Trial Outcomes & Findings for Power-Up: An Effectiveness Trial of the Diabetes Prevention Program (NCT NCT04104243)

Last Updated: 2026-03-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

301 participants

Primary outcome timeframe

Up to 6 months, after the delivery of the 16th session (end of the core phase)

Results posted on

2026-03-30

Participant Flow

Using the electronic health record (EHR) systems of a large academic medical center and a network of small to medium independent primary care practices throughout New York City, Black and Latino men who met eligibility criteria for NDPP were identified and enrolled in a randomized controlled trial and assigned 1:1 to receive Power-Up or the standard, mixed-gender NDPP over 1 year via online videoconferencing. The participants were recruited over the phone.

The study team began with a total of N=11052 participants (Ps). We were unable to contact n=6235 Ps. Before screening, n=1489 Ps declined to participate, and n=486 Ps were lost to follow-up. During screening, n=476 Ps were ineligible, and n=1739 Ps were eligible and declined to consent. After consent, n=326 Ps were lost to follow-up and not randomized. Enrolled is defined, according to the protocol, as being randomized into one of the study arms. Only 301 Ps were randomized.

Participant milestones

Participant milestones
Measure	Power-Up Participants randomized to this arm underwent 16 classes tailored for men that discussed food choices, physical activity, and managing stress over 6 months, defined as the core phase, and 8 classes over the following 6 months, defined as the maintenance phase.	Standard NDPP (National Diabetes Prevention Program) Participants randomized to this arm underwent 16 mixed gender classes that discussed food choices, physical activity, and managing stress over 6 months, defined as the core phase, and 8 classes over the following 6 months, defined as the maintenance phase.
Overall Study STARTED	155	146
Overall Study COMPLETED	154	146
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Power-Up Participants randomized to this arm underwent 16 classes tailored for men that discussed food choices, physical activity, and managing stress over 6 months, defined as the core phase, and 8 classes over the following 6 months, defined as the maintenance phase.	Standard NDPP (National Diabetes Prevention Program) Participants randomized to this arm underwent 16 mixed gender classes that discussed food choices, physical activity, and managing stress over 6 months, defined as the core phase, and 8 classes over the following 6 months, defined as the maintenance phase.
Overall Study Death	1	0

Baseline Characteristics

Participants excluded, declined, or refused to answer the question. n=23.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Power-Up n=155 Participants Participants randomized to this arm underwent 16 classes tailored for men that discussed food choices, physical activity, and managing stress over 6 months, defined as the core phase, and 8 classes over the following 6 months, defined as the maintenance phase.	Standard NDPP (National Diabetes Prevention Program) n=146 Participants Participants randomized to this arm underwent 16 mixed gender classes that discussed food choices, physical activity, and managing stress over 6 months, defined as the core phase, and 8 classes over the following 6 months, defined as the maintenance phase.	Total n=301 Participants Total of all reporting groups
Age, Continuous	53.226 Years STANDARD_DEVIATION 12.737 • n=155 Participants	50.595 Years STANDARD_DEVIATION 12.179 • n=146 Participants	51.95 Years STANDARD_DEVIATION 12.518 • n=301 Participants
Age, Customized Age at First Session	53.3 Years STANDARD_DEVIATION 12.7 • n=155 Participants	50.7 Years STANDARD_DEVIATION 12.2 • n=146 Participants	52.1 Years STANDARD_DEVIATION 12.5 • n=301 Participants
Sex: Female, Male Female	0 Participants n=155 Participants	0 Participants n=146 Participants	0 Participants n=301 Participants
Sex: Female, Male Male	155 Participants n=155 Participants	146 Participants n=146 Participants	301 Participants n=301 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	77 Participants n=155 Participants	74 Participants n=146 Participants	151 Participants n=301 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	76 Participants n=155 Participants	71 Participants n=146 Participants	147 Participants n=301 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=155 Participants	1 Participants n=146 Participants	3 Participants n=301 Participants
Race/Ethnicity, Customized Race · Black	86 Participants n=143 Participants • Participants excluded, declined, or refused to answer the question. n=23.	85 Participants n=135 Participants • Participants excluded, declined, or refused to answer the question. n=23.	171 Participants n=278 Participants • Participants excluded, declined, or refused to answer the question. n=23.
Race/Ethnicity, Customized Race · Multiracial	14 Participants n=143 Participants • Participants excluded, declined, or refused to answer the question. n=23.	14 Participants n=135 Participants • Participants excluded, declined, or refused to answer the question. n=23.	28 Participants n=278 Participants • Participants excluded, declined, or refused to answer the question. n=23.
Race/Ethnicity, Customized Race · American Indian/Alaska Native	3 Participants n=143 Participants • Participants excluded, declined, or refused to answer the question. n=23.	0 Participants n=135 Participants • Participants excluded, declined, or refused to answer the question. n=23.	3 Participants n=278 Participants • Participants excluded, declined, or refused to answer the question. n=23.
Race/Ethnicity, Customized Race · Pacific Islander/Native Hawaiian	0 Participants n=143 Participants • Participants excluded, declined, or refused to answer the question. n=23.	1 Participants n=135 Participants • Participants excluded, declined, or refused to answer the question. n=23.	1 Participants n=278 Participants • Participants excluded, declined, or refused to answer the question. n=23.
Race/Ethnicity, Customized Race · White	9 Participants n=143 Participants • Participants excluded, declined, or refused to answer the question. n=23.	5 Participants n=135 Participants • Participants excluded, declined, or refused to answer the question. n=23.	14 Participants n=278 Participants • Participants excluded, declined, or refused to answer the question. n=23.
Race/Ethnicity, Customized Race · Other	31 Participants n=143 Participants • Participants excluded, declined, or refused to answer the question. n=23.	30 Participants n=135 Participants • Participants excluded, declined, or refused to answer the question. n=23.	61 Participants n=278 Participants • Participants excluded, declined, or refused to answer the question. n=23.
Region of Enrollment United States	155 participants n=155 Participants	146 participants n=146 Participants	301 participants n=301 Participants
Has Health Insurance? Yes	144 Participants n=155 Participants • Participant excluded, declined, or refused to answer the question. n=1	141 Participants n=145 Participants • Participant excluded, declined, or refused to answer the question. n=1	285 Participants n=300 Participants • Participant excluded, declined, or refused to answer the question. n=1
Has Health Insurance? No	9 Participants n=155 Participants • Participant excluded, declined, or refused to answer the question. n=1	3 Participants n=145 Participants • Participant excluded, declined, or refused to answer the question. n=1	12 Participants n=300 Participants • Participant excluded, declined, or refused to answer the question. n=1
Has Health Insurance? Don't Know/Not Sure	2 Participants n=155 Participants • Participant excluded, declined, or refused to answer the question. n=1	1 Participants n=145 Participants • Participant excluded, declined, or refused to answer the question. n=1	3 Participants n=300 Participants • Participant excluded, declined, or refused to answer the question. n=1
Source of Health Insurance Medicaid including Medicaid Managed Care	51 Participants n=145 Participants • Participants excluded, declined, or refused to answer the question. n=16	59 Participants n=140 Participants • Participants excluded, declined, or refused to answer the question. n=16	110 Participants n=285 Participants • Participants excluded, declined, or refused to answer the question. n=16
Source of Health Insurance Medicare	25 Participants n=145 Participants • Participants excluded, declined, or refused to answer the question. n=16	18 Participants n=140 Participants • Participants excluded, declined, or refused to answer the question. n=16	43 Participants n=285 Participants • Participants excluded, declined, or refused to answer the question. n=16
Source of Health Insurance Other/Unknown	18 Participants n=145 Participants • Participants excluded, declined, or refused to answer the question. n=16	12 Participants n=140 Participants • Participants excluded, declined, or refused to answer the question. n=16	30 Participants n=285 Participants • Participants excluded, declined, or refused to answer the question. n=16
Source of Health Insurance Private	51 Participants n=145 Participants • Participants excluded, declined, or refused to answer the question. n=16	51 Participants n=140 Participants • Participants excluded, declined, or refused to answer the question. n=16	102 Participants n=285 Participants • Participants excluded, declined, or refused to answer the question. n=16
Highest Level of Education Completed Elementary/Primary School (Includes grades 1-5)	8 Participants n=154 Participants • Participant excluded, declined, or refused to answer the question. n=1	2 Participants n=146 Participants • Participant excluded, declined, or refused to answer the question. n=1	10 Participants n=300 Participants • Participant excluded, declined, or refused to answer the question. n=1
Highest Level of Education Completed Middle School/Junior High (Includes grades 6-8)	9 Participants n=154 Participants • Participant excluded, declined, or refused to answer the question. n=1	11 Participants n=146 Participants • Participant excluded, declined, or refused to answer the question. n=1	20 Participants n=300 Participants • Participant excluded, declined, or refused to answer the question. n=1
Highest Level of Education Completed High School/Preparatory School	75 Participants n=154 Participants • Participant excluded, declined, or refused to answer the question. n=1	58 Participants n=146 Participants • Participant excluded, declined, or refused to answer the question. n=1	133 Participants n=300 Participants • Participant excluded, declined, or refused to answer the question. n=1
Highest Level of Education Completed Some College	1 Participants n=154 Participants • Participant excluded, declined, or refused to answer the question. n=1	3 Participants n=146 Participants • Participant excluded, declined, or refused to answer the question. n=1	4 Participants n=300 Participants • Participant excluded, declined, or refused to answer the question. n=1
Highest Level of Education Completed Trade School/Vocational School	8 Participants n=154 Participants • Participant excluded, declined, or refused to answer the question. n=1	6 Participants n=146 Participants • Participant excluded, declined, or refused to answer the question. n=1	14 Participants n=300 Participants • Participant excluded, declined, or refused to answer the question. n=1
Highest Level of Education Completed University/College	53 Participants n=154 Participants • Participant excluded, declined, or refused to answer the question. n=1	66 Participants n=146 Participants • Participant excluded, declined, or refused to answer the question. n=1	119 Participants n=300 Participants • Participant excluded, declined, or refused to answer the question. n=1
Employment Status Working full-time	77 Participants n=155 Participants	68 Participants n=146 Participants	145 Participants n=301 Participants
Employment Status Working part-time (including seasonal/work-study, etc.)	21 Participants n=155 Participants	21 Participants n=146 Participants	42 Participants n=301 Participants
Employment Status Retired	22 Participants n=155 Participants	18 Participants n=146 Participants	40 Participants n=301 Participants
Employment Status Perform volunteer work	2 Participants n=155 Participants	3 Participants n=146 Participants	5 Participants n=301 Participants
Employment Status Not working, unable to work	17 Participants n=155 Participants	16 Participants n=146 Participants	33 Participants n=301 Participants
Employment Status Not working, not looking for work	8 Participants n=155 Participants	5 Participants n=146 Participants	13 Participants n=301 Participants
Employment Status Not working, but looking for work	7 Participants n=155 Participants	13 Participants n=146 Participants	20 Participants n=301 Participants
Employment Status Not Reported	1 Participants n=155 Participants	2 Participants n=146 Participants	3 Participants n=301 Participants
Ever Smoked Yes	60 Participants n=155 Participants	40 Participants n=146 Participants	100 Participants n=301 Participants
Ever Smoked No	95 Participants n=155 Participants	106 Participants n=146 Participants	201 Participants n=301 Participants
Current Smoking Frequency Daily	12 Participants n=154 Participants • Participant excluded, declined, or refused to answer the question. n=2	13 Participants n=145 Participants • Participant excluded, declined, or refused to answer the question. n=2	25 Participants n=299 Participants • Participant excluded, declined, or refused to answer the question. n=2
Current Smoking Frequency Some Days	10 Participants n=154 Participants • Participant excluded, declined, or refused to answer the question. n=2	5 Participants n=145 Participants • Participant excluded, declined, or refused to answer the question. n=2	15 Participants n=299 Participants • Participant excluded, declined, or refused to answer the question. n=2
Current Smoking Frequency Not at all	132 Participants n=154 Participants • Participant excluded, declined, or refused to answer the question. n=2	127 Participants n=145 Participants • Participant excluded, declined, or refused to answer the question. n=2	259 Participants n=299 Participants • Participant excluded, declined, or refused to answer the question. n=2
Marital Status Married	60 Participants n=155 Participants	63 Participants n=146 Participants	123 Participants n=301 Participants
Marital Status Single	59 Participants n=155 Participants	51 Participants n=146 Participants	110 Participants n=301 Participants
Marital Status Living with a partner	8 Participants n=155 Participants	11 Participants n=146 Participants	19 Participants n=301 Participants
Marital Status Divorced	12 Participants n=155 Participants	10 Participants n=146 Participants	22 Participants n=301 Participants
Marital Status Separated	14 Participants n=155 Participants	6 Participants n=146 Participants	20 Participants n=301 Participants
Marital Status Widow(er)	2 Participants n=155 Participants	5 Participants n=146 Participants	7 Participants n=301 Participants
Household Income <= $50,000	67 Participants n=155 Participants	68 Participants n=146 Participants	135 Participants n=301 Participants
Household Income > $50,000	49 Participants n=155 Participants	43 Participants n=146 Participants	92 Participants n=301 Participants
Household Income Declined to answer	39 Participants n=155 Participants	35 Participants n=146 Participants	74 Participants n=301 Participants
Number of People Supported on Household Income	2.3 People STANDARD_DEVIATION 1.4 • n=116 Participants • Participants who declined to provide income information were excluded from these analyses. n=74	2.6 People STANDARD_DEVIATION 1.6 • n=111 Participants • Participants who declined to provide income information were excluded from these analyses. n=74	2.4 People STANDARD_DEVIATION 1.5 • n=227 Participants • Participants who declined to provide income information were excluded from these analyses. n=74
Born in US Yes	76 Participants n=155 Participants	72 Participants n=146 Participants	148 Participants n=301 Participants
Born in US No	79 Participants n=155 Participants	74 Participants n=146 Participants	153 Participants n=301 Participants
Personal Health Questionnaire (PHQ-8) score	4.9 score on a scale STANDARD_DEVIATION 5.1 • n=155 Participants	5.2 score on a scale STANDARD_DEVIATION 5.0 • n=146 Participants	5.0 score on a scale STANDARD_DEVIATION 5.0 • n=301 Participants
Delay between Randomization and Start	47.5 days STANDARD_DEVIATION 31.8 • n=155 Participants	40.2 days STANDARD_DEVIATION 46.9 • n=146 Participants	43.9 days STANDARD_DEVIATION 39.9 • n=301 Participants
Life Difficulty from PHQ-8 Symptoms Not at all difficult	72 Participants n=120 Participants • Participants who did not have any PHQ-8 symptoms during the baseline questionnaire were excluded. n=65	64 Participants n=116 Participants • Participants who did not have any PHQ-8 symptoms during the baseline questionnaire were excluded. n=65	136 Participants n=236 Participants • Participants who did not have any PHQ-8 symptoms during the baseline questionnaire were excluded. n=65
Life Difficulty from PHQ-8 Symptoms Somewhat difficult	32 Participants n=120 Participants • Participants who did not have any PHQ-8 symptoms during the baseline questionnaire were excluded. n=65	38 Participants n=116 Participants • Participants who did not have any PHQ-8 symptoms during the baseline questionnaire were excluded. n=65	70 Participants n=236 Participants • Participants who did not have any PHQ-8 symptoms during the baseline questionnaire were excluded. n=65
Life Difficulty from PHQ-8 Symptoms Very difficult	9 Participants n=120 Participants • Participants who did not have any PHQ-8 symptoms during the baseline questionnaire were excluded. n=65	10 Participants n=116 Participants • Participants who did not have any PHQ-8 symptoms during the baseline questionnaire were excluded. n=65	19 Participants n=236 Participants • Participants who did not have any PHQ-8 symptoms during the baseline questionnaire were excluded. n=65
Life Difficulty from PHQ-8 Symptoms Extremely difficult	7 Participants n=120 Participants • Participants who did not have any PHQ-8 symptoms during the baseline questionnaire were excluded. n=65	4 Participants n=116 Participants • Participants who did not have any PHQ-8 symptoms during the baseline questionnaire were excluded. n=65	11 Participants n=236 Participants • Participants who did not have any PHQ-8 symptoms during the baseline questionnaire were excluded. n=65
Baseline Weight	211.5 Pounds STANDARD_DEVIATION 43.6 • n=155 Participants	213.9 Pounds STANDARD_DEVIATION 44.9 • n=146 Participants	212.7 Pounds STANDARD_DEVIATION 44.1 • n=301 Participants
Baseline Body Mass Index (BMI)	33.4 kg/m^2 STANDARD_DEVIATION 7.3 • n=155 Participants	33.6 kg/m^2 STANDARD_DEVIATION 7.3 • n=146 Participants	33.5 kg/m^2 STANDARD_DEVIATION 7.3 • n=301 Participants

PRIMARY outcome

Timeframe: Up to 6 months, after the delivery of the 16th session (end of the core phase)

Population: The difference in participants is due to the available data. If a valid weight was not available at 16 weeks (within -2 weeks or +4 weeks), the participant was excluded. Analyses were split into Intent to treat (ITT), including all participants with valid weights, having attended \>=4 sessions (Engaged), and \>=9 sessions (Retained). All data is crude and unadjusted with no imputation.

Outcome measures

Outcome measures
Measure	Power-Up n=119 Participants Participants randomized to this arm underwent 16 classes tailored for men that discussed food choices, physical activity, and managing stress over 6 months, defined as the core phase, and 8 classes over the following 6 months, defined as the maintenance phase.	Standard NDPP (National Diabetes Prevention Program) n=105 Participants Participants randomized to this arm underwent 16 mixed gender classes that discussed food choices, physical activity, and managing stress over 6 months, defined as the core phase, and 8 classes over the following 6 months, defined as the maintenance phase.
Percent Weight Change Through 16 Sessions Intent to Treat >=0 Sessions	-2.4 percent weight change Standard Error 2.5	-1.3 percent weight change Standard Error 0.8
Percent Weight Change Through 16 Sessions Intent to Treat Engaged (Attended >=4 Sessions)	-1.5 percent weight change Standard Error 4.2	-1.6 percent weight change Standard Error 1.1
Percent Weight Change Through 16 Sessions Intent to Treat Retained (Attended >= 9 Sessions)	-2.4 percent weight change Standard Error 4.5	-1.8 percent weight change Standard Error 1.2

PRIMARY outcome

Timeframe: 12 Months (At end of maintenance phase)

Population: The difference in participants is due to the available data. If a valid weight was not available at 12 months (within -2 or +4 weeks), the participant was excluded. Analyses were split into Intent to treat including all participants with valid weights, having attended \>=4 sessions (Engaged), and \>=9 sessions (Retained).

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.

Outcome measures

Outcome measures
Measure	Power-Up n=61 Participants Participants randomized to this arm underwent 16 classes tailored for men that discussed food choices, physical activity, and managing stress over 6 months, defined as the core phase, and 8 classes over the following 6 months, defined as the maintenance phase.	Standard NDPP (National Diabetes Prevention Program) n=67 Participants Participants randomized to this arm underwent 16 mixed gender classes that discussed food choices, physical activity, and managing stress over 6 months, defined as the core phase, and 8 classes over the following 6 months, defined as the maintenance phase.
Percent Weight Change Through the 12 Month Trial Intent to Treat (Attended >=0 Sessions)	-2.6 percent weight change Standard Error 2.5	-0.7 percent weight change Standard Error 0.9
Percent Weight Change Through the 12 Month Trial Intent to Treat Engaged (Attended >=4 Sessions)	-0.9 percent weight change Standard Error 4.3	-0.9 percent weight change Standard Error 1.3
Percent Weight Change Through the 12 Month Trial Intent to Treat Retained (Attended >= 9 Sessions)	-1.8 percent weight change Standard Error 4.7	-1.8 percent weight change Standard Error 1.6

SECONDARY outcome

Timeframe: 6 Months (At end of the core phase)

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.

Outcome measures

Outcome measures
Measure	Power-Up n=155 Participants Participants randomized to this arm underwent 16 classes tailored for men that discussed food choices, physical activity, and managing stress over 6 months, defined as the core phase, and 8 classes over the following 6 months, defined as the maintenance phase.	Standard NDPP (National Diabetes Prevention Program) n=146 Participants Participants randomized to this arm underwent 16 mixed gender classes that discussed food choices, physical activity, and managing stress over 6 months, defined as the core phase, and 8 classes over the following 6 months, defined as the maintenance phase.
Engagement of Men in Power-Up vs Standard National Diabetes Prevention Program Attended 0-3 Sessions	100 Participants	97 Participants
Engagement of Men in Power-Up vs Standard National Diabetes Prevention Program Attended >= 4 Sessions (Engaged)	55 Participants	49 Participants

SECONDARY outcome

Timeframe: 12 Months (At end of the maintenance phase)

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.

Outcome measures

Outcome measures
Measure	Power-Up n=155 Participants Participants randomized to this arm underwent 16 classes tailored for men that discussed food choices, physical activity, and managing stress over 6 months, defined as the core phase, and 8 classes over the following 6 months, defined as the maintenance phase.	Standard NDPP (National Diabetes Prevention Program) n=146 Participants Participants randomized to this arm underwent 16 mixed gender classes that discussed food choices, physical activity, and managing stress over 6 months, defined as the core phase, and 8 classes over the following 6 months, defined as the maintenance phase.
Retention of Men in Power-Up vs Standard National Diabetes Prevention Program Attended 0-8 Sessions	106 Participants	108 Participants
Retention of Men in Power-Up vs Standard National Diabetes Prevention Program Attended >= 9 Sessions (Retained)	49 Participants	38 Participants

Adverse Events

Power-Up

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Standard NDPP (National Diabetes Prevention Program)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Earle C. Chambers, PhD, MPH

Albert Einstein College of Medicine

Phone: 718-430-3057

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place