Effectiveness of the run-a-mile intervention

ISRCTN	ISRCTN12698269
DOI	https://doi.org/10.1186/ISRCTN12698269
Secondary identifying numbers	Section 106

Submission date: 27/10/2016
Registration date: 06/12/2016
Last edited: 20/08/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Contact information

Dr Sandra Passmore
Public

Health Education Service
Services for Education
10 Edward Street
Birmingham
B1 2RX
United Kingdom

ORCID ID	0000-0002-7476-7242
Phone	+44 (0)1213 669955
Email	sandra.passmore@servicesforeducation.co.uk

Study information

Study design	Pragmatic cluster randomised controlled trial
Primary study design	Interventional
Secondary study design	Cluster randomised trial
Study setting(s)	School
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	To evaluate the effectiveness and cost effectiveness of the daily ‘run a mile’ intervention implemented across primary schools located in Birmingham
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(s)	University of Birmingham Ethics Committee, 22/04/2016, ref: ERN_16-0064
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
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 study start date	01/11/2016
Overall study end date	31/03/2018

Eligibility

Participant type(s)	Other
Age group	Child
Sex	Both
Target number of participants	Cluster randomised trial with 40 clusters with 60 participants in each cluster
Total final enrolment	2280
Participant inclusion criteria	1. Children in school years 3 and 5 2. Attending participating schools
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

England
United Kingdom

Study participating centres

Health Education Service, Services for Education

Tudor Court
Warwick House
10 Edward Street
Birmingham
B1 2RX
United Kingdom

School of Public Health, University of Birmingham

Edgbaston
Birmingham
B15 2TT
United Kingdom

School of Health Economics, University of Birmingham

Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor information

University of Birmingham
University/education

School of Public Health
Birmingham
B5 2TT
England
United Kingdom

"ROR"	https://ror.org/03angcq70

Funders

Funder type

Government

Birmingham City Council

No information available

Results and Publications

Intention to publish date	31/03/2019
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	11/01/2018		Yes	No
Results article	results	01/04/2020	20/08/2020	Yes	No

Editorial Notes

20/08/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
30/01/2018: Publication reference added.