Clinical trial NCT04104243: Power-Up: An Effectiveness Trial of the Diabetes Prevention Program
Official title: Power-Up: An Effectiveness Trial of the Diabetes Prevention Program Tailored for Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Pre-Diabetes
Keywords: Pre-Diabetes
Men's Health
Type 2 Diabetes
Racial Disparities
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: New York City Department of Health and Mental Hygiene
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-09-26
Enrollment: 301
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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 22-28 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 phases. The core phase of the program will consist of at least 16 classes over the first 6 months. After the core, participants will attend maintenance classes over the next 6 months. Participants will be asked over the course of the 12 months to complete surveys at three 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 is 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 Centers for Disease Control and Prevention (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.

Eligibility criteria: 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 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

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 baseline telephone surveys or follow-up surveys in English or Spanish

Primary outcomes:
measure: Percent Weight Loss through 16 sessions
timeFrame: Up to 6 months, after the delivery of the 16th session (end of the core phase)
measure: Percent Weight Loss through the 12 month trial
timeFrame: 12 Months (At end of maintenance phase)
Secondary outcomes:
measure: Comparison of Engagement and Retention of Men vs Standard Diabetes Prevention Program
timeFrame: Up to 6 months, after the delivery of the 16th session (end of the core phase)
measure: Comparison of Engagement and Retention of Men vs Standard Diabetes Prevention Program
timeFrame: 12 Months (At end of the maintenance phase)
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Earle Chambers, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.