NCT02012881

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
870

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 16, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

June 26, 2014

Status Verified

June 1, 2014

Enrollment Period

8 months

First QC Date

October 11, 2013

Last Update Submit

June 25, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Executive function accuracy

    Executive function (part of cognitive function) measured by a modified computer-based flanker-test

    Up to 8 months

Secondary Outcomes (5)

  • Academic achievement

    November 2013 -June 2014

  • Physical activity

    November 2013-June 2014

  • Aerobic fitness

    November 2013 - June 2014

  • Anthropometric measures

    November 2013 - June 2014

  • Questionnaire

    November 2013 - June 2014

Other Outcomes (1)

  • SMS tracking

    November 2013- June 2014

Study Arms (2)

Physical activity intervention

EXPERIMENTAL

60 minutes of physical activity on every school day

Behavioral: Physical activity intervention

Control

ACTIVE COMPARATOR

Usual practice

Behavioral: Usual practice

Interventions

Physical activity during recess, in academic subjects, active transportation and PA home work

Physical activity intervention
Usual practiceBEHAVIORAL

Normal curriculum

Control

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Sports Science and Clinical Biomechanics

Odense, 5230, Denmark

Location

Related Publications (2)

  • Tarp J, Domazet SL, Froberg K, Hillman CH, Andersen LB, Bugge A. Effectiveness of a School-Based Physical Activity Intervention on Cognitive Performance in Danish Adolescents: LCoMotion-Learning, Cognition and Motion - A Cluster Randomized Controlled Trial. PLoS One. 2016 Jun 24;11(6):e0158087. doi: 10.1371/journal.pone.0158087. eCollection 2016.

  • Bugge A, Tarp J, Ostergaard L, Domazet SL, Andersen LB, Froberg K. LCoMotion - Learning, Cognition and Motion; a multicomponent cluster randomized school-based intervention aimed at increasing learning and cognition - rationale, design and methods. BMC Public Health. 2014 Sep 18;14:967. doi: 10.1186/1471-2458-14-967.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post Doc

Study Record Dates

First Submitted

October 11, 2013

First Posted

December 16, 2013

Study Start

October 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

June 26, 2014

Record last verified: 2014-06

Locations