Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000089932
Ethics application status
Approved
Date submitted
24/01/2011
Date registered
25/01/2011
Date last updated
25/01/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Popping the bubble wrap- unleashing the power of play: an innovative playground intervention to increase children's physical activity
Scientific title
Cluster randomised controlled trial of an innovative intervention to increase children's physical activity
Secondary ID [1] 253475 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inactivity 4550 0
Obesity 261023 0
Social skills and self-esteem 261024 0
Condition category
Condition code
Public Health 4841 4841 0 0
Health promotion/education
Mental Health 259162 259162 0 0
Other mental health disorders
Diet and Nutrition 259165 259165 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
- Reprioritising play and reframing risk: one 2 hour workshop with teachers and parents. The adults will examine their beliefs regarding play and risk associated with active play. Discussions will focus on the benefits of play, healthy vs unhealthy risk and the consequences of preventing children from engaging in play and healthy risk taking.
- Introduction of unstructured play materials: The play material (e.g. car tyres, milk crates, crash mats etc.) will be present on the school playgrounds during the 13 week intervention and can be used by all the children at the school.
Intervention code [1] 4315 0
Behaviour
Intervention code [2] 4316 0
Prevention
Comparator / control treatment
Regular school recess where the children are free to engage in activity as they normally would.
Control group
Active

Outcomes
Primary outcome [1] 5700 0
Significantly higher levels of physical activity during recess and after school (measured by accelerometers and time use diaries)
Timepoint [1] 5700 0
Difference pre- and post-test
Primary outcome [2] 5701 0
Significant gains in social skills (Social Skills Inventory System, Gresham and Elliott) and self-esteem (The Pictorial scale of perceived competence and social acceptance for young children, Harter and Pike)
Timepoint [2] 5701 0
Difference pre- and post-test
Secondary outcome [1] 268957 0
Changes in social interaction as assessed by coding social interactions following a modified Pellegrini method from 15 minute video tapes. The video's will be taped during the outdoor recess.
Timepoint [1] 268957 0
Difference pre- and post-test

Eligibility
Key inclusion criteria
Children in kindergarten or year 1 where the parents have given consent. The children to be approached to participate from each school are randomly chosen.
Minimum age
5 Years
Maximum age
7 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parents refuse to sign consent. No other exclusion criteria

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258387 0
Government body
Name [1] 258387 0
ARC
Country [1] 258387 0
Australia
Funding source category [2] 258388 0
Government body
Name [2] 258388 0
NHMRC
Country [2] 258388 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 257530 0
Individual
Name [1] 257530 0
Prof Anita Bundy
Address [1] 257530 0
Room J010
East Street
Lidcombe NSW 214
Country [1] 257530 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260364 0
University of Sydney's Human Research Ethics Committee
Ethics committee address [1] 260364 0
Ethics committee country [1] 260364 0
Australia
Date submitted for ethics approval [1] 260364 0
Approval date [1] 260364 0
Ethics approval number [1] 260364 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29456 0
Address 29456 0
Country 29456 0
Phone 29456 0
Fax 29456 0
Email 29456 0
Contact person for public queries
Name 12703 0
Prof Anita Bundy
Address 12703 0
Room J010
East Street
Lidcombe NSW 2141
Country 12703 0
Australia
Phone 12703 0
+61 2 9351 9857
Fax 12703 0
Email 12703 0
[email protected]
Contact person for scientific queries
Name 3631 0
Anita Bundy
Address 3631 0
Room J010
East Street
Lidcombe NSW 2141
Country 3631 0
Australia
Phone 3631 0
+61 2 9351 9857
Fax 3631 0
Email 3631 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIThe sydney playground project: popping the bubblewrap - unleashing the power of play: a cluster randomized controlled trial of a primary school playground-based intervention aiming to increase children's physical activity and social skills2011https://doi.org/10.1186/1471-2458-11-680
EmbaseUnderstanding Patterns of Young Children's Physical Activity After School--It's all About Context: A Cross-Sectional Study.2015https://dx.doi.org/10.1123/jpah.2013-0153
EmbaseYoung children's after-school activities - there's more to it than screen time: a cross-sectional study of young primary school children.2015https://dx.doi.org/10.1123/jpah.2013-0075
N.B. These documents automatically identified may not have been verified by the study sponsor.