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

Cognitive Function Clinical Trial

— LCoMotion  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02012881
• Other study ID #: S-20130104
• Status: Completed
• Phase: N/A
• First received: October 11, 2013
• Last updated: June 25, 2014
• Start date: October 2013
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 870
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 16 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cognitive Function

Intervention

Behavioral:
• Physical activity intervention
Physical activity during recess, in academic subjects, active transportation and PA home work
• Usual practice
Normal curriculum

Locations

Country	Name	City	State
Denmark	Institute of Sports Science and Clinical Biomechanics	Odense

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Denmark	The Danish Ministry of Education

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	SMS tracking	Asking questions on compliance with the intervention	November 2013- June 2014	No
Primary	Executive function accuracy	Executive function (part of cognitive function) measured by a modified computer-based flanker-test	Up to 8 months	No
Secondary	Academic achievement	A standardized math test	November 2013 -June 2014	No
Secondary	Physical activity	Measured with accelerometers for one week both pre- and post-intervention and supplemented with a questionnaire	November 2013-June 2014	No
Secondary	Aerobic fitness	Measured with an intermittent running test (Andersen test)	November 2013 - June 2014	No
Secondary	Anthropometric measures	Body height, body weight, waist circumference and puberty status (self-assessed)	November 2013 - June 2014	No
Secondary	Questionnaire	To students and parents. SES, family diseases, physical activity, sport participation	November 2013 - June 2014	No

External Links

•   Link about the project (only in Danish)