The Svendborg-project (CHAMPS-DK)
26 de abril de 2018 actualizado por: University of Southern Denmark
The Childhood Health, Activity, and Motor Performance School Study Denmark
The main aim of this study is to describe differences in development of health and motor performance over time in relation to type of school and other background variables.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
1209
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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-
-
Odense, Dinamarca, 5230
- University of Southern Denmark
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
5 años a 11 años (Niño)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Enrolled at school participating in study
- Grade 0 - 4
- written, informed consent provided by parent or legal guardian
Exclusion Criteria:
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intervention
Trebling of weekly curricular physical education (270 minutes per week)
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Augmented physical education program
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Sin intervención: Control
Standard curriculum physical education (90 minutes per week)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Body weight (kilograms)
Periodo de tiempo: Change over 2 years
|
Standardized assessments performed by trained personal using an electronic scale.
|
Change over 2 years
|
|
Dual-energy X-ray absorptiometry (DXA) determined bone mineral content (grams)
Periodo de tiempo: Change over 2 years
|
Standardized assessments performed by trained personal.
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Change over 2 years
|
|
Musculoskeletal problems (injuries, defined as inability to participate in sports)
Periodo de tiempo: Total incidence of musculoskeletal problems across 2.5 years
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Weekly short-message-service tracking of participants to determine severity, frequency and nature (acute/overuse) of injuries.
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Total incidence of musculoskeletal problems across 2.5 years
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Height (centimeters)
Periodo de tiempo: Change over 2 years
|
Standardized assessments performed by trained personal using a stadiometer.
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Change over 2 years
|
|
Body-mass index (kg/m^2)
Periodo de tiempo: Change over 2 years
|
Calculated from measured height and weight
|
Change over 2 years
|
|
Waist circumference (centimeters)
Periodo de tiempo: Change over 2 years
|
Standardized assessments performed by trained personal at the level of the umbilical cord
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Change over 2 years
|
|
DXA determined body fat (%)
Periodo de tiempo: Change over 2 years
|
In subcohort only.
Standardized assessments performed by trained personal.
|
Change over 2 years
|
|
Serum fasting insulin (IU/l)
Periodo de tiempo: Change over 2 years
|
Standardized assessments performed by trained biomedical laboratory technicians.
Fasting status affirmed verbally.
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Change over 2 years
|
|
Serum fasting glucose (mmol/l)
Periodo de tiempo: Change over 2 years
|
Standardized assessments performed by trained biomedical laboratory technicians.
Fasting status affirmed verbally.
|
Change over 2 years
|
|
Serum fasting triglycerides (mmol/l)
Periodo de tiempo: Change over 2 years
|
Standardized assessments performed by trained biomedical laboratory technicians.
Fasting status affirmed verbally.
|
Change over 2 years
|
|
Serum fasting total cholesterol (mmol/l)
Periodo de tiempo: Change over 2 years
|
Standardized assessments performed by trained biomedical laboratory technicians.
Fasting status affirmed verbally.
|
Change over 2 years
|
|
Serum fasting low-density lipoprotein cholesterol (mmol/l)
Periodo de tiempo: Change over 2 years
|
Standardized assessments performed by trained biomedical laboratory technicians.
Fasting status affirmed verbally.
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Change over 2 years
|
|
Serum fasting high-density lipoprotein cholesterol (mmol/l)
Periodo de tiempo: Change over 2 years
|
Standardized assessments performed by trained biomedical laboratory technicians.
Fasting status affirmed verbally.
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Change over 2 years
|
|
Serum fasting C-reactive protein (mg/l)
Periodo de tiempo: Change over 2 years
|
Standardized assessments performed by trained biomedical laboratory technicians.
Fasting status affirmed verbally.
|
Change over 2 years
|
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Homeostasis model assessment of insulin resistance (HOMA-IR)
Periodo de tiempo: Change over 2 years
|
Calculated as fasting insulin (IU/l) x fasting glucose (mmol/l))/ 22.5
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Change over 2 years
|
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Resting systolic blood pressure (mmHg)
Periodo de tiempo: Change over 2 years
|
Standardized assessments performed by trained personal
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Change over 2 years
|
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Resting diastolic blood pressure (mmHg)
Periodo de tiempo: Change over 2 years
|
Standardized assessments performed by trained personal
|
Change over 2 years
|
|
Composite risk factor score (z-scores)
Periodo de tiempo: Change over 2 years
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Standardized (z-scores) values of HOMA-IR, triglycerides, cholesterol-fractions, systolic blood pressure, and cardiorespiratory fitness
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Change over 2 years
|
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Cardiorespiratory fitness (meters)
Periodo de tiempo: Change over 2 years
|
Performance on indirect cardiorespiratory fitness test (Andersen-test).
Standardized assessments performed by trained personal
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Change over 2 years
|
|
Handgrip strength (kg)
Periodo de tiempo: Change over 2.5 years
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Maximal strength measured by a dynamometer.
Standardized assessments performed by trained personal
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Change over 2.5 years
|
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Agility (seconds)
Periodo de tiempo: Change over 2.5 years
|
Measured by the 50 meter short-shuttle test.
Standardized assessments performed by trained personal
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Change over 2.5 years
|
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Backward balance (0-72 points)
Periodo de tiempo: Change over 2.5 years
|
From the "Korperkoordinations Test fur Kinder".
Standardized assessments performed by trained personal
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Change over 2.5 years
|
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Maximal vertical jump performance (centimeters)
Periodo de tiempo: Change over 2.5 years
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Standardized assessments performed by trained personal
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Change over 2.5 years
|
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Precision throw (0-30 points)
Periodo de tiempo: Change over 2.5 years
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From ''Der Allgemeiner Sportmotorischer Test fur Kinder von 6-11 Jahren''
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Change over 2.5 years
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Physical activity determined objectively using waist-worn accelerometry. Participants will be asked to wear the monitors for at least one week.
Periodo de tiempo: Non-specific follow-up duration as multiple time-points are considered (follow-up at 2, 3.5 and 6.5 years)
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Physical activity outcomes include; mean count/min, light-physical activity, moderate-physical activity, vigorous-physical activity.
First physical activity assessment made during year 1 of the intervention
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Non-specific follow-up duration as multiple time-points are considered (follow-up at 2, 3.5 and 6.5 years)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Niels Wedderkopp, Prof, University of Southern Denmark
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Wedderkopp N, Jespersen E, Franz C, Klakk H, Heidemann M, Christiansen C, Moller NC, Leboeuf-Yde C. Study protocol. The Childhood Health, Activity, and Motor Performance School Study Denmark (The CHAMPS-study DK). BMC Pediatr. 2012 Aug 20;12:128. doi: 10.1186/1471-2431-12-128.
- Cheron C, Leboeuf-Yde C, Le Scanff C, Jespersen E, Rexen CT, Franz C, Wedderkopp N. Leisure-time sport and overuse injuries of extremities in children age 6-13, a 2.5 years prospective cohort study: the CHAMPS-study DK. BMJ Open. 2017 Jan 13;7(1):e012606. doi: 10.1136/bmjopen-2016-012606.
- Huang T, Gejl AK, Tarp J, Andersen LB, Peijs L, Bugge A. Cross-sectional associations of objectively measured physical activity with brain-derived neurotrophic factor in adolescents. Physiol Behav. 2017 Mar 15;171:87-91. doi: 10.1016/j.physbeh.2016.12.026. Epub 2016 Dec 24.
- Hebert JJ, Moller NC, Andersen LB, Wedderkopp N. Organized Sport Participation Is Associated with Higher Levels of Overall Health-Related Physical Activity in Children (CHAMPS Study-DK). PLoS One. 2015 Aug 11;10(8):e0134621. doi: 10.1371/journal.pone.0134621. eCollection 2015.
- Heidemann M, Holst R, Schou AJ, Klakk H, Husby S, Wedderkopp N, Molgaard C. The influence of anthropometry and body composition on children's bone health: the childhood health, activity and motor performance school (the CHAMPS) study, Denmark. Calcif Tissue Int. 2015 Feb;96(2):97-104. doi: 10.1007/s00223-014-9941-9. Epub 2014 Dec 25.
- Larsen LR, Kristensen PL, Junge T, Rexen CT, Wedderkopp N. Motor Performance as Predictor of Physical Activity in Children: The CHAMPS Study-DK. Med Sci Sports Exerc. 2015 Sep;47(9):1849-56. doi: 10.1249/MSS.0000000000000604.
- Klakk H, Grontved A, Moller NC, Heidemann M, Andersen LB, Wedderkopp N. Prospective association of adiposity and cardiorespiratory fitness with cardiovascular risk factors in healthy children. Scand J Med Sci Sports. 2014 Aug;24(4):e275-82. doi: 10.1111/sms.12163. Epub 2014 Jan 8.
- Moller NC, Tarp J, Kamelarczyk EF, Brond JC, Klakk H, Wedderkopp N. Do extra compulsory physical education lessons mean more physically active children--findings from the childhood health, activity, and motor performance school study Denmark (The CHAMPS-study DK). Int J Behav Nutr Phys Act. 2014 Sep 24;11:121. doi: 10.1186/s12966-014-0121-0.
- Heidemann M, Jespersen E, Holst R, Schou AJ, Husby S, Molgaard C, Wedderkopp N. The impact on children's bone health of a school-based physical education program and participation in leisure time sports: the Childhood Health, Activity and Motor Performance School (the CHAMPS) study, Denmark. Prev Med. 2013 Aug;57(2):87-91. doi: 10.1016/j.ypmed.2013.04.015. Epub 2013 Apr 30.
- Klakk H, Chinapaw M, Heidemann M, Andersen LB, Wedderkopp N. Effect of four additional physical education lessons on body composition in children aged 8-13 years--a prospective study during two school years. BMC Pediatr. 2013 Oct 17;13:170. doi: 10.1186/1471-2431-13-170.
- Klakk H, Andersen LB, Heidemann M, Moller NC, Wedderkopp N. Six physical education lessons a week can reduce cardiovascular risk in school children aged 6-13 years: a longitudinal study. Scand J Public Health. 2014 Mar;42(2):128-36. doi: 10.1177/1403494813505726. Epub 2013 Sep 20.
- Jespersen E, Rexen CT, Franz C, Moller NC, Froberg K, Wedderkopp N. Musculoskeletal extremity injuries in a cohort of schoolchildren aged 6-12: a 2.5-year prospective study. Scand J Med Sci Sports. 2015 Apr;25(2):251-8. doi: 10.1111/sms.12177. Epub 2014 Jan 29.
- Tarp J, Jespersen E, Moller NC, Klakk H, Wessner B, Wedderkopp N, Bugge A. Long-term follow-up on biological risk factors, adiposity, and cardiorespiratory fitness development in a physical education intervention: a natural experiment (CHAMPS-study DK). BMC Public Health. 2018 May 9;18(1):605. doi: 10.1186/s12889-018-5524-4.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de agosto de 2008
Finalización primaria (Actual)
1 de junio de 2015
Finalización del estudio (Actual)
1 de junio de 2015
Fechas de registro del estudio
Enviado por primera vez
12 de abril de 2018
Primero enviado que cumplió con los criterios de control de calidad
26 de abril de 2018
Publicado por primera vez (Actual)
27 de abril de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de abril de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
26 de abril de 2018
Última verificación
1 de abril de 2018
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- S-20080047
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Data are available upon request from the CHAMPS Study Steering Committee due to legal and ethical restrictions.
Interested parties may contact Dr Niels Wedderkopp (nwedderkopp@health.sdu.dk), and the following information will be required at the time of application: a description of how the data will be used, securely managed, and permanently deleted.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .