The Svendborg-project

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity, Childhood, Risk Factor, Cardiovascular, Sports Injury, Physical Activity, Motor Activity

Intervention / Treatment
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* Behavioral: Augmented physical education program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrolled at school participating in study Grade 0 - 4 written, informed consent provided by parent or legal guardian Exclusion Criteria:

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Trebling of weekly curricular physical education (270 minutes per week) | Behavioral: Augmented physical education program<br>* Augmented physical education program<br>|
| No Intervention: Control<br>Standard curriculum physical education (90 minutes per week) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight (kilograms) | Standardized assessments performed by trained personal using an electronic scale. | Change over 2 years | 
| Dual-energy X-ray absorptiometry (DXA) determined bone mineral content (grams) | Standardized assessments performed by trained personal. | Change over 2 years | 
| 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 | 
| Height (centimeters) | Standardized assessments performed by trained personal using a stadiometer. | Change over 2 years | 
| Body-mass index (kg/m^2) | Calculated from measured height and weight | Change over 2 years | 
| Waist circumference (centimeters) | Standardized assessments performed by trained personal at the level of the umbilical cord | Change over 2 years | 
| DXA determined body fat (%) | In subcohort only. Standardized assessments performed by trained personal. | Change over 2 years | 
| Serum fasting insulin (IU/l) | Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally. | Change over 2 years | 
| Serum fasting glucose (mmol/l) | Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally. | Change over 2 years | 
| Serum fasting triglycerides (mmol/l) | Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally. | Change over 2 years | 
| Serum fasting total cholesterol (mmol/l) | Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally. | Change over 2 years | 
| Serum fasting low-density lipoprotein cholesterol (mmol/l) | Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally. | Change over 2 years | 
| Serum fasting high-density lipoprotein cholesterol (mmol/l) | Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally. | Change over 2 years | 
| Serum fasting C-reactive protein (mg/l) | Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally. | Change over 2 years | 
| 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 | 
| Resting systolic blood pressure (mmHg) | Standardized assessments performed by trained personal | Change over 2 years | 
| Resting diastolic blood pressure (mmHg) | Standardized assessments performed by trained personal | Change over 2 years | 
| 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 | 
| Cardiorespiratory fitness (meters) | Performance on indirect cardiorespiratory fitness test (Andersen-test). Standardized assessments performed by trained personal | Change over 2 years | 
| Handgrip strength (kg) | Maximal strength measured by a dynamometer. Standardized assessments performed by trained personal | Change over 2.5 years | 
| Agility (seconds) | Measured by the 50 meter short-shuttle test. Standardized assessments performed by trained personal | Change over 2.5 years | 
| Backward balance (0-72 points) | From the Korperkoordinations Test fur Kinder. Standardized assessments performed by trained personal | Change over 2.5 years | 
| Maximal vertical jump performance (centimeters) | Standardized assessments performed by trained personal | Change over 2.5 years | 
| Precision throw (0-30 points) | From ''Der Allgemeiner Sportmotorischer Test fur Kinder von 6-11 Jahren'' | Change over 2.5 years |