Physical ActivityNCT03436355
Active School. A School-based Intervention to Increase Childrens Daily Physical Activity Level.
A study testing Physical activity in people with Physical Activity and Aerobic Fitness, run by University of Stavanger.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Aerobic Fitness, Executive Function
- What is being tested?
- Physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 449 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- all children attending 5th grade at the included schools in Stavanger, Norway during the school-year 2014/2015.
Who cannot join
- not able to participate in daily physical activity and physical education and complete the cognitive tests.
About this study
Official title: 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.
- Conditions
- Physical Activity, Aerobic Fitness, Executive Function
- Being tested
- Physical activity
- Keywords
- Behavioral, Physical activity, Intervention, School children
- Medical subject headings
- Motor Activity, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity | Experimental | 60 minutes of daily physical activity (see intervention) Receives: Behavioral: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 months intervention
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
Measured: 8 months intervention
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.
Measured: 8 months intervention
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.
Measured: 8 months intervention
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.
Measured: 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.
Measured: 8 months intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study startAug 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 449 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Stavanger
- Sponsor type
- University, hospital or other
- Collaborators
- Municipality of Stavanger, Rogaland County Council, Regional Research Fund, Norway
- Responsible party
- Sponsor
- Investigators
- Elaine Munthe, PhD, Study chair, University of Stavanger
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436355
- Sponsor's protocol ID
- Prosjektnr NSD: 38509
- Status last verified
- Dec 2018
- First submitted
- 1 Feb 2018
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A plan to share data will be decided when all of the planned papers is published.
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 29510699Kvalo 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 28207976Seljebotn 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active School. A School-based Intervention to Increase Childrens Daily Physical Activity and Its Effect on Childrens Self-regulation
- ClinicalTrials.gov ID
- NCT03436355
- Acronym / sponsor ID
- Prosjektnr NSD: 38509
- Conditions
- Physical Activity, Aerobic Fitness, Executive Function
- Keywords
- Behavioral, Physical activity, Intervention, School children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 449 participants (actual)
- Lead sponsor
- University of StavangerUniversity, hospital or other
- Collaborators
- Municipality of Stavanger, Rogaland County Council, Regional Research Fund, Norway
- Study start
- Aug 2014 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical activity | Experimental | Behavioral: Physical activity60 minutes of daily physical activity (see intervention) |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- all children attending 5th grade at the included schools in Stavanger, Norway during the school-year 2014/2015.
Key exclusion criteria (1 listed)
- not able to participate in daily physical activity and physical education and complete the cognitive tests.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityThe "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. | Behavioural | Physical activity |
Primary outcome
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.
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
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.
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.
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.
1 secondary outcome
Self-regulation
Time frame: 8 months intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- Results publication: PubMed 29510699Dyrstad 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.
- Results publication: PubMed 28207976Kvalo 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.
- Derived from this study: PubMed 30656132Seljebotn 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.
- Individual participant dataSharing planned: Undecided. A plan to share data will be decided when all of the planned papers is published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elaine Munthe, PhD study chair
University of Stavanger
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Physical Activity and Aerobic Fitness, run by University of Stavanger.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inhibition (time frame: 8 months intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03436355, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2018.