Physical Exercise for Education ('Fit to Study')

Study Overview
=================
Brief Summary
-----------------
Neuroscience evidence suggests that physical exercise can influence brain function and structure, both immediately and in the long-term. The 'Fit to Study' project is a randomised controlled trial to test the effects on academic performance (as well as fitness, wellbeing and cognitive function) of a teacher-training intervention designed to optimise the content of PE for brain and cognitive function during secondary school (Year 8) Physical Education (PE) lessons. The project aims to rigorously test the impact of this intervention in 100 state-funded secondary schools.

Detailed Description
-----------------
Physical exercise has been shown to have positive effects on the brain and to improve cognitive performance, both immediately and in the long-term. This project is being conducted to understand better how the content of school PE, focusing on Year8 pupils during the academic year 2017/18, affects brain function and structure, and academic performance. A programme of activities for PE lessons has been developed by Oxford Brookes University (in collaboration with Oxfordshire Sport and Physical Activity) to try to optimise the benefit of PE for brain function. Staff from Oxford Brookes University will train PE teachers to deliver this programme. 'Fit to Study' is aiming to recruit 100 state-funded secondary schools from within a radius of Oxford. The National Foundation for Education Research will help with recruitment by sending materials to target schools, collating responses, collecting pupil information from schools that sign up, and passing information to the research teams and NatCen Social Research (who will be responsible for randomisation). Participating schools will be randomly assigned to either an Intervention Group (IG) and be asked to deliver the new PE programme, or to a Control Group (CG) and asked to continue with their normal PE lessons. Randomisation will be achieved using a random sequence generated using Stata12. Balance between treatment and control groups will be achieved across a range of covariates (i.e. to ensure not all girls schools are assigned to one condition). For both Groups there will be a number of activities for schools to undertake, both at the start, during, and at the end of the study. The key tasks are listed, and then described, below: Online Cognitive Tests (pre- and post-study) Wellbeing Questionnaires (pre- and post-study) Physical Activity Assessments (before and during the study) PE Teacher Training for Intervention Schools Fitness (Beep) Tests (pre- and post-study) NatCen will undertake an Independent Evaluation of the 'Fit to Study' programme. In all schools, the pupils in the target year group will undergo baseline assessments (in the final term of Year 7), which will comprise tests of physical fitness; cognitive assessments; and questionnaires (about physical activity, sleep patterns, mood, motivation and wellbeing). The tests of physical fitness will be administered during PE lessons and will involve measures of speed and endurance. The school PE teachers will be involved in the administration of these tests. The cognitive tests (which will include tests of memory, executive functions and attention using button responses), and some of the questionnaires, will be computer-based and may be administered over the web, at school or at home, using a well-established online testing package. PE teachers in the intervention condition schools will be trained to administer our intervention. Our training package will comprise a set of focused lesson principles and techniques for their delivery. To foster friendly competition between schools, the investigators may produce newsletters/bulletins containing school league tables indicating summary physical activity levels during PE and/or proportion of assessments completed, but these will never contain individual pupils' data. The investigators will use activity monitors to compare physical activity during intervention and control PE lessons. At the end of the intervention period (which is intended to be an academic year), the Year 8 pupils in all schools will repeat the assessments. In addition, the University of Oxford will be conducting a sub-study with a small number of pupils from a subset of schools. This is an optional part of the project and will be subject to separate written / informed consent from the pupils' parents/guardians. This will involve MRI brain scanning at the University of Oxford, as well as additional fitness and cognitive tests. Further detail will be made available to schools that are selected to take part in the Main Study (from May 2017).

Official Title
-----------------
Physical Exercise for Education ('Fit to Study')

Conditions
-----------------
Physical Activity, Mental Health Wellness 1, Cognitive Function 1, Social, Academic Attainment, Fitness Testing

Intervention / Treatment
-----------------
* Behavioral: Physical Education (PE) Programme


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion is by school year group - typically aged 11-14: Year 7 pupils during the academic year 2016/17 (Age 11-12, KS3). Year 8 pupils during the academic year 2017/18 (Age 12-13, KS3). Exclusion Criteria: Any pupils that are exempted from PE. Pupils that have 'opted out' of data sharing / storage for research purposes

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>The Control Group will be asked to continue with their normal PE lessons. | |
| Experimental: Intervention Group<br>'Physical Education (PE) Programme' | Behavioral: Physical Education (PE) Programme<br>* A programme of activities for PE lessons has been developed by Oxford Brookes University (in collaboration with Oxfordshire Sport and Physical Activity) to try to optimise the benefit of PE for brain function. Staff from Oxford Brookes University will train PE teachers to deliver this programme. The Intervention involves roughly 20 minutes of prescribed activities per week, to be delivered within school PE lessons.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mathematical attainment: as measured using the level 13 Progress in Maths test (provided at GL assessment) at the end of the school year (June 2018). | The Primary Outcome Measure is recorded on the ISRCTN registry with study ID ISRCTN15730512. Mathematical attainment as measured using the level 13 Progress in Maths test (provided at GL assessment) at the end of the school year. | 1 hour: Last month of the study (June 2018). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wellbeing Survey | A battery of surveys each including a number of measures: adolescent mental health and wellbeing; daytime sleepiness; physical and global self-esteem; PE enjoyment; single measures of health-related quality of life and weekly moderate to vigorous physical activity (MVPA); attitudes, social norms, competence, intentions and willingness in relation to physical activity. Approximately 60 questions in total, taking 30 minutes to complete. | 30 minutes: Baseline (June 2017) and final month of the study (June 2018) | 
| Cognitive Test of Attention and Reaction Time | This is one of five (computer-based) cognitive tasks developed via jsPsych that are completed by participants at one sitting. It is an attention/ reaction-time task, to appearance of red triangles on the screen. | 10 minutes: Baseline (June 2017) and final month of the study (June 2018) | 
| Cognitive Test of Memory (Image Associates) | This is one of five (computer-based) cognitive tasks developed via jsPsych that are completed by participants at one sitting. It is an (image) association of place, person and object (memory) task. | 10 minutes: Baseline (June 2017) and final month of the study (June 2018) | 
| Eriksen Flanker Test | This is one of five (computer-based) cognitive tasks developed via jsPsych that are completed by participants at one sitting. It is a (modified) Eriksen Flanker task. | 10 minutes: Baseline (June 2017) and final month of the study (June 2018) | 
| Cognitive Test of Memory (Two-back Image Task) | This is one of five (computer-based) cognitive tasks developed via jsPsych that are completed by participants at one sitting. It is a two-back image (memory) task (saying whether a picture is the same as the one before last). | 10 minutes: Baseline (June 2017) and final month of the study (June 2018) | 
| Cognitive Test of Executive Function | This is one of five (computer-based) cognitive tasks developed via jsPsych that are completed by participants at one sitting. It is a task-switching (executive function) task (arms up or arms down characters in relation to shape or colour questions). | 10 minutes: Baseline (June 2017) and final month of the study (June 2018) | 
| Fitness Assessment (20m Beep Test) | A distance of 20m is measured; cones are placed at lines indicating the distance. Pupils stand behind one of the lines facing the 2nd line, and begin running when instructed by an audio recording. The pupils continue running between the two lines, turning when signalled by the recorded beeps. After one minute, a sound indicates an increase in speed, and the beeps will be closer together. This continues each minute (level). If the line is reached before the beep sounds, the subject must wait until the beep sounds before continuing. If the line is not reached before the beep sounds, the subject is given a warning and must continue to run to the line, then turn and try to catch up with the pace within two more 'beeps'. The test is stopped if the subject fails to reach the line (within 2m) for two consecutive ends after a warning. Participants are instructed to remember the last number that was called before they stopped and tell the teacher who is recording the scores. | 20 minutes: Baseline (June 2017) and final month of the study (June 2018) | 
| Physical Activity Measurements | All pupils will be provided with wrist-worn Axivity AX3 accelerometers, to be worn on the non-dominant wrist, to record their physical activity (PA) during a PE lesson. The AX3 is a tri-axial accelerometer which measures linear acceleration from +/- 2g to +/- 16g range along three orthogonal axes known as 'z' (upward and downward), 'y' (left and right) and 'x' (forward and backward). | 60 minutes: Baseline (June 2017), at 14 weeks, at 28 weeks and final month of the study (June 2018). |