NCT03286725

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 18, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

2.2 years

First QC Date

August 16, 2017

Last Update Submit

April 18, 2022

Conditions

Physical ActivityMental Health Wellness 1Cognitive Function 1, SocialAcademic AttainmentFitness Testing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Wellbeing Survey

    30 minutes: Baseline (June 2017) and final month of the study (June 2018)

  • Cognitive Test of Attention and Reaction Time

    10 minutes: Baseline (June 2017) and final month of the study (June 2018)

  • Cognitive Test of Memory (Image Associates)

    10 minutes: Baseline (June 2017) and final month of the study (June 2018)

  • Eriksen Flanker Test

    10 minutes: Baseline (June 2017) and final month of the study (June 2018)

  • Cognitive Test of Memory (Two-back Image Task)

    10 minutes: Baseline (June 2017) and final month of the study (June 2018)

  • +3 more secondary outcomes

Study Arms (2)

Control Group

NO INTERVENTION

The Control Group will be asked to continue with their normal PE lessons.

Intervention Group

EXPERIMENTAL

'Physical Education (PE) Programme'

Behavioral: Physical Education (PE) Programme

Interventions

Physical Education (PE) ProgrammeBEHAVIORAL

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.

Intervention Group

Eligibility Criteria

Age11 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • Any pupils that are exempted from PE.
  • Pupils that have 'opted out' of data sharing / storage for research purposes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oxford Brookes University

Oxford, Oxfordshire, OX3 0BP, United Kingdom

Location

Related Publications (3)

  • Wassenaar TM, Wheatley CM, Beale N, Nichols T, Salvan P, Meaney A, Atherton K, Diaz-Ordaz K, Dawes H, Johansen-Berg H. The effect of a one-year vigorous physical activity intervention on fitness, cognitive performance and mental health in young adolescents: the Fit to Study cluster randomised controlled trial. Int J Behav Nutr Phys Act. 2021 Mar 31;18(1):47. doi: 10.1186/s12966-021-01113-y.

    PMID: 33789683DERIVED

  • Beale N, Eldridge E, Delextrat A, Esser P, Bushnell O, Curtis E, Wassenaar T, Wheatley C, Johansen-Berg H, Dawes H. Exploring activity levels in physical education lessons in the UK: a cross-sectional examination of activity types and fitness levels. BMJ Open Sport Exerc Med. 2021 Mar 9;7(1):e000924. doi: 10.1136/bmjsem-2020-000924. eCollection 2021.

    PMID: 33768961DERIVED

  • Wassenaar TM, Wheatley CM, Beale N, Salvan P, Meaney A, Possee JB, Atherton KE, Duda JL, Dawes H, Johansen-Berg H. Effects of a programme of vigorous physical activity during secondary school physical education on academic performance, fitness, cognition, mental health and the brain of adolescents (Fit to Study): study protocol for a cluster-randomised trial. Trials. 2019 Apr 2;20(1):189. doi: 10.1186/s13063-019-3279-6.

    PMID: 30940164DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Helen Dawes

    Oxford Brookes University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single blind (outcome assessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 16, 2017

First Posted

September 18, 2017

Study Start

May 1, 2017

Primary Completion

July 1, 2019

Study Completion

July 1, 2020

Last Updated

April 20, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

On conclusion of the project, the Fischer Family Trust (see http://www.fft.org.uk/) will collate and upload anonymised data to the UK Data Archive (for the primary outcome measure). This archived data (for the primary outcome measure) will only be available in an anonymised form with restricted access for research purposes only.

Locations

GB(1)