Clinical trial NCT03510494: The Svendborg-project
Official title: The Childhood Health, Activity, and Motor Performance School Study Denmark
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Risk Factor, Cardiovascular
Sports Injury
Physical Activity
Motor Activity
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: University College Lillebælt
First posted: 2018-04-27
Enrollment: 1209
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group receiving 270 minutes of weekly physical education Control group receiving 90 minutes of weekly physical education Intervention group physical education teachers receiving physical education courses (ATK-concept)
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Primary outcomes:
measure: Body weight (kilograms)
timeFrame: Change over 2 years
measure: Dual-energy X-ray absorptiometry (DXA) determined bone mineral content (grams)
timeFrame: Change over 2 years
measure: Musculoskeletal problems (injuries, defined as inability to participate in sports)
timeFrame: Total incidence of musculoskeletal problems across 2.5 years
measure: Height (centimeters)
timeFrame: Change over 2 years
measure: Body-mass index (kg/m^2)
timeFrame: Change over 2 years
measure: Waist circumference (centimeters)
timeFrame: Change over 2 years
measure: DXA determined body fat (%)
timeFrame: Change over 2 years
measure: Serum fasting insulin (IU/l)
timeFrame: Change over 2 years
measure: Serum fasting glucose (mmol/l)
timeFrame: Change over 2 years
measure: Serum fasting triglycerides (mmol/l)
timeFrame: Change over 2 years
measure: Serum fasting total cholesterol (mmol/l)
timeFrame: Change over 2 years
measure: Serum fasting low-density lipoprotein cholesterol (mmol/l)
timeFrame: Change over 2 years
measure: Serum fasting high-density lipoprotein cholesterol (mmol/l)
timeFrame: Change over 2 years
measure: Serum fasting C-reactive protein (mg/l)
timeFrame: Change over 2 years
measure: Homeostasis model assessment of insulin resistance (HOMA-IR)
timeFrame: Change over 2 years
measure: Resting systolic blood pressure (mmHg)
timeFrame: Change over 2 years
measure: Resting diastolic blood pressure (mmHg)
timeFrame: Change over 2 years
measure: Composite risk factor score (z-scores)
timeFrame: Change over 2 years
measure: Cardiorespiratory fitness (meters)
timeFrame: Change over 2 years
measure: Handgrip strength (kg)
timeFrame: Change over 2.5 years
measure: Agility (seconds)
timeFrame: Change over 2.5 years
measure: Backward balance (0-72 points)
timeFrame: Change over 2.5 years
measure: Maximal vertical jump performance (centimeters)
timeFrame: Change over 2.5 years
measure: Precision throw (0-30 points)
timeFrame: Change over 2.5 years
Secondary outcomes:
Other outcomes:
measure: Physical activity determined objectively using waist-worn accelerometry. Participants will be asked to wear the monitors for at least one week.
timeFrame: Non-specific follow-up duration as multiple time-points are considered (follow-up at 2, 3.5 and 6.5 years)
Locations:
city: Odense
country: Denmark
facility: University of Southern Denmark
Study officials:
affiliation: University of Southern Denmark
name: Niels Wedderkopp, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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.
citation: 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.
citation: 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.
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.
citation: 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.
citation: 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.
citation: 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.
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: 10.1186/1471-2431-13-170.
citation: 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.
citation: 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.
citation: 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.