Life StyleSITNCT01221363
Reduction of Sitting Time: Sedentarism Intervention Trial
A study testing Life style intervention in people with Life Style and Physical Activity, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Life Style, Physical Activity, Sedentary Behavior
- What is being tested?
- Life style intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2010to Jun 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum selfreported 3 ½ hours of sedentary leisure time per day
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Research Centre for Prevention and Health, The Capital Region of Denmark
Glostrup Municipality, 2600
About this study
Official title: 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.
Read the 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.
- Conditions
- Life Style, Physical Activity, Sedentary Behavior
- Being tested
- Life style intervention
- Keywords
- Life style disease, Obesity, Sedentary behaviour, Cardiovascular biomarkers
- Medical subject headings
- Motor Activity, Sedentary Behavior, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life style interventionBehavioural
Also called Life style counselling
Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counselling | Active comparator | 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. Receives: Behavioral: Life style intervention |
| Control group | No intervention | No intervention control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days of measurement / change in sitting time from baseline and 6 months follow-up
Secondary outcomes (1)
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
Measured: Change in measured HDL from baseline and 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionMar 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Life StyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck Foundation, Sygekassernes Helsefond
- Responsible party
- Principal investigator, Allan Linneberg, Glostrup University Hospital, Copenhagen
- Investigators
- Torben Jørgensen, Prof. DrMedSc, Study director, Research Centre for Prevention and Health, the Capital Region of Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01221363
- Sponsor's protocol ID
- NCT00289237
- Acronym
- SIT
- Status last verified
- Jan 2015
- First submitted
- 14 Oct 2010
- Last updated
- 21 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20008695Dunstan 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.
PubMed 20065160Wijndaele 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.
PubMed 20139784Wijndaele 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.
PubMed 20576628Hamilton 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. doi: 10.2337/db07-0882. Epub 2007 Sep 7.
PubMed 17827399Katzmarzyk 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.
PubMed 19346988Aadahl M, Kjaer M, Jorgensen 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. doi: 10.1097/HJR.0b013e3280c284c5.
PubMed 17925625
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Sitting Time - a Randomized Controlled Intervention Study
- ClinicalTrials.gov ID
- NCT01221363
- Acronym / sponsor ID
- SIT / NCT00289237
- Conditions
- Life Style, Physical Activity, Sedentary Behavior
- Keywords
- Life style disease, Obesity, Sedentary behaviour, Cardiovascular biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Collaborators
- Lundbeck Foundation, Sygekassernes Helsefond
- Study start
- Nov 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 15 Oct 2010 (estimated)
- Results
- Posted 21 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counselling | Active comparator | Behavioral: Life style interventionTheory 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. |
| Control group | No intervention | –No intervention control group |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Minimum selfreported 3 ½ hours of sedentary leisure time per day
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Life style interventionAlso: Life style counsellingReduction of sedentary behavior through theory-based individually tailored lifestyle intervention. | Behavioural | Lifestyle counselling |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20008695Otten 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.
- Background: PubMed 20065160Dunstan 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.
- Background: PubMed 20139784Wijndaele 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.
- Background: PubMed 20576628Wijndaele 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.
- Background: PubMed 17827399Hamilton 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. doi: 10.2337/db07-0882. Epub 2007 Sep 7.
- Background: PubMed 19346988Katzmarzyk 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.
- Background: PubMed 17925625Aadahl M, Kjaer M, Jorgensen 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. doi: 10.1097/HJR.0b013e3280c284c5.
- Research Centre for Prevention and Health, The Capital Region of DenmarkLink provided by the sponsor.
Related trials for Life Style
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Yoga vs. Stretching-Strengthening: Physical Fitness in Sedentary Young Adults
Sedentary Lifestlye, Exercise
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torben Jørgensen, Prof. DrMedSc study director
Research Centre for Prevention and Health, the Capital Region of Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Life style intervention in people with Life Style and Physical Activity, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01221363, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2015.