NCT03593863

Brief Summary

Physical activity has shown beneficial effects for cognitive and brain health, suggesting it may provide a highly scalable intervention to improve academic achievement. This project is part of a large-scale randomised controlled trial called Fit to Study (ClinicalTrials.gov ID: NCT03286725). The main Fit to Study trial aims to test the effect of a school-based physical activity intervention on academic performance (as well as cognition and physical measures) across Year 8 pupils in 100 secondary schools. The current study - the Fit to Study - Brain imaging sub-study - will target a sub-sample of participants in the large-scale trial, in order to test pre- to post intervention changes in hippocampal volume, as well as cognitive performance, mental health and brain organisation. We hypothesise that the intervention will change anterior hippocampal volume of Year-8 pupils, as well as mental health, cognitive performance, and more generally, brain structure and function. We further hypothesise that changes in brain organisation (e.g. hippocampal volume) may mediate changes in cognitive performance and mental health.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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
1 year until next milestone

First Submitted

Initial submission to the registry

May 9, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 20, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

February 28, 2019

Status Verified

July 1, 2018

Enrollment Period

2.3 years

First QC Date

May 9, 2018

Last Update Submit

February 27, 2019

Conditions

Physical Activity

Keywords

Brain structure and functionAdolescentsPhysical activityCognitive functionMental healthFitness

Outcome Measures

Primary Outcomes (1)

  • Anterior hippocampal volume (change)

    Change in anterior hippocampal volume is derived using a T1-weighted magnetic resonance imaging (MRI) sequence.

    5mins, Baseline/pre-intervention (July - September 2017) and after 1 year (July - September 2018)

Secondary Outcomes (11)

  • Structural magnetic resonance imaging

    35mins, Baseline/pre-intervention (July - September 2017) and after 1 year (May - September 2018)

  • Functional magnetic resonance imaging

    15mins, Baseline/pre-intervention(July - September 2017) and after 1 year (May - September 2018)

  • Memory function [cognitive functioning]

    20mins, Baseline/pre-intervention (July - September 2017), after 1 year (July - September 2018) and at follow-up after 23 months (June 2018)

  • Memory function [cognitive functioning]

    7mins,Baseline/pre-intervention (July - September 2017), after 1 year (July - September 2018) and at follow-up after 23 months (June 2018)

  • Cognitive flexibility [cognitive functioning]

    7mins, Baseline/pre-intervention (July - September 2017), after 1 year (July - September 2018) and at follow-up after 23 months (June 2018)

  • +6 more secondary outcomes

Study Arms (2)

"PE as Usual" 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

The intervention consists of a 10-month (one academic year, September-June) physical activity programme delivered by PE teachers during regular Year-8 PE lessons. The Intervention involves roughly 20 minutes of prescribed activities per week.

Intervention Group

Eligibility Criteria

Age11 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Enrolled in the the Fit to Study Main trial
  • Within a 75 miles radius from Oxford
  • Lower lower socio-economic background, as indicated by percentage of free school meal (FSM)-eligible pupils or postcode-derived index of multiple deprivation
  • Pupil level:
  • Enrolled in the Fit to Study Main Trial
  • English speaking

You may not qualify if:

  • Contraindication to MRI
  • Contraindication to VO2max fitness test
  • Cohort 2
  • School level:
  • High completion rates of baseline cognitive, questionnaire and fitness data relative to other schools
  • Responsive to messages from the Fit to Study research team
  • Lower socio-economic background, as indicated by the percentage of FSM or postcode-derived index of multiple deprivation
  • For intervention schools only: adherence to the intervention.
  • From those schools that met criteria, a sub-sample of 10 schools is chosen by the trial manager.
  • Pupil level:
  • Low fitness compared to other pupils of their school who expressed an interest, based on their baseline fitness assessment (part of Fit to Study Main Trial)
  • Enrolled in the Fit to Study Main Trial
  • English speaking
  • \- Contraindication to MRI
  • If selected schools are not interested in the brain-imaging sub-study, these schools are replaced by other schools from the Fit to Study sample that are within reasonable travel distance (max 1.5h) from the brain imaging centre.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wellcome Centre for Integrative Neuroimaging (WIN)

Oxford, United Kingdom

Location

Related Publications (2)

  • Neil-Sztramko SE, Caldwell H, Dobbins M. School-based physical activity programs for promoting physical activity and fitness in children and adolescents aged 6 to 18. Cochrane Database Syst Rev. 2021 Sep 23;9(9):CD007651. doi: 10.1002/14651858.CD007651.pub3.

    PMID: 34555181DERIVED

  • 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 ActivityPsychological Well-Being

Condition Hierarchy (Ancestors)

BehaviorPersonal Satisfaction

Study Officials

  • Heidi Johansen-Berg

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: The Fit to Study brain imaging study is embedded in the Fit to Study trial, which is a parallel group, superiority cluster-randomised efficacy trial of a 10-month (one academic year) vigorous physical activity (VPA) intervention versus control.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2018

First Posted

July 20, 2018

Study Start

May 1, 2017

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

February 28, 2019

Record last verified: 2018-07

Locations

GB(1)