Trial Outcomes & Findings for Feasibility of a Partnered Approach to Prevent Diabetes (NCT NCT00302055)

Results Overview

We analyzed repeated outcome measures using longitudinal linear regression with 3 observations per participant (baseline, 6 months, and 12 months)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

72 participants

Primary outcome timeframe

12 months

Results posted on

2016-12-01

Participant Flow

Participant milestones

Participant milestones
Measure	One-on-one Lifestyle Clinical referral for diabetes prevention lifestyle intervention at School of Medicine campus	Group-based Community Lifestyle Clinical referral to group diabetes prevention lifestyle intervention program in community
Overall Study STARTED	23	49
Overall Study COMPLETED	14	36
Overall Study NOT COMPLETED	9	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility of a Partnered Approach to Prevent Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	One-on-one Lifestyle n=23 Participants Clinical referral for diabetes prevention lifestyle intervention at School of Medicine campus	Group-based Community Lifestyle n=49 Participants Clinical referral to group diabetes prevention lifestyle intervention program in community	Total n=72 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	23 Participants n=5 Participants	49 Participants n=7 Participants	72 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	53.0 years STANDARD_DEVIATION 10.7 • n=5 Participants	52.8 years STANDARD_DEVIATION 13.1 • n=7 Participants	52.9 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	42 Participants n=7 Participants	59 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants	49 participants n=7 Participants	72 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

We analyzed repeated outcome measures using longitudinal linear regression with 3 observations per participant (baseline, 6 months, and 12 months)

Outcome measures

Outcome measures
Measure	One-on-one Lifestyle n=23 Participants Clinical referral for diabetes prevention lifestyle intervention at School of Medicine campus	Group-based Community Lifestyle n=49 Participants Clinical referral to group diabetes prevention lifestyle intervention program in community
Weight Loss	4.37 kilograms Interval 3.33 to 5.42	3.23 kilograms Interval 2.16 to 4.3

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

Adverse Events

One-on-one Lifestyle

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group-based Community Lifestyle

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: (312) 503-6400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place