- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03510494
The Svendborg-project (CHAMPS-DK)
April 26, 2018 updated by: 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1209
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Odense, Denmark, 5230
- University of Southern Denmark
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 11 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Enrolled at school participating in study
- Grade 0 - 4
- written, informed consent provided by parent or legal guardian
Exclusion Criteria:
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Trebling of weekly curricular physical education (270 minutes per week)
|
Augmented physical education program
|
No Intervention: Control
Standard curriculum physical education (90 minutes per week)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body weight (kilograms)
Time Frame: 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)
Time Frame: Change over 2 years
|
Standardized assessments performed by trained personal.
|
Change over 2 years
|
Musculoskeletal problems (injuries, defined as inability to participate in sports)
Time Frame: 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)
Time Frame: Change over 2 years
|
Standardized assessments performed by trained personal using a stadiometer.
|
Change over 2 years
|
Body-mass index (kg/m^2)
Time Frame: Change over 2 years
|
Calculated from measured height and weight
|
Change over 2 years
|
Waist circumference (centimeters)
Time Frame: 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 (%)
Time Frame: Change over 2 years
|
In subcohort only.
Standardized assessments performed by trained personal.
|
Change over 2 years
|
Serum fasting insulin (IU/l)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: Change over 2 years
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Calculated as fasting insulin (IU/l) x fasting glucose (mmol/l))/ 22.5
|
Change over 2 years
|
Resting systolic blood pressure (mmHg)
Time Frame: Change over 2 years
|
Standardized assessments performed by trained personal
|
Change over 2 years
|
Resting diastolic blood pressure (mmHg)
Time Frame: Change over 2 years
|
Standardized assessments performed by trained personal
|
Change over 2 years
|
Composite risk factor score (z-scores)
Time Frame: Change over 2 years
|
Standardized (z-scores) values of HOMA-IR, triglycerides, cholesterol-fractions, systolic blood pressure, and cardiorespiratory fitness
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Change over 2 years
|
Cardiorespiratory fitness (meters)
Time Frame: 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)
Time Frame: 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
|
Agility (seconds)
Time Frame: Change over 2.5 years
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Measured by the 50 meter short-shuttle test.
Standardized assessments performed by trained personal
|
Change over 2.5 years
|
Backward balance (0-72 points)
Time Frame: 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
|
Maximal vertical jump performance (centimeters)
Time Frame: Change over 2.5 years
|
Standardized assessments performed by trained personal
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Change over 2.5 years
|
Precision throw (0-30 points)
Time Frame: 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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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical activity determined objectively using waist-worn accelerometry. Participants will be asked to wear the monitors for at least one week.
Time Frame: 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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Niels Wedderkopp, Prof, University of Southern Denmark
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2008
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
April 12, 2018
First Submitted That Met QC Criteria
April 26, 2018
First Posted (Actual)
April 27, 2018
Study Record Updates
Last Update Posted (Actual)
April 27, 2018
Last Update Submitted That Met QC Criteria
April 26, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S-20080047
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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