Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
The pre-school years is a critical period for establishing healthy lifestyle behaviours such as physical activity (PA). There are many benefits of taking part in regular PA for pre-school children, e.g. maintaining a healthy weight. Tackling childhood obesity is a national public health priority. Although the rate of rise in childhood obesity is slowing, levels in England remain high in urban areas, in those from deprived backgrounds and in ethnic minority groups such as South Asians. Regular PA also has many other important health and social benefits for pre-school children; it is valuable for developing motor skills, enhancing bone and muscle development and for learning social skills. Despite the well-known health benefits of PA there are high levels of physical inactivity across the UK in all age groups, including the pre-school years. Only a few PA programmes for pre-school children have been tested to see how effective they are and the results of these studies are mixed. In a report published in July 2011 the UKs Chief Medical Officer highlighted that we need new programmes that promote movement in the early years (0-5 years old) in the UK. The 'pre-schoolers in the playground' (PiP) programme aims to increase PA levels in children aged 18 months - 4 years old. PiP will open up school playgrounds for pre-school siblings to use with their parent/carer. The 'school run' occurs on every week day for 39 weeks a year, regardless of weather. Capitalising on this daily routine to provide a safe, organised, supervised area for pre-school children to enjoy active play outdoors may increase PA and over time, reduce adiposity. Additionally, involving parents in their community settings has the potential to bond them together and improve their well-being.

Who can participate?
Children aged 18 months to 4 years of age

What does the study involve?
Eight schools will be selected from locations across deprived areas of Bradford. Four of the schools will have mostly South Asian pupils and the 4 schools will have mostly Caucasian (white) pupils. Families will be invited to take part in the study, before the schools are randomly allocated to one of the two groups. Four schools will be allocated to the PiP programme and 4 to a group where the usual practice (the control). All participants taking part in the study will have to complete a questionnaire at the start of the study and at 10 weeks, 30 weeks and 52 weeks during the study

Where is the study run from?
Bradford Teaching Hospitals NHS Foundation Trust - Born in Bradford Project

What are the possible benefits and risks of participating?
There may be no benefit to taking part in the trial; however, parents will be given a £10 voucher towards play equipment following each completed measurement session. The disadvantages to taking part in the trial may include injuries to the child whilst engaging in play and for the adults participating, the time taken to complete the data collection.

When is the study starting and how long is it expected to run for?
The PiP trial is expected to be completed two years from the start of the first wave in September 2012. The second wave of recruitment will take place in January 2013 and the third and final wave in April 2013.

Who is funding the study?
National Institute for Health Research (NIHR) - Public Health Research Programme (UK).

Who is the main contact?
Dr Sally Barber

Trial website

Contact information



Primary contact

Prof John Wright


Contact details

Bradford Teaching Hospitals NHS Foundation Trust
Bradford Institute for Health Research
Temple Bank House
Bradford Royal Infirmary
Duckworth Lane
United Kingdom
+44 (0)1274 364 279

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

'Pre-schoolers in the Playground' (PiP) - a pilot cluster randomised controlled trial of a physical activity intervention for children aged 18 months to 4 years old



Study hypothesis

Preschoolers in the Playground (PiP) aims to assess the feasiblity of opening primary school playgrounds to preschool children aged 18 months to 4 years of age, in order to increase phyiscal activity levels over a sustrained period of time leading to a healthier lifestyle and reduced risk of childhood obesity.

Ethics approval

NRES Committee Yorkshire and The Humber, 30/07/2012 ref: 12/YH/0334

Study design

Two-armed pilot cluster randomised controlled trial

Primary study design


Secondary study design

Cluster randomised trial

Trial setting


Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Childhood obesity


The intervention will include the introduction of organised and supported phyiscal activity sessions in playgrounds, followed by access to the playgrounds and play equipment unsupported up to 52 weeks from the start.

Intervention type



Not Applicable

Drug names

Primary outcome measure

1. Increased levels of physical activity in preschoolers
2. Improved wellbeing and self efficacy for adults attending the intervention with the preschoolers

Secondary outcome measures

1.Child health related quality of life (PedsQL) as well as anthropmetric measurements from the children
2. Parent health-related quality of life (EQ5D)
3. Self-efficacy (GSES)
4. Wellbeing (ComQol-A5)

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Children aged 18 months to 4 years of age not in school

Participant type


Age group




Target number of participants


Total final enrolment


Participant exclusion criteria

1. Children aged less than 18 months of age and those children aged 4 years and over
2. Enrolled into school

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Bradford Teaching Hospitals NHS Foundation Trust
United Kingdom

Sponsor information


Bradford Teaching Hospitals NHS Foundation Trust (UK)

Sponsor details

Bradford Institute for Health Research
Temple Bank House
Research and Governance Support Office 2
Bradford Royal Infirmary
Duckworth Lane
United Kingdom
+44 (0)1274 362 575

Sponsor type

Hospital/treatment centre



Funder type


Funder name

NIHR - Public Health Research Programme (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2013 protocol in
2015 results in
2016 results in
2020 results in (added 30/01/2020)

Publication citations

  1. Protocol

    Barber SE, Jackson C, Akhtar S, Bingham DD, Ainsworth H, Hewitt C, Richardson G, Summerbell CD, Pickett KE, Moore HJ, Routen AC, O'Malley CL, Brierley S, Wright J, "Pre-schoolers in the playground" an outdoor physical activity intervention for children aged 18 months to 4 years old: study protocol for a pilot cluster randomised controlled trial., Trials, 2013, 14, 326, doi: 10.1186/1745-6215-14-326.

Additional files

Editorial Notes

30/01/2020: The following changes have been made: 1. Publication reference added. 2. The total final enrolment number has been added from the 2015 reference. 22/02/2016: Publication reference added.