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

NCT04104243 | Completed Results DMC

• 2 other identifiers: 2019-103435R01DK121896-04
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Pre-Diabetes

Keywords

Pre-Diabetes; Men's Health; Type 2 Diabetes; Racial Disparities

Outcome Measures

Primary Outcomes (2)

• Percent Weight Change Through 16 Sessions

  The percent weight change through 16 sessions was compared. Mean percent weight change for each arm for all intent-to-treat (ITT) participants (i.e.. attended \>=0 sessions), as well as those who were considered "Engaged" (i.e., attended \>=4 sessions) or "Retained" (i.e., attended \>=9 sessions), through 16 scheduled sessions, was determined. All data is crude and unadjusted with no imputation.

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

• Percent Weight Change Through the 12 Month Trial

  The percent weight change through 12 months was compared. Mean percent weight change for each arm for all intent-to-treat (ITT) participants (i.e., attended \>=0 sessions), as well as those who were considered "Engaged" (i.e., attended \>=4 sessions) or "Retained" (i.e., attended \>=9 sessions), through 12 months, was determined. All data is crude and unadjusted with no imputation.

  12 Months (At end of maintenance phase)

Secondary Outcomes (2)

• Engagement of Men in Power-Up vs Standard National Diabetes Prevention Program

  6 Months (At end of the core phase)

• Retention of Men in Power-Up vs Standard National Diabetes Prevention Program

  12 Months (At end of the maintenance phase)

Study Arms (2)

Power-Up

EXPERIMENTAL

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)

Standard NDPP (National Diabetes Prevention Program)

NO 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.

Interventions

Men-Tailored DPP (Power-Up) OTHER

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

Power-Up

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: We are only enrolling men.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 6 months)
• Access to a device that can join sessions virtually either through a virtual conferencing application
• Have valid address and telephone contact information
• Have no plans to change their health system/primary care provider or move from their current, NYC area, address in the next year

You may not qualify if:

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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• New York City Department of Health and Mental Hygiene: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Related Publications (4)

• Walker EA, Weiss L, Gary-Webb TL, Realmuto L, Kamler A, Ravenell J, Tejeda C, Lukin J, Schechter CB. Power Up for Health: Pilot Study Outcomes of a Diabetes Prevention Program for Men from Disadvantaged Neighborhoods. Am J Mens Health. 2018 Jul;12(4):989-997. doi: 10.1177/1557988318758787. Epub 2018 Mar 15.

  PMID: 29540129 BACKGROUND

• Realmuto L, Kamler A, Weiss L, Gary-Webb TL, Hodge ME, Pagan JA, Walker EA. Power Up for Health-Participants' Perspectives on an Adaptation of the National Diabetes Prevention Program to Engage Men. Am J Mens Health. 2018 Jul;12(4):981-988. doi: 10.1177/1557988318758786. Epub 2018 Mar 15.

  PMID: 29540130 BACKGROUND

• Gary-Webb TL, Walker EA, Realmuto L, Kamler A, Lukin J, Tyson W, Carrasquillo O, Weiss L. Translation of the National Diabetes Prevention Program to Engage Men in Disadvantaged Neighborhoods in New York City: A Description of Power Up for Health. Am J Mens Health. 2018 Jul;12(4):998-1006. doi: 10.1177/1557988318758788. Epub 2018 Mar 15.

  PMID: 29540131 BACKGROUND

• Chambers EC, Walker EA, Schechter C, Gil E, Herbert T, Diaz K, Gonzalez J. Virtual Diabetes Prevention Program Tailored to Increase Participation of Black and Latino Men: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Jun 24;14:e64405. doi: 10.2196/64405.

  PMID: 40554781 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Glucose Intolerance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia

Results Point of Contact

• Title: Earle C. Chambers, PhD, MPH
• Organization: Albert Einstein College of Medicine

earle.chambers@einsteinmed.edu

718-430-3057

Study Officials

• Earle Chambers, PhD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There will be 6 intervention cycles. Approximately 50 men will be randomized 1:1 to each study arm. There will be 4 control cycles for every intervention workshop. Therefore we will have 6 intervention workshops and 24 control workshops. The participants will be randomized to either undergo Power-Up or standard Diabetes Prevention Program sessions.

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 26, 2019
• Study Start: August 9, 2021
• Primary Completion: February 7, 2025
• Study Completion: February 7, 2025
• Last Updated: March 30, 2026
• Results First Posted: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)