NCT03817047

Brief Summary

This study evaluates the effect of 120 minutes extra of physical education (PE) or physical activity (PA) on adolescents' physical health, mental health, academic performance and learning environment. This is a cluster-randomized controlled trial with three arms, where the participants in two of the groups will have different models of increased PE/PA during the school week, whereas the participants in the third arm is the control group including current practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,045

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

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

April 3, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed
Last Updated

January 28, 2019

Status Verified

January 1, 2019

Enrollment Period

1.2 years

First QC Date

January 14, 2019

Last Update Submit

January 25, 2019

Conditions

Physical ActivityAcademic AchievementMental Health

Keywords

AdolescentsPhysical activityPhysical fitnessAcademic performanceCluster RCTMental healthSecondary schoolPhysical educationPhysical active educational lessonsAccelerometer

Outcome Measures

Primary Outcomes (1)

  • Mean physical activity level

    The participants mean physical activity level measured by accelerometers

    Measured baseline and after 12 months

Secondary Outcomes (15)

  • Time spent in moderate-to-vigorous physical activity (MVPA)

    Measured baseline and after 12 months

  • Time spent sedentary

    Measured baseline and after 12 months

  • Sedentary behaviour

    Measured baseline and after 12 months

  • Upper limb strength

    Measured baseline and after 12 months

  • Explosive strength in the lower body

    Measured baseline and after 12 months

  • +10 more secondary outcomes

Other Outcomes (5)

  • Body mass index

    Measured baseline and after 12 months

  • Waist circumference

    Measured baseline and after 12 months

  • Satisfaction of basic psychological needs

    Measured baseline and after 12 months

  • +2 more other outcomes

Study Arms (3)

Physical active learning (PAL)

EXPERIMENTAL

Three components: 1. Physical education (60 minutes) 2. Physical active learning (30 minutes) 3. Physical activity (30 minutes)

Behavioral: Physical educationBehavioral: Physical active learningBehavioral: Physical activity

Don't worry - be happy

EXPERIMENTAL

Two components: 1. Physical education (60 minutes) - don't worry class 2. Physical activity (60 minutes) - be happy class

Behavioral: Physical educationBehavioral: Be happy

Control group

NO INTERVENTION

Current practice

Interventions

Physical educationBEHAVIORAL

Physical education (60 minutes): In addition to the ordinary PE-lessons. The pedagogical activities taught in this lesson should be in line with the curriculum of 9th grade and led by the PE-teacher. In the Don't worry - be happy intervention this class was also organized by the students. The students practiced their Be Happy-activities, or they introduced their class peers to their "Be Happy"-activity. A PE-teacher was present to support the students if necessary.

Also known as: PE-intervention
Don't worry - be happyPhysical active learning (PAL)
Physical active learningBEHAVIORAL

The curriculum of the subjects (i.e. maths, English, Norwegian) were taught in a physically active manner. The lesson should last 30 minutes and be led by the teacher of the current subject.

Physical active learning (PAL)
Physical activityBEHAVIORAL

Without a connection to any specific subject "Physical activity" should be performed as 30 minutes a week. There are no specific aims to be taught in this lesson, but physical activities that stimulates mastery, joy and well-being should be in focus.

Physical active learning (PAL)
Be happyBEHAVIORAL

The Be Happy classes were self-organized activity groups of at least three students, developed according to activity preferences across regular classes. The Be Happy groups practiced traditional sports and physical activities, lifestyle sports, dancing, out-door recreation, drama etc. - inside or outside school.

Don't worry - be happy

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects enrolled in 9th grade

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian School of Sport Sciences

Oslo, 0852, Norway

Location

Related Publications (8)

  • Malnes L, Haugen T, Nordbo ECA, Ivarsson A, Kolle E, Resaland GK, Solberg RB, Avitsland A, Berntsen S. Objectively measured environmental factors in relation to school travel mode among adolescents: a decision tree analysis. Int J Behav Nutr Phys Act. 2025 Mar 4;22(1):26. doi: 10.1186/s12966-025-01727-6.

    PMID: 40038743DERIVED

  • Malnes L, Berntsen S, Kolle E, Ivarsson A, Dyrstad SM, Resaland GK, Solberg R, Haugen T. School-based physical activity in relation to active travel - a cluster randomized controlled trial among adolescents enrolled in the school in motion study in Norway. Int J Behav Nutr Phys Act. 2023 Nov 21;20(1):136. doi: 10.1186/s12966-023-01534-x.

    PMID: 37990252DERIVED

  • Leibinger E, Avitsland A, Resaland GK, Solberg RB, Kolle E, Dyrstad SM. Relationship between health-related quality of life and physical fitness in Norwegian adolescents. Qual Life Res. 2023 Apr;32(4):1133-1141. doi: 10.1007/s11136-022-03309-6. Epub 2022 Dec 17.

    PMID: 36527570DERIVED

  • Malnes L, Haugen T, Hansen BH, Kolle E, Berntsen S. Establishing the Convergent Validity of the Travel Habit Questions in the Health Behavior in School-Aged Children Questionnaire by Quantifying Active Travel in Norwegian Adolescents. Front Sports Act Living. 2022 Apr 6;4:761723. doi: 10.3389/fspor.2022.761723. eCollection 2022.

    PMID: 35463834DERIVED

  • Neil-Sztramko SE, Caldwell H, Dobbins M. School-based physical activity programs for promoting physical activity and fitness in children and adolescents aged 6 to 18. Cochrane Database Syst Rev. 2021 Sep 23;9(9):CD007651. doi: 10.1002/14651858.CD007651.pub3.

    PMID: 34555181DERIVED

  • Solberg RB, Steene-Johannessen J, Anderssen SA, Ekelund U, Safvenbom R, Haugen T, Berntsen S, Avitsland A, Lerum O, Resaland GK, Kolle E. Effects of a school-based physical activity intervention on academic performance in 14-year old adolescents: a cluster randomized controlled trial - the School in Motion study. BMC Public Health. 2021 May 6;21(1):871. doi: 10.1186/s12889-021-10901-x.

    PMID: 33957895DERIVED

  • Kolle E, Solberg RB, Safvenbom R, Dyrstad SM, Berntsen S, Resaland GK, Ekelund U, Anderssen SA, Steene-Johannessen J, Grydeland M. The effect of a school-based intervention on physical activity, cardiorespiratory fitness and muscle strength: the School in Motion cluster randomized trial. Int J Behav Nutr Phys Act. 2020 Nov 26;17(1):154. doi: 10.1186/s12966-020-01060-0.

    PMID: 33243246DERIVED

  • Avitsland A, Leibinger E, Haugen T, Lerum O, Solberg RB, Kolle E, Dyrstad SM. The association between physical fitness and mental health in Norwegian adolescents. BMC Public Health. 2020 May 24;20(1):776. doi: 10.1186/s12889-020-08936-7.

    PMID: 32448149DERIVED

MeSH Terms

Conditions

Motor ActivityPsychological Well-Being

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorPersonal Satisfaction

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Elin Kolle, PhD

    Norwegian School of Sport Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This is a cluster-randomized trial with three parallel arms
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice rector

Study Record Dates

First Submitted

January 14, 2019

First Posted

January 25, 2019

Study Start

April 3, 2017

Primary Completion

June 22, 2018

Study Completion

June 22, 2018

Last Updated

January 28, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all primary and secondary outcome measures will be made available.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Data will be available within 24 months of study completion
Access Criteria
Data access will be reviewed by the study's publication group. Requestors will be required to sign a data access agreement

Locations

NO(1)