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

Type 2 Diabetes Clinical Trial

— Power-Up  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04104243
• Other study ID #: 2019-10343
• Secondary ID: 5R01DK121896-042
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 9, 2021
• Est. completion date: August 1, 2024

Study information

• Verified date: February 2024
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 301
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Pre-Diabetes
• Prediabetic State
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	Bronx	New York

Sponsors (3)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), New York City Department of Health and Mental Hygiene

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Weight Loss through the 12 month trial	Compare Percent Weight Loss through the 12 month trial	12 Months (At end of maintenance phase)
Primary	Percent Weight Loss through 16 sessions	Compare Percent Weight Loss through 16 sessions.	up to 6 months, after the delivery of the 16th session (end of the core phase)
Primary	Comparison of Engagement and Retention of Men vs Standard Diabetes Prevention Program	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)
Primary	Comparison of Engagement and Retention of Men vs Standard Diabetes Prevention Program	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	Compare change in hemoglobin A1c over 12 months	Compare the change in hemoglobin A1c over 12 months	12 Months (At end of the maintenance phase)
Secondary	Compare change in hemoglobin A1c over 6 months	Compare the change in hemoglobin A1c over 6 months	6 months (At end of the core phase)