Reduction of Sitting Time: Sedentarism Intervention Trial (SIT)

January 19, 2015 updated by: Allan Linneberg, Glostrup University Hospital, Copenhagen

Reduction of Sitting Time - a Randomized Controlled Intervention Study

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

171

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Glostrup, Denmark, 2600
        • Research Centre for Prevention and Health, The Capital Region of Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention.
Other Names:
  • Life style counselling
No Intervention: Control group
No intervention control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Torben Jørgensen, Prof. DrMedSc, Research Centre for Prevention and Health, The Capital Region of Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

October 14, 2010

First Submitted That Met QC Criteria

October 14, 2010

First Posted (Estimate)

October 15, 2010

Study Record Updates

Last Update Posted (Estimate)

January 21, 2015

Last Update Submitted That Met QC Criteria

January 19, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • NCT00289237

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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