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CompletedNCT03436355Updated Dec 5, 2018

Active School. A School-based Intervention to Increase Childrens Daily Physical Activity Level.

An interventional study of Physical activity in Physical Activity, Aerobic Fitness and Executive Function, sponsored by University of Stavanger. Completed. Open to participants aged 8 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-05.

Sponsored by University of Stavanger · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
449
Allocation
Not applicable
Ages
8 Years to 11 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Physical Activity
  • Aerobic Fitness
  • Executive Function

Keywords

  • Behavioral
  • Physical activity
  • Intervention
  • School children
03

Who can participate

Ages eligible
8 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • not able to participate in daily physical activity and physical education and complete the cognitive tests.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
449 participants (actual)

Study arms

  • Experimental
    Physical activity

    60 minutes of daily physical activity (see intervention)

    Behavioral: Physical activity

Interventions

  • BehavioralPhysical 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.

05

What researchers measure

Primary outcomes

  1. Inhibition

    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.

    Time frame: 8 months intervention

  2. Working memory

    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

    Time frame: 8 months intervention

  3. Cognitive flexibility

    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.

    Time frame: 8 months intervention

  4. Aerobic fitness

    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.

    Time frame: 8 months intervention

  5. Physical activity

    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.

    Time frame: 8 months intervention

Secondary outcomes

  1. Self-regulation

    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.

    Time frame: 8 months intervention

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Dyrstad SM, Kvalo SE, Alstveit M, Skage I. Physically active academic lessons: acceptance, barriers and facilitators for implementation. BMC Public Health. 2018 Mar 6;18(1):322. doi: 10.1186/s12889-018-5205-3. PubMed 29510699 ↗
  • Kvalo SE, Bru E, Bronnick K, Dyrstad SM. Does increased physical activity in school affect children's executive function and aerobic fitness? Scand J Med Sci Sports. 2017 Dec;27(12):1833-1841. doi: 10.1111/sms.12856. Epub 2017 Mar 16. PubMed 28207976 ↗
  • Seljebotn PH, Skage I, Riskedal A, Olsen M, Kvalo SE, Dyrstad SM. Physically active academic lessons and effect on physical activity and aerobic fitness. The Active School study: A cluster randomized controlled trial. Prev Med Rep. 2018 Dec 28;13:183-188. doi: 10.1016/j.pmedr.2018.12.009. eCollection 2019 Mar. PubMed 30656132 ↗

Individual participant data

Plan to share: Undecided — A plan to share data will be decided when all of the planned papers is published.

08

Registry details

Key details

Study ID
NCT03436355
Lead sponsor
University of Stavanger
Collaborators
Municipality of Stavanger, Rogaland County Council, Regional Research Fund, Norway
Responsible party
Sponsor
First posted
Feb 19, 2018
Start date
Aug 2014
Primary completion
Jun 2015
Completion
Jun 2015
Last update
Dec 5, 2018

Study contacts

Elaine Munthe, PhD
study chair · University of Stavanger

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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