<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03817047</url>
  </required_header>
  <id_info>
    <org_study_id>2207ScIM</org_study_id>
    <nct_id>NCT03817047</nct_id>
  </id_info>
  <brief_title>The Effect of Increased Physical Activity on Adolescents' Health and Academic Performance: The School in Motion Study</brief_title>
  <acronym>ScIM</acronym>
  <official_title>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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian School of Sport Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Stavanger</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Agder</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Western Norway University of Applied Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Norwegian School of Sport Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the effect of 120 minutes extra of physical education (PE) or physical&#xD;
      activity (PA) on adolescents' physical health, mental health, academic performance and&#xD;
      learning environment. This is a cluster-randomized controlled trial with three arms, where&#xD;
      the participants in two of the groups will have different models of increased PE/PA during&#xD;
      the school week, whereas the participants in the third arm is the control group including&#xD;
      current practice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a school-based, three-arm cluster randomized controlled trial (RCT) recruiting&#xD;
      adolescents from secondary schools in Norway. Adolescents (aged 14-15 years) were the unit of&#xD;
      analysis, and schools (clusters) were randomly assigned to one of three conditions:&#xD;
&#xD;
        1. the physical active learning group (PAL-group), where the schools each week include one&#xD;
           additional physical education (PE) lesson, 30 minutes of physical active learning, and&#xD;
           30 minutes of physical activity (intervention condition);&#xD;
&#xD;
        2. the don't worry - be happy group (DWBH-group), where the schools include one new&#xD;
           activity class (60 minutes: Be Happy class) and one additional PE-class (60 minutes:&#xD;
           Don't Worry class) per week (intervention condition);or&#xD;
&#xD;
        3. current practice (control condition). An identical set of outcome measures are taken&#xD;
           from all participants at baseline, and approximately 12 months after the baseline&#xD;
           measures, when the participants were at the end of year 9&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 3, 2017</start_date>
  <completion_date type="Actual">June 22, 2018</completion_date>
  <primary_completion_date type="Actual">June 22, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This is a cluster-randomized trial with three parallel arms</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean physical activity level</measure>
    <time_frame>Measured baseline and after 12 months</time_frame>
    <description>The participants mean physical activity level measured by accelerometers</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time spent in moderate-to-vigorous physical activity (MVPA)</measure>
    <time_frame>Measured baseline and after 12 months</time_frame>
    <description>Mean minutes spent in MVPA per day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time spent sedentary</measure>
    <time_frame>Measured baseline and after 12 months</time_frame>
    <description>Mean minutes spent sedentary each day, measured both objectively using accelerometers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedentary behaviour</measure>
    <time_frame>Measured baseline and after 12 months</time_frame>
    <description>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 &quot;No time at all&quot; to &quot;More than 6 hours per day&quot;. There are also questions about which screen activity they perform. The answers are categorized into six alternatives ranging from &quot;No time at all&quot; to &quot;More than 3 hours per day&quot;. There are also questions about time spent doing homework. The answers are categorized into nine alternatives ranging from &quot;No time at all&quot; to &quot; More than 7 hours per day&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Upper limb strength</measure>
    <time_frame>Measured baseline and after 12 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Explosive strength in the lower body</measure>
    <time_frame>Measured baseline and after 12 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abdominal muscle endurance</measure>
    <time_frame>Measured baseline and after 12 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiorespiratory fitness</measure>
    <time_frame>Measured baseline and after 12 months</time_frame>
    <description>Intermittent running test. Participants run for 10 minutes, and the distance covered (in meters) is recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Academic performance in reading</measure>
    <time_frame>Measured baseline and after 9 months</time_frame>
    <description>Specific standardized Norwegian National tests in reading.The test is designed and administrated by The Norwegian Directorate for Education and Training.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Academic performance in numeracy</measure>
    <time_frame>Measured baseline and after 9 months</time_frame>
    <description>Specific standardized Norwegian National tests in numeracy. The test is designed and administrated by The Norwegian Directorate for Education and Training.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall psychosocial problems and strengths</measure>
    <time_frame>Measured baseline and after 12 months</time_frame>
    <description>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.&#xD;
Each statement is answered as &quot;Not true&quot;, &quot;Somewhat true&quot; and &quot;Certainly true&quot;. 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adolescents' subjective health and well-being</measure>
    <time_frame>Measured baseline and after 12 months</time_frame>
    <description>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 &amp; autonomy (7 items), 4) social support &amp; peers (4 items), and 5) school environment (5 items).&#xD;
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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The adolescents domain specific self-evaluation of competence or adequacy</measure>
    <time_frame>Measured baseline and after 12 months</time_frame>
    <description>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.&#xD;
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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms of anxiety and depression</measure>
    <time_frame>Measured baseline and after 12 months</time_frame>
    <description>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.&#xD;
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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Learning environment in the classroom</measure>
    <time_frame>Measured baseline and after 12 months</time_frame>
    <description>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.&#xD;
All questions are answered on a four-point scale: &quot;Strongly agree&quot;, &quot;Somewhat agree&quot;, &quot;Somewhat disagree&quot;, &quot;Strongly disagree&quot;. All points are summed to a total score. Higher scores indicates higher classroom environment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>School environment</measure>
    <time_frame>Measured baseline and after 12 months</time_frame>
    <description>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 &quot;totally disagree&quot; to &quot;totally agree&quot;. A mean score from the three questions will be made, and a higher score indicates better school environment.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Body mass index</measure>
    <time_frame>Measured baseline and after 12 months</time_frame>
    <description>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).</description>
  </other_outcome>
  <other_outcome>
    <measure>Waist circumference</measure>
    <time_frame>Measured baseline and after 12 months</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Satisfaction of basic psychological needs</measure>
    <time_frame>Measured baseline and after 12 months</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Emotional responses to physical education</measure>
    <time_frame>Measured baseline and after 12 months</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Eagerness to join physical education</measure>
    <time_frame>Measured baseline and after 12 months</time_frame>
    <description>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.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">2045</enrollment>
  <condition>Physical Activity</condition>
  <condition>Academic Achievement</condition>
  <condition>Mental Health</condition>
  <arm_group>
    <arm_group_label>Physical active learning (PAL)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Three components:&#xD;
Physical education (60 minutes)&#xD;
Physical active learning (30 minutes)&#xD;
Physical activity (30 minutes)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Don't worry - be happy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two components:&#xD;
Physical education (60 minutes) - don't worry class&#xD;
Physical activity (60 minutes) - be happy class</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Current practice</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical education</intervention_name>
    <description>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 &quot;Be Happy&quot;-activity. A PE-teacher was present to support the students if necessary.</description>
    <arm_group_label>Don't worry - be happy</arm_group_label>
    <arm_group_label>Physical active learning (PAL)</arm_group_label>
    <other_name>PE-intervention</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical active learning</intervention_name>
    <description>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.</description>
    <arm_group_label>Physical active learning (PAL)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical activity</intervention_name>
    <description>Without a connection to any specific subject &quot;Physical activity&quot; 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.</description>
    <arm_group_label>Physical active learning (PAL)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Be happy</intervention_name>
    <description>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.</description>
    <arm_group_label>Don't worry - be happy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects enrolled in 9th grade&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elin Kolle, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Norwegian School of Sport Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Norwegian School of Sport Sciences</name>
      <address>
        <city>Oslo</city>
        <zip>0852</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 25, 2019</last_update_submitted>
  <last_update_submitted_qc>January 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Norwegian School of Sport Sciences</investigator_affiliation>
    <investigator_full_name>Elin Kolle</investigator_full_name>
    <investigator_title>Vice rector</investigator_title>
  </responsible_party>
  <keyword>Adolescents</keyword>
  <keyword>Physical activity</keyword>
  <keyword>Physical fitness</keyword>
  <keyword>Academic performance</keyword>
  <keyword>Cluster RCT</keyword>
  <keyword>Mental health</keyword>
  <keyword>Secondary school</keyword>
  <keyword>Physical education</keyword>
  <keyword>Physical active educational lessons</keyword>
  <keyword>Accelerometer</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual participant data for all primary and secondary outcome measures will be made available.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Data will be available within 24 months of study completion</ipd_time_frame>
    <ipd_access_criteria>Data access will be reviewed by the study's publication group. Requestors will be required to sign a data access agreement</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 1, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/47/NCT03817047/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03817047
org study id: 2207ScIM
nct id: NCT03817047
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a cluster-randomized trial with three parallel arms
primary purpose: Prevention
masking: None (Open Label)
measure: Mean physical activity level
time frame: Measured baseline and after 12 months
description: The participants mean physical activity level measured by accelerometers
measure: Time spent in moderate-to-vigorous physical activity (MVPA)
time frame: Measured baseline and after 12 months
description: Mean minutes spent in MVPA per day
measure: Time spent sedentary
time frame: Measured baseline and after 12 months
description: Mean minutes spent sedentary each day, measured both objectively using accelerometers
measure: Sedentary behaviour
time frame: Measured baseline and after 12 months
description: 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".
measure: Upper limb strength
time frame: Measured baseline and after 12 months
description: 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.
measure: Explosive strength in the lower body
time frame: Measured baseline and after 12 months
description: 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.
measure: Abdominal muscle endurance
time frame: Measured baseline and after 12 months
description: 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.
measure: Cardiorespiratory fitness
time frame: Measured baseline and after 12 months
description: Intermittent running test. Participants run for 10 minutes, and the distance covered (in meters) is recorded.
measure: Academic performance in reading
time frame: Measured baseline and after 9 months
description: Specific standardized Norwegian National tests in reading.The test is designed and administrated by The Norwegian Directorate for Education and Training.
measure: Academic performance in numeracy
time frame: Measured baseline and after 9 months
description: Specific standardized Norwegian National tests in numeracy. The test is designed and administrated by The Norwegian Directorate for Education and Training.
measure: Overall psychosocial problems and strengths
time frame: Measured baseline and after 12 months
description: 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.
measure: Adolescents' subjective health and well-being
time frame: Measured baseline and after 12 months
description: 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.
measure: The adolescents domain specific self-evaluation of competence or adequacy
time frame: Measured baseline and after 12 months
description: 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).
measure: Symptoms of anxiety and depression
time frame: Measured baseline and after 12 months
description: 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.
measure: Learning environment in the classroom
time frame: Measured baseline and after 12 months
description: 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.
measure: School environment
time frame: Measured baseline and after 12 months
description: 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.
measure: Body mass index
time frame: Measured baseline and after 12 months
description: 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).
measure: Waist circumference
time frame: Measured baseline and after 12 months
description: 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.
measure: Satisfaction of basic psychological needs
time frame: Measured baseline and after 12 months
description: 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.
measure: Emotional responses to physical education
time frame: Measured baseline and after 12 months
description: 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.
measure: Eagerness to join physical education
time frame: Measured baseline and after 12 months
description: 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.
arm group label: Physical active learning (PAL)
arm group type: Experimental
description: Three components:
Physical education (60 minutes)
Physical active learning (30 minutes)
Physical activity (30 minutes)
arm group label: Don't worry - be happy
arm group type: Experimental
description: Two components:
Physical education (60 minutes) - don't worry class
Physical activity (60 minutes) - be happy class
arm group label: Control group
arm group type: No Intervention
description: Current practice
intervention type: Behavioral
intervention name: Physical education
description: 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.
arm group label: Don't worry - be happy
arm group label: Physical active learning (PAL)
other name: PE-intervention
intervention type: Behavioral
intervention name: Physical active learning
description: 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.
arm group label: Physical active learning (PAL)
intervention type: Behavioral
intervention name: Physical activity
description: 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.
arm group label: Physical active learning (PAL)
intervention type: Behavioral
intervention name: Be happy
description: 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.
arm group label: Don't worry - be happy
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Elin Kolle, PhD
role: Principal Investigator
affiliation: Norwegian School of Sport Sciences
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Norwegian School of Sport Sciences
investigator full name: Elin Kolle
investigator title: Vice rector
sharing ipd: Yes
ipd description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: Data will be available within 24 months of study completion
ipd access criteria: Data access will be reviewed by the study's publication group. Requestors will be required to sign a data access agreement
provided document: 