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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01221363
Reduction of Sitting Time: Sedentarism Intervention Trial (SIT)
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Glostrup, Dinamarca, 2600
- Research Centre for Prevention and Health, The Capital Region of Denmark
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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.
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Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention.
Otros nombres:
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Sin intervención: Grupo de control
No hay grupo de control de intervención
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Objectively Measured Sitting Time From Baseline to 6 Months Follow-up
Periodo de tiempo: 7 days of measurement / change in sitting time from baseline and 6 months follow-up
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in High Density Lipoprotein (HDL) From Baseline to 6 Months Follow-up.
Periodo de tiempo: Change in measured HDL from baseline and 6 months follow-up
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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
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Change in measured HDL from baseline and 6 months follow-up
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Torben Jørgensen, Prof. DrMedSc, Research Centre for Prevention and Health, The Capital Region of Denmark
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- NCT00289237
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