CHAMPS-DK: The Svendborg-project

Sponsor
University of Southern Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT03510494
Collaborator
University College Lillebælt (Other)
1,209
1
2
82
14.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Augmented physical education program
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
1209 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
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)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)
Primary Purpose:
Prevention
Official Title:
The Childhood Health, Activity, and Motor Performance School Study Denmark
Actual Study Start Date :
Aug 1, 2008
Actual Primary Completion Date :
Jun 1, 2015
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

Trebling of weekly curricular physical education (270 minutes per week)

Behavioral: Augmented physical education program
Augmented physical education program

No Intervention: Control

Standard curriculum physical education (90 minutes per week)

Outcome Measures

Primary Outcome Measures

  1. Body weight (kilograms) [Change over 2 years]

    Standardized assessments performed by trained personal using an electronic scale.

  2. Dual-energy X-ray absorptiometry (DXA) determined bone mineral content (grams) [Change over 2 years]

    Standardized assessments performed by trained personal.

  3. Musculoskeletal problems (injuries, defined as inability to participate in sports) [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.

  4. Height (centimeters) [Change over 2 years]

    Standardized assessments performed by trained personal using a stadiometer.

  5. Body-mass index (kg/m^2) [Change over 2 years]

    Calculated from measured height and weight

  6. Waist circumference (centimeters) [Change over 2 years]

    Standardized assessments performed by trained personal at the level of the umbilical cord

  7. DXA determined body fat (%) [Change over 2 years]

    In subcohort only. Standardized assessments performed by trained personal.

  8. Serum fasting insulin (IU/l) [Change over 2 years]

    Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.

  9. Serum fasting glucose (mmol/l) [Change over 2 years]

    Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.

  10. Serum fasting triglycerides (mmol/l) [Change over 2 years]

    Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.

  11. Serum fasting total cholesterol (mmol/l) [Change over 2 years]

    Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.

  12. Serum fasting low-density lipoprotein cholesterol (mmol/l) [Change over 2 years]

    Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.

  13. Serum fasting high-density lipoprotein cholesterol (mmol/l) [Change over 2 years]

    Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.

  14. Serum fasting C-reactive protein (mg/l) [Change over 2 years]

    Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.

  15. Homeostasis model assessment of insulin resistance (HOMA-IR) [Change over 2 years]

    Calculated as fasting insulin (IU/l) x fasting glucose (mmol/l))/ 22.5

  16. Resting systolic blood pressure (mmHg) [Change over 2 years]

    Standardized assessments performed by trained personal

  17. Resting diastolic blood pressure (mmHg) [Change over 2 years]

    Standardized assessments performed by trained personal

  18. Composite risk factor score (z-scores) [Change over 2 years]

    Standardized (z-scores) values of HOMA-IR, triglycerides, cholesterol-fractions, systolic blood pressure, and cardiorespiratory fitness

  19. Cardiorespiratory fitness (meters) [Change over 2 years]

    Performance on indirect cardiorespiratory fitness test (Andersen-test). Standardized assessments performed by trained personal

  20. Handgrip strength (kg) [Change over 2.5 years]

    Maximal strength measured by a dynamometer. Standardized assessments performed by trained personal

  21. Agility (seconds) [Change over 2.5 years]

    Measured by the 50 meter short-shuttle test. Standardized assessments performed by trained personal

  22. Backward balance (0-72 points) [Change over 2.5 years]

    From the "Korperkoordinations Test fur Kinder". Standardized assessments performed by trained personal

  23. Maximal vertical jump performance (centimeters) [Change over 2.5 years]

    Standardized assessments performed by trained personal

  24. Precision throw (0-30 points) [Change over 2.5 years]

    From ''Der Allgemeiner Sportmotorischer Test fur Kinder von 6-11 Jahren''

Other Outcome Measures

  1. Physical activity determined objectively using waist-worn accelerometry. Participants will be asked to wear the monitors for at least one week. [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 11 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Enrolled at school participating in study

  • Grade 0 - 4

  • written, informed consent provided by parent or legal guardian

Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Southern Denmark Odense Denmark 5230

Sponsors and Collaborators

  • University of Southern Denmark
  • University College Lillebælt

Investigators

  • Principal Investigator: Niels Wedderkopp, Prof, University of Southern Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT03510494
Other Study ID Numbers:
  • S-20080047
First Posted:
Apr 27, 2018
Last Update Posted:
Apr 27, 2018
Last Verified:
Apr 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2018