Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000731493
Ethics application status
Approved
Date submitted
20/05/2016
Date registered
3/06/2016
Date last updated
13/03/2020
Date data sharing statement initially provided
11/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Internet-based Professional Learning to help teachers support Activity in Youth: The iPLAY Project
Scientific title
Internet-based Professional Learning to help teachers support Activity in Youth: The iPLAY Cluster Randomised Controlled Trial
Secondary ID [1] 289164 0
None
Universal Trial Number (UTN)
Trial acronym
iPLAY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Secular decline in children's cardiorespiratory fitness 298694 0
Physical inactivity in children 298734 0
Condition category
Condition code
Public Health 298750 298750 0 0
Health promotion/education
Cardiovascular 298931 298931 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial will test the effectiveness and cost-effectiveness of the “Internet-based Professional Learning to help teachers support Activity in Youth (iPLAY)” intervention. The aim of this project is to modify, scale-up and evaluate the effectiveness of an intervention previously shown to be efficacious in improving children’s physical activity, fundamental movement skills and cardiorespiratory fitness. iPLAY will include six components to promote physical activity participation and fundamental movement skill competency. These components are 1) quality physical education and school sport; 2) classroom movement breaks; 3) physically active homework; 4) active playgrounds; 5) community physical activity links; 6) parent and caregiver engagement. Teachers will be trained in the components using a mixture of face-to-face workshops, online learning, and individualised observation and feedback.

iPLAY Mentors (employed by the project) will deliver the intervention to teachers. Mentors will be current and retired teachers with NSW Board of Studies Teaching and Educational Standards (BOSTES) specialist accreditation in Health and PE. Mentors will complete two days face-to-face training from the project team to deliver the intervention. Workshops will include: (i) familiarisation with the intervention components and procedures, (ii) review of answers to pre-determined ‘frequently asked questions’, (iii) discussion regarding methods to establish mentors’ credibility, ‘relatability’ and likeability, (iv) problem solving exercises regarding likely challenging scenarios and (v) role-playing exercises.

The iPLAY Mentors will deliver a 2 hour face-to-face professional learning workshop to classroom teachers within each primary schools. Materials for the workshops include professional learning videos, presentation slides, and discussion questions, which will all be provided to mentors by the project team. For each teacher, mentors will observe one PE or school sport lesson teacher and use a structured template to provide individualised feedback to the teacher during a 30-minute meeting. The observation will occur once per teacher during the 3 terms following the workshop (i.e., 1 observation per teacher total).

In the 3 school terms following the face-to-face workshop, teachers will complete 8 x 30-minute online learning modules (i.e., 4 hours). Each module will consist of short (i.e., 3-5min) videos describing strategies and good and poor practice examples. Teachers are requested to complete the modules within the 3 terms following the workshop. Teachers will be prompted to reflect on the strategies learnt, and set action plans to assist them in implementing the learnt strategies. Teachers are also asked to reflect on their implementation at the beginning of each online module. The face-to-face workshop and 8 online modules are designed to assist all classroom teachers to implement three of the six iPLAY components – 1) quality PE and school sport; 2) classroom movement breaks; and 3) physically active homework. To support implementation, teachers will also have access to the following resources: 1) the resource section of the iPLAY website, which includes suggested games, activities, classroom breaks, and example physically active homework tasks; 2) the iPLAY smartphone app, which will provide reminders to implement teaching strategies from their action plan with customisable frequency; 3) a physical activity monitoring system (one per school) consisting of a smartphone with software and 25 digital pedometers, which provides teachers with information on their student physical activity levels during a PE or sport lesson. Teachers are continuously able to access resources on iPLAY, including after the main intervention delivery period (i.e., 12-months after baseline).

Within each school, up to three classroom teachers will be identified as “iPLAY Leaders”. Leaders will deliver the remaining three iPLAY components - 1) active playgrounds; 2) community physical activity links; 3) parent and caregiver engagement. Additionally, iPLAY leaders will support other teachers with their implementation of the iPLAY components. The iPLAY leaders will complete an additional 3 hours online learning (6 x 30min modules) over a period of 4-5 weeks, and and will have 4 face-to-face meetings with their iPLAY mentor (approximately once per term).

Teachers will be expected to deliver the intervention across the entire duration of the trial (i.e., 24 months).
Intervention code [1] 294690 0
Prevention
Intervention code [2] 294711 0
Lifestyle
Intervention code [3] 294712 0
Behaviour
Comparator / control treatment
Attention control.
Teachers in the 10 schools allocated to the attention control arm will be offered teacher professional learning designed to improve their delivery of the NSW Kindergarten-Year 6 Science and Technology curriculum. This program, known as My Science, has been shown to increase teacher confidence and student engagement in science; however, it is not expected to influence the outcomes of the trial. Schools allocated to the attention control will be eligible to receive iPLAY after the study has been completed (i.e., 24-month post-baseline).
Control group
Active

Outcomes
Primary outcome [1] 298231 0
Cardiorespiratory fitness measured by 20 metre multistage fitness test.

Welk G, Meredith MD: Fitnessgram/Activitygram reference guide. Dallas, TX: The Cooper Institute 2008, 3.
Timepoint [1] 298231 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [1] 323620 0
Proportion of within school time students spend in different intensities of physical activity (i.e., light, moderate, vigorous) and sedentary over 7 days, objectively measured using GENEActiv accelerometers [1].

[1] Phillips LR, Parfitt G, Rowlands AV: Calibration of the GENEA accelerometer for assessment of physical activity intensity in children. J Sci Med Sport 2013, 16(2):124-128.
Timepoint [1] 323620 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [2] 323655 0
Proportion of after school time students spend in different intensities of physical activity (i.e., light, moderate, vigorous) and sedentary over 7 days, objectively measured using GENEActiv accelerometers [1].

[1] Phillips LR, Parfitt G, Rowlands AV: Calibration of the GENEA accelerometer for assessment of physical activity intensity in children. J Sci Med Sport 2013, 16(2):124-128.
Timepoint [2] 323655 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [3] 323656 0
Proportion of weekend time students spend in different intensities of physical activity (i.e., light, moderate, vigorous) and sedentary over 7 days, objectively measured using GENEActiv accelerometers [1].

[1] Phillips LR, Parfitt G, Rowlands AV: Calibration of the GENEA accelerometer for assessment of physical activity intensity in children. J Sci Med Sport 2013, 16(2):124-128.
Timepoint [3] 323656 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [4] 323657 0
Proportion of total time students spend in different intensities of physical activity (i.e., light, moderate, vigorous) and sedentary over 7 days, objectively measured using GENEActiv accelerometers [1].

[1] Phillips LR, Parfitt G, Rowlands AV: Calibration of the GENEA accelerometer for assessment of physical activity intensity in children. J Sci Med Sport 2013, 16(2):124-128.
Timepoint [4] 323657 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [5] 323658 0
Students' BMI using objective measures of height and weight from stadiometers and digital scales, respectively.
Timepoint [5] 323658 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [6] 323667 0
Student self-reported typical physical activity participation [1].

[1] Ridgers ND, Timperio A, Crawford D, Salmon J: Validity of a brief self-report instrument for assessing compliance with physical activity guidelines amongst adolescents. Journal of Science and Medicine in Sport 2012, 15(2):136-141.
Timepoint [6] 323667 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [7] 323668 0
Student self-reported physical activity participation in the last week [1].

[1] Ridgers ND, Timperio A, Crawford D, Salmon J: Validity of a brief self-report instrument for assessing compliance with physical activity guidelines amongst adolescents. Journal of Science and Medicine in Sport 2012, 15(2):136-141.
Timepoint [7] 323668 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [8] 323669 0
Student organised team sport participation in the past year using a single item from the Active Health Kids Australia Report [1].

[1] Active Healthy Kids Australia: Is Sport Enough? The 2014 Active Healthy Kids Australia Report Card on Physical Activity for Children and Young People In. Adelaide, South Australia: Active Healthy Kids Australia; 2014.
Timepoint [8] 323669 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [9] 323670 0
Student organised individualised sport participation in the past year using a single item from the Active Health Kids Australia Report [1].

[1] Active Healthy Kids Australia: Is Sport Enough? The 2014 Active Healthy Kids Australia Report Card on Physical Activity for Children and Young People In. Adelaide, South Australia: Active Healthy Kids Australia; 2014.
Timepoint [9] 323670 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [10] 323672 0
Student frequency of active travel to school using a single item from the Active Health Kids Australia Report [1].

[1] Active Healthy Kids Australia: Is Sport Enough? The 2014 Active Healthy Kids Australia Report Card on Physical Activity for Children and Young People In. Adelaide, South Australia: Active Healthy Kids Australia; 2014.
Timepoint [10] 323672 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [11] 323676 0
Students’ perceptions of need support from their teacher measured using three items from an adapted to PE version of the Teacher as Social Context questionnaire [1] and one item from the Controlling Teacher Scale [2].

[1]Belmont M, Skinner E, Wellborn J, Connell J: Teacher as Social Context: A measure of student perceptions of teacher provision of involvement, structure and autonomy support. Rochester, NY: University of Rochester; 1992.

[2] Jang H, Reeve J, Ryan RM, Kim A: Can self-determination theory explain what underlies the productive, satisfying learning experiences of collectivistically oriented Korean students? Journal of Educational Psychology 2009, 101(3):644-661.
Timepoint [11] 323676 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [12] 323681 0
Student effort during PE and Sport will be assessed using two items from the Student Engagement in School questionnaire [1] and one item from the effort subscale of the Intrinsic Motivation Inventory [2].

[1] Lam S-f, Jimerson S, Wong BPH, Kikas E, Shin H, Veiga FH, Hatzichristou C, Polychroni F, Cefai C, Negovan V et al: Understanding and measuring student engagement in school: The results of an international study from 12 countries. School Psychology Quarterly 2014, 29(2):213-232.

[2] McAuley E, Duncan T, Tammen VV: Psychometric Properties of the Intrinsic Motivation Inventory in a Competitive Sport Setting: A Confirmatory Factor Analysis. Research Quarterly for Exercise and Sport 1989, 60(1):48-58.
Timepoint [12] 323681 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [13] 323682 0
Student enjoyment of PE and school sport will be assessed using three items adapted to PE and school sport of the Student Engagement in School questionnaire [1].

[1] Lam S-f, Jimerson S, Wong BPH, Kikas E, Shin H, Veiga FH, Hatzichristou C, Polychroni F, Cefai C, Negovan V et al: Understanding and measuring student engagement in school: The results of an international study from 12 countries. School Psychology Quarterly 2014, 29(2):213-232.
Timepoint [13] 323682 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [14] 323690 0
Student concentration in PE and school sport will be assessed using three items from Satndage et al[1].

[1] Standage, M., Duda, J. L., & Ntoumanis, N. (2005). A test of self-determination theory in school physical education. British Journal of Educational Psychology, 75(3), 411-433.
Timepoint [14] 323690 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [15] 323691 0
Students use of strategies when trying to learn in PE and school sport will be measured using the Use of Strategies subscale of the Cognitive Processes Questionnaire in Physical Education [1].

[1] Solmon MA, Lee AM: Development of an instrument to assess cognitive processes in physical education classes. Research Quarterly for Exercise and Sport 1997, 68(2):152-160.
Timepoint [15] 323691 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [16] 323692 0
Students perceived well-being will be measured using 10 items from the World Health Organisation's Health Behavior in School-aged Children questionnaire [1].

[1] World Health Organisation. (2016). Health Behavior in School-aged Children Questionnaire. Retrieved from http://www.hbsc.org/
Timepoint [16] 323692 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [17] 323693 0
Students academic achievement will be measured using standardised numeracy and literacy scores, provided by National Assessment Program - Literacy and Numeracy (NAPLAN)
Timepoint [17] 323693 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [18] 323694 0
Students fundamental movement skill competency will be measured using three object-control skills (overarm throw, catch, and kick) from the Test of Gross Motor Development-2 [1].*

[1] Ulrich DT: Test of Gross Motor Development Examiner's Manual, 2nd edition edn. Austin, Texas: Pro.Ed; 2000.

* To be conducted in a subsample only - one class per school.
Timepoint [18] 323694 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [19] 323695 0
Children’s working memory and inhibition be measured using modified AX-Continuous Performance Task [1].*

[1] Paxton, J.L., Barch, D.M., Racine, C.A., Braver, T.S., 2008. Cognitive control, goal maintenance, and prefrontal function in healthy aging. Cerbral Cortex 18, 1010–1028.

* To be conducted in a subsample only - one class per school.
Timepoint [19] 323695 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [20] 323698 0
Principals' perceptions of facilities, equipment, time allocation, and support for PE and school sport using 13 items from the NSW School Physical Activity and Nutrition Survey [1].

[1] Hardy LL, King L, Espinel P, Cosgrove C, Bauman A: NSW Schools Physical Activity and Nutrition Survey (SPANS): Full report. In. Sydney: NSW Ministry of Health; 2010.
Timepoint [20] 323698 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [21] 323699 0
Principal reported use of "Sporting Schools" funding from a single questionnaire item developed for this study.
Timepoint [21] 323699 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [22] 323700 0
Teacher self-reported typical physical activity participation using the same measure as for students[1].

[1] Ridgers ND, Timperio A, Crawford D, Salmon J: Validity of a brief self-report instrument for assessing compliance with physical activity guidelines amongst adolescents. Journal of Science and Medicine in Sport 2012, 15(2):136-141.
Timepoint [22] 323700 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [23] 323701 0
Teacher self-reported physical activity participation in the last week using the same measure as for students[1].

[1] Ridgers ND, Timperio A, Crawford D, Salmon J: Validity of a brief self-report instrument for assessing compliance with physical activity guidelines amongst adolescents. Journal of Science and Medicine in Sport 2012, 15(2):136-141.
Timepoint [23] 323701 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [24] 323702 0
Teacher organised team sport participation in the past year using the same single item as used with students [1].

[1] Active Healthy Kids Australia: Is Sport Enough? The 2014 Active Healthy Kids Australia Report Card on Physical Activity for Children and Young People In. Adelaide, South Australia: Active Healthy Kids Australia; 2014.
Timepoint [24] 323702 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [25] 323703 0
Teacher organised individualised sport participation in the past year using the same single item as used with students[1].

[1] Active Healthy Kids Australia: Is Sport Enough? The 2014 Active Healthy Kids Australia Report Card on Physical Activity for Children and Young People In. Adelaide, South Australia: Active Healthy Kids Australia; 2014.
Timepoint [25] 323703 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [26] 323704 0
Teacher frequency of active travel to school using the same single item as used with students[1].

[1] Active Healthy Kids Australia: Is Sport Enough? The 2014 Active Healthy Kids Australia Report Card on Physical Activity for Children and Young People In. Adelaide, South Australia: Active Healthy Kids Australia; 2014.
Timepoint [26] 323704 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [27] 323705 0
Teacher reported accreditation to coach sport.
Timepoint [27] 323705 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [28] 323706 0
Teacher reported confidence in teaching PE and school sport using adapted items [1].

[1] Morgan P, Bourke S: Non-specialist teachers' confidence to teach PE: the nature and influence of personal school experiences in PE. Physical Education and Sport Pedagogy 2008, 13(1):1-29.
Timepoint [28] 323706 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [29] 323707 0
Teacher reported confidence in teaching English using adapted items [1].

[1] Morgan P, Bourke S: Non-specialist teachers' confidence to teach PE: the nature and influence of personal school experiences in PE. Physical Education and Sport Pedagogy 2008, 13(1):1-29.
Timepoint [29] 323707 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [30] 323708 0
Teacher reported confidence in teaching Mathematics using adapted items [1].

[1] Morgan P, Bourke S: Non-specialist teachers' confidence to teach PE: the nature and influence of personal school experiences in PE. Physical Education and Sport Pedagogy 2008, 13(1):1-29.
Timepoint [30] 323708 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [31] 323709 0
Teacher reported confidence in teaching Science and Technology using adapted items [1].

[1] Morgan P, Bourke S: Non-specialist teachers' confidence to teach PE: the nature and influence of personal school experiences in PE. Physical Education and Sport Pedagogy 2008, 13(1):1-29.
Timepoint [31] 323709 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [32] 323710 0
Teacher perception of student conduct will be measured using a single item[1].

[1] Lam S-f, Jimerson S, Wong BPH, Kikas E, Shin H, Veiga FH, Hatzichristou C, Polychroni F, Cefai C, Negovan V et al: Understanding and measuring student engagement in school: The results of an international study from 12 countries. School Psychology Quarterly 2014, 29(2):213-232.
Timepoint [32] 323710 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [33] 323711 0
Teacher perceptions of their students' engagement in PE and school sport lessons using an adapted version of Student Engagement in School questionnaire [1].

[1] Lam S-f, Jimerson S, Wong BPH, Kikas E, Shin H, Veiga FH, Hatzichristou C, Polychroni F, Cefai C, Negovan V et al: Understanding and measuring student engagement in school: The results of an international study from 12 countries. School Psychology Quarterly 2014, 29(2):213-232.
Timepoint [33] 323711 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [34] 323715 0
Teacher internet self-efficacy using an eight-item scale [1].

[1] Eastin MS, LaRose R: Internet self-efficacy and the psychology of the digital divide. Journal of Computer-Mediated Communication 2000, 6(1)
Timepoint [34] 323715 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [35] 323716 0
Teacher job satisfaction will be measured using a single-item [1].

[1] Wanous, J. P., Reichers, A. E., & Hudy, M. J. (1997). Overall job satisfaction: how good are single-item measures? Journal of Applied Psychology, 82(2), 247.
Timepoint [35] 323716 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [36] 323717 0
Teacher absenteeism will be reported by each teacher's principal.
Timepoint [36] 323717 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [37] 324042 0
Intervention cost effectiveness will be measured by:
*Identification of costs to be included, using ‘pathway analysis’, where activities in all stages of the roll out of the iPLAY project are fully specified; A societal perspective and steady state operation of the intervention will be assumed (up and running to its full effectiveness potential). Costs will largely relate to the time costs of specialist mentors, leaders, classroom teachers, and school principals (using opportunity cost principles). Any administrative resources used at the program management level also will be identified and included, although research-driven activities will be separated from the activities that would be carried out should the program be adopted by primary schools;

*Measurement of the resources consumed in natural units (number of hours spent by specialist mentors/leaders within school/principals to deliver the intervention, number and length of school visits, etc.);

*Valuation of these resources in monetary units (using 2018 as the reference year).
Timepoint [37] 324042 0
Baseline, 12 and 24 months post-baseline.
Secondary outcome [38] 324105 0
Students' BMI Z-score [1].

[1] Flegal KM, Cole TJ: Construction of LMS parameters for the Centers for Disease Control and Prevention 2000 growth charts. Natl Health Stat Report 2013, 63:1-4.
Timepoint [38] 324105 0
12 and 24 months

Eligibility
Key inclusion criteria
Students, teachers and principals at government-funded NSW primary schools will be eligible to express their interest to participate in the project.
Minimum age
7 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students, teachers and principals at schools designated as ‘Schools for Specific Purposes’ (i.e., for students who require intensive levels of support) will not be eligible for the cluster RCT. Schools that participated in our original efficacy study (ACTRN12611001080910) will also be excluded from the cluster RCT.
School will be additionally excluded if: the principal does not provide consent, less than 50% of Stage 2 (Years 3 and 4) teachers choose not to participate, or if no staff members are willing to be an iPLAY leader.

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 is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Two cohorts (10 schools per cohort) will be recruited into the cluster RCT. A four step approach will be used.
1. Stratification - all schools that express interest and are among the 90 selected to participate in each cohort will be stratified according to socioeconomic status (SES) and geographic location. This process will produce four strata: (i) urban-rich, (ii) urban-poor, (iii) provincial-rich, and (iv) provincial-poor.
2. Match-pairing - We will employ a Euclidian distance minimisation strategy to create pairs of similar schools from within strata. The variables used in this minimization process will be: (i) school-level SES, (ii) school size (number of students enrolled), (iii) average scores on National standardized test of numeracy and literacy that are completed by all NSW children (see outcomes section for further details), and (iv) schools participation (or not) in a state-wide physical activity and nutrition program, known as Live Life Well at School, that took place from 2008-2015.
3. Pair Selection - Once schools have been matched using the minimisation procedure, we will select the 2-3 most similar pairs of schools from within each strata to participate in the cluster RCT.
4. Randomisation: Following baseline data collection, schools will be randomly assigned from within each pair to the experimental or control arm of the cluster RCT. An experienced statistician who is not part of the research team will conduct the randomisation procedure using a computer-generated algorithm.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Schools not assigned to the cluster RCT will still be eligible to receive the intervention as part of a separate dissemination study. They will complete a different set of measures.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
We will test for between arm differences in changes in outcomes using linear mixed model with standard errors corrected for clustering. We will analyse data according to intention to treat principles (main analyses) and per-protocol principles (sensitivity analyses). We conducted a power analysis using procedures appropriate for complex nested designs [1]. In this analysis the effect size for between-arm differences in cardiorespiratory fitness (primary outcome) was conservatively set to .35 (note: effect in our efficacy trial was .54) with ICCs based on our efficacy trial [14] (class = .09, school = .01). Analysis indicated that 1080 students from 60 classes in 20 schools (i.e., 3 classes per school) would provide power of .91.

We will explore potential moderators of intervention effects including children’s age, gender, ethnicity, weight status and SES, as well as baseline levels of cardio-respiratory fitness, physical activity and fundamental movement skill competence. As with the main analyses, we will employ mixed modeling approach to explore moderation hypotheses by including appropriate interaction terms in the regression models. The trial is not powered to detect interactions; thus, we will employ a significance level of p < 0.1 to explore potential moderators. We will explore significant interaction terms by testing sub-groups differences on the primary outcome and selected secondary outcomes.

Per protocol analyses will investigate the influence of iPLAY leaders’ and other teachers’ adoption of the intervention, as indicated by the proportion of intervention components completed (e.g., workshops attended and online tasks completed), on student outcomes.

Linear mixed models will be also used to examine potential mediating processes. For example, in our efficacy study we found that changes in fundamental movement skills mediated the effect of the intervention on children’s physical activity and cardiorespiratory fitness. Mediating effects will be estimated using a cluster-bootstrapped based product- of-coefficients test that is appropriate for cluster randomized controlled trials.

An economic evaluation will be conducted to determine if iPLAY represents ‘value-for-money’ measured incrementally against the attention control arm. This allocative efficiency focus will determine whether the cost of the intervention is justified by the benefits derived from it, measured against usual practice. Costs in each arm of the trial will be estimated from a societal perspective using detailed pathway analysis to identify resource use and measurement processes for the reference year 2016. The incremental differences in costs will be combined with the behavioural and biomarker outcomes observed in the trial to produce a range of incremental cost effectiveness ratios. In addition to a ‘trial-based evaluation’ (costs and outcomes exactly as per the trial), depending on the outcomes, a modelled economic evaluation with the extended time horizon may be undertaken to further translate the benefits observed in the trial into final health benefits, assessed as disability-adjusted life years (DALYs) averted. The modelled economic evaluation will simulate the impact of increased physical activity and the competency of movement skills on the overall well-being of the lifetime of the cohort compared with usual practice. A Markov model consisting of health states associated with different levels of physical activities/competency of movement skills will be used to accrue costs and benefits over the time horizon. The long-term improved outcome may translate into the cost savings which offset the increased cost associated with the implementation of iPLAY project. Simulation-modelling using the @RISK software package will calculate 95% uncertainty intervals around the epidemiological probabilities and cost estimates.

[1] Judd CM, Westfall J, Kenny DA: Research Designs in Psychology with Multiple Random Factors. Annual Review of Psychology, 67(1).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/06/2016
Actual
13/06/2016
Date of last participant enrolment
Anticipated
1/07/2017
Actual
7/12/2017
Date of last data collection
Anticipated
20/12/2019
Actual
6/12/2019
Sample size
Target
1080
Accrual to date
Final
1219
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 293554 0
Government body
Name [1] 293554 0
NHMRC
Country [1] 293554 0
Australia
Funding source category [2] 293555 0
Government body
Name [2] 293555 0
New South Wales Department of Education School Sport Unit
Country [2] 293555 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
ACU Strathfield Campus
25A Barker Road Strathfield NSW 2135
Country
Australia
Secondary sponsor category [1] 292370 0
None
Name [1] 292370 0
Address [1] 292370 0
Country [1] 292370 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295013 0
State Education Research Applications Process
Ethics committee address [1] 295013 0
Ethics committee country [1] 295013 0
Australia
Date submitted for ethics approval [1] 295013 0
22/10/2014
Approval date [1] 295013 0
05/11/2015
Ethics approval number [1] 295013 0
2014260
Ethics committee name [2] 295014 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [2] 295014 0
Ethics committee country [2] 295014 0
Australia
Date submitted for ethics approval [2] 295014 0
Approval date [2] 295014 0
31/10/2014
Ethics approval number [2] 295014 0
2014 185N

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

Contacts
Principal investigator
Name 65390 0
A/Prof Chris Lonsdale
Address 65390 0
Institute for Positive Psychology and Education
Australian Catholic University
Locked Bag 2002
Strathfield NSW 2135
Country 65390 0
Australia
Phone 65390 0
+61 2 9701 4642
Fax 65390 0
Email 65390 0
[email protected]
Contact person for public queries
Name 65391 0
Chris Lonsdale
Address 65391 0
Institute for Positive Psychology and Education
Australian Catholic University
Locked Bag 2002
Strathfield NSW 2135
Country 65391 0
Australia
Phone 65391 0
+61 2 9701 4642
Fax 65391 0
Email 65391 0
[email protected]
Contact person for scientific queries
Name 65392 0
Chris Lonsdale
Address 65392 0
Institute for Positive Psychology and Education
Australian Catholic University
Locked Bag 2002
Strathfield NSW 2135
Country 65392 0
Australia
Phone 65392 0
+61 2 9701 4642
Fax 65392 0
Email 65392 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We will be reviewing our ethics approval before making a decision about individual data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1561Study protocol    https://bmcpublichealth.biomedcentral.com/articles... [More Details]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of a Scalable School-Based Intervention on Cardiorespiratory Fitness in Children: A Cluster Randomized Clinical Trial.2021https://dx.doi.org/10.1001/jamapediatrics.2021.0417
N.B. These documents automatically identified may not have been verified by the study sponsor.