The Effect of Increased Physical Activity on Adolescents' Health and Academic Performance: The School in Motion Study (ScIM)

January 25, 2019 updated by: Elin Kolle, Norwegian School of Sport Sciences

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

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.

Study Overview

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:

  1. 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);
  2. 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
  3. 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

Interventional

Enrollment (Actual)

2045

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Oslo, Norway, 0852
        • Norwegian School of Sport Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects enrolled in 9th grade

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:

  1. Physical education (60 minutes)
  2. Physical active learning (30 minutes)
  3. Physical activity (30 minutes)
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:
  • PE-intervention
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:

  1. Physical education (60 minutes) - don't worry class
  2. Physical activity (60 minutes) - be happy class
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:
  • PE-intervention
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

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.
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.
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.
Measured baseline and after 9 months
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.
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.
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.
Measured baseline and after 12 months
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Elin Kolle, PhD, Norwegian School of Sport Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 3, 2017

Primary Completion (ACTUAL)

June 22, 2018

Study Completion (ACTUAL)

June 22, 2018

Study Registration Dates

First Submitted

January 14, 2019

First Submitted That Met QC Criteria

January 24, 2019

First Posted (ACTUAL)

January 25, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 28, 2019

Last Update Submitted That Met QC Criteria

January 25, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

Data will be available within 24 months of study completion

IPD Sharing Access Criteria

Data access will be reviewed by the study's publication group. Requestors will be required to sign a data access agreement

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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