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Reduction of Sitting Time: Sedentarism Intervention Trial (SIT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Glostrup University Hospital, Copenhagen.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Lundbeck Foundation
Sygekassernes Helsefond
Information provided by:
Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT01221363
First received: October 14, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

Recent studies have suggested that prolonged daily sitting time may in itself have a negative effect on health, even in people who engage in daily physical activity.

The aim of the present study is to explore whether individually tailored lifestyle counselling aimed at reducing TV-viewing and other sedentary activities during leisure time and at work, can reduce sitting time and waist circumference, weight and blood pressure; and improve serum lipid levels. From a population-based health survey, 150 adult men and women with more than 3.5 hours of daily leisure time sitting time are recruited and randomly assigned to 1) an intervention group or 2) a control group. The intervention group will participate in 4 individually tailored lifestyle intervention sessions focussing on reduction of daily sitting time. The control group will receive no intervention.


Condition Intervention
Life Style
Physical Activity
Sedentary Behavior
Behavioral: Life style intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Reduction of Sitting Time - a Randomized Controlled Intervention Study

Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • Objectively measured sitting time [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Participants will wear an ActivePAL monitor seven days at inclusion and seven days at follow-up. The ActivePAL measures sitting time.


Secondary Outcome Measures:
  • High density lipoprotein (HDL) [ Time Frame: Baseline and follow-up ] [ Designated as safety issue: No ]
    Blood samples are drawn at inclusion and at follow-up.


Estimated Enrollment: 150
Study Start Date: November 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Behavioral: Life style intervention
Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention.
Other Name: Life style counselling
No Intervention: Control group
No intervention control group.
Behavioral: Life style intervention
Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention.
Other Name: Life style counselling

Detailed Description:

Evidence for the health benefits of regular physical activity is clear and unanimous. Recently, observational studies have found that prolonged bouts of sitting time are associated with chronic disease and mortality, even in individuals who engage in regular physical activity. These new findings indicate that sedentary behaviour should be regarded as a distinct class of behaviour with independent effects on disease risk, separate from the behaviour of leisure time physical activity. Prolonged daily sitting time is prevalent in modern, western society, making further exploration into this field of research a relevant public health issue.

It remains to be tested, whether it is possible to reduce sedentary leisure time in adults and whether a reduction of sedentary leisure time will lead to a decrease in biological CVD risk factors.

The investigators hypothesize that sedentary behaviour during leisure time and at work may be reduced through a theory-based individually tailored lifestyle intervention.

Aim: To examine whether an individually tailored lifestyle intervention aimed at reducing TV-viewing and other sedentary activities during leisure time and at work, can reduce sitting time, waist circumference, BMI and blood pressure; and improve serum lipid level.

Study population: From the "Health2010" study, that was initiated February 2010 at the RCPH, 150 sedentary participants will be consecutively invited and randomised by computer-generated random numbers into A) an intervention group (n=75) and B) a control group (n=75), when visiting the RCPH for the health examination. The entire Health2010 population will comprise 4.000 men and women between 19 and 69 years of age.

Control group: The control group will be instructed to maintain their usual lifestyle, including physical activity level and sedentary behaviour. After the intervention period is terminated, participants in the control group will be given the written material (booklets etc.).

Primary outcome measure: Time engaging in sedentary activities (hours & minutes per day), as measured by ActivPAL. Secondary outcome measures: self-reported physical activity and sitting time, total cholesterol, HDL, triglycerides, LDL, weight, waist circumference, systolic and diastolic blood pressure. Outcome measures will be obtained at baseline (inclusion) and after 6 months.

A possible effect of the intervention on self-reported sedentary leisure time (primary outcome) and biological CVD risk factors (secondary outcomes) will be explored by comparison of intervention and control group at baseline and follow-up. Regression analysis and intention-to-treat analysis will be applied and a significance level of 0.05 will be used.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Minimum selfreported 3 ½ hours of sedentary leisure time per day

Exclusion Criteria:

  • More than 8 hours of vigorous activity per week
  • Physical handicap or illness that prevent reduction of sitting time
  • Must be able to read and understand Danish
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221363

Contacts
Contact: Mette Aadahl, MPH, PhD +45 38 63 33 59 metaad01@glo.regionh.dk
Contact: Allan Linneberg, MD, PhD +45 38 63 31 87 alli@glo.regionh.dk

Locations
Denmark
Research Centre for Prevention and Health, The Capital Region of Denmark Not yet recruiting
Glostrup, Denmark, 2600
Contact: Mette Aadahl, MPH, PhD    +45 38 63 33 59    metaad01@glo.regionh.dk   
Contact: Allan Linneberg, MD, PhD    +45 38 63 31 87    alli@glo.regionh.dk   
Principal Investigator: Mette Aadahl, MPH, PhD         
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Lundbeck Foundation
Sygekassernes Helsefond
Investigators
Study Director: Torben Jørgensen, Prof. DrMedSc Research Centre for Prevention and Health, the Capital Region of Denmark
  More Information

Additional Information:
Publications:

Responsible Party: Director DrMedSc Torben Jørgensen / Post.doc. Mette Aadahl, Research Centre for Prevention and Health, The Capital Region of Denmark
ClinicalTrials.gov Identifier: NCT01221363     History of Changes
Other Study ID Numbers: NCT00289237
Study First Received: October 14, 2010
Last Updated: October 14, 2010
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Keywords provided by Glostrup University Hospital, Copenhagen:
Life style disease
Obesity
Sedentary behaviour
Cardiovascular biomarkers

ClinicalTrials.gov processed this record on November 27, 2014