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

Physical Activity Clinical Trial

— ScIM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03817047
• Other study ID #: 2207ScIM
• Status: Completed
• Phase: N/A
• Start date: April 3, 2017
• Est. completion date: June 22, 2018

Study information

• Verified date: January 2019
• Source: Norwegian School of Sport Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2045
• Est. completion date: June 22, 2018
• Est. primary completion date: June 22, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Subjects enrolled in 9th grade

Exclusion Criteria:

Related Conditions & MeSH terms

• Academic Achievement
• Mental Health
• Physical Activity

Intervention

Behavioral:
• Physical education
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.
• Physical active learning
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 activity
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.
• Be happy
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.

Locations

Country	Name	City	State
Norway	Norwegian School of Sport Sciences	Oslo

Sponsors (4)

Lead Sponsor	Collaborator
Norwegian School of Sport Sciences	University of Agder, University of Stavanger, Western Norway University of Applied Sciences

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body mass index	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
Other	Waist circumference	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
Other	Satisfaction of basic psychological needs	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
Other	Emotional responses to physical education	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
Other	Eagerness to join physical education	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
Primary	Mean physical activity level	The participants mean physical activity level measured by accelerometers	Measured baseline and after 12 months
Secondary	Time spent in moderate-to-vigorous physical activity (MVPA)	Mean minutes spent in MVPA per day	Measured baseline and after 12 months
Secondary	Time spent sedentary	Mean minutes spent sedentary each day, measured both objectively using accelerometers	Measured baseline and after 12 months
Secondary	Sedentary behaviour	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
Secondary	Upper limb strength	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
Secondary	Explosive strength in the lower body	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
Secondary	Abdominal muscle endurance	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
Secondary	Cardiorespiratory fitness	Intermittent running test. Participants run for 10 minutes, and the distance covered (in meters) is recorded.	Measured baseline and after 12 months
Secondary	Academic performance in reading	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
Secondary	Academic performance in numeracy	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
Secondary	Overall psychosocial problems and strengths	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
Secondary	Adolescents' subjective health and well-being	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
Secondary	The adolescents domain specific self-evaluation of competence or adequacy	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
Secondary	Symptoms of anxiety and depression	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
Secondary	Learning environment in the classroom	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
Secondary	School environment	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