

Participants are monitored for engagement, retention, and weight loss outcomes

12 months

Treatment Details

Interventions

• Men-Tailored DPP (Power-Up)

Trial Overview The study tests the effectiveness of a Diabetes Prevention Program specifically designed for men (Power-Up). The program aims to reduce diabetes risk among male participants through tailored interventions.

Participant Groups

Group I: Power-Up Experimental Treatment 1 Intervention

Participants randomized to this arm will undergo 16 classes tailored for men, that discuss food choices, physical activity, and managing stress over 6 months, which are called the core, and 6 classes over the following 6 months, which is called the maintenance phase.

Group II: Standard NDPP (National Diabetes Prevention Program) Active Control 1 Intervention

Participants randomized to this arm will undergo 16 mixed gender classes that discuss food choices, physical activity, and managing stress over 6 months which are called the core and 6 classes over the following 6 months which is called the maintenance phase.

Who Is Running the Clinical Trial?

Albert Einstein College of Medicine

Lead Sponsor

Trials

302

Recruited

11,690,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

New York City Department of Health and Mental Hygiene

Collaborator

Trials

20

Recruited

19,400+