The Svendborg-project

Physical Activity Clinical Trial

— CHAMPS-DK  

Official title:

The Childhood Health, Activity, and Motor Performance School Study Denmark

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03510494
• Other study ID #: S-20080047
• Status: Completed
• Phase: N/A
• First received: April 12, 2018
• Last updated: April 26, 2018
• Start date: August 2008
• Est. completion date: June 2015

Study information

• Verified date: April 2018
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1209
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 11 Years

Eligibility

Inclusion Criteria:

• Enrolled at school participating in study

• Grade 0 - 4

• written, informed consent provided by parent or legal guardian

Exclusion Criteria:

Related Conditions & MeSH terms

• Athletic Injuries
• Motor Activity
• Obesity, Childhood
• Pediatric Obesity
• Physical Activity
• Risk Factor, Cardiovascular
• Sports Injury

Intervention

Behavioral:
• Augmented physical education program
Augmented physical education program

Locations

Country	Name	City	State
Denmark	University of Southern Denmark	Odense

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Denmark	University College Lillebælt

Country where clinical trial is conducted

Denmark, 

References & Publications (12)

Chéron 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. — View Citation

Hebert JJ, Møller 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. — View Citation

Heidemann M, Holst R, Schou AJ, Klakk H, Husby S, Wedderkopp N, Mølgaard 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. — View Citation

Heidemann M, Jespersen E, Holst R, Schou AJ, Husby S, Mølgaard 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 Performanc — View Citation

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. — View Citation

Jespersen E, Rexen CT, Franz C, Møller 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 J — View Citation

Klakk H, Andersen LB, Heidemann M, Møller 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: 10.1177/140349481 — View Citation

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: 10.1186/1 — View Citation

Klakk H, Grøntved A, Møller 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. — View Citation

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. — View Citation

Møller NC, Tarp J, Kamelarczyk EF, Brønd 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-s — View Citation

Wedderkopp N, Jespersen E, Franz C, Klakk H, Heidemann M, Christiansen C, Møller 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical activity determined objectively using waist-worn accelerometry. Participants will be asked to wear the monitors for at least one week.	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)
Primary	Body weight (kilograms)	Standardized assessments performed by trained personal using an electronic scale.	Change over 2 years
Primary	Dual-energy X-ray absorptiometry (DXA) determined bone mineral content (grams)	Standardized assessments performed by trained personal.	Change over 2 years
Primary	Musculoskeletal problems (injuries, defined as inability to participate in sports)	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
Primary	Height (centimeters)	Standardized assessments performed by trained personal using a stadiometer.	Change over 2 years
Primary	Body-mass index (kg/m^2)	Calculated from measured height and weight	Change over 2 years
Primary	Waist circumference (centimeters)	Standardized assessments performed by trained personal at the level of the umbilical cord	Change over 2 years
Primary	DXA determined body fat (%)	In subcohort only. Standardized assessments performed by trained personal.	Change over 2 years
Primary	Serum fasting insulin (IU/l)	Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.	Change over 2 years
Primary	Serum fasting glucose (mmol/l)	Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.	Change over 2 years
Primary	Serum fasting triglycerides (mmol/l)	Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.	Change over 2 years
Primary	Serum fasting total cholesterol (mmol/l)	Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.	Change over 2 years
Primary	Serum fasting low-density lipoprotein cholesterol (mmol/l)	Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.	Change over 2 years
Primary	Serum fasting high-density lipoprotein cholesterol (mmol/l)	Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.	Change over 2 years
Primary	Serum fasting C-reactive protein (mg/l)	Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.	Change over 2 years
Primary	Homeostasis model assessment of insulin resistance (HOMA-IR)	Calculated as fasting insulin (IU/l) x fasting glucose (mmol/l))/ 22.5	Change over 2 years
Primary	Resting systolic blood pressure (mmHg)	Standardized assessments performed by trained personal	Change over 2 years
Primary	Resting diastolic blood pressure (mmHg)	Standardized assessments performed by trained personal	Change over 2 years
Primary	Composite risk factor score (z-scores)	Standardized (z-scores) values of HOMA-IR, triglycerides, cholesterol-fractions, systolic blood pressure, and cardiorespiratory fitness	Change over 2 years
Primary	Cardiorespiratory fitness (meters)	Performance on indirect cardiorespiratory fitness test (Andersen-test). Standardized assessments performed by trained personal	Change over 2 years
Primary	Handgrip strength (kg)	Maximal strength measured by a dynamometer. Standardized assessments performed by trained personal	Change over 2.5 years
Primary	Agility (seconds)	Measured by the 50 meter short-shuttle test. Standardized assessments performed by trained personal	Change over 2.5 years
Primary	Backward balance (0-72 points)	From the "Korperkoordinations Test fur Kinder". Standardized assessments performed by trained personal	Change over 2.5 years
Primary	Maximal vertical jump performance (centimeters)	Standardized assessments performed by trained personal	Change over 2.5 years
Primary	Precision throw (0-30 points)	From ''Der Allgemeiner Sportmotorischer Test fur Kinder von 6-11 Jahren''	Change over 2.5 years