Plain English Summary
Background and study aims
Childhood obesity has become markedly more common in the last 30 years. Recently, a lot of media attention has been focused on a primary school based in Stirling, Scotland they have encouraged all children in all weathers to either walk or run a mile each day. Although the extent of the benefits are yet to be determined, many involved speak of improved fitness levels, cognitive (mental processing) behaviour, improved learning, lower obesity levels and to children feeling much happier. The aim of this study is to evaluate the effectiveness and cost effectiveness of the ‘run a mile’ program in primary schools in Birmingham.
Who can participate?
Children in school years 3 and 5 attending participating schools
What does the study involve?
Participating schools are randomly allocated to one of two groups. Over the course of one schools year, hildren attending schools in the first group work with their teachers to map out a track within the school grounds and work out how many times they need to complete the track to reach a mile. Every day, at random times, children are encouraged to walk or run this track with the aim of achieving a mile. This aims to make sure all children achieve an extra 15 minutes of exercise each day. Schools in the second group continue as normal for the duration of the study. At the start of the study and again after six and 12 months, children attending schools in both groups have their physical activity levels measured, as well as their weight, academic achievement and mental wellbeing. At the same time, teachers who work at schools in both groups have their wellbeing measured using a questionnaire.
What are the possible benefits and risks of participating?
Pupils and teachers who take part in the program benefit from an extra 15 minutes physical activity every school day. There are no direct risks involved with participating.
Where is the study run from?
The study is run from Services for Education (Health Education Service) and University of Birmingham (Schools of Public Health and Health Economics) and takes place in 40 primary schools in the Birmingham area (UK)
When is the study starting and how long is it expected to run for?
November 2016 to March 2018
Who is funding the study?
Birmingham City Council (UK)
Who is the main contact?
Dr Sandra Passmore
sandra.passmore@servicesforeducation.co.uk
Trial website
Contact information
Type
Public
Primary contact
Dr Sandra Passmore
ORCID ID
http://orcid.org/0000-0002-7476-7242
Contact details
Health Education Service
Services for Education
10 Edward Street
Birmingham
B1 2RX
United Kingdom
+44 (0)1213 669955
sandra.passmore@servicesforeducation.co.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Section 106
Study information
Scientific title
To evaluate the effectiveness and cost effectiveness of the daily ‘run a mile’ intervention implemented across primary schools located in Birmingham
Acronym
Study hypothesis
The aim of this study is to evaluate the effectiveness and cost effectiveness of the ‘run a mile’ intervention implemented across primary schools located in Birmingham.
Ethics approval
University of Birmingham Ethics Committee, 22/04/2016, ref: ERN_16-0064
Study design
Pragmatic cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Schools
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Obesity prevention, physical activity
Intervention
Participating schools are randomised to one of two study arms.
Intervention arm: Children in the schools allocated to the intervention arm will work with their teachers to map out a track within the school grounds and calculate how many laps of the track will be equivalent to a mile. Every day, at random times of the day, all children will be encouraged to walk or run this track with the aim of achieving a mile. The aim is for all children to achieve 15 minutes additional physical activity per day. The schools will also continue with their usual practice so the mile will be additional physical activity. The intervention will run over one academic school year.
Control arm: Children in schools allocated to the control arm continue with their usual practice for the suration of the intervention.
All the schools will be asked to not take on any other health, physical activity related initiatives during the intervention period but also to continue with any that they are currently doing - such as walking to school, gardening, physical activity clubs, bikeability etc.
After 6 and 12 months, pupils in both study arms are weighted and have their body fat measured, as well as completing assessments of physical activity and wellbeing. Teacher wellbeing is also measured at these timepoints.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Pupils' weight and height and percentage body fat is measured at baseline, 6 and 12 months
2. Health-related quality of life is measured using the Child-Health Utilities 9-Dimensional Instrument at baseline, 6 and 12 months
Secondary outcome measures
Pupils:
1. Cardiovascular fitness is measured using the Pupils' Physical bleep test at baseline, 6 and 12 months
2. Wellbeing is measured using the Middle Years Development Instrument at baseline, 6 and 12 months
3. Education Attainment is measured through a teacher assessment at baseline, 6 and 12 months
Teachers:
Wellbeing is measured using the Warwick Edinburgh Mental Wellbeing Scale at baseline, 6 and 12 months
Overall trial start date
01/11/2016
Overall trial end date
31/03/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Children in school years 3 and 5
2. Attending participating schools
Participant type
Other
Age group
Child
Gender
Both
Target number of participants
Cluster randomised trial with 40 clusters with 60 participants in each cluster
Participant exclusion criteria
1. Disability that prevents children from running/walking a mile a day
2. Unable to have BMI measured
Recruitment start date
25/11/2016
Recruitment end date
31/01/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Health Education Service, Services for Education
Tudor Court
Warwick House
10 Edward Street
Birmingham
B1 2RX
United Kingdom
Trial participating centre
School of Public Health, University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
Trial participating centre
School of Health Economics, University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
Funders
Funder type
Government
Funder name
Birmingham City Council
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD Sharing plan:
For access to trial data contact Dr Sandra Passmore, Sandra.passmore@servicesforeducation.co.uk
Intention to publish date
31/03/2019
Participant level data
Available on request
Basic results (scientific)
Publication list
2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29325517