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Trial record 1 of 1 for:    NCT03436355
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Active School. A School-based Intervention to Increase Childrens Daily Physical Activity Level.

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ClinicalTrials.gov Identifier: NCT03436355
Recruitment Status : Completed
First Posted : February 19, 2018
Last Update Posted : December 5, 2018
Sponsor:
Collaborators:
Municipality of Stavanger
Rogaland County Council
Regional Research Fund, Norway
Information provided by (Responsible Party):
University of Stavanger

Brief Summary:

This study seeks to explore whether increased physical activity in school affects children's executive function, aerobic Fitness and childrens self-regulation. The "Active school" study was a 10-month randomized controlled trial. The sample included 449 children (10-11 years old) in five intervention and four control schools. The weekly interventions were 2×45 minutes physically active academic lessons, 5×10 minutes physically active breaks, and 5×10 minutes physically active homework. Aerobic fitness was measured using a 10-minute interval running test. Executive function was tested using four cognitive tests (Stroop, verbal fluency, digit span, and Trail Making). A composite score for executive function was computed and used in analyses.

Self-regulation was measured by the Child Behavior Rating Scale.


Condition or disease Intervention/treatment Phase
Physical Activity Aerobic Fitness Executive Function Behavioral: Physical activity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 449 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Active School. A School-based Intervention to Increase Childrens Daily Physical Activity and Its Effect on Childrens Self-regulation
Actual Study Start Date : August 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Physical activity
60 minutes of daily physical activity (see intervention)
Behavioral: Physical activity
The "Active school" study was a 10-month randomized controlled trial.The weekly interventions were 2×45 minutes physically active academic lessons, 5×10 minutes physically active breaks, and 5×10 minutes physically active homework.




Primary Outcome Measures :
  1. Inhibition [ Time Frame: 8 months intervention ]
    Response inhibition was measured by Stroop Golden color-word test. Participants were naming the printed color of color words while suppressing the reading of the words. The measure was the number of words read in 45 Seconds.

  2. Working memory [ Time Frame: 8 months intervention ]

    Working memory was tested by the Wechsler Adult Intelligence Scale (WAIS)-IV-test, a forward and backward digit span, a test that measures working memory function. The measure was the length of the correct series of numbers repeated by the participant.

    was included


  3. Cognitive flexibility [ Time Frame: 8 months intervention ]
    Cognitive flexibility was tested by two tests. First the participants were asked to list all the animals they could think of in 60 seconds as fast as they could.The number of animals was the score. Second, participants performed the Trail Making test. This involves drawing a line connecting consecutive numbers from 1 to 25 as fast as possible. Then participants were drawing a similar line, connecting alternating numbers and letters in sequence, example: 1-A-2-B. Time to complete each "trail" was recorded.

  4. Aerobic fitness [ Time Frame: 8 months intervention ]

    Aerobic fitness was assessed by a 10-minute interval running test. The children ran back and forth between two lines placed 20 m apart, touching the ground behind the line with their hand every time they reversed direction.

    After 15 seconds, a teacher signaled stop and the children rested for 15 seconds before they once more ran for 15 seconds. This procedure lasted 10 minutes, and the running distance was the outcome measure.


  5. Physical activity [ Time Frame: 8 months intervention ]

    Physical activity was measured using accelerometry (ActiGraph GT1M/GT3X/GT3X+, LLC, Pensacola, Florida, USA).

    The children were asked to wear the accelerometer on the right hip for seven consecutive days, removing it only during water-based activities (e.g., swimming) and while sleeping. Data were considered valid if a child had at least two days with a wear time of ≥480 min/day accumulated between 06:00 and 24:00.



Secondary Outcome Measures :
  1. Self-regulation [ Time Frame: 8 months intervention ]
    Self-regulation was measured by the Child Behavior Rating Scale (CBRS). This is a teacher rating based on the Bronson Social Task and Skill Profile, designed to assess children's classroom goal-oriented behaviors and strategies used to regulate behavior in academic and social situations. The teacher report consisted of 10 items used to assess children's self-regulation in the classroom.



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Ages Eligible for Study:   8 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • all children attending 5th grade at the included schools in Stavanger, Norway during the school-year 2014/2015.

Exclusion Criteria:

  • not able to participate in daily physical activity and physical education and complete the cognitive tests.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03436355


Sponsors and Collaborators
University of Stavanger
Municipality of Stavanger
Rogaland County Council
Regional Research Fund, Norway
Investigators
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Study Chair: Elaine Munthe, PhD University of Stavanger
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Stavanger
ClinicalTrials.gov Identifier: NCT03436355    
Other Study ID Numbers: Prosjektnr NSD: 38509
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: A plan to share data will be decided when all of the planned papers is published.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Stavanger:
Behavioral
Physical activity
Intervention
School children