Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000675820
Ethics application status
Approved
Date submitted
22/06/2012
Date registered
25/06/2012
Date last updated
6/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving school playgrounds to enhance activity in children: the Play study
Scientific title
Play Study: Improving school playgrounds to enhance physical activity in children
Secondary ID [1] 280721 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight/obesity in children 286765 0
Physical activity in children 286766 0
Play in children 286767 0
Condition category
Condition code
Diet and Nutrition 287072 287072 0 0
Obesity
Public Health 287073 287073 0 0
Health promotion/education
Public Health 287074 287074 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sixteen low-mid decile primary schools with minimum rolls of 150 in Dunedin (n=8) and Waitakere (n=8) cities will be randomly assigned to control and intervention conditions. The study processes in both study centres will closely mirror each other.

After an initial baseline assessment of all playgrounds carried out by a certified playworker, a series of meetings will be held with each intervention school (parents, Board of Trustees, teachers, and pupils) to decide what changes to play facilities and the play environment would be advantageous. Cost, potential popularity, existing structures, age restrictions, safety and space requirements, and availability will be taken into consideration. Once each school has decided what playground redevelopment they would like to have, the research team will assist the school wherever possible with obtaining additional funds. The development of the playground action plans and installation of new equipment/rules will take at least 12 months.

Anthropometry, physical activity (accelerometry), bullying and diet will be measured in 50 Year 2 (6-7 years) and Year 4 (8-9 years) children from each of the 16 schools at baseline, and at 12 months and 24 months. The wider school environment (policies, procedures) as it pertains to physical activity will also be evaluated at each time point.
Intervention code [1] 285143 0
Prevention
Intervention code [2] 285144 0
Lifestyle
Intervention code [3] 285145 0
Behaviour
Comparator / control treatment
The control schools will carry on as usual and have been asked to make no changes to playground, physical activity or rules around play behaviour. Children in the control schools will be measured at the same time as the children in the matched intervention school at each time point.
Control group
Active

Outcomes
Primary outcome [1] 287398 0
Physical activity in terms of number of steps per day, and minutes of Moderate to Vigorous Activity (MVPA) at various times of the day. Measured using Actigraph GT3X accelerometers.
Timepoint [1] 287398 0
Baseline, 12 months and 24 months.
Primary outcome [2] 287399 0
Excessive weight gain in terms of body mass index (BMI) z-score and waist circumference. BMI will be calculated as weight in kilograms divided by height in metres squared. BMI will then be converted to z-scores using age- and sex-specific CDC reference data.
Timepoint [2] 287399 0
Baseline, 12 months and 24 months.
Secondary outcome [1] 298060 0
Perceived bullying assessed using a peer-relations package (PRAQ-R) for use with students, parents and teachers.
Timepoint [1] 298060 0
Baseline, 12 months and 24 months.
Secondary outcome [2] 298061 0
Forms of play that best promote activity. Assessed using the same playworker's evaluations of each school's play area and rating it according to a set schedule resulting an overall score for the whole school play environment. Additional assessment of this secondary outcome via small group interviews with students at the school. Both will be used in conjunction with accelerometery data.
Timepoint [2] 298061 0
Baseline, 12 months and 24 months.
Secondary outcome [3] 298062 0
Nutrition assessed by a modified version of the Children's Dietary Questionnaire administered to parents.
Timepoint [3] 298062 0
Baseline, 12 months and 24 months.

Eligibility
Key inclusion criteria
Selection of schools: Primary schools are the sampling unit and must be decile 1-6 (i.e. low-mid SES) based on 2008 New Zealand Ministry of Education decile ratings with a minimum roll of 150 in Dunedin (n=8) and Waitakere (n=8). A school will need to agree to participate before being randomly assigned to control or intervention conditions.

Selection of children: Each school will be asked to choose two Year 2 and two Year 4 classes. All of the children in these two classes will be invited to participate in the measurements (to obtain approximately 50 children per school). Consenting children will be measured at all 3 timepoints over the 24 month period.
Minimum age
6 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unable to participate in physical activity.
Not planning to be resident in the Dunedin or Auckland area for the next two years.

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)
Allocation was undertaken using 16 sealed opaque envelopes which contained 8 intervention and 8 control labels.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/03/2011
Actual
16/03/2011
Date of last participant enrolment
Anticipated
30/11/2011
Actual
7/12/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
800
Accrual to date
Final
840
Recruitment outside Australia
Country [1] 4377 0
New Zealand
State/province [1] 4377 0

Funding & Sponsors
Funding source category [1] 285504 0
Government body
Name [1] 285504 0
Health Research Council of New Zealand
Country [1] 285504 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
University of Otago,
PO Box 56,
Dunedin 9054.
Country
New Zealand
Secondary sponsor category [1] 284344 0
None
Name [1] 284344 0
Address [1] 284344 0
Country [1] 284344 0
Other collaborator category [1] 276878 0
University
Name [1] 276878 0
Auckland University of Technology (AUT)
Address [1] 276878 0
AUT University,
Private Bag 92006,
Auckland 1142.
Country [1] 276878 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287518 0
University of Otago Human Ethics Committee
Ethics committee address [1] 287518 0
Ethics committee country [1] 287518 0
New Zealand
Date submitted for ethics approval [1] 287518 0
Approval date [1] 287518 0
27/04/2010
Ethics approval number [1] 287518 0
1/10/0077
Ethics committee name [2] 287519 0
Auckland University of Technology Ethics Committee (AUTEC)
Ethics committee address [2] 287519 0
Ethics committee country [2] 287519 0
New Zealand
Date submitted for ethics approval [2] 287519 0
Approval date [2] 287519 0
01/09/2010
Ethics approval number [2] 287519 0
10/95

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

Contacts
Principal investigator
Name 34353 0
A/Prof Rachael Taylor
Address 34353 0
Department of Medicine
University of Otago
PO Box 56
Dunedin 9016
Country 34353 0
New Zealand
Phone 34353 0
+64 3 470 9180
Fax 34353 0
Email 34353 0
rachael.taylor@otago.ac.nz
Contact person for public queries
Name 17600 0
Associate Professor Rachael Taylor
Address 17600 0
Edgar National Centre for Diabetes and Obesity Research,
C/- Department of Human Nutrition,
University of Otago,
PO Box 56,
Dunedin 9054.
Country 17600 0
New Zealand
Phone 17600 0
+64 3 4709180
Fax 17600 0
+64 3 479 7958
Email 17600 0
rachael.taylor@otago.ac.nz
Contact person for scientific queries
Name 8528 0
Associate Professor Rachael Taylor
Address 8528 0
Edgar National Centre for Diabetes and Obesity Research,
C/- Department of Human Nutrition,
University of Otago,
PO Box 56,
Dunedin 9054.
Country 8528 0
New Zealand
Phone 8528 0
+64 3 470 9180
Fax 8528 0
+64 3 479 7958
Email 8528 0
rachael.taylor@otago.ac.nz

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
EmbaseThe effect of increasing risk and challenge in the school playground on physical activity and weight in children: A cluster randomised controlled trial (PLAY).2017https://dx.doi.org/10.1038/ijo.2017.41
EmbaseDo differences in compositional time use explain ethnic variation in the prevalence of obesity in children? Analyses using 24-hour accelerometry.2020https://dx.doi.org/10.1038/s41366-019-0377-1
EmbaseQuantity versus quality of objectively measured sleep in relation to body mass index in children: cross-sectional and longitudinal analyses.2020https://dx.doi.org/10.1038/s41366-020-0552-4
N.B. These documents automatically identified may not have been verified by the study sponsor.