Type 2 DiabetesPower-UpNCT04104243
Power-Up: An Effectiveness Trial of the Diabetes Prevention Program
A study testing Men-Tailored DPP (Power-Up) in people with Type 2 Diabetes and Pre-Diabetes, run by Albert Einstein College of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Type 2 Diabetes, Pre-Diabetes
- What is being tested?
- Men-Tailored DPP (Power-Up)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2021to 7 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Official title: Power-Up: An Effectiveness Trial of the Diabetes Prevention Program Tailored for Men
The goal of this study is to address the risk of diabetes among men by creating a Diabetes Prevention Program (DPP) tailored to men.
Read the 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.
- Conditions
- Type 2 Diabetes, Pre-Diabetes
- Being tested
- Men-Tailored DPP (Power-Up)
- Keywords
- Pre-Diabetes, Men's Health, Type 2 Diabetes, Racial Disparities
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 Months (At end of maintenance phase)
Secondary outcomes (2)
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.
Measured: 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.
Measured: 12 Months (At end of the maintenance phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start9 Aug 2021
- Primary completion7 Feb 2025
- Study completion7 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- New York City Department of Health and Mental Hygiene, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Earle Chambers, PhD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104243
- Sponsor's protocol ID
- 2019-10343
- Other IDs
- 5R01DK121896-04, 2019-10343, 2019
- Acronym
- Power-Up
- Status last verified
- Mar 2026
- First submitted
- 19 Sep 2019
- Last updated
- 30 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29540129Realmuto 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.
PubMed 29540130Gary-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.
PubMed 29540131Chambers 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.
PubMed 40554781
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Power-Up: An Effectiveness Trial of the Diabetes Prevention Program Tailored for Men
- ClinicalTrials.gov ID
- NCT04104243
- Acronym / sponsor ID
- Power-Up / 2019-10343
- Conditions
- Type 2 Diabetes, Pre-Diabetes
- Keywords
- Pre-Diabetes, Men's Health, Type 2 Diabetes, Racial Disparities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- New York City Department of Health and Mental Hygiene, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 7 Feb 2025 (actual)
- Study completion
- 7 Feb 2025 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Posted 30 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Power-Up | Experimental | Other: Men-Tailored DPP (Power-Up)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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Power-Up |
Primary outcome
Percent Weight Change Through 16 Sessions
Time frame: Up to 6 months, after the delivery of the 16th session (end of the core phase)
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.
Percent Weight Change Through the 12 Month Trial
Time frame: 12 Months (At end of maintenance phase)
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.
2 secondary outcomes
Engagement of Men in Power-Up vs Standard National Diabetes Prevention Program
Time frame: 6 Months (At end of the core phase)
Retention of Men in Power-Up vs Standard National Diabetes Prevention Program
Time frame: 12 Months (At end of the maintenance phase)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29540129Walker 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.
- Background: PubMed 29540130Realmuto 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.
- Background: PubMed 29540131Gary-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.
- Results publication: PubMed 40554781Chambers 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Earle Chambers, PhD principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Men-Tailored DPP (Power-Up) in people with Type 2 Diabetes and Pre-Diabetes, run by Albert Einstein College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Weight Change Through 16 Sessions (time frame: Up to 6 months, after the delivery of the 16th session (end of the core phase)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04104243, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.