- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03436355
Active School. A School-based Intervention to Increase Childrens Daily Physical Activity Level.
Active School. A School-based Intervention to Increase Childrens Daily Physical Activity and Its Effect on Childrens Self-regulation
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Physical activity
60 minutes of daily physical activity (see intervention)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
8 months intervention
|
|
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 |
8 months intervention
|
|
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.
|
8 months intervention
|
|
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. |
8 months intervention
|
|
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. |
8 months intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
8 months intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Elaine Munthe, PhD, University of Stavanger
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Prosjektnr NSD: 38509
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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