The Svendborg-project (CHAMPS-DK)

April 26, 2018 updated by: University of Southern Denmark

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

1209

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Odense, Denmark, 5230
        • University of Southern Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 11 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Trebling of weekly curricular physical education (270 minutes per week)
Augmented physical education program
No Intervention: Control
Standard curriculum physical education (90 minutes per week)

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Non-specific follow-up duration as multiple time-points are considered (follow-up at 2, 3.5 and 6.5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2008

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

April 12, 2018

First Submitted That Met QC Criteria

April 26, 2018

First Posted (Actual)

April 27, 2018

Study Record Updates

Last Update Posted (Actual)

April 27, 2018

Last Update Submitted That Met QC Criteria

April 26, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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