Trial Outcomes & Findings for Pilot Project of Health Promotion for People With Diabetes (NCT NCT00970294)

NCT ID: NCT00970294

Last Updated: 2012-08-21

Results Overview

% of enrolled subjects who completed the trial

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: 10 weeks
• Results posted on: 2012-08-21

Participant Flow

Participant milestones

Measure	Health Promotion Program Supervised exercise, educational sessions, dietary counseling
Overall Study STARTED	11
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Health Promotion Program Supervised exercise, educational sessions, dietary counseling
Overall Study Physician Decision	4
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Pilot Project of Health Promotion for People With Diabetes

Baseline characteristics by cohort

Measure	Health Promotion Program n=11 Participants Supervised exercise, educational sessions, dietary counseling
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=93 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants
Age Continuous	58.7 years STANDARD_DEVIATION 8.8 • n=93 Participants
Sex: Female, Male Female	7 Participants n=93 Participants
Sex: Female, Male Male	4 Participants n=93 Participants
Region of Enrollment United States	11 participants n=93 Participants

PRIMARY outcome

Timeframe: 10 weeks

% of enrolled subjects who completed the trial

Outcome measures

Measure	Health Promotion Program n=11 Participants Supervised exercise, educational sessions, dietary counseling
Recruitment, Retention, Adherence	55 percentage of participants

SECONDARY outcome

Timeframe: Baseline and at 10 weeks (change score)

peak VO2 as measured with a graded maximal exercise test on a cycle ergometer

Outcome measures

Measure	Health Promotion Program n=6 Participants Supervised exercise, educational sessions, dietary counseling
Aerobic Fitness	0.75 mL/kg/m Standard Deviation 1.78

SECONDARY outcome

Timeframe: Baseline and at 10 weeks (change score)

HbA1c measure

Outcome measures

Measure	Health Promotion Program n=6 Participants Supervised exercise, educational sessions, dietary counseling
Glycemic Control	-0.5 percentage of glycosolated hemoglobin Standard Deviation 0.5

Adverse Events

Health Promotion 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

Patricia Kluding PT PhD

University of Kansas Medical Center

Phone: 913-588-6918

Email: pkluding@kumc.edu

Results disclosure agreements

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