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OpenTrials
Completed

NCT Number: NCT03510494

The Svendborg-project

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.

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Key information

Conditions

Obesity, Childhood Athletic Injuries Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Physical Activity Risk Factor, Cardiovascular Signs and Symptoms Sports Injury Wounds and Injuries

Age range

5 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern Denmark

Odense, 5230, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

Augmented physical education program

Behavioral

Augmented physical education program

Primary outcomes

  1. Body weight (kilograms)

    Time frame: 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)

    Time frame: Change over 2 years

    Standardized assessments performed by trained personal.

  3. 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.

  4. Height (centimeters)

    Time frame: Change over 2 years

    Standardized assessments performed by trained personal using a stadiometer.

  5. Body-mass index (kg/m^2)

    Time frame: Change over 2 years

    Calculated from measured height and weight

  6. Waist circumference (centimeters)

    Time frame: Change over 2 years

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

  7. DXA determined body fat (%)

    Time frame: Change over 2 years

    In subcohort only. Standardized assessments performed by trained personal.

  8. Serum fasting insulin (IU/l)

    Time frame: Change over 2 years

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

  9. Serum fasting glucose (mmol/l)

    Time frame: Change over 2 years

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

  10. Serum fasting triglycerides (mmol/l)

    Time frame: Change over 2 years

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

  11. Serum fasting total cholesterol (mmol/l)

    Time frame: 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)

    Time frame: 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)

    Time frame: Change over 2 years

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

  14. 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.

  15. Homeostasis model assessment of insulin resistance (HOMA-IR)

    Time frame: Change over 2 years

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

  16. Resting systolic blood pressure (mmHg)

    Time frame: Change over 2 years

    Standardized assessments performed by trained personal

  17. Resting diastolic blood pressure (mmHg)

    Time frame: Change over 2 years

    Standardized assessments performed by trained personal

  18. 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

  19. Cardiorespiratory fitness (meters)

    Time frame: Change over 2 years

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

  20. Handgrip strength (kg)

    Time frame: Change over 2.5 years

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

  21. Agility (seconds)

    Time frame: 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)

    Time frame: Change over 2.5 years

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

  23. Maximal vertical jump performance (centimeters)

    Time frame: Change over 2.5 years

    Standardized assessments performed by trained personal

  24. Precision throw (0-30 points)

    Time frame: Change over 2.5 years

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

Other outcomes

  1. 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)

    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

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • University College Lillebælt

Registry information

Official study title

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

Acronym: CHAMPS-DK

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Apr 27, 2018
Registry last updated
Apr 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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