Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001155785
Ethics application status
Approved
Date submitted
3/10/2013
Date registered
16/10/2013
Date last updated
16/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the effects of the Lunchtime Enjoyment Activity and Play (LEAP) school playground intervention
Scientific title
Evaluating the effects of the Lunchtime Enjoyment Activity and Play (LEAP) school playground intervention on children's quality of life, enjoyment and participation in physical activity
Secondary ID [1] 283353 0
Nil known
Universal Trial Number (UTN)
Trial acronym
LEAP Intervention
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical activity in schools
Childrens wellbeing 290251 0
Condition category
Condition code
Public Health 290641 290641 0 0
Other public health
Public Health 290664 290664 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Movable/recycled materials with no fixed purpose were introduced to a grass field in a brand new Catholic primary school from the end of term 1 to the middle of term 2 (after 7-weeks: post-test) and continued to be introduced until the end of term 2 during Autumn and Winter in 2010. The movable/recycled materials introduced to the playground by the researchers were items generally not considered to be typical play materials for children within schools, with the exception of play balls, hoops and skipping ropes. The materials included milk crates, swimming noodles, buckets, cardboard boxes, tyre tubes, pipes, vacuum/pool hoses, plastic walls and sheets, hessian bags, buckets, water/sand shells, tractor/motorbike and bicycle tyres, swimming boards, exercise mats, buckets and hay bales.

All students (5-12-year-olds) had access to the playground simultaneously. The provision of small pieces of portable sports equipment was made available by the school such as footballs, bats and balls as per usual practice in primary schools. Two teachers were rostered on school playground supervision (yard duty) during school breaks as was usual practice, one teacher was allocated to supervise the grass field and the other to supervise the bitumen car park area. The principal briefed the teachers prior to students commencing the intervention, explaining that the items were to encourage children to create their own play and not to intervene unless children’s safety was at risk.
Intervention code [1] 288077 0
Behaviour
Comparator / control treatment
The Control School did not have access to the movable/recycled materials used with the intervention school and consisted of a morning break of 15 minutes and a lunchtime break of 45 minutes. Children had access to sports equipment as is usual practice in many primary schools to use on the hard-surfaced area at the front of the school and on the grass field during break periods.

Two teachers supervised the playground during lunchtime at all times (one supervisor was allocated to the fixed playground area at the front of the school, the other teacher supervised the grass field and basketball court areas at the bottom of the school).
Control group
Active

Outcomes
Primary outcome [1] 290657 0
The primary outcome variable of the LEAP intervention was physical activity, individually and objectively measured by pedometers in children aged 5-12-years-old. In addition, the System of Observing Play and Leisure Activities in Youth (SOPLAY), an area-level direct observation instrument was used to provide contextual information on the children’s physical activity within the school playground.
Timepoint [1] 290657 0
This matched controlled trial, the LEAP intervention study, was uniquely tailored to compare the intervention and control schools at baseline (March/April, 2010), post-testing (after 7-weeks; April-June, 2010) and at a follow-up (after 8-months; November, 2010)
Secondary outcome [1] 304986 0
The Physical Activity Enjoyment Scale (PACES) was used to determine children’s general enjoyment of physical activity in children aged 8-12-years-old. The PACES consists of a 16 statement scale starting with the question stem ‘When I am physically active…” with a 5-point likert scale (1=disagree a lot; 2=disagree; 3=no opinion; 4=agree; 5=agree a lot). A score was computed by calculating the mean of the 16 items.
Timepoint [1] 304986 0
This matched controlled trial, the LEAP intervention study, was uniquely tailored to compare the intervention and control schools at baseline (March/April, 2010), post-testing (after 7-weeks; April-June, 2010) and at a follow-up (after 8-months; November, 2010).
Secondary outcome [2] 305026 0
The Lunchtime Enjoyment of Activity and Play (LEAP) Questionnaire was used to measure enjoyment of school play activities in children aged 8-12-years-old. All enjoyment items were rated on a five-point likert scale (1=very unhappy; 2=unhappy; 3=not sure; 4=happy; 5=very happy). A score was computed by calculating the average of each social-ecological model component.
Timepoint [2] 305026 0
This matched controlled trial, the LEAP intervention study, was uniquely tailored to compare the intervention and control schools at baseline (March/April, 2010), post-testing (after 7-weeks; April-June, 2010) and at a follow-up (after 8-months; November, 2010).
Secondary outcome [3] 305027 0
The Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0), a 23-item validated questionnaire was used to measure the quality of life in children aged 8-12-years-old. The PedsQL 4.0 instrument measured quality of life in three scales; psychosocial, physical and total quality of life. The questionnaire was scored using a five-point likert scale (0=never; 1=almost never; 2=sometimes; 3=almost always; 4=always), with items then converted to a score out of 100 (0=100; 1=75; 2=50; 3=25; 4=0). A mean score was calculated for the psychosocial and physical quality of life scales. The scales were averaged to obtain a total quality of life score.
Timepoint [3] 305027 0
This matched controlled trial, the LEAP intervention study, was uniquely tailored to compare the intervention and control schools at baseline (March/April, 2010), post-testing (after 7-weeks; April-June, 2010) and at a follow-up (after 8-months; November, 2010).

Eligibility
Key inclusion criteria
A newly developed catholic co-educational primary school with no fixed playground equipment was approached to participate. A control school matched by sector, school type (co-education, prep to year 6; 5-12-year-olds, socio-economic status, size of school grounds and enrolment) was selected and recruited to participate in the study via emails, phone calls and on-site visits to the Principal. Both schools were located in the same geographical area in Regional Western Victoria, Australia. All children in the study participated in their regular daily school routines. All children within each primary school (aged 5-12-years-old) received a plain language statement outlining the research, along with a participant and parental consent form.
Minimum age
5 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Schools from different sectors and possessing different school characteristics to the intervention school were excluded (e.g. such as being single gender, prep to year 12; 5-18-year-olds, socio-economic status, size of school grounds and enrolment). No children were excluded at the intervention or control school from participating in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A newly developed catholic co-educational primary school with no fixed playground equipment was approached to participate. A control school matched by sector, school type (co-education, prep to year 6; 5-12-year-olds, socio-economic status, size of school grounds and enrolment) was selected and recruited to participate in the study via emails, phone calls and on-site visits to the Principal. Both schools were located in the same geographical area in Regional Western Victoria, Australia. All children in the study participated in their regular daily school routines.

The intervention provided movable/recycled materials for children to use in the school playground with usual playground supervision by teachers (yard duty). Children in the control school continued their physical activity with their usual sports equipment, fixed playground equipment and teacher supervision.
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
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The study was based on a matched control trial, comparing the pedometer steps and distance between intervention and control schools at baseline, 7-week post-testing and an 8-month follow-up. Although there were self-reported outcome measures, the sample size calculation was based on participants’ steps and distance. For baseline, post-test and follow-up, the steps and distance were measured for intervention and control schools. From a previous pilot study, we hypothesised that the estimated mean difference would be 5 steps/minute (intervention school: 60 steps/minute; control school: 55 steps/minute) or 5 metres distance (intervention school: 40 metres; control school: 35 metres) with equal standard deviations (SD=15 steps/minute or SD=15 meters) for both schools. A correlation between baseline and follow-up was set to 0.45 from the previous pilot study. The above information was analysed by comparing each child ‘s difference between the mean of post intervention treatment measurements and the mean of baseline measurements, that is, the change method of sampsi command under STATA software. Group sample sizes of 117 children in the intervention school and 117 children in the control school achieved 80% power to detect a difference between the school differences of 5 with equal variation (SD=15). The significance level of the test was targeted at 0.05 (two-sided). The statistical procedure for repeated measurements includes the specified parameters used to estimate the sample sizes or power, the relative efficiency of the design and the adjustment to the standard deviation. Allowing for an ‘attrition rate’ of 10%, we therefore aimed to recruit 129 children in the intervention school and 129 children in the control school.

An independent sample t-test and chi-square test were used to determine significant differences between the intervention and control schools for demographic characteristics and baseline objective measurements between the intervention and control schools (p<0.05 was significant).

A non-parametric Mann-Whitney U test were used to determine the significant difference between ranks of each observation for each self-reported measure between the intervention and control schools (p<0.05 was significant).

A multilevel mixed effect linear regression model was applied using STATA (version 12.0) using the xtmixed command to fit linear mixed models for pedometer steps and distance per minute, enjoyment of physical activity, enjoyment of lunchtime play activities and quality of life. The model was used to determine the treatment effects (adjusted mean change in the intervention school compared to the control school at each time point) and interaction effects (overall effects on the intervention school compared to the control school for all three time points: pre, post and follow-up). Models will be adjusted for covariates. A chi-square test was used to compare the direct observation proportions in each physical activity intensity and activity type between intervention and control schools. Missing data for a time point (e.g. missing questionnaire responses) were excluded pairwise from the analyses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/03/2010
Date of last participant enrolment
Anticipated
1/03/2010
Actual
1/03/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
234
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 288082 0
University
Name [1] 288082 0
PhD Scholarship
Country [1] 288082 0
Australia
Funding source category [2] 288124 0
University
Name [2] 288124 0
RMIT University
Country [2] 288124 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
School of Medical Sciences,
Plenty Road,
Bundoora, Victoria 3083
Country
Australia
Secondary sponsor category [1] 286806 0
University
Name [1] 286806 0
University of Ballarat
Address [1] 286806 0
University Drive,
Mount Helen, Victoria 3353
Country [1] 286806 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290009 0
University of Ballarat Human Research Ethics Committee
Ethics committee address [1] 290009 0
Ethics committee country [1] 290009 0
Australia
Date submitted for ethics approval [1] 290009 0
Approval date [1] 290009 0
27/01/2010
Ethics approval number [1] 290009 0
A09-190

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

Contacts
Principal investigator
Name 43446 0
A/Prof Amanda Telford
Address 43446 0
School of Medical Sciences,
RMIT University,
PO Box 71,
Melbourne, Victoria
3083
Country 43446 0
Australia
Phone 43446 0
+61 3 9925 7420
Fax 43446 0
Email 43446 0
[email protected]
Contact person for public queries
Name 43447 0
Brendon Hyndman
Address 43447 0
School of Medical Sciences,
RMIT University,
PO Box 71,
Melbourne, Victoria
3083
Country 43447 0
Australia
Phone 43447 0
+61 3 9925 7861
Fax 43447 0
Email 43447 0
[email protected]
Contact person for scientific queries
Name 43448 0
Brendon Hyndman
Address 43448 0
School of Medical Sciences,
RMIT University,
PO Box 71,
Melbourne, Victoria
3083
Country 43448 0
Australia
Phone 43448 0
+61 3 9925 7861
Fax 43448 0
Email 43448 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

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