- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03817047
The Effect of Increased Physical Activity on Adolescents' Health and Academic Performance: The School in Motion Study (ScIM)
A Cluster-randomized Controlled Trial Evaluating the Effect of Increased Physical Education and Physical Activity on Adolescents' Physical and Mental Health, Academic Performance and Learning Environment
Study Overview
Status
Conditions
Detailed Description
This is a school-based, three-arm cluster randomized controlled trial (RCT) recruiting adolescents from secondary schools in Norway. Adolescents (aged 14-15 years) were the unit of analysis, and schools (clusters) were randomly assigned to one of three conditions:
- the physical active learning group (PAL-group), where the schools each week include one additional physical education (PE) lesson, 30 minutes of physical active learning, and 30 minutes of physical activity (intervention condition);
- the don't worry - be happy group (DWBH-group), where the schools include one new activity class (60 minutes: Be Happy class) and one additional PE-class (60 minutes: Don't Worry class) per week (intervention condition);or
- current practice (control condition). An identical set of outcome measures are taken from all participants at baseline, and approximately 12 months after the baseline measures, when the participants were at the end of year 9
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Oslo, Norway, 0852
- Norwegian School of Sport Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects enrolled in 9th grade
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Physical active learning (PAL)
Three components:
|
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.
Other Names:
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.
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.
|
EXPERIMENTAL: Don't worry - be happy
Two components:
|
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.
Other Names:
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.
|
NO_INTERVENTION: Control group
Current practice
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean physical activity level
Time Frame: Measured baseline and after 12 months
|
The participants mean physical activity level measured by accelerometers
|
Measured baseline and after 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time spent in moderate-to-vigorous physical activity (MVPA)
Time Frame: Measured baseline and after 12 months
|
Mean minutes spent in MVPA per day
|
Measured baseline and after 12 months
|
Time spent sedentary
Time Frame: Measured baseline and after 12 months
|
Mean minutes spent sedentary each day, measured both objectively using accelerometers
|
Measured baseline and after 12 months
|
Sedentary behaviour
Time Frame: Measured baseline and after 12 months
|
Self-reported in a questionnaire.
There are questions related to minutes spent in front of a screen.
The answers are categorized into seven alternatives ranging from "No time at all" to "More than 6 hours per day".
There are also questions about which screen activity they perform.
The answers are categorized into six alternatives ranging from "No time at all" to "More than 3 hours per day".
There are also questions about time spent doing homework.
The answers are categorized into nine alternatives ranging from "No time at all" to " More than 7 hours per day".
|
Measured baseline and after 12 months
|
Upper limb strength
Time Frame: Measured baseline and after 12 months
|
Handgrip strength using a hand dynamometer.
The participants will use the dominant hand, with the arm completely extended and squeeze the dynamometer with maximum isometric effort, for about 2-3 seconds.
|
Measured baseline and after 12 months
|
Explosive strength in the lower body
Time Frame: Measured baseline and after 12 months
|
Standing broad jump.
The participants will stand behind a line with feet slightly apart.
They will be instructed to perform a two-foot take-off and landing, and to jump as far as possible, landing on both feet without falling backwards.
The distance from the take-off line to the nearest point of contact on the landing (back of the heels) will be measured, and the better of two attempts will be used for analyses.
|
Measured baseline and after 12 months
|
Abdominal muscle endurance
Time Frame: Measured baseline and after 12 months
|
Abdominal muscular endurance will be measured by a sit-up test.
The participant will start in a lying position with hands clasped behind the neck, knees bent at a 45° angle with the heels and feet flat on the floor and held down by the tester.
The subject then rise to a position with the elbows pointed forward until they touched the knees.
The total number of correctly performed and completed sit-ups within 30 seconds is counted.
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Measured baseline and after 12 months
|
Cardiorespiratory fitness
Time Frame: Measured baseline and after 12 months
|
Intermittent running test.
Participants run for 10 minutes, and the distance covered (in meters) is recorded.
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Measured baseline and after 12 months
|
Academic performance in reading
Time Frame: Measured baseline and after 9 months
|
Specific standardized Norwegian National tests in reading.The test is designed and administrated by The Norwegian Directorate for Education and Training.
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Measured baseline and after 9 months
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Academic performance in numeracy
Time Frame: Measured baseline and after 9 months
|
Specific standardized Norwegian National tests in numeracy.
The test is designed and administrated by The Norwegian Directorate for Education and Training.
|
Measured baseline and after 9 months
|
Overall psychosocial problems and strengths
Time Frame: Measured baseline and after 12 months
|
Assessed with the Strength and Difficulties Questionnaire (SDQ). This is a short screening instrument consisting of 25 items equally divided across five scales measuring emotional symptoms, conduct problems, hyperactivity-inattention, peer problems, and prosocial behavior. Each statement is answered as "Not true", "Somewhat true" and "Certainly true". Some questions have reversed form, which is reversed in the scoring of the instrument. Replies were scored from 0 to 2, and the subscales are summed to a score ranging from 0-10 for each subscale. Added together, the first four scores generate a total difficulties score, ranging from 0 to 40. Higher scores indicate more problems. |
Measured baseline and after 12 months
|
Adolescents' subjective health and well-being
Time Frame: Measured baseline and after 12 months
|
Adolescent's subjective health and well-being is assessed using the Kidscreen-27 questionnaire. The instrument consists of 27 items covering the following five quality of life dimensions: 1) physical well-being (5 items), 2) psychological well-being (7 items), 3) parents/guardians relations & autonomy (7 items), 4) social support & peers (4 items), and 5) school environment (5 items). The questions are answered on a 5-point likert scale. Scores can be created for each of the five dimensions. The methodology given in the developers manual will be used to obtain the T-scores; mean (±SD) scores of 50 ± 10 define normality for children and adolescents aged 8-18 years across Europe. Higher scores indicate a better health-related quality of life. |
Measured baseline and after 12 months
|
The adolescents domain specific self-evaluation of competence or adequacy
Time Frame: Measured baseline and after 12 months
|
Assessed through Harter's Self-perception Profile for Adolescents (SPPA). The instrument consists of seven subscales covering the following domains: 1) scholastic competence, 2) social competence, 3) athletic competence, 4) physical appearance, 5) job competence, 6) close friendship, and 7) romantic appeal. Each subscale contains four items, each having four options: 1 (Describes me very poorly), 2 (Describes me fairly poorly), 3 (Describes me fairly well), and 4 (Describes me very well), providing a mean score of perceived competence in that area, ranging from 1 (lowest level of self-esteem) to 4 (highest level of self-esteem). |
Measured baseline and after 12 months
|
Symptoms of anxiety and depression
Time Frame: Measured baseline and after 12 months
|
Assessed by the short version of Hopkins Symptom Checklist (HSCL-10). HSCL-10 consists of 10 symptoms or problems that people sometimes have in which adolescents answered how much the symptoms have bothered or distressed them during the last week. All 10 questions have 4 response categories: 'Not at all', 'A little', 'Quite a bit' and 'Extremely'. The responses are summarized across all items and the mean score is used as a measure of psychological distress. Higher values indicates higher psychological distress. |
Measured baseline and after 12 months
|
Learning environment in the classroom
Time Frame: Measured baseline and after 12 months
|
The Classroom Climate Scale is used to assess learning environment. This instrument consist of 22 questions related to intrinsic and extrinsic motivation, anticipation and teacher-student relations. All questions are answered on a four-point scale: "Strongly agree", "Somewhat agree", "Somewhat disagree", "Strongly disagree". All points are summed to a total score. Higher scores indicates higher classroom environment. |
Measured baseline and after 12 months
|
School environment
Time Frame: Measured baseline and after 12 months
|
Learning environment at school in general is self-reported in a questionnaire.
It consist of three separate questions, and the questions are answered on a 7-point likert scale ranging from "totally disagree" to "totally agree".
A mean score from the three questions will be made, and a higher score indicates better school environment.
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Measured baseline and after 12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body mass index
Time Frame: Measured baseline and after 12 months
|
Body mass (weight; 0.1 kg) is measured using an electronic scale with participants wearing light clothing.
Stature (height; 0.1 cm) is measured using a portable stadiometer.
The individual face forward, with shoes removed.
Body mass index is calculated as body weight (kg) divided by the height squared (m2).
|
Measured baseline and after 12 months
|
Waist circumference
Time Frame: Measured baseline and after 12 months
|
Measured with an ergonomic circumference measuring tape.
The measure is taken at the midway between the lower rib and iliac crest with the individual's abdomen relaxed at the end of a gentle expiration.
|
Measured baseline and after 12 months
|
Satisfaction of basic psychological needs
Time Frame: Measured baseline and after 12 months
|
Assessed by Basic Psychological Needs in Exercise Scale (BPNES).
BPNES consist of 12 questions that are answered on a 7-point Likert scale (ranging from 1 (Certainly untrue) to 7 (Certainly true)).
The responses are summarized and a mean score is made.
Higher values indicates higher satisfaction.
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Measured baseline and after 12 months
|
Emotional responses to physical education
Time Frame: Measured baseline and after 12 months
|
Assessed by the Basic Emotions Trait Test (BETT).
BETT consists of 9 statements that will measure positive, negative and eudaimonic emotions.
Participants respond on a 7-point Likert scale ranging from 1 (Never) to 7 (Always).
The responses are summarized across the three sub-scales and a mean score for each sub-scale is made.
Higher values indicates higher emotions.
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Measured baseline and after 12 months
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Eagerness to join physical education
Time Frame: Measured baseline and after 12 months
|
Assessed by Eagerness for Physical Activity Scale (EPAS).
EPAS is a one-dimensional scale, consisting of 12 statements that affect emotional expressions and cognitive assessments as well as future physical activity behavior.
The participants respond to the statements on a scale ranging from 1 (completely disagree) to 7 (completely agree).
The responses are summarized and a mean score is made.
Higher values indicates higher eagerness.
|
Measured baseline and after 12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Elin Kolle, PhD, Norwegian School of Sport Sciences
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
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
Keywords
Other Study ID Numbers
- 2207ScIM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
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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