LCoMotion. Learning, Cognition and Motion. Effect of a Four Month School-based Cluster-randomized Intervention (LCoMotion)

June 25, 2014 updated by: Anna Bugge, Post Doc, University of Southern Denmark
The purpose of this study is to determine the effect of a four months school-based physical activity intervention on cognition, academic achievement, physical activity and aerobic fitness in 12-15 year old adolescents.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

870

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

  • Denmark
      • Odense, Denmark, 5230
        • Institute of Sports Science and Clinical Biomechanics

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

12 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • six or seventh grader in a Danish public school
  • participating in normal math lessons

Exclusion Criteria:

  • private school
  • receiving extra math lessons because of special needs

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physical activity intervention
60 minutes of physical activity on every school day
Behavioral: Physical activity intervention
Physical activity during recess, in academic subjects, active transportation and PA home work
Active Comparator: Control
Usual practice
Behavioral: Usual practice
Normal curriculum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Executive function accuracy
Time Frame: Up to 8 months
Executive function (part of cognitive function) measured by a modified computer-based flanker-test
Up to 8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Academic achievement
Time Frame: November 2013 -June 2014
A standardized math test
November 2013 -June 2014
Physical activity
Time Frame: November 2013-June 2014
Measured with accelerometers for one week both pre- and post-intervention and supplemented with a questionnaire
November 2013-June 2014
Aerobic fitness
Time Frame: November 2013 - June 2014
Measured with an intermittent running test (Andersen test)
November 2013 - June 2014
Anthropometric measures
Time Frame: November 2013 - June 2014
Body height, body weight, waist circumference and puberty status (self-assessed)
November 2013 - June 2014
Questionnaire
Time Frame: November 2013 - June 2014
To students and parents. SES, family diseases, physical activity, sport participation
November 2013 - June 2014

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
SMS tracking
Time Frame: November 2013- June 2014
Asking questions on compliance with the intervention
November 2013- June 2014

Collaborators and Investigators

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

Sponsor

University of Southern Denmark

Collaborators

Ministry of Education, 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

October 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

October 11, 2013

First Submitted That Met QC Criteria

December 10, 2013

First Posted (Estimate)

December 16, 2013

Study Record Updates

Last Update Posted (Estimate)

June 26, 2014

Last Update Submitted That Met QC Criteria

June 25, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • S-20130104

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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