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

Albert Einstein College of Medicine301 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

301

Conditions

Type 2 Diabetes Pre-Diabetes

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

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Albert Einstein College of Medicine

The Bronx, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 12 Months (At end of maintenance phase)

Secondary Outcomes

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

Engagement of men at risk for diabetes in Power-Up vs. Standard NDPP was compared based on the number of sessions attended. Engagement is characterized as attending \>= 4 sessions. Counts and percentages of participants who attended at least 4 sessions in the first six months of the workshops are summarized by study arm. This is halfway through the entire trial.

Time frame: 6 Months (At end of the core phase)

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

Retention of men at risk for diabetes in Power-Up vs. Standard NDPP was compared based on the number of sessions attended. Participants are defined as "retained" if they attended \>=9 more sessions. It is expected that 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. Counts and percentages of participants who attended at least 9 sessions through the 12 months of workshops are summarized by study arm.

Data from ClinicalTrials.gov

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