NCT01221363

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 15, 2010

Completed
17 days until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

January 21, 2015

Completed
Last Updated

January 21, 2015

Status Verified

January 1, 2015

Enrollment Period

1.3 years

First QC Date

October 14, 2010

Results QC Date

January 12, 2015

Last Update Submit

January 19, 2015

Conditions

Life StylePhysical ActivitySedentary Behavior

Keywords

Life style diseaseObesitySedentary behaviourCardiovascular biomarkers

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Change in High Density Lipoprotein (HDL) From Baseline to 6 Months Follow-up.

    Change in measured HDL from baseline and 6 months follow-up

Study Arms (2)

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.

Behavioral: Life style intervention

Control group

NO INTERVENTION

No intervention control group

Interventions

Life style interventionBEHAVIORAL

Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention.

Also known as: Life style counselling
Lifestyle counselling

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Glostrup Municipality, 2600, Denmark

Location

Related Publications (7)

  • 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.

    PMID: 20008695BACKGROUND

  • 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.

    PMID: 20065160BACKGROUND

  • 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.

    PMID: 20139784BACKGROUND

  • 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.

    PMID: 20576628BACKGROUND

  • 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. doi: 10.2337/db07-0882. Epub 2007 Sep 7.

    PMID: 17827399BACKGROUND

  • 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.

    PMID: 19346988BACKGROUND

  • Aadahl 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.

    PMID: 17925625BACKGROUND

Related Links

MeSH Terms

Conditions

Motor ActivitySedentary BehaviorObesity

Condition Hierarchy (Ancestors)

BehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Mette Aadahl
Organization
Research Centre for Prevention and Health
mette.aadahl@regionh.dk
+45 38663359

Study Officials

  • Torben Jørgensen, Prof. DrMedSc

    Research Centre for Prevention and Health, the Capital Region of Denmark

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researchmanager

Study Record Dates

First Submitted

October 14, 2010

First Posted

October 15, 2010

Study Start

November 1, 2010

Primary Completion

March 1, 2012

Study Completion

June 1, 2012

Last Updated

January 21, 2015

Results First Posted

January 21, 2015

Record last verified: 2015-01

Locations

DK(1)