Trial Outcomes & Findings for Evaluation of a Lifestyle Intervention for Employees With Prediabetes (NCT NCT01682954)

NCT ID: NCT01682954

Last Updated: 2014-10-30

Results Overview

Change in body weight

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 78 participants
• Primary outcome timeframe: 4 months
• Results posted on: 2014-10-30

Participant Flow

Participant milestones

Measure	Lifestyle Counseling Diabetes Prevention Program lifestyle intervention Lifestyle counseling: 16-week nutrition, physical activity and behavioral intervention	Usual Care Usual care from primary care physician
Overall Study STARTED	40	38
Overall Study COMPLETED	35	33
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of a Lifestyle Intervention for Employees With Prediabetes

Baseline characteristics by cohort

Measure	Lifestyle Counseling n=40 Participants Diabetes Prevention Program lifestyle intervention Lifestyle counseling: 16-week nutrition, physical activity and behavioral intervention	Usual Care n=38 Participants Usual care from primary care physician	Total n=78 Participants Total of all reporting groups
Age, Continuous	50.75 years STANDARD_DEVIATION 9.49 • n=5 Participants	50.55 years STANDARD_DEVIATION 7.99 • n=7 Participants	50.65 years STANDARD_DEVIATION 8.73 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	30 Participants n=7 Participants	61 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants	38 participants n=7 Participants	78 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 months

Change in body weight

Outcome measures

Measure	Lifestyle Counseling n=35 Participants Diabetes Prevention Program lifestyle intervention Lifestyle counseling: 16-week nutrition, physical activity and behavioral intervention	Usual Care n=34 Participants Usual care from primary care physician
Body Weight	-5.12 kg Standard Error 0.63	-0.37 kg Standard Error 0.64

PRIMARY outcome

Timeframe: 7 Months

Change in body weight

Outcome measures

Measure	Lifestyle Counseling n=35 Participants Diabetes Prevention Program lifestyle intervention Lifestyle counseling: 16-week nutrition, physical activity and behavioral intervention	Usual Care n=33 Participants Usual care from primary care physician
Body Weight	-4.86 kg Standard Error 0.62	-0.35 kg Standard Error 0.64

Adverse Events

Lifestyle Counseling

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

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. Carla Miller

Ohio State University

Phone: 614-292-1391

Email: miller.4453@osu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place