The Effects of an In-school Physical Activity Intervention on Adolescents' Brain Structure and Function
NCT ID: NCT03593863
Last Updated: 2019-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
103 participants
INTERVENTIONAL
2017-05-01
2019-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The Fit to Study main 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. A full description of the Fit to study main trail, including its outcome measures, has been provided as part of its registration at ClinicalTrials.gov (NCT03286725).
The Fit to Study - Brain imaging sub-study will target a sub-sample of participants of the large-scale trial, in order to test pre to post intervention changes in anterior hippocampal volume, as well as cognitive performance, mental health and brain organisation. The assessments will take place pre-intervention, immediately post-intervention and 12-months post-intervention, and will comprise structural and functional magnetic resonance imaging (MRI) scans.
Fit to Study main trial participants are considered eligible for brain imaging sub-study. The brain imaging sub-study consists of two sub-samples, recruited at different times during the trial:
1. The first cohort of 60 participants completed assessments pre-intervention, will complete identical assessments post-intervention to investigate pre-to-post intervention changes, and will be invited to take part in follow-up assessments.
2. A second cohort of \~50 participants will be recruited for post-intervention assessments that are similar, but not identical, to the assessments of the first group, as well as 1-year follow-up assessments. This cohort will enable cross-sectional analysis of between-group (intervention-control) differences in a larger sample.
The assessments are similar, but not identical for the two cohorts. The key assessments are listed here and details are provided in the 'outcome measures' section.
1. Cohort 1
* Magnetic resonance imaging (at pre- and post intervention)
* Computer-based cognitive tasks (at pre-, and post intervention and follow-up)
* Mental health questionnaires (at pre-, and post intervention and follow-up)
* Physical activity assessments (at pre-, and post intervention, and follow-up)
* Fitness assessments (at pre-, and post intervention)
* Gait assessments (at pre- and post intervention)
2. Cohort 2
* Magnetic resonance imaging (at post intervention only)
* Computer-based cognitive tasks (at post intervention and follow-up)
* Mental health questionnaires (at post intervention and follow-up)
* Physical activity assessments (at post intervention and follow-up)
* Gait assessments (at post-intervention only)
The primary aims of the study are:
1. To examine cross-sectional relations between anterior hippocampal volume and physical activity and fitness at baseline (cohort 1)
2. To examine whether changes in anterior hippocampal volume are greater in the intervention group compared to the control group (i.e. group by time interaction tested in cohort 1)
Secondary aims are:
1. To examine cross-sectional relations between brain structure and function, and physical activity and fitness at baseline (cohort 1)
2. To examine whether changes in brain organisation, mental health, cognitive performance and fitness are greater in the intervention group compared to the control group (i.e. group by time interaction tested in cohort 1)
3. To examine whether brain organisation, mental health, cognitive performance and fitness is different in the intervention group compared to the control group post intervention
4. To identify MRI markers predisposing the PA intervention effect
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
"PE as Usual" Control Group
The Control Group will be asked to continue with their normal PE lessons
No interventions assigned to this group
Intervention Group
Physical Education (PE) Programme
Physical Education (PE) programme
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Physical Education (PE) programme
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
Exclusion Criteria
* Contraindication to VO2max fitness test
2. Cohort 2
School level:
\- 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.
11 Years
16 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Oxford Brookes University
OTHER
University of Oxford
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Heidi Johansen-Berg
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Wellcome Centre for Integrative Neuroimaging (WIN)
Oxford, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EEF2681
Identifier Type: OTHER
Identifier Source: secondary_id
HMR00670
Identifier Type: -
Identifier Source: org_study_id