Reduction of Sitting Time: Sedentarism Intervention Trial (SIT)

This study has been completed.
Sponsor:
Collaborators:
Lundbeck Foundation
Sygekassernes Helsefond
Information provided by (Responsible Party):
Allan Linneberg, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT01221363
First received: October 14, 2010
Last updated: January 19, 2015
Last verified: January 2015
Results First Received: January 12, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Life Style
Physical Activity
Sedentary Behavior
Intervention: Behavioral: Life style intervention

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

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.


Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Lifestyle Counselling     Control Group  
STARTED     93     73  
COMPLETED     81     68  
NOT COMPLETED     12     5  
Pregnancy                 1                 0  
Withdrawal by Subject                 11                 5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
    Lifestyle Counselling     Control Group     Total  
Number of Participants  
[units: participants]
  93     73     166  
Age  
[units: years]
Mean (Standard Deviation)
  52.2  (13.8)     51.8  (14.3)     52  (14)  
Gender  
[units: participants]
     
Female     59     36     95  
Male     34     37     71  
Region of Enrollment  
[units: participants]
     
Denmark     93     73     166  



  Outcome Measures
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1.  Primary:   Change in Objectively Measured Sitting Time From Baseline to 6 Months Follow-up   [ Time Frame: 7 days of measurement / change in sitting time from baseline and 6 months follow-up ]

2.  Secondary:   Change in High Density Lipoprotein (HDL) From Baseline to 6 Months Follow-up.   [ Time Frame: Change in measured HDL from baseline and 6 months follow-up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Mette Aadahl
Organization: Research Centre for Prevention and Health
phone: +45 38663359
e-mail: mette.aadahl@regionh.dk


Publications:


Responsible Party: Allan Linneberg, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT01221363     History of Changes
Study First Received: October 14, 2010
Results First Received: January 12, 2015
Last Updated: January 19, 2015
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee