Trial from ANZCTR


Trial ID ACTRN12611000089932
Trial Status: Registered
Date Submitted: 24/01/2011
Date Registered: 25/01/2011
Retrospectively registered

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Public title Popping the bubble wrap- unleashing the power of play: an innovative playground intervention to increase children's physical activity
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format Cluster randomised controlled trial of an innovative intervention to increase children's physical activity
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Secondary ID [1] 253475 0
none
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UTN
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Health condition(s) or problem(s) studied:
Inactivity 4550 0
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Obesity 261023 0
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Social skills and self-esteem 261024 0
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Condition category: Condition code:
Public Health Health promotion/education
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4841 4841 0 0
Mental Health Other mental health disorders
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259162 259162 0 0
Diet and nutrition Obesity
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259165 259165 0 0

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Descriptions 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.
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Intervention Code:
Behaviour 4315 0
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Intervention Code:
Prevention 4316 0
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Comparator / control treatment Regular school recess where the children are free to engage in activity as they normally would.
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Control group Active
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Primary Outcome: Significantly higher levels of physical activity during recess and after school (measured by accelerometers and time use diaries) 5700 0
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Timepoint: Difference pre- and post-test 5700 0
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Primary Outcome: 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) 5701 0
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Timepoint: Difference pre- and post-test 5701 0
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Secondary Outcome: 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. 268957 0
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Timepoint: Difference pre- and post-test 268957 0
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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.
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Minimum age 5 Years
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Maximum age 7 Years
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Gender Both males and females
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Healthy volunteers? Yes
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Key exclusion criteria Parents refuse to sign consent. No other exclusion criteria
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Study type Interventional
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Purpose of the study Prevention
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded (choose all that apply)


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Assignment
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Phase
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Anticipated date of first participant enrolment 1/05/2009
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Target sample size 250
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Recruitment status Recruiting
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Recruitment in Australia

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Recruitment outside Australia

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Funding Source: Government body 258387 0
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Name: ARC 258387 0
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Address: Level 2, 11 Lancaster Place
Majura Park ACT 2609
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Country: Australia 258387 0
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Funding Source: Government body 258388 0
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Name: NHMRC 258388 0
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Address: Level 1
16 Marcus Clarke Street
Canberra ACT 2601
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Country: Australia 258388 0
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Primary Sponsor University
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Name: University of Sydney
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Address: The University of Sydney
NSW 2006
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Country: Australia
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Secondary Sponsor: Individual 257530 0
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Name: Prof Anita Bundy 257530 0
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Address: Room J010
East Street
Lidcombe NSW 214
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Country: Australia 257530 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: University of Sydney's Human Research Ethics Committee 260364 0
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Address: 260364 0
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Country: Australia 260364 0
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Approval Date: 260364 0
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Submitted Date: 260364 0
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HREC: 260364 0
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Brief summary Disturbing numbers of children in Australia are overweight, bullied or have poor mental health – problems that are often inter-related. Recent decreases in outdoor play may be partly responsible. Outdoor play “pulls for” social interaction and physical activity; indoor play is often sedentary and solitary. Most young children love active outdoor play but parents and teachers fear injury.

This project is a school-based intervention to increase outdoor play by: (1) adding 'loose part' materials to the playground and (2) helping adults change their views of risk associated with active play. We expect to demonstrate a significant effect on children’s activity levels, coping and social skills through strategies that are replicable in every school playground in the nation and to contribute to policy regarding play, health, and education.
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Trial website
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Principal Investigator
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Contact person for public queries
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Name: Prof Anita Bundy
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Address: Room J010 East Street Lidcombe NSW 2141
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Country: Australia
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Tel: +61 2 9351 9857
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Email: anita.bundy@sydney.edu.au
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Contact person for scientific queries
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Name: Anita Bundy
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Address: Room J010 East Street Lidcombe NSW 2141
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Contact person responsible for updating information
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Name: Lina Engelen
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