Trial Outcomes & Findings for Translating the DPP Into the Community (NCT NCT00302042)

Results Overview

6 months minus baseline

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

92 participants

Primary outcome timeframe

Baseline, 6 months

Results posted on

2017-07-18

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental: 1: Brief Counseling Plus Group Lifestyle Brief counseling for pre-diabetes plus access to a group-based diabetes prevention lifestyle intervention in the community	Active Comparator: 2: Brief Counseling Alone Brief Counseling for pre-diabetes alone without access to group lifestyle
Overall Study STARTED	46	46
Overall Study COMPLETED	39	38
Overall Study NOT COMPLETED	7	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Translating the DPP Into the Community

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: 1: Brief Counseling Plus Group Lifestyle n=46 Participants Brief counseling for pre-diabetes plus access to a group-based diabetes prevention lifestyle intervention in the community	Active Comparator: 2: Brief Counseling Alone n=46 Participants Brief Counseling for pre-diabetes alone without access to group lifestyle	Total n=92 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=5 Participants	43 Participants n=7 Participants	88 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	56.5 years STANDARD_DEVIATION 9.7 • n=5 Participants	60.1 years STANDARD_DEVIATION 10.5 • n=7 Participants	58.3 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	28 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	18 Participants n=7 Participants	41 Participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants	46 participants n=7 Participants	92 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 6 months

6 months minus baseline

Outcome measures

Outcome measures
Measure	Experimental: 1: Brief Counseling Plus Group Lifestyle n=39 Participants Brief counseling for pre-diabetes plus access to a group-based diabetes prevention lifestyle intervention in the community	Active Comparator: 2: Brief Counseling Alone n=38 Participants Brief Counseling for pre-diabetes alone without access to group lifestyle
Change in Weight	-6.0 percentage of change in weight Interval -7.3 to -4.7	-2.0 percentage of change in weight Interval -3.3 to -0.6

SECONDARY outcome

Timeframe: Baseline, 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6 months

Outcome measures

Outcome data not reported

Adverse Events

Experimental: 1: Brief Counseling Plus Group Lifestyle

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Active Comparator: 2: Brief Counseling Alone

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. Ronald T. Ackermann

Northwestern University

Phone: 3126036400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place