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The Svendborg-project (CHAMPS-DK)

26. april 2018 opdateret af: 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.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1209

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Odense, Danmark, 5230
        • University of Southern Denmark

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

5 år til 11 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Enrolled at school participating in study
  • Grade 0 - 4
  • written, informed consent provided by parent or legal guardian

Exclusion Criteria:

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention
Trebling of weekly curricular physical education (270 minutes per week)
Augmented physical education program
Ingen indgriben: Control
Standard curriculum physical education (90 minutes per week)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Body weight (kilograms)
Tidsramme: 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)
Tidsramme: Change over 2 years
Standardized assessments performed by trained personal.
Change over 2 years
Musculoskeletal problems (injuries, defined as inability to participate in sports)
Tidsramme: 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.
Total incidence of musculoskeletal problems across 2.5 years
Height (centimeters)
Tidsramme: Change over 2 years
Standardized assessments performed by trained personal using a stadiometer.
Change over 2 years
Body-mass index (kg/m^2)
Tidsramme: Change over 2 years
Calculated from measured height and weight
Change over 2 years
Waist circumference (centimeters)
Tidsramme: 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 (%)
Tidsramme: Change over 2 years
In subcohort only. Standardized assessments performed by trained personal.
Change over 2 years
Serum fasting insulin (IU/l)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Change over 2 years
Standardized assessments performed by trained personal
Change over 2 years
Resting diastolic blood pressure (mmHg)
Tidsramme: Change over 2 years
Standardized assessments performed by trained personal
Change over 2 years
Composite risk factor score (z-scores)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Change over 2.5 years
Maximal strength measured by a dynamometer. Standardized assessments performed by trained personal
Change over 2.5 years
Agility (seconds)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Change over 2.5 years
Standardized assessments performed by trained personal
Change over 2.5 years
Precision throw (0-30 points)
Tidsramme: Change over 2.5 years
From ''Der Allgemeiner Sportmotorischer Test fur Kinder von 6-11 Jahren''
Change over 2.5 years

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Physical activity determined objectively using waist-worn accelerometry. Participants will be asked to wear the monitors for at least one week.
Tidsramme: 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
Non-specific follow-up duration as multiple time-points are considered (follow-up at 2, 3.5 and 6.5 years)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Niels Wedderkopp, Prof, University of Southern Denmark

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. august 2008

Primær færdiggørelse (Faktiske)

1. juni 2015

Studieafslutning (Faktiske)

1. juni 2015

Datoer for studieregistrering

Først indsendt

12. april 2018

Først indsendt, der opfyldte QC-kriterier

26. april 2018

Først opslået (Faktiske)

27. april 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. april 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. april 2018

Sidst verificeret

1. april 2018

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • S-20080047

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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