Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621001132831
Ethics application status
Approved
Date submitted
29/06/2021
Date registered
23/08/2021
Date last updated
23/08/2021
Date data sharing statement initially provided
23/08/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
State-wide dissemination of the Internet-based Professional Learning to help teachers to support Activity in Youth (iPLAY) intervention
Scientific title
Evaluating the scale-up of an internet-based professional learning program on teachers' implementation and children's participation in physical activity
Secondary ID [1] 304643 0
None
Universal Trial Number (UTN)
Trial acronym
iPLAY II
Linked study record
This study is the next phase of ACTRN12616000731493. The aforementioned study was a cluster RCT which evaluated the iPLAY program, prior to state-wide dissemination (the current study).

Health condition
Health condition(s) or problem(s) studied:
Secular decline in children's cardiorespiratory fitness 322584 0
Physical inactivity in children 322585 0
Condition category
Condition code
Public Health 320199 320199 0 0
Health promotion/education
Cardiovascular 320200 320200 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial will test implementation of the Internet-based Professional Learning to help teachers support Activity in Youth (iPLAY) program, whilst secondarily collecting information related to effectiveness of the iPLAY intervention.

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.

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.

Teachers from all NSW elementary schools were eligible to enroll in the iPLAY dissemination study. Following enrolment, teachers were trained to deliver the iPLAY intervention via a combination of face-to-face and online learning modalities. First, iPLAY mentors delivered a two-hour face-to-face workshop to teachers in a group setting. Second, teachers received one hour of individual implementation support from the iPLAY mentor. Following this, teachers then completed an additional four hours of online learning via the iPLAY website, consisting of 8 x 30-minute online learning modules. Each module consisted of short (i.e., 3-5min) videos describing strategies and good and poor practice examples. Teachers were prompted to reflect on the strategies learnt, and set action plans to assist them in implementing the learnt strategies. Teachers were also asked to reflect on their implementation at the beginning of each online module. The face-to-face workshop, implementation support (from the mentor) and 8 online modules were 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. The iPLAY website not only provided teachers and leaders with their online training modules, but also provided downloadable resources (e.g., lesson plans, activity descriptions, and classroom movement break videos) to support implementation. Teachers were continuously able to access resources on the iPLAY website. Teachers were asked to start implementing the intervention straight after attending the face-to-face workshop. The intervention is designed to be sustainable, as it requires teachers to change their teaching practices and increase opportunities for students to be active at school. Support from the iPLAY mentor is provided for a duration of 12-months.

Additionally, school principals also chose 1-3 teachers to be school leaders. These individuals received further online training and were responsible for the implementation of the non-curricular intervention components (i.e., active playgrounds; community physical activity links; parent and caregiver engagement). iPLAY leaders completed four online learning modules (30 mins × 4 modules = 2 hours) designed to teach them how to implement the non-curricular components (i.e., active playgrounds; community physical activity links; parent and caregiver engagement) of the intervention. Additionally, iPLAY leaders will support other teachers with their implementation of the iPLAY components.

Intervention adherence in PE lessons was monitored using lesson observations completed by the iPLAY mentors. Adherence to the non-curricular intervention components was self-reported by teachers using the iPLAY website. This information was then reviewed by mentors and discussed in meetings with teachers.
Intervention code [1] 320997 0
Prevention
Intervention code [2] 320998 0
Lifestyle
Intervention code [3] 320999 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328081 0
The total number of students who may have been exposed to the iPLAY program. This estimate will be calculated via teacher workshop enrolment data, class size data, and school enrolment data.
Timepoint [1] 328081 0
Calculation to be done at the end of the evaluation period (July 2021).
Primary outcome [2] 328082 0
Any change in students' self-reported physical activity will be assessed in a sub-sample of students using a validated measure [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. J Sci Med Sport. 2012;15(2):136–41.
Timepoint [2] 328082 0
Baseline and 12-months (post-program)
Secondary outcome [1] 397537 0
Any change in students’ perceptions of need support from their teacher will be 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] in a sub-sample of students.

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: University of Rochester; 1988.

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? J Educ Psychol. 2009;101(3):644.
Timepoint [1] 397537 0
Baseline and 12-months (post-program)
Secondary outcome [2] 397538 0
Any change in 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 BP, Kikas E, Shin H, Veiga FH, Hatzichristou C, Polychroni F, Cefai C, Negovan V. Understanding and measuring student engagement in school: The results of an international study from 12 countries. Sch Psychol Q. 2014;29(2):213.

[2] McAuley E, Duncan T, Tammen VV. Psychometric properties of the intrinsic motivation inventory in a competitive sport setting: a confirmatory factor analysis. Res Q Exerc Sport. 1989;60:48–58.
Timepoint [2] 397538 0
Baseline and 12-months (post-program)
Secondary outcome [3] 397540 0
Any change in teacher self-reported typical physical activity participation will be assessed 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. J Sci Med Sport. 2012;15(2):136–41.
Timepoint [3] 397540 0
Baseline and 12-months (post-program)
Secondary outcome [4] 397548 0
Any change in teacher reported confidence to teach PE and school sport will be assessed using an existing measure [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 [4] 397548 0
Baseline and 12-months (post-program)
Secondary outcome [5] 397549 0
Any change in teacher perceptions of their students' engagement in PE and school sport lessons will be assessed using an adapted version of Student Engagement in School questionnaire [1].

[1] Lam S-F, Jimerson S, Wong BP, Kikas E, Shin H, Veiga FH, Hatzichristou C, Polychroni F, Cefai C, Negovan V. Understanding and measuring student engagement in school: The results of an international study from 12 countries. Sch Psychol Q. 2014;29(2):213.
Timepoint [5] 397549 0
Baseline and 12-months (post-program)
Secondary outcome [6] 397551 0
The total number of schools that have participated in the iPLAY program (composite outcome). Based on website iPLAY website data compared to school data from MySchool website.
Timepoint [6] 397551 0
School enrolments to be assessed at the end of the dissemination evaluation period (July 2021).
Secondary outcome [7] 397552 0
The total number of teachers that have participated in the iPLAY program (composite outcome). Based on website iPLAY website data compared to school data from MySchool website.
Timepoint [7] 397552 0
Teacher enrolments will be assessed at the end of the dissemination evaluation period (July 2021).
Secondary outcome [8] 397553 0
Adoption of the iPLAY program by leaders (composite outcome). Proportion of leaders who complete the (i) 5 x online training modules and (ii) 4 x action planning meetings..
Timepoint [8] 397553 0
Website usage will be assessed at the end of the dissemination evaluation period (July 2021).
Secondary outcome [9] 397557 0
Adoption of the iPLAY program by teachers (composite outcome). Proportion of teachers who complete the (i) workshop module, (ii) 8 x online training modules, (iii) 3 x school-based reflection modules, (iv) download resources, (v) download mobile app, (vi) used class activity monitoring system, and (vii) used posters, water bottles and lanyards.
Timepoint [9] 397557 0
Website data will be assessed at the end of the dissemination evaluation period (July 2021).
Secondary outcome [10] 397559 0
Implementation of the non-curricular intervention components reported by leaders (composite outcome). Proportion of schools that implement: (i) active playground strategies), (ii) Sporting Schools funding, (iii) teacher accreditation with a recognised sporting body, (iv) parent newsletters, (v) parent information session(s), (vi) physically active school fundraiser.
Timepoint [10] 397559 0
Website data will be assessed at the end of the dissemination evaluation period (July 2021).
Secondary outcome [11] 397560 0
Implementation of the curricular intervention components reported by teachers (composite outcome). Proportion of teachers that implement: (i) 150 mins of PE/sport/week, (ii) quality PE as determined by mentor lesson observations (i.e., mean SAAFE rating >3.0), (iii) 10 classroom energizers per week, and (iv) 1 weekly active homework activity.
Timepoint [11] 397560 0
Website data will be assessed at the end of the dissemination evaluation period (July 2021).
Secondary outcome [12] 397561 0
Maintenance of the program will be determined using interviews with teachers, leaders and principles. Semi-structured interviews (~30 minutes) will be conducted to determine the extent to which the iPLAY program has become institutionalized in schools.
Timepoint [12] 397561 0
18-months from baseline.

Eligibility
Key inclusion criteria
All government primary schools in NSW were eligible to participate, including their staff (for training) and students (for participation).
Minimum age
5 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students will be ineligible if they have a medical condition or physical injury preventing participation in physical activity.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/06/2016
Date of last participant enrolment
Anticipated
Actual
30/06/2020
Date of last data collection
Anticipated
Actual
31/07/2021
Sample size
Target
20000
Accrual to date
Final
27000
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 309004 0
Government body
Name [1] 309004 0
NHMRC
Country [1] 309004 0
Australia
Funding source category [2] 309016 0
Government body
Name [2] 309016 0
New South Wales Department of Education School Sport Unit
Country [2] 309016 0
Australia
Primary sponsor type
Individual
Name
Prof David Lubans
Address
Priority Research Centre for Physical Activity and Nutrition
Level 3 ATC building
University of Newcastle
University Drive
Callaghan, NSW 2308
Country
Australia
Secondary sponsor category [1] 309951 0
Individual
Name [1] 309951 0
Prof Chris Lonsdale
Address [1] 309951 0
Australian Catholic University
40 Edward St
North Sydney NSW 2060
Country [1] 309951 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308893 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [1] 308893 0
Manager, Ethics and Integrity
c/o Office of the Deputy Vice Chancellor (Research)
Australian Catholic University
North Sydney Campus
PO Box 968
NORTH SYDNEY, NSW 2059
Ethics committee country [1] 308893 0
Australia
Date submitted for ethics approval [1] 308893 0
Approval date [1] 308893 0
31/10/2014
Ethics approval number [1] 308893 0
2014 185N
Ethics committee name [2] 309239 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 309239 0
University of Newcastle
Callaghan Campus
University Drive
NSW 2308
Ethics committee country [2] 309239 0
Australia
Date submitted for ethics approval [2] 309239 0
29/04/2016
Approval date [2] 309239 0
04/08/2016
Ethics approval number [2] 309239 0
H-2016-0135

Summary
Brief summary
Whole-of-school programs are considered one of eight investments that work for physical activity promotion by the International Society for Physical Activity and Health. However, very few whole-of-school interventions progress beyond efficacy testing to implementation at-scale. The ‘Internet-based Professional Learning to help teachers support Activity in Youth’ (iPLAY) program ) is a whole-of-school physical activity intervention, that includes three curricular and three non-curricular components: (i) quality physical education, (ii) classroom energisers, (iii) active homework, (iv) active playgrounds, (v) parental engagement, and (vi) community links. The iPLAY program was designed to improve cardiorespiratory fitness by providing children with opportunities to participate in moderate-to-vigorous physical activity within and beyond the school setting. The iPLAY program was evaluated via a cluster randomised controlled trial (RCT) in 22 New South Wales (NSW) primary schools (ACTRN12616000731493). At 12- and 24-months, students in the iPLAY group had greater increases in cardiorespiratory fitness than students in the control group. The aim of this study was to examine the dissemination of the iPLAY program in NSW primary schools using the RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) framework.
Trial website
www.iplay.org.au
Trial related presentations / publications


Public notes
The first reference below provides a rationale for the study and describes the study methods. The second reference reports the findings from the iPLAY cluster randomised controlled trial, which was embedded within the larger dissemination study.

Lonsdale, C., Sanders, T., Cohen, K., Parker, P., Noetel, M., Hartwig, T., . . . Lubans, D. (2016). Scaling-up an efficacious school-based physical activity intervention: Study protocol for the 'Internet-based Professional Learning to help teachers support Activity in Youth' (iPLAY) cluster randomized controlled trial and scale-up implementation evaluation. BMC Public Health, 16(873). doi:10.1186/s12889-016-3243-2

Lonsdale, C., Sanders, T., Parker, P., Noetel, M., Hartwig, T., Vasconcellos, D., . . . Lubans, D. R. (2021). Effect of a scalable school-based intervention on cardiorespiratory fitness in children: A cluster randomized clinical trial. Journal of the American Medical Association Pediatrics, 175, 680-688. doi:10.1001/jamapediatrics.2021.0417.

Contacts
Principal investigator
Name 112246 0
Prof David Lubans
Address 112246 0
Priority Research Centre for Physical Activity and Nutrition
University of Newcastle
University Drive Callaghan NSW 2308
Country 112246 0
Australia
Phone 112246 0
+61 02 49212049
Fax 112246 0
Email 112246 0
[email protected]
Contact person for public queries
Name 112247 0
David Lubans
Address 112247 0
Priority Research Centre for Physical Activity and Nutrition
University of Newcastle
University Drive Callaghan NSW 2308
Country 112247 0
Australia
Phone 112247 0
+61 02 49212049
Fax 112247 0
Email 112247 0
[email protected]
Contact person for scientific queries
Name 112248 0
David Lubans
Address 112248 0
Priority Research Centre for Physical Activity and Nutrition
University of Newcastle
University Drive Callaghan NSW 2308
Country 112248 0
Australia
Phone 112248 0
+61 02 49212049
Fax 112248 0
Email 112248 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


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.