Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000575437
Ethics application status
Approved
Date submitted
1/04/2016
Date registered
4/05/2016
Date last updated
4/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Healthy Active Peaceful Playgrounds for Youth (HAPPY) Study. An inclusive and evidence-based approach to primary school physical activity environments.
Scientific title
Healthy Active Peaceful Playgrounds for Youth (HAPPY) Study: Measuring the effectiveness of a multi-component playground intervention to increase physical activity in primary school students
Secondary ID [1] 288897 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The HAPPY Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical activity 298231 0
On-task behaviour 298232 0
Social support 298233 0
Condition category
Condition code
Public Health 298367 298367 0 0
Health promotion/education
Mental Health 298368 298368 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will test a non-curricular intervention designed to increase the amount of physical activity that children amass during recess and lunch breaks, the social support children receive to be physically active, teacher confidence and commitment to delivering physically active lessons, and the related impact this has on student’s on-task behaviour in classes after breaks.

The intervention will contain four components, and be run over a single term as part of the study (two schools will run the intervention in Terms 2, 3 and 4).;
1) The addition of permanent multi-coloured playground markings at each school. Markings are designed to encourage play, and will be developed in consultation with school staff, and students.
2) Teacher training on how to use these markings to promote physical activity and reducing bullying in the playground. Teachers will receive a face-to-face training session (1.5-2 hours), as well as being provided with access to online resources including activity downloads, webinars and discussion forums via peacefulplayground.com.au. The face-to-face training will be conducted with all participating teachers from a school, and run by Janice Atkin, an Education Consultant and director of Peaceful Playgrounds Australia.
Teacher attendance at the face-to-face training will be recorded, and their use of the online website monitored.
3) The introduction of a student leadership program to promote physical activity within peer groups. Groups of Stage 3 students will be given training on how to promote and encourage physical activity during lunch and recess for their peers. Students will be nominated by schools, and it is expected they will select house captains, or school captains (approx. 4-8 students at each school). Teachers will be provided a teacher Facilitator Guide with a step-by-step process for training the student leaders. Each student will receive a PAL Playbook, which is a learning journal for them to record their development and action plan for the program. This component of the intervention will be monitored by the teachers who are trained through the intervention.
4) A suite of resources for teachers to use for setting up games during recess and lunch breaks. These will be provided as a printed resources for each school, as well as made available online via the Peaceful Playgrounds website. Resources include a folder of games that can be played with the schools chosen markings, guides for teachers to delivery physical activity lessons, information on teaching fundamental movement skills, and social skills such as conflict resolution, and DVDs for teachers who want refresher training, or new teachers on how to direct activities.

The observations of playgrounds during lunch and recess will also record teacher behaviours, and the use of equipment, so provide some indication of training adherence. The survey delivered to find sources of encouragement for students to by physically active should also show whether teachers are using the resources and strategies provided through the intervention if the levels of support increase after implementation.
As there will be relatively small numbers of teachers and students participating directly in the intervention, the research team will plan regular communications to reduce attrition and monitor adherence.
Intervention code [1] 294354 0
Behaviour
Intervention code [2] 294386 0
Lifestyle
Intervention code [3] 294389 0
Prevention
Comparator / control treatment
A stepped wedge CT design has been chosen for this study as the effects of the intervention can be queried in detail with analysis done to determine the overall effectiveness of the intervention by comparison of data sets in the control section of the wedge with those in the intervention section. The cohorts that receive the intervention in each period will be randomised.

The control group will be the schools who do not receive the intervention during the period, however by the end of the study, all schools will have received the intervention.
Control group
Active

Outcomes
Primary outcome [1] 297838 0
Physical activity levels in students, as observed and recorded using The System for Observing Play and Recreation in Communities (SOPARC) tool
Timepoint [1] 297838 0
Observations will take place on three days in each school, during each school term (total of 12 days during the study). The observations will take place on three random days during the term.
Primary outcome [2] 297839 0
On-task behaviour of students in classes following physical activity. This will be measured using the Behavioral Observation of Students in Schools (BOSS) software.
Timepoint [2] 297839 0
Observations will take place on three days in each school, during each school term (total of 12 days during the study). The observations will take place on three random days during the term.
Primary outcome [3] 297840 0
Self-report data on where students receive encouragement to be physically active from. This will be measured using responses to the Physical Activity Social Support Survey provided by all Stage 3 students.
Timepoint [3] 297840 0
The survey will be administered once each term (total of four collections).
Secondary outcome [1] 322396 0
Teacher confidence at delivering physically active lessons. This will be collected through interviews.
Timepoint [1] 322396 0
Interviews will be held with participating teachers during the first two weeks of the term following the one their school received the intervention (i.e. if they receive the intervention in Term 2, teachers will be interviewed in the first two weeks of Term 3).
Secondary outcome [2] 322397 0
Student confidence to encourage and promote physical activity participation in peers. This will be collected through interviews and surveys designed specifically for this study.
Timepoint [2] 322397 0
Interviews will be held with participating students during the first two weeks of the term following the one their school received the intervention (i.e. if they receive the intervention in Term 2, teachers will be interviewed in the first two weeks of Term 3).

Eligibility
Key inclusion criteria
- Primary schools must be located in Metropolitan New South Wales
- Primary schools must be managed by the Department of Education and Communities New South Wales
- Primary schools must be co-educational
- Primary schools must have Stage 3 students
- Schools must have a minimum of one teacher consent to participating in the intervention
- Students completing the Physical Activity Social Support Survey and BOSS data collection must be in Stage 3 (years 5 and 6) as the tools have been validated fro this age group.
- Any teacher at participating schools will be offered the training as part of the intervention
Minimum age
4 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Primary schools must not be Schools for Specific Purposes
- Childcare services, and high schools will be excluded
- Primary schools that do not provide consent will be excluded
- Primary schools managed by the Catholic Education Office or the Association of Independent Schools were excluded
- Primary schools outside of Metropolitan New South Wales
- Schools participating in other physical activity studies will be excluded
- Students in Stages 1 and 2 (years K-4) will be excluded from data collection using the Physical Activity Social Support Survey and BOSS.

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)
Central randomisation by phone/fax/computer. (RAND() function in Excel)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation). (RAND() function in Excel)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power calculations were conducted to determine the sample size and number of observations required to detect changes in students physical activity levels, their on-task behaviour and where encouragement to be physically active came from. Calculations assumed baseline-post test expected effect size gains of d = 0.4/r = 0.19 and were based on 80% power, with alpha levels set at p < 0.05. Using the standard deviation (SD) of change of SD = .5.

6 schools will be required fort he study, and all students at these schools observed for the physical activity levels (~.2500 students) All of the stage 3 students (years 5 and 6, ~ 800) will be given the physical activity survey about social support, and only 5 students from each school are needed for observations about behaviour during class using the BOSS software.

Using the Statistical Package for Social Sciences (SPSS, v21), descriptive statistics and measures of central tendency will be used to describe the effect of the intervention from baseline to follow-up data in the different groups.

Analyses involving percentage of occurrence (i.e. frequency) data will be analysed using x2. To analyse sex and period differences in activity variables, a series of 2 x 2 (sex by period) mixed-model ANCOVAs in SPSS will be computed. Each mixed model will be fitted to the data using the restricted maximum likelihood method. For each mixed model, gender will be included as fixed effects, with the school included as a random effect to account for the effects of stepping by school.

For analyses involving school level characteristics of physical activity, the unit of analysis will be one scan of one area. For all other variables the unit of analysis will be a gender and period specific daily summary of each school, with the exception of summary school-level variables (e.g. total play space per school), where school will be the unit of analysis. To compute gender and period specific daily summaries for each school and physical activity levels based on the three observation days for each school will be analysed. Using these scores, outcome variables will be computed by aggregating counts across activity areas separately by sex and period for each school.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/01/2016
Actual
25/01/2016
Date of last participant enrolment
Anticipated
2/05/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2550
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 293250 0
Government body
Name [1] 293250 0
Department of Education and Communities NSW
Country [1] 293250 0
Australia
Funding source category [2] 293251 0
University
Name [2] 293251 0
Macquarie University
Country [2] 293251 0
Australia
Primary sponsor type
Individual
Name
Dr Dean Dudley
Address
Faculty of Human Sciences/School of Education
Level 8, C3A Building
1 Macquarie Drive
Macquarie University, NSW 2109
Country
Australia
Secondary sponsor category [1] 292051 0
University
Name [1] 292051 0
Macquarie University
Address [1] 292051 0
1 Macquarie Drive
Macquarie University, NSW 2109
Country [1] 292051 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294728 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 294728 0
Ethics committee country [1] 294728 0
Australia
Date submitted for ethics approval [1] 294728 0
Approval date [1] 294728 0
23/10/2015
Ethics approval number [1] 294728 0
HREA 5201500676
Ethics committee name [2] 294729 0
State Education Research Applications Process
Ethics committee address [2] 294729 0
Ethics committee country [2] 294729 0
Australia
Date submitted for ethics approval [2] 294729 0
Approval date [2] 294729 0
17/11/2015
Ethics approval number [2] 294729 0
SERAP 2015423

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

Contacts
Principal investigator
Name 64842 0
Dr Dean A Dudley
Address 64842 0
Macquarie University
Faculty of Human Sciences/School of Education
Level 8, C3A Building
Macquarie University, NSW 2109
Country 64842 0
Australia
Phone 64842 0
+61 2 9850 4864
Fax 64842 0
Email 64842 0
dean.dudley@mq.edu.au
Contact person for public queries
Name 64843 0
Dean A Dudley
Address 64843 0
Macquarie University
Faculty of Human Sciences/School of Education
Level 8, C3A Building
Macquarie University, NSW 2109
Country 64843 0
Australia
Phone 64843 0
+61 2 9850 4864
Fax 64843 0
Email 64843 0
dean.dudley@mq.edu.au
Contact person for scientific queries
Name 64844 0
Dean A Dudley
Address 64844 0
Macquarie University
Faculty of Human Sciences/School of Education
Level 8, C3A Building
Macquarie University, NSW 2109
Country 64844 0
Australia
Phone 64844 0
+61 2 9850 4864
Fax 64844 0
Email 64844 0
dean.dudley@mq.edu.au

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
No additional documents have been identified.