Reduction of Sitting Time: Sedentarism Intervention Trial

Physical Activity Clinical Trial

— SIT  

Official title:

Reduction of Sitting Time - a Randomized Controlled Intervention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01221363
• Other study ID #: NCT00289237
• Status: Completed
• Phase: N/A
• First received: October 14, 2010
• Last updated: January 19, 2015
• Start date: November 2010
• Est. completion date: June 2012

Study information

• Verified date: January 2015
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: June 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Life Style
• Physical Activity
• Sedentary Behavior

Intervention

Behavioral:
• Life style intervention
Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention.

Locations

Country	Name	City	State
Denmark	Research Centre for Prevention and Health, The Capital Region of Denmark	Glostrup

Sponsors (3)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen	Lundbeck Foundation, Sygekassernes Helsefond

Country where clinical trial is conducted

Denmark, 

References & Publications (7)

Aadahl M, Kjaer M, Jørgensen T. Influence of time spent on TV viewing and vigorous intensity physical activity on cardiovascular biomarkers. The Inter 99 study. Eur J Cardiovasc Prev Rehabil. 2007 Oct;14(5):660-5. — View Citation

Dunstan DW, Barr EL, Healy GN, Salmon J, Shaw JE, Balkau B, Magliano DJ, Cameron AJ, Zimmet PZ, Owen N. Television viewing time and mortality: the Australian Diabetes, Obesity and Lifestyle Study (AusDiab). Circulation. 2010 Jan 26;121(3):384-91. doi: 10.1161/CIRCULATIONAHA.109.894824. Epub 2010 Jan 11. — View Citation

Hamilton MT, Hamilton DG, Zderic TW. Role of low energy expenditure and sitting in obesity, metabolic syndrome, type 2 diabetes, and cardiovascular disease. Diabetes. 2007 Nov;56(11):2655-67. Epub 2007 Sep 7. Review. — View Citation

Katzmarzyk PT, Church TS, Craig CL, Bouchard C. Sitting time and mortality from all causes, cardiovascular disease, and cancer. Med Sci Sports Exerc. 2009 May;41(5):998-1005. doi: 10.1249/MSS.0b013e3181930355. — View Citation

Otten JJ, Jones KE, Littenberg B, Harvey-Berino J. Effects of television viewing reduction on energy intake and expenditure in overweight and obese adults: a randomized controlled trial. Arch Intern Med. 2009 Dec 14;169(22):2109-15. doi: 10.1001/archinternmed.2009.430. — View Citation

Wijndaele K, Brage S, Besson H, Khaw KT, Sharp SJ, Luben R, Wareham NJ, Ekelund U. Television viewing time independently predicts all-cause and cardiovascular mortality: the EPIC Norfolk study. Int J Epidemiol. 2011 Feb;40(1):150-9. doi: 10.1093/ije/dyq105. Epub 2010 Jun 23. — View Citation

Wijndaele K, Healy GN, Dunstan DW, Barnett AG, Salmon J, Shaw JE, Zimmet PZ, Owen N. Increased cardiometabolic risk is associated with increased TV viewing time. Med Sci Sports Exerc. 2010 Aug;42(8):1511-8. doi: 10.1249/MSS.0b013e3181d322ac. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Objectively Measured Sitting Time From Baseline to 6 Months Follow-up	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.	7 days of measurement / change in sitting time from baseline and 6 months follow-up	No
Secondary	Change in High Density Lipoprotein (HDL) From Baseline to 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	Change in measured HDL from baseline and 6 months follow-up	No

External Links

•   Research Centre for Prevention and Health, The Capital Region of Denmark