Trial Outcomes & Findings for Reduction of Sitting Time: Sedentarism Intervention Trial (NCT NCT01221363)

Results Overview

Participants wore an ActivePAL monitor for seven days at inclusion and seven days at follow-up. The ActivePAL measures sitting time. Change in sitting time from baseline to 6 months follow up was evaluated.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

171 participants

Primary outcome timeframe

7 days of measurement / change in sitting time from baseline and 6 months follow-up

Results posted on

2015-01-21

Participant Flow

171 participants were consecutively included. However 5 patients withdrew before randomisation, leaving 166 participants to be included and randomised to either the intervention or the control group. Reasons for withdrawal were: 4 participants changed their mind because of lack of time, 1 participant reported skin reaction to monitor attachment.

Participant milestones

Participant milestones
Measure	Lifestyle Counselling Theory based individually tailored lifestyle counselling aimed at reduction of sitting time during leisure time and at work. Four individual sessions over a six months period. Life style intervention: Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention.	Control Group No intervention control group
Overall Study STARTED	93	73
Overall Study COMPLETED	81	68
Overall Study NOT COMPLETED	12	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Lifestyle Counselling Theory based individually tailored lifestyle counselling aimed at reduction of sitting time during leisure time and at work. Four individual sessions over a six months period. Life style intervention: Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention.	Control Group No intervention control group
Overall Study Pregnancy	1	0
Overall Study Withdrawal by Subject	11	5

Baseline Characteristics

Reduction of Sitting Time: Sedentarism Intervention Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lifestyle Counselling n=93 Participants Theory based individually tailored lifestyle counselling aimed at reduction of sitting time during leisure time and at work. Four individual sessions over a six months period. Life style intervention: Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention.	Control Group n=73 Participants No intervention control group	Total n=166 Participants Total of all reporting groups
Age, Continuous	52.2 years STANDARD_DEVIATION 13.8 • n=5 Participants	51.8 years STANDARD_DEVIATION 14.3 • n=7 Participants	52 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	59 Participants n=5 Participants	36 Participants n=7 Participants	95 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	37 Participants n=7 Participants	71 Participants n=5 Participants
Region of Enrollment Denmark	93 participants n=5 Participants	73 participants n=7 Participants	166 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days of measurement / change in sitting time from baseline and 6 months follow-up

Population: Within group difference

Participants wore an ActivePAL monitor for seven days at inclusion and seven days at follow-up. The ActivePAL measures sitting time. Change in sitting time from baseline to 6 months follow up was evaluated.

Outcome measures

Outcome measures
Measure	Lifestyle Counselling n=81 Participants Theory based individually tailored lifestyle counselling aimed at reduction of sitting time during leisure time and at work. Four individual sessions over a six months period. Life style intervention: Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention.	Control Group n=68 Participants No intervention control group
Change in Objectively Measured Sitting Time From Baseline to 6 Months Follow-up	-0.27 Hours per day Standard Deviation 1.7	0.06 Hours per day Standard Deviation 1.7

SECONDARY outcome

Timeframe: Change in measured HDL from baseline and 6 months follow-up

Blood samples are drawn at inclusion and at 6 months follow-up. Change in measured HDL (mmol/L) from baseline to 6 months follow-up

Outcome measures

Outcome measures
Measure	Lifestyle Counselling n=81 Participants Theory based individually tailored lifestyle counselling aimed at reduction of sitting time during leisure time and at work. Four individual sessions over a six months period. Life style intervention: Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention.	Control Group n=68 Participants No intervention control group
Change in High Density Lipoprotein (HDL) From Baseline to 6 Months Follow-up.	-0.03 mmol/Liter Standard Deviation 0.2	-0.02 mmol/Liter Standard Deviation 0.2

Adverse Events

Lifestyle Counselling

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

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

Mette Aadahl

Research Centre for Prevention and Health

Phone: +45 38663359

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place