Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/10/2016
Date assigned
06/12/2016
Last edited
06/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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 will 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 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 below 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 measures

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

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

Sponsor information

Organisation

School of Public Health, Birmingham University

Sponsor details

Birmingham University
Birmingham
B5 2TT
United Kingdom

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes