The Svendborg-project (CHAMPS-DK)
26 aprile 2018 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
1209
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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-
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Odense, Danimarca, 5230
- University of Southern Denmark
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-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 5 anni a 11 anni (Bambino)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Enrolled at school participating in study
- Grade 0 - 4
- written, informed consent provided by parent or legal guardian
Exclusion Criteria:
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Intervention
Trebling of weekly curricular physical education (270 minutes per week)
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Augmented physical education program
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Nessun intervento: Control
Standard curriculum physical education (90 minutes per week)
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Body weight (kilograms)
Lasso di tempo: 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)
Lasso di tempo: Change over 2 years
|
Standardized assessments performed by trained personal.
|
Change over 2 years
|
|
Musculoskeletal problems (injuries, defined as inability to participate in sports)
Lasso di tempo: Total incidence of musculoskeletal problems across 2.5 years
|
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
|
|
Height (centimeters)
Lasso di tempo: Change over 2 years
|
Standardized assessments performed by trained personal using a stadiometer.
|
Change over 2 years
|
|
Body-mass index (kg/m^2)
Lasso di tempo: Change over 2 years
|
Calculated from measured height and weight
|
Change over 2 years
|
|
Waist circumference (centimeters)
Lasso di tempo: Change over 2 years
|
Standardized assessments performed by trained personal at the level of the umbilical cord
|
Change over 2 years
|
|
DXA determined body fat (%)
Lasso di tempo: Change over 2 years
|
In subcohort only.
Standardized assessments performed by trained personal.
|
Change over 2 years
|
|
Serum fasting insulin (IU/l)
Lasso di tempo: Change over 2 years
|
Standardized assessments performed by trained biomedical laboratory technicians.
Fasting status affirmed verbally.
|
Change over 2 years
|
|
Serum fasting glucose (mmol/l)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: Change over 2 years
|
Standardized assessments performed by trained biomedical laboratory technicians.
Fasting status affirmed verbally.
|
Change over 2 years
|
|
Serum fasting high-density lipoprotein cholesterol (mmol/l)
Lasso di tempo: Change over 2 years
|
Standardized assessments performed by trained biomedical laboratory technicians.
Fasting status affirmed verbally.
|
Change over 2 years
|
|
Serum fasting C-reactive protein (mg/l)
Lasso di tempo: Change over 2 years
|
Standardized assessments performed by trained biomedical laboratory technicians.
Fasting status affirmed verbally.
|
Change over 2 years
|
|
Homeostasis model assessment of insulin resistance (HOMA-IR)
Lasso di tempo: Change over 2 years
|
Calculated as fasting insulin (IU/l) x fasting glucose (mmol/l))/ 22.5
|
Change over 2 years
|
|
Resting systolic blood pressure (mmHg)
Lasso di tempo: Change over 2 years
|
Standardized assessments performed by trained personal
|
Change over 2 years
|
|
Resting diastolic blood pressure (mmHg)
Lasso di tempo: Change over 2 years
|
Standardized assessments performed by trained personal
|
Change over 2 years
|
|
Composite risk factor score (z-scores)
Lasso di tempo: Change over 2 years
|
Standardized (z-scores) values of HOMA-IR, triglycerides, cholesterol-fractions, systolic blood pressure, and cardiorespiratory fitness
|
Change over 2 years
|
|
Cardiorespiratory fitness (meters)
Lasso di tempo: Change over 2 years
|
Performance on indirect cardiorespiratory fitness test (Andersen-test).
Standardized assessments performed by trained personal
|
Change over 2 years
|
|
Handgrip strength (kg)
Lasso di tempo: Change over 2.5 years
|
Maximal strength measured by a dynamometer.
Standardized assessments performed by trained personal
|
Change over 2.5 years
|
|
Agility (seconds)
Lasso di tempo: Change over 2.5 years
|
Measured by the 50 meter short-shuttle test.
Standardized assessments performed by trained personal
|
Change over 2.5 years
|
|
Backward balance (0-72 points)
Lasso di tempo: Change over 2.5 years
|
From the "Korperkoordinations Test fur Kinder".
Standardized assessments performed by trained personal
|
Change over 2.5 years
|
|
Maximal vertical jump performance (centimeters)
Lasso di tempo: Change over 2.5 years
|
Standardized assessments performed by trained personal
|
Change over 2.5 years
|
|
Precision throw (0-30 points)
Lasso di tempo: Change over 2.5 years
|
From ''Der Allgemeiner Sportmotorischer Test fur Kinder von 6-11 Jahren''
|
Change over 2.5 years
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Physical activity determined objectively using waist-worn accelerometry. Participants will be asked to wear the monitors for at least one week.
Lasso di tempo: Non-specific follow-up duration as multiple time-points are considered (follow-up at 2, 3.5 and 6.5 years)
|
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)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Niels Wedderkopp, Prof, University of Southern Denmark
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 agosto 2008
Completamento primario (Effettivo)
1 giugno 2015
Completamento dello studio (Effettivo)
1 giugno 2015
Date di iscrizione allo studio
Primo inviato
12 aprile 2018
Primo inviato che soddisfa i criteri di controllo qualità
26 aprile 2018
Primo Inserito (Effettivo)
27 aprile 2018
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
27 aprile 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
26 aprile 2018
Ultimo verificato
1 aprile 2018
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- S-20080047
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano 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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .