Men-Tailored DPP for Prediabetes

(Power-Up Trial)

No longer recruiting at 1 trial location

Overseen By Eric N Gil

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Albert Einstein College of Medicine

Disqualifiers: Physical limitations, Consent issues, Language barriers

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 22

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist men at risk for diabetes by testing a Diabetes Prevention Program (DPP) specifically designed for them, called Men-Tailored DPP (Power-Up). Participants will join either a standard class with mixed-gender sessions or a men-only class, both focusing on food choices, exercise, and stress management over a year. Ideal candidates are men living in the NYC area with a recent diagnosis of prediabetes—a condition where blood sugar levels are higher than normal but not high enough to be diabetes—and a BMI of 25 or higher. As an unphased trial, this study offers participants the chance to contribute to innovative research tailored to their needs.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this Diabetes Prevention Program is safe for men?

Research has shown that the Men-Tailored DPP, also known as Power-Up, helps men manage prediabetes. In one study with 23 men, participants attended about 11 out of 16 sessions. They reported feeling better, eating healthier, exercising more, and improving their overall health, suggesting the program is easy to follow. The studies reported no negative effects, which is encouraging. Since the program involves changes in diet and exercise, it is generally considered safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Men-Tailored DPP (Power-Up) because it offers a fresh approach to managing prediabetes, specifically designed for men. Unlike the standard National Diabetes Prevention Program, which is mixed-gender, this program tailors its classes to address the unique lifestyle and health challenges faced by men. By focusing on personalized discussions around food choices, physical activity, and stress management, Power-Up aims to enhance engagement and effectiveness for male participants, potentially leading to better outcomes in preventing the progression to diabetes.

What evidence suggests that the Men-Tailored DPP could be effective for prediabetes?

Research has shown that a special Diabetes Prevention Program (DPP) for men, called Power-Up, can aid in weight loss and maintaining engagement. Participants in this trial may be randomized to the Power-Up arm, which studies suggest results in greater weight loss at both 16 weeks and 1 year compared to regular programs. The program addresses men's specific needs and challenges in managing diet, exercise, and stress. This personalized approach aims to enhance participation and effectiveness for men at risk of diabetes. ^{2 3 6 7 8}

Who Is on the Research Team?

Earle Chambers, MD MS

Principal Investigator

Albert Einstein College of Medicine

Are You a Good Fit for This Trial?

This trial is for men who are at least 18 years old with a recent HbA1c level between 5.7%-6.4% or a Diabetes Risk Score of 5 or higher, and a BMI of 25 or more. It's not for those unable to attend group sessions in person, give consent by phone, or complete surveys in English/Spanish.

Inclusion Criteria

Your body mass index (BMI) is 25 or higher based on your recent weight and height measurements.

My latest HbA1c is between 5.7% and 6.4%, or my diabetes risk score is 5 or higher.

Exclusion Criteria

Unable to provide informed consent by telephone

I cannot or do not want to attend group sessions in person.

I cannot or do not want to complete surveys in English or Spanish.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Core Phase

Participants attend at least 16 classes over the first 6 months focusing on food choices, physical activity, and managing stress

6 months

16 classes (in-person or virtual)

Maintenance Phase

Participants attend 6 additional classes over the next 6 months to maintain lifestyle changes

6 months

6 classes (in-person or virtual)

Follow-up

Participants are monitored for engagement, retention, and weight loss outcomes

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Men-Tailored DPP (Power-Up)

Trial Overview The study tests the effectiveness of a Diabetes Prevention Program specifically designed for men (Power-Up). The program aims to reduce diabetes risk among male participants through tailored interventions.

How Is the Trial Designed?

Group I: Power-Up Experimental Treatment 1 Intervention

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.

Group II: Standard NDPP (National Diabetes Prevention Program) Active Control 1 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.

Who Is Running the Clinical Trial?

Albert Einstein College of Medicine

Lead Sponsor

Trials

302

Recruited

11,690,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

New York City Department of Health and Mental Hygiene

Collaborator

Trials

20

Recruited

19,400+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40554781/

Virtual Diabetes Prevention Program Tailored to Increase ... Results: We identified 11,052 men for outreach based on EHR data, successfully screened 26% of them, consented and enrolled 22% of these ...

2. reporter.nih.gov reporter.nih.gov/project-details/10020897

Power-Up: An Effectiveness Trial of the Diabetes Prevention ... We hypothesize that men randomized to Power-Up will achieve significantly greater weight loss (% weight loss from baseline) at 16-weeks and 1-year than men ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2835424

Engagement in the National Diabetes Prevention Program ... This qualitative study evaluated reasons for Hispanic men's low engagement in the National Diabetes Prevention Program (NDPP) compared with ...

4. trials-api.montefioreeinstein.org trials-api.montefioreeinstein.org/node/262881

An Effectiveness Trial of the Diabetes Prevention Program 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 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04104243

Power-Up: An Effectiveness Trial of the Diabetes ... 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12238785/

Virtual Diabetes Prevention Program Tailored to Increase ... The primary aim of the project is to assess the effect of Power-Up versus NDPP on weight loss among men with prediabetes. The secondary aim ...

7. journals.sagepub.com journals.sagepub.com/doi/10.1177/1557988318758787

Power Up for Health: Pilot Study Outcomes of a Diabetes ... Men (n = 23) attended a mean of 11.6 of 16 sessions. Improvement in depressive symptoms, healthy eating and exercise, and health status were ...

8. researchgate.net researchgate.net/publication/323783091_Power_Up_for_Health_Pilot_Study_Outcomes_of_a_Diabetes_Prevention_Program_for_Men_from_Disadvantaged_Neighborhoods

(PDF) Power Up for Health : Pilot Study Outcomes of a ... Men (n = 23) attended a mean of 11.6 of 16 sessions. Improvement in depressive symptoms, healthy eating and exercise, and health status were also seen. While ...