The Svendborg-project (CHAMPS-DK)
26 de abril de 2018 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
1209
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Odense, Dinamarca, 5230
- University of Southern Denmark
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
5 anos a 11 anos (Filho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Enrolled at school participating in study
- Grade 0 - 4
- written, informed consent provided by parent or legal guardian
Exclusion Criteria:
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Intervention
Trebling of weekly curricular physical education (270 minutes per week)
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Augmented physical education program
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Sem intervenção: Control
Standard curriculum physical education (90 minutes per week)
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Body weight (kilograms)
Prazo: Change over 2 years
|
Standardized assessments performed by trained personal using an electronic scale.
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Change over 2 years
|
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Dual-energy X-ray absorptiometry (DXA) determined bone mineral content (grams)
Prazo: Change over 2 years
|
Standardized assessments performed by trained personal.
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Change over 2 years
|
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Musculoskeletal problems (injuries, defined as inability to participate in sports)
Prazo: 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)
Prazo: Change over 2 years
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Standardized assessments performed by trained personal using a stadiometer.
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Change over 2 years
|
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Body-mass index (kg/m^2)
Prazo: Change over 2 years
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Calculated from measured height and weight
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Change over 2 years
|
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Waist circumference (centimeters)
Prazo: Change over 2 years
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Standardized assessments performed by trained personal at the level of the umbilical cord
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Change over 2 years
|
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DXA determined body fat (%)
Prazo: Change over 2 years
|
In subcohort only.
Standardized assessments performed by trained personal.
|
Change over 2 years
|
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Serum fasting insulin (IU/l)
Prazo: Change over 2 years
|
Standardized assessments performed by trained biomedical laboratory technicians.
Fasting status affirmed verbally.
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Change over 2 years
|
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Serum fasting glucose (mmol/l)
Prazo: 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 triglycerides (mmol/l)
Prazo: Change over 2 years
|
Standardized assessments performed by trained biomedical laboratory technicians.
Fasting status affirmed verbally.
|
Change over 2 years
|
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Serum fasting total cholesterol (mmol/l)
Prazo: 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)
Prazo: Change over 2 years
|
Standardized assessments performed by trained biomedical laboratory technicians.
Fasting status affirmed verbally.
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Change over 2 years
|
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Serum fasting high-density lipoprotein cholesterol (mmol/l)
Prazo: Change over 2 years
|
Standardized assessments performed by trained biomedical laboratory technicians.
Fasting status affirmed verbally.
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Change over 2 years
|
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Serum fasting C-reactive protein (mg/l)
Prazo: 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)
Prazo: Change over 2 years
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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)
Prazo: 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)
Prazo: Change over 2 years
|
Standardized assessments performed by trained personal
|
Change over 2 years
|
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Composite risk factor score (z-scores)
Prazo: 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)
Prazo: Change over 2 years
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Performance on indirect cardiorespiratory fitness test (Andersen-test).
Standardized assessments performed by trained personal
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Change over 2 years
|
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Handgrip strength (kg)
Prazo: Change over 2.5 years
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Maximal strength measured by a dynamometer.
Standardized assessments performed by trained personal
|
Change over 2.5 years
|
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Agility (seconds)
Prazo: Change over 2.5 years
|
Measured by the 50 meter short-shuttle test.
Standardized assessments performed by trained personal
|
Change over 2.5 years
|
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Backward balance (0-72 points)
Prazo: Change over 2.5 years
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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)
Prazo: Change over 2.5 years
|
Standardized assessments performed by trained personal
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Change over 2.5 years
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Precision throw (0-30 points)
Prazo: 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
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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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.
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Niels Wedderkopp, Prof, University of Southern Denmark
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de agosto de 2008
Conclusão Primária (Real)
1 de junho de 2015
Conclusão do estudo (Real)
1 de junho de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
12 de abril de 2018
Enviado pela primeira vez que atendeu aos critérios de CQ
26 de abril de 2018
Primeira postagem (Real)
27 de abril de 2018
Atualizações de registro de estudo
Última Atualização Postada (Real)
27 de abril de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
26 de abril de 2018
Última verificação
1 de abril de 2018
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- S-20080047
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .