← Back to Search

Behavioural Intervention

Men-Tailored DPP for Prediabetes (Power-Up Trial)

N/A

Waitlist Available

Led By Earle Chambers, PhD

Research Sponsored by Albert Einstein College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years old

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months, after the delivery of the 16th session (end of the core phase)

Awards & highlights

Power-Up Trial Summary

This trial will test if a Diabetes Prevention Program tailored to men can lower their risk of developing diabetes.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

As this trial involves lifestyle modifications rather than medication, side effects may include muscle soreness from increased physical activity and potential dietary changes-related discomfort.

Power-Up Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Power-Up Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months, after the delivery of the 16th session (end of the core phase)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months, after the delivery of the 16th session (end of the core phase)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months, after the delivery of the 16th session (end of the core phase) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Comparison of Engagement and Retention of Men vs Standard Diabetes Prevention Program

Percent Weight Loss through 16 sessions

Percent Weight Loss through the 12 month trial

Secondary outcome measures

Compare change in hemoglobin A1c over 12 months

Compare change in hemoglobin A1c over 6 months

Power-Up Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Power-UpExperimental Treatment1 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 Control1 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Albert Einstein College of MedicineLead Sponsor

286 Previous Clinical Trials

11,856,680 Total Patients Enrolled

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

2,356 Previous Clinical Trials

4,314,765 Total Patients Enrolled

New York City Department of Health and Mental HygieneOTHER_GOV

18 Previous Clinical Trials

18,232 Total Patients Enrolled

Media Library

Men-Tailored DPP (Power-Up) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04104243 — N/A

Type 2 Diabetes Research Study Groups: Standard NDPP (National Diabetes Prevention Program), Power-Up

Type 2 Diabetes Clinical Trial 2023: Men-Tailored DPP (Power-Up) Highlights & Side Effects. Trial Name: NCT04104243 — N/A

Men-Tailored DPP (Power-Up) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04104243 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the enrollment size for this clinical research endeavor?

"Yes, the information on clinicaltrials.gov indicates that this investigation is actively recruiting research subjects. This trial was initially posted on August 9th 2021 and has since been revised for accuracy as recently as September 9th 2022. The study calls for 300 patients to be recruited from a single medical facility."

Answered by AI

Who is the ideal demographic for this research protocol?

"This medical trial seeks 300 volunteers, aged 18-80, who have been diagnosed with type 2 diabetes mellitus and possess a BMI of 25 or greater in the last 6 months."

Answered by AI

Are there current opportunities to partake in this investigation?

"Affirmative, clinicaltrials.gov reveals that this medical trial is still recruiting patients. Initially posted on August 9th 2021 and last updated on September 9th 2022, the study requires 300 individuals to participate at 1 location."

Answered by AI