Trial Outcomes & Findings for PowerUp for Health: A Diabetes Prevention Program for Men (NCT NCT02555631)

Results Overview

the goal is to lose 5-7% of baseline body weight for pre-diabetic men

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

29 participants

Primary outcome timeframe

Baseline, 16 weeks

Results posted on

2018-06-28

Participant Flow

Participant milestones

Participant milestones
Measure	Lifestyle Intervention In this pilot study, each subject will receive the lifestyle intervention of the diabetes prevention program, a modified program for men from disadvantaged neighborhoods--a 16 weekly sessions of 1 hour each session lifestyle: In this pilot study, each subject will receive the lifestyle intervention of the diabetes prevention program, a modified program for men from disadvantaged neighborhoods--a 16 weekly sessions of 1 hour each session
Overall Study STARTED	29
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PowerUp for Health: A Diabetes Prevention Program for Men

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lifestyle Intervention n=29 Participants In this pilot study, each subject will receive the lifestyle intervention of the diabetes prevention program, a modified program for men from disadvantaged neighborhoods--a 16 weekly sessions of 1 hour each session lifestyle: In this pilot study, each subject will receive the lifestyle intervention of the diabetes prevention program, a modified program for men from disadvantaged neighborhoods--a 16 weekly sessions of 1 hour each session
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	49.9 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants
Region of Enrollment United States	29 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 16 weeks

the goal is to lose 5-7% of baseline body weight for pre-diabetic men

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=25 Participants In this pilot study, each subject will receive the lifestyle intervention of the diabetes prevention program, a modified program for men from disadvantaged neighborhoods--a 16 weekly sessions of 1 hour each session lifestyle: In this pilot study, each subject will receive the lifestyle intervention of the diabetes prevention program, a modified program for men from disadvantaged neighborhoods--a 16 weekly sessions of 1 hour each session
Change in Weight in Pounds	3.8 percentage of body weight lost Interval -0.2 to 8.1

SECONDARY outcome

Timeframe: 8 weeks

measured by numbers of men and the timeframe in which the recruitment takes place;

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=29 Participants In this pilot study, each subject will receive the lifestyle intervention of the diabetes prevention program, a modified program for men from disadvantaged neighborhoods--a 16 weekly sessions of 1 hour each session lifestyle: In this pilot study, each subject will receive the lifestyle intervention of the diabetes prevention program, a modified program for men from disadvantaged neighborhoods--a 16 weekly sessions of 1 hour each session
Number of Men Enrolled During 8 Weeks of Recruitment	29 Participants

SECONDARY outcome

Timeframe: 16 weeks

with a measured goal of at least attendance observed and recorded at 9/16 sessions on average

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=25 Participants In this pilot study, each subject will receive the lifestyle intervention of the diabetes prevention program, a modified program for men from disadvantaged neighborhoods--a 16 weekly sessions of 1 hour each session lifestyle: In this pilot study, each subject will receive the lifestyle intervention of the diabetes prevention program, a modified program for men from disadvantaged neighborhoods--a 16 weekly sessions of 1 hour each session
Number of Sessions Attended	11.7 Sessions Attended Standard Deviation 3.9

SECONDARY outcome

Timeframe: 16 weeks

this is measured by direct observation at selected sessions; report by the lifestyle coach; and discussion during focus groups at the end of the 16 weeks

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=25 Participants In this pilot study, each subject will receive the lifestyle intervention of the diabetes prevention program, a modified program for men from disadvantaged neighborhoods--a 16 weekly sessions of 1 hour each session lifestyle: In this pilot study, each subject will receive the lifestyle intervention of the diabetes prevention program, a modified program for men from disadvantaged neighborhoods--a 16 weekly sessions of 1 hour each session
Number of Participants That Participated in Each Session	25 Participants

Adverse Events

Lifestyle Intervention

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

Dr. Elizabeth Walker

Albert Einstein College of Medicine

Phone: 718-430-3242

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place