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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

Must not have

Not physically able or willing to attend in-person, group-based sessions

Unable or unwilling to complete follow-up surveys in English or Spanish

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

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

Select...

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent Weight Loss through 16 sessions

Percent Weight Loss through the 12 month trial

Secondary study objectives

Compare change in hemoglobin A1c over 12 months

Compare change in hemoglobin A1c over 6 months

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 3Eligibility criteria met