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

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ClinicalTrials.gov Identifier: NCT04104243
Recruitment Status : Not yet recruiting
First Posted : September 26, 2019
Last Update Posted : January 12, 2021
Sponsor:
Collaborators:
New York City Department of Health and Mental Hygiene
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Earle Chambers, Albert Einstein College of Medicine

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Pre-Diabetes Other: Men-Tailored DPP (Power-Up) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: There will be 15 intervention cycles of approximately 30 men randomized 1:1 to each study arm. The participants will be randomized to either undergo Power-Up or standard Diabetes Prevention Program sessions.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Power-Up: An Effectiveness Trial of the Diabetes Prevention Program Tailored for Black and Latino Men
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Percent of Patients with Weight Loss [ Time Frame: 12 Months (At end of maintenance phase) ]
    Percent Weight Loss throughout the trial for each study arm.

  2. Comparison of Engagement and Retention of Men vs Standard Diabetes Prevention Program [ Time Frame: 12 Months (At end of maintenance phase) ]
    Compare engagement of men at risk for diabetes in Power-Up vs. Standard DPP. Engagement rates is 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   We are only enrolling men.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years old.
  • most recent HbA1c: 5.7%-6.4% (within last year)
  • most recent BMI ≥ 25 (within last 6mos)

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04104243


Contacts
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Contact: Eric N Gil 718-430-2599 eric.gil@einstein.yu.edu

Sponsors and Collaborators
Albert Einstein College of Medicine
New York City Department of Health and Mental Hygiene
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Earle Chambers, PhD Albert Einstein College of Medicine
Publications:
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Responsible Party: Earle Chambers, Principal Investigator, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT04104243    
Other Study ID Numbers: 2019-10343
R01DK121896 ( U.S. NIH Grant/Contract )
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Earle Chambers, Albert Einstein College of Medicine:
Pre-Diabetes
Men's Health
Type 2 Diabetes
Racial Disparities
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia