Back to resultsThe Svendborg-project (CHAMPS-DK)
Primary Purpose
Obesity, Childhood, Risk Factor, Cardiovascular, Sports Injury
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Augmented physical education program
Sponsored by
About this trial
This is an interventional prevention trial for Obesity, Childhood
Eligibility Criteria
Inclusion Criteria:
- Enrolled at school participating in study
- Grade 0 - 4
- written, informed consent provided by parent or legal guardian
Exclusion Criteria:
Sites / Locations
- University of Southern Denmark
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Trebling of weekly curricular physical education (270 minutes per week)
Standard curriculum physical education (90 minutes per week)
Outcomes
Primary Outcome Measures
Body weight (kilograms)
Standardized assessments performed by trained personal using an electronic scale.
Dual-energy X-ray absorptiometry (DXA) determined bone mineral content (grams)
Standardized assessments performed by trained personal.
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.
Height (centimeters)
Standardized assessments performed by trained personal using a stadiometer.
Body-mass index (kg/m^2)
Calculated from measured height and weight
Waist circumference (centimeters)
Standardized assessments performed by trained personal at the level of the umbilical cord
DXA determined body fat (%)
In subcohort only. Standardized assessments performed by trained personal.
Serum fasting insulin (IU/l)
Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.
Serum fasting glucose (mmol/l)
Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.
Serum fasting triglycerides (mmol/l)
Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.
Serum fasting total cholesterol (mmol/l)
Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.
Serum fasting low-density lipoprotein cholesterol (mmol/l)
Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.
Serum fasting high-density lipoprotein cholesterol (mmol/l)
Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.
Serum fasting C-reactive protein (mg/l)
Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.
Homeostasis model assessment of insulin resistance (HOMA-IR)
Calculated as fasting insulin (IU/l) x fasting glucose (mmol/l))/ 22.5
Resting systolic blood pressure (mmHg)
Standardized assessments performed by trained personal
Resting diastolic blood pressure (mmHg)
Standardized assessments performed by trained personal
Composite risk factor score (z-scores)
Standardized (z-scores) values of HOMA-IR, triglycerides, cholesterol-fractions, systolic blood pressure, and cardiorespiratory fitness
Cardiorespiratory fitness (meters)
Performance on indirect cardiorespiratory fitness test (Andersen-test). Standardized assessments performed by trained personal
Handgrip strength (kg)
Maximal strength measured by a dynamometer. Standardized assessments performed by trained personal
Agility (seconds)
Measured by the 50 meter short-shuttle test. Standardized assessments performed by trained personal
Backward balance (0-72 points)
From the "Korperkoordinations Test fur Kinder". Standardized assessments performed by trained personal
Maximal vertical jump performance (centimeters)
Standardized assessments performed by trained personal
Precision throw (0-30 points)
From ''Der Allgemeiner Sportmotorischer Test fur Kinder von 6-11 Jahren''
Secondary Outcome Measures
Full Information
NCT ID
NCT03510494
First Posted
April 12, 2018
Last Updated
April 26, 2018
Sponsor
University of Southern Denmark
Collaborators
University College Lillebælt
1. Study Identification
Unique Protocol Identification Number
NCT03510494
Brief Title
The Svendborg-project
Acronym
CHAMPS-DK
Official Title
The Childhood Health, Activity, and Motor Performance School Study Denmark
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
August 2008 (Actual)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern Denmark
Collaborators
University College Lillebælt
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood, Risk Factor, Cardiovascular, Sports Injury, Physical Activity, Motor Activity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1209 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Trebling of weekly curricular physical education (270 minutes per week)
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard curriculum physical education (90 minutes per week)
Intervention Type
Behavioral
Intervention Name(s)
Augmented physical education program
Intervention Description
Augmented physical education program
Primary Outcome Measure Information:
Title
Body weight (kilograms)
Description
Standardized assessments performed by trained personal using an electronic scale.
Time Frame
Change over 2 years
Title
Dual-energy X-ray absorptiometry (DXA) determined bone mineral content (grams)
Description
Standardized assessments performed by trained personal.
Time Frame
Change over 2 years
Title
Musculoskeletal problems (injuries, defined as inability to participate in sports)
Description
Weekly short-message-service tracking of participants to determine severity, frequency and nature (acute/overuse) of injuries.
Time Frame
Total incidence of musculoskeletal problems across 2.5 years
Title
Height (centimeters)
Description
Standardized assessments performed by trained personal using a stadiometer.
Time Frame
Change over 2 years
Title
Body-mass index (kg/m^2)
Description
Calculated from measured height and weight
Time Frame
Change over 2 years
Title
Waist circumference (centimeters)
Description
Standardized assessments performed by trained personal at the level of the umbilical cord
Time Frame
Change over 2 years
Title
DXA determined body fat (%)
Description
In subcohort only. Standardized assessments performed by trained personal.
Time Frame
Change over 2 years
Title
Serum fasting insulin (IU/l)
Description
Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.
Time Frame
Change over 2 years
Title
Serum fasting glucose (mmol/l)
Description
Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.
Time Frame
Change over 2 years
Title
Serum fasting triglycerides (mmol/l)
Description
Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.
Time Frame
Change over 2 years
Title
Serum fasting total cholesterol (mmol/l)
Description
Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.
Time Frame
Change over 2 years
Title
Serum fasting low-density lipoprotein cholesterol (mmol/l)
Description
Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.
Time Frame
Change over 2 years
Title
Serum fasting high-density lipoprotein cholesterol (mmol/l)
Description
Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.
Time Frame
Change over 2 years
Title
Serum fasting C-reactive protein (mg/l)
Description
Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.
Time Frame
Change over 2 years
Title
Homeostasis model assessment of insulin resistance (HOMA-IR)
Description
Calculated as fasting insulin (IU/l) x fasting glucose (mmol/l))/ 22.5
Time Frame
Change over 2 years
Title
Resting systolic blood pressure (mmHg)
Description
Standardized assessments performed by trained personal
Time Frame
Change over 2 years
Title
Resting diastolic blood pressure (mmHg)
Description
Standardized assessments performed by trained personal
Time Frame
Change over 2 years
Title
Composite risk factor score (z-scores)
Description
Standardized (z-scores) values of HOMA-IR, triglycerides, cholesterol-fractions, systolic blood pressure, and cardiorespiratory fitness
Time Frame
Change over 2 years
Title
Cardiorespiratory fitness (meters)
Description
Performance on indirect cardiorespiratory fitness test (Andersen-test). Standardized assessments performed by trained personal
Time Frame
Change over 2 years
Title
Handgrip strength (kg)
Description
Maximal strength measured by a dynamometer. Standardized assessments performed by trained personal
Time Frame
Change over 2.5 years
Title
Agility (seconds)
Description
Measured by the 50 meter short-shuttle test. Standardized assessments performed by trained personal
Time Frame
Change over 2.5 years
Title
Backward balance (0-72 points)
Description
From the "Korperkoordinations Test fur Kinder". Standardized assessments performed by trained personal
Time Frame
Change over 2.5 years
Title
Maximal vertical jump performance (centimeters)
Description
Standardized assessments performed by trained personal
Time Frame
Change over 2.5 years
Title
Precision throw (0-30 points)
Description
From ''Der Allgemeiner Sportmotorischer Test fur Kinder von 6-11 Jahren''
Time Frame
Change over 2.5 years
Other Pre-specified Outcome Measures:
Title
Physical activity determined objectively using waist-worn accelerometry. Participants will be asked to wear the monitors for at least one week.
Description
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
Time Frame
Non-specific follow-up duration as multiple time-points are considered (follow-up at 2, 3.5 and 6.5 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Enrolled at school participating in study
Grade 0 - 4
written, informed consent provided by parent or legal guardian
Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels Wedderkopp, Prof
Organizational Affiliation
University of Southern Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern Denmark
City
Odense
ZIP/Postal Code
5230
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
22906115
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.
Results Reference
background
PubMed Identifier
28087543
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.
Results Reference
background
PubMed Identifier
28027935
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.
Results Reference
background
PubMed Identifier
26262678
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.
Results Reference
background
PubMed Identifier
25539855
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.
Results Reference
background
PubMed Identifier
25539477
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.
Results Reference
background
PubMed Identifier
24397591
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.
Results Reference
background
PubMed Identifier
25248973
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.
Results Reference
result
PubMed Identifier
23643934
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.
Results Reference
result
PubMed Identifier
24131778
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.
Results Reference
result
PubMed Identifier
24055828
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.
Results Reference
result
PubMed Identifier
24472003
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.
Results Reference
result
PubMed Identifier
29739385
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.
Results Reference
derived
Learn more about this trial
The Svendborg-project
We'll reach out to this number within 24 hrs