Power-Up: An Effectiveness Trial of the Diabetes Prevention Program (Power-Up)

February 5, 2024 updated by: Earle Chambers, Albert Einstein College of Medicine

Power-Up: An Effectiveness Trial of the Diabetes Prevention Program Tailored for Black and Latino Men

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The rising epidemic of type 2 diabetes is a major cause of disability and death that disproportionately affects men. Compared to women, men have much worse health and higher death rates for several chronic conditions, including diabetes. The National Diabetes Prevention Program (NDPP) has been shown to help decrease the chances of developing type 2 diabetes. The NDPP has shown the value of lifestyle change for weight loss and diabetes prevention. The Power-Up study is being done because although the evidence points to the effectiveness of the Diabetes Prevention Program (DPP), men are less likely to be engaged or participate in DPP.

The Power-up study was designed to see whether a DPP tailored for men can help improve engagement, participation, and results for men. Participants will be randomized to either undergo the Power-Up or standard NDPP classes. An assessment of whether a DPP created for men will increase participation in the program, and decrease the risk for diabetes as compared to the standard NDPP. Power-Up is designed to Aim 1) Assess the effect of Power-Up vs. standard care NDPP on percent weight loss among men at risk for diabetes; Aim 2) Compare engagement of minority men at risk for diabetes in Power-Up vs. standard care NDPP; and Aim 3) Evaluate the Reach, Effectiveness, Adoption, Implementation, and Costs of Power-Up using the RE-AIM framework.The Power-Up intervention is tailored to the needs and preferences of men and uses: a) men coaches; b) men-only groups; c) messaging tailored to be appreciated and motivational to men; d) adapted content that highlights issues relevant to men.

There are 22 classes over the course of 12 months for both Power-Up and standard NDPP. The classes are split into two phases which are called the core and the maintenance phase. The core phase of the program will consist of 16 classes over the first 6 months. After the core of the program, participants will attend 6 maintenance classes over the next 6 months. Participants will be asked over the course of the 12 months to complete surveys at four different times before, during, and after completing the classes.

The hypothesis is that men randomized to Power-Up will achieve significantly greater weight loss (% weight loss from baseline) at 16-weeks and 1-year than men randomized to the standard care, mixed-gender NDPP group (Aim 1). Evaluation of engagement and retention for Aim 2 will be based on attendance records for Power-Up and NDPP sessions electronically collected by trained coaches and monitored by study staff. The standards will be followed for NDPP evaluation where engagement is defined as equal or greater than 4 core sessions attended and retention is defined as equal or greater than 9 sessions attended. There will be a collection of quantitative and qualitative data that will be rigorously evaluated: the reach of our recruitment, broader patient-important indicators of effectiveness, adoption at the practice level, and implementation of the intervention (Aim 3).

Enrollment consists of 300 participants through our health system partners. Men will be randomized 1:1 to either the Power-Up intervention arm or referred to the standard NDPP at their clinic site. Consistent with current CDC standards and current NDPP practices of our health system partners, telephone make-up sessions will be offered by coaches in both conditions to men who miss in-person sessions.

Study Type

Interventional

Enrollment (Actual)

301

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Albert Einstein College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • At least 18 years old.
  • most recent HbA1c: 5.7%-6.4% (within last year) or Diabetes Risk Score >= 5
  • most recent BMI ≥ 25 (within last 6mos)
  • access to a device that can join sessions virtually either through a virtual conferencing application

Exclusion Criteria:

  • Not physically able or willing to attend Virtual, group-based sessions.
  • Unable to provide informed consent by telephone.
  • Unable or unwilling to complete follow-up surveys in English or Spanish.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Power-Up
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.
Other: Men-Tailored DPP (Power-Up)
Evaluating whether a diabetes prevention program (DPP) tailored for men (Power-Up) will show better or similar percent weight loss and retention than a standard mixed-gender DPP
No Intervention: Standard NDPP (National Diabetes Prevention Program)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Weight Loss through the 12 month trial
Time Frame: 12 Months (At end of maintenance phase)
Compare Percent Weight Loss through the 12 month trial
12 Months (At end of maintenance phase)
Percent Weight Loss through 16 sessions
Time Frame: up to 6 months, after the delivery of the 16th session (end of the core phase)
Compare Percent Weight Loss through 16 sessions.
up to 6 months, after the delivery of the 16th session (end of the core phase)
Comparison of Engagement and Retention of Men vs Standard Diabetes Prevention Program
Time Frame: 12 Months (At end of the maintenance phase)
Compare engagement of men at risk for diabetes in Power-Up vs. Standard DPP. The number of sessions attended. Engagement rates are characterized as attending at least 4 sessions. Retention is defined as attending 9 or more sessions. We expect men randomized to the Power-Up sessions will have greater engagement and retention rates than men randomized to standard care and referred to mixed-gender NDPP classes.
12 Months (At end of the maintenance phase)
Comparison of Engagement and Retention of Men vs Standard Diabetes Prevention Program
Time Frame: up to 6 months, after the delivery of the 16th session (end of the core phase)
Compare engagement of men at risk for diabetes in Power-Up vs. Standard DPP. The number of sessions scheduled.
up to 6 months, after the delivery of the 16th session (end of the core phase)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare change in hemoglobin A1c over 12 months
Time Frame: 12 Months (At end of the maintenance phase)
Compare the change in hemoglobin A1c over 12 months
12 Months (At end of the maintenance phase)
Compare change in hemoglobin A1c over 6 months
Time Frame: 6 months (At end of the core phase)
Compare the change in hemoglobin A1c over 6 months
6 months (At end of the core phase)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albert Einstein College of Medicine

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
New York City Department of Health and Mental Hygiene

Investigators

  • Principal Investigator: Earle Chambers, PhD, Albert Einstein College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2021

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

September 19, 2019

First Submitted That Met QC Criteria

September 24, 2019

First Posted (Actual)

September 26, 2019

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-10343 (Other Identifier: Einstein - IRB ID)
  • 5R01DK121896-04 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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