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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

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Background: Despite the health benefits of regular physical activity, most children are insufficiently active. Schools are ideally placed to promote physical activity; however, many do not provide children with sufficient in-school activity or ensure they have the skills and motivation to be active beyond the school setting. 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. The 'Internet-based Professional Learning to help teachers support Activity in Youth' (iPLAY) study will focus largely on online delivery to enhance translational capacity. Methods/design: The intervention will be implemented at school and teacher levels, and will include six components: (i) quality physical education and school sport, (ii) classroom movement breaks, (iii) physically active homework, (iv) active playgrounds, (v) community physical activity links and (vi) parent/caregiver engagement. Experienced physical education teachers will deliver professional learning workshops and follow-up, individualized mentoring to primary teachers (i.e., Kindergarten - Year 6). These activities will be supported by online learning and resources. Teachers will then deliver the iPLAY intervention components in their schools. We will evaluate iPLAY in two complementary studies in primary schools across New South Wales (NSW), Australia. A cluster randomized controlled trial (RCT), involving a representative sample of 20 schools within NSW (1:1 allocation at the school level to intervention and attention control conditions), will assess effectiveness and cost-effectiveness at 12 and 24 months. Students' cardiorespiratory fitness will be the primary outcome in this trial. Key secondary outcomes will include students' moderate-to-vigorous physical activity (via accelerometers), fundamental movement skill proficiency, enjoyment of physical education and sport, cognitive control, performance on standardized tests of numeracy and literacy, and cost-effectiveness. A scale-up implementation study guided by the RE-AIM framework will evaluate the reach, effectiveness, adoption, implementation, and maintenance of the intervention when delivered in 160 primary schools in urban and regional areas of NSW. Discussion: This project will provide the evidence and a framework for government to guide physical activity promotion throughout NSW primary schools and a potential model for adoption in other states and countries. Trial registration: Australia and New Zealand Clinical Trials Registry ( ACTRN12616000731493 ). Date of registration: June 3, 2016.
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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
Lonsdale et al.
Lonsdale et al. BMC Public Health (2016) 16:873
DOI 10.1186/s12889-016-3243-2
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
S T U D Y P R O T O C O L Open Access
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
Chris Lonsdale
1*
, Taren Sanders
1
, Kristen E. Cohen
2
, Philip Parker
1
, Michael Noetel
3
, Tim Hartwig
4
,
Diego Vasconcellos
1
, Morwenna Kirwan
5
, Philip Morgan
2
, Jo Salmon
6
, Marj Moodie
7
, Heather McKay
8
,
Andrew Bennie
9
, Ron Plotnikoff
2
, Renata L. Cinelli
10
, David Greene
4
, Louisa R. Peralta
11
, Dylan P. Cliff
12
,
Gregory S. Kolt
9
, Jennifer M. Gore
13
, Lan Gao
7
and David R. Lubans
2
Abstract
Background: Despite the health benefits of regular physical activity, most children are insufficiently active. Schools are
ideally placed to promote physical activity; however, many do not provide children with sufficient in-school activity or
ensure they have the skills and motivation to be active beyond the school setting. The aim of this project is to modify,
scale up and evaluate the effectiveness of an intervention previously shown to be efficacious in improving childrens
physical activity, fundamental movement skills and cardiorespiratory fitness. The Internet-based Professional Learning to
help teachers support Activity in Youth(iPLAY) study will focus largely on online delivery to enhance translational capacity.
Methods/Design: The intervention will be implemented at school and teacher levels, and will include six components: (i)
quality physical education and school sport, (ii) classroom movement breaks, (iii) physically active homework, (iv) active
playgrounds, (v) community physical activity links and (vi) parent/caregiver engagement. Experienced physical education
teachers will deliver professional learning workshops and follow-up, individualized mentoring to primary teachers (i.e.,
Kindergarten Year 6). These activities will be supported by online learning and resources. Teachers will then deliver the
iPLAY intervention components in their schools. We will evaluate iPLAY in two complementary studies in primary schools
across New South Wales (NSW), Australia. A cluster randomized controlled trial (RCT), involving a representative sample of
20 schools within NSW (1:1 allocation at the school level to intervention and attention control conditions), will assess
effectiveness and cost-effectiveness at 12 and 24 months. Studentscardiorespiratory fitness will be the primary outcome
in this trial. Key secondary outcomes will include studentsmoderate-to-vigorous physical activity (via accelerometers),
fundamental movement skill proficiency, enjoyment of physical education and sport, cognitive control, performance on
standardized tests of numeracy and literacy, and cost-effectiveness. A scale-up implementation study guided by the
RE-AIM framework will evaluate the reach, effectiveness, adoption, implementation, and maintenance of the intervention
when delivered in 160 primary schools in urban and regional areas of NSW.
(Continued on next page)
* Correspondence: chris.lonsdale@acu.edu.au
1
Institute for Positive Psychology and Education, Australian Catholic University,
Edward Clancy Building 167-169 Albert St, Strathfield, NSW 2135, Australia
Full list of author information is available at the end of the article
© 2016 The Author(s). Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Lonsdale et al. BMC Public Health (2016) 16:873
DOI 10.1186/s12889-016-3243-2
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
(Continued from previous page)
Discussion: This project will provide the evidence and a framework for government to guide physical activity promotion
throughout NSW primary schools and a potential model for adoption in other states and countries.
Trial registration: Australia and New Zealand Clinical Trials Registry (ACTRN12616000731493). Date of registration: June
3, 2016.
Keywords: Cardiorespiratory fitness, Physical activity, Teacher professional development, Teacher professional learning,
Online, Internet
Background
Physical inactivity is a global pandemic, with far-reach-
ing health, economic, environmental and social conse-
quences[1]. Among children, the health benefits of
physical activity are extensive and include improved
physical fitness and bone health as well as reduced risk
of obesity and cardiometabolic precursors of diseases
such as type II diabetes [2, 3]. Physical activity may also
improve psychological well-being and prevent mental
health disorders such as depression and anxiety [35].
Recent evidence also indicates that, compared with their
less active peers, physically active children can exert bet-
ter cognitive control [6], are more engaged with school
[7], and perform better on standardized tests of aca-
demic achievement [8].
The International Society for Physical Activity and
Health [9] considers schools to be among the seven best
investmentsfor evidence-based physical activity promo-
tion. Unfortunately, many schools are failing to provide
children with sufficient opportunities to be active at
school and do not equip them with the necessary skills
and motivation to be active beyond the school setting
[10, 11]. In systematic reviews, multi-component, flex-
ible models were deemed more effective than single
component models [12, 13]. Similarly, the US Centers
for Disease Control and Prevention recommend schools
deliver comprehensive school physical activity programs
[14] that involve coordination across five components:
(i) quality physical education (PE), (ii) activity during the
school day, (iii) activity before and after school, (iv) staff
involvement and (v) family and community involvement.
Despite convincing evidence of their effectiveness, few
studies have implemented and evaluated comprehensive
school physical activity programs. [15] Instead, most in-
terventions have focused on one component of the
school day (e.g., PE or recess/lunch breaks) [16, 17] and
have neglected to address the multiple opportunities for
physical activity promotion that exist within and be-
yond the school setting [18]. Among interventions that
embraced a multi-component approach, few objectively
measured effects on childrens physical activity (e.g., via
accelerometers) [19].
The SCORES intervention was a comprehensive, multi-
component physical activity and fundamental movement
skills program for primary schools [2022]. A socio-
ecological model [23] provided the framework for the 12-
month intervention, which consisted of components
designed to engage teachers, students, parents and com-
munity sport organizations. Implementation strategies
included: (i) professional learning and mentoring for
teachers, (ii) feedback for teachers based on the quality of
their PE and school sport, (iii) lesson resources for
teachers, (iv) physical activity equipment, (v) school phys-
ical activity policy review and recommendations, (vi)
training student leaders, (vii) parent engagement via news-
letters, homework and information sessions, and (viii) en-
gagement with local community sport. Our efficacy study
[21] showed significant intervention effects at 12 months
for cardiorespiratory fitness (5.4 laps; 95 % CI, 2.3 to 8.6),
daily moderate-to-vigorous physical activity (12.7 mins/
day; 5.0 to 20.5), and overall movement skill competency
(4.9 units; -0.04 to 9.8). In addition, SCORES was delivered
with a high degree of fidelity and teachers and students
reported high satisfaction with the program.
There is a considerable gap between successful interven-
tions like SCORES, and widespread dissemination in real
world contexts [24, 25]. This is crucial, as to improve
health of populations, interventions that have been effect-
ive in research settings must be delivered more broadly
[26] and with less lag time between evidence generation
and implementation. Indeed, there has been a prolifera-
tion of school-based physical activity intervention efficacy
trials in recent years [18], yet these studies have made little
impact on policy and practice [27].
In our project we will scale up and evaluate the effective-
ness of a modified version of the SCORES intervention.
The modified intervention centres around online delivery
of professional learning to teachers. This customized, web-
based delivery system was initially developed for a school-
based physical activity intervention also led by our research
team [28]. Teachers will deliver the intervention to students
and parents and engage with community sport and recre-
ation organizations. The modified intervention will be
known as iPLAY (Internet-based Professional Learning to
help teachers to support Activity in Youth) and will be
among the first comprehensive school-based physical activ-
ity interventions with a large proportion of the program
delivered online. A web-based delivery system is attractive
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as it may support scaling up and sustainability, and recent
evidence indicates that online professional learning for
teachers can be as effective as face-to-face training [29].
Aims and hypotheses
We will conduct two complementary studies involving
primary schools across New South Wales (NSW),
Australia. In the first study, we will conduct a cluster
randomized controlled trial (RCT) with a sample of 20
schools. The aim of this trial will be to evaluate the
effectiveness and cost-effectiveness of iPLAY at 12 and
24 months, with cardiorespiratory fitness as the
primary outcome. Key secondary outcomes will include
objectively-measured moderate-to-vigorous physical
activity, fundamental movement skills, cognitive control
and student performance on standardized tests of
numeracy and literacy. We hypothesize that:
1. compared with the control condition, the iPLAY
intervention will produce positive effects on childrens
outcomes in the short-term (post-intervention,
12 months after baseline, primary endpoint for the
trial),
2. these benefits will be maintained 12 months after the
end of the intervention (24 months after baseline), and
3. the intervention will represent value-for-money.
The aim of the second study will be to evaluate the inter-
ventions wide-scale implementation (scale up). To achieve
this goal we will adopt the RE-AIM framework and assess
Reach, Effectiveness, Adoption, Implementation, and Main-
tenance of iPLAY in 160 NSW primary schools (i.e.,
Kindergarten Year 6).
Methods
Design
We will concurrently conduct two complementary eval-
uations (see Fig. 1):
1. A cluster RCT involving 20 schools (1:1 allocation
to intervention and attention control conditions)
to evaluate the Effectiveness and incremental
cost-effectiveness of the iPLAY intervention, with
cardiorespiratory fitness as the primary outcome.
2. A scale-up implementation study will examine iPLAYs
Reach, Adoption, Implementation and Maintenance
with a reduced examination of Effectiveness and
cost-effectiveness. These aspects will be measured
in 160 schools.
All teachers in each school selected for the cluster RCT
and scale-up implementation study will be invited to
complete the iPLAY intervention (or attention control
intervention for 10 schools in the cluster RCT). However,
only the student cohorts in Years 3 and 4 at baseline will
complete outcome assessments (i.e., students in Years 3
and 4 at baseline, students in Years 4 and 5 at post-
intervention [12 months], students in Years 5 and 6 at
maintenance [24 months]). These students will be avail-
able for assessment at all time-points (c.f. most Year 5 and
6 students will leave the school by 24 months), and will
have the cognitive ability to complete the questionnaires
(c.f., Years 1 and 2). In addition, these years represent the
ideal period to develop fundamental movement skill com-
petency [30], which may help prevent the decline in phys-
ical activity typically observed during the transition from
childhood to adolescence [31].
Recruitment, selection and randomization for both
investigations
All government-funded NSW primary schools (N= 1,600)
[32] will be invited to participate in the project. All
schools will be eligible to participate in the scale-up
implementation study, but those 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 the original SCORES efficacy
study [21] will be eligible for the scale-up implementation
study, but will be excluded from the cluster RCT.
Schools will be recruited via presentations at confer-
ences and meetings (e.g., regional meetings of the NSW
Primary Principals Association) and advertisements sent
by the NSW Department of Education and the Australian
Council for Health, Physical Education and Recreation.
We will also advertise via the NSW Department of Educa-
tion Twitter feeds and Facebook pages. We aim to recruit
a total of 180 schools (>10 % of the total number of NSW
government-funded primary schools). From the schools
that express interest prior to May 2016, we will use a
computer-generated algorithm to randomly select 90 to
form Cohort 1. Recruitment will continue through to
March 2017 at which point we will randomly select 90
schools to form Cohort 2.
From within each cohort, we will select 10 schools to
participate in the cluster RCT; the other 80 schools will
participate in the scale-up implementation study. Select-
ing schools for the cluster RCT will involve a four-step
approach. The aims of this process are to ensure that
schools in the cluster RCT are: (i) broadly representative
of schools in NSW and (ii) assigned to trial arms such
that most school-level covariates (e.g., socioeconomic
status [SES], geographic location) are balanced, thereby
increasing the likelihood that children in the two condi-
tions are similar on the outcome variables at baseline.
The four steps are:
1. Stratification: All schools that express interest in the
study and are among the 90 selected to participate
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in each cohort will be stratified according to SES
and geographic location. Given the number of
schools is small, the stratification process will require
relatively coarse groupings. The Index of Community
Socio-educational Advantage (ICSEA) will serve as
the SES variable. This index includes information re-
garding parental SES and Indigenous representation
[33]. The index has a median of 1000 and ranges
Australia-wide from 300 to 1300 indicating heavy
negative skew [33]. NSW has a similar distribution
ranging from 582 to 1202 with a median of 1003. We
will split the sample into a higher SES stratum
(ICSEA < =1003) and a lower SES stratum >1003.
These strata will be further split by geographic
distribution using the Australian Bureau of Statistics
remoteness index by postcode. The index has 12
categories but this will be reduced to two: urban (less
remote) and provincial (more remote). This process
will produce four strata: (i) urban-higher SES, (ii)
urban-lower SES, (iii) provincial-higher SES, and (iv)
provincial-lower SES.
2. Match-pairing: We will employ a Euclidian distance
minimization strategy to create pairs of similar
schools from within strata. The variables used in this
minimization process will be: (i) ICSEA, (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) school
participation (or not) in a state-wide physical activity
and nutrition program, known as Live Life Well at
School [34], that took place from 2008 to 2015.
3. Pair selection: Once schools have been matched using
the minimization procedure, we will select the two or
three most similar pairs of schools from within each
stratum to participate in the cluster RCT. Through
this process, four schools will be selected from each of
the provincial strata and six schools are chosen from
Fig. 1 Modified CONSORT Flow Diagram
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each of the urban strata. This strategy will allow for
calculation of average treatment effects and
differences in treatment effects by strata.
4. Randomization: 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 randomization
procedure using a computer-generated algorithm.
From within each cohort of 90 schools, the 80 schools
not selected for the cluster RCT will be included in the
scale-up implementation study.
Intervention
The intervention design and delivery will be identical
for schools in the cluster RCT and the scale-up im-
plementation study. iPLAY will include six compo-
nents to promote physical activity participation and
fundamental movement skill competency (see Table 1).
An iPLAY Mentor(employed by the project) will de-
liver a professional learning workshop and follow-up
individualized mentoring to primary teachers. These
activities will be supported by an online learning and
resource platform (see implementation strategies in
Fig. 2). Teachers within the schools will then deliver
intervention components. All classroom teachers will
deliver curricular components of the intervention
(e.g., quality PE and school sport). Within each school
the principal will identify up to three classroom
teachers as iPLAY Leaders. Leaders will deliver non-
curricular components of the intervention (e.g., active
playgrounds) and support other teachers with imple-
mentation of curricular components.
iPLAY mentors
Mentors will be current and recently retired teachers with
NSW Board of Studies Teaching and Educational Standards
(BOSTES) specialist accreditation in Health and PE. These
specialist teachers are ideally placed to deliver iPLAY as
primary school teachers will regard them as credible. In
addition to holding BOSTES accreditation in Health and
PE, inclusion criteria for mentors will include: (i) smart-
phone ownership, (ii) basic computer skills, (iii) a valid
drivers license and (iv) access to a vehicle to travel to
schools. Mentors will be recruited via professional associa-
tions (Australian Council for Health Physical Education
and Recreation), NSW Department of Education social
media advertising and the project teamsexistingprofes-
sional networks.
The project will provide funding to schools to cover
the cost of a substitute teacher when current teachers
who become mentors are seconded to work on iPLAY.
Current teachers will receive no direct payment, but
their training and participation will earn them credit
towards designation as a BOSTES Highly Accomplished
Teacher. Achieving this level of accreditation increases
teacherssalaries and is required for those seeking school
leadership roles (e.g., Principal).
The project will pay retired teachers a rate ($400/day
or $200/half-day) that is equivalent to the rate for substi-
tute teachers in NSW. All mentors will be reimbursed
for travel expenses when travelling to schools more than
25 km from their home.
iPLAY mentor training During two 7-h face-to-face
workshops, the project team will train mentors to
deliver the intervention. Workshops will include: (i)
familiarization with the intervention components and
procedures and their rationale, (ii) review of answers to
predetermined frequently asked questions,(iii)discus-
sion regarding methods to establish mentorscredibility,
relatabilityand likeability [35], (iv) problem solving ex-
ercises regarding likely challenging scenarios, and (v)
role-playing exercises.
iPLAY mentor delivery As shown in in Fig. 2, mentors
will complete the following tasks in each school:
1. Meet with iPLAY leaders to facilitate implementation
of non-curricular intervention components (4 × 1 hour
meetings 1 per term). In most cases, these meetings
will be conducted face-to-face on the same day as
mentors visit schools to observe teachersdelivery of
PE and school sport lessons. However, in some
circumstances (e.g., very small schools in which
mentors only need to visit once or twice to observe all
classroom teachersPE/school sport lessons), a
teleconference or internet-mediated videoconference
may be chosen to complete this meeting.
2. Deliver a 2-hour workshop at the school to all
teachers. The workshop will focus on the curricular
components of the intervention. It will include a
1-hour classroom session in which the mentors
will present information videos with iPLAY
content and then facilitate discussion and
activities using presentation slides provided by the
project. The workshop will also include a 1-hour
practical session in which the mentor will
demonstrate quality teaching using a lesson plan
provided by the project.
3. Observe one PE or school sport lesson for each
teacher and provide feedback to the teacher during a
30-minute meeting. This observation and feedback
process will require mentors to visit each school,
with the number of visits determined by the number
of teachers in the school. On average, we expect
mentors to visit once per term.
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Methods to ensure high quality and consistent delivery
of the workshop and the observation feedback meetings
include:
1. At the end of the training workshops and before
delivering the intervention in schools, mentors will
complete an examination regarding project
procedures and workshop content (e.g., answers to
frequently asked questions).
2. During the face-to-face workshops, mentors will
deliver all content to teachers using videos produced
by the project team.
3. Discussion of video content and learning activities for
teachers during the workshop will be based on slides
and a lesson plan provided by the project team.
4. Mentors will access videos and presentation slides
through the project website. Thus, the project team
will be able to verify if and when each component
was accessed.
5. The project team will provide mentors with answers
to frequently asked questions for each workshop,
and update this list as the project progresses.
6. Mentors will upload their lesson observations using
a structured template within the project website or
smartphone app (iOS and Android versions will be
available).
7. Mentors will participate in bi-annual meetings
that will provide them with ongoing professional
learning and support. The project team will lead
these face-to-face meetings.
Table 1 iPLAY Intervention Components
Curricular Components Description Implementation Measurement
Quality PE and
school sport
Teachers will deliver 150 minutes of planned PE or school
sport each week.
Lessons will be delivered according to the SAAFE principles
(Supportive, Active, Autonomous, Fair and Enjoyable).
Students will spend >40 % of PE/sport lesson time being
physically active (i.e., in MVPA).
Classroom teachers will self-report delivery of PE and
School Sport on eight occasions during the intervention
at the start of each online learning module.
Mentors will observe and rate each teachers delivery
using the SAAFE checklist once during the intervention.
Monitored using the class activity tracking system
provided to each school.
Classroom movement
breaks
Teachers will deliver 2 × 3-minute classroom
energizer activities per day (30 minutes per week)
Teachers will self-report at the start of each of the eight
online learning modules.
Teachers usage of the video-based classroom movement
breaks on the website (resources section) will be
monitored.
Physically active
homework
Teachers will provide one physically active homework
activity per week (except in schools that have a
no homeworkpolicy)
Teachers will self-report at the start of each of the eight
online learning modules.
Non-Curricular
Components
Description Implementation Measurement
Active playgrounds Children will spend >40 % of recess and lunch
breaks in MVPA.
Leaders will rate via the website their implementation
of active playground strategies. Ratings will occur three
times during the intervention (during meetings with
mentors).
Student physical activity during breaks will be measured
via accelerometry at each assessment time-point (baseline,
12 months, 24 months), but will not be measured during
the intervention.
Community physical
activity links
Schools will utilize the Sporting Schoolsfunding to
offer after-school physical activity program
at least once per week across two school terms.
During the intervention at least one teacher in
each school will complete accreditation/training
procedures with a recognized sporting body
that will allow them to deliver the Sporting
Schoolsprogram in their school.
Principals will report on all non-curricular sport and
recreation in each school.
Teachers will report the sport accreditation/training they
complete.
Parent and caregiver
engagement
Schools will deliver 1 × newsletter item per
fortnight, which will include a link to the
parent portion of the iPLAY website.
Schools will deliver 2 × iPLAY update presentations
to parents per year during existing parent-teacher
events.
Schools will organize one physically active school
fundraising event each year.
Leaders will record via the website the frequency
of newsletter distribution and parent meetings.
Parent access to the iPLAY website will be monitored.
Leaders will provide evidence of school fundraiser events.
Note:MVPA moderate to vigorous physical activity
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Curricular components classroom teachers
Classroom teachers will participate in professional learning
designed to help them implement the curricular interven-
tion components. This training will involve a 2-h workshop
(face-to-face), 4 h of online learning (8 × 30 minute
modules), a mentoring meeting, a peer observation, and a
discussion at a staff meeting focused on iPLAY implemen-
tation. Completion of these activities will provide each
classroom teacher with 14 h of professional learning that is
registered with NSW BOSTES. To maintain their accredit-
ation, NSW teachers are required to accumulate 50 h of
BOSTES registered professional learning every five years.
The project team will provide this professional learning
free of charge. The project team will not offer any other
compensation to teachers.
Professional learning for classroom teachers Profes-
sional learning will assist teachers to implement three com-
ponents: (i) quality PE and school sport, (ii) classroom
movement breaks (known as energizers), and iii) physically
active homework. To begin, an iPLAY mentor will facilitate
one 2-h face-to-face workshop or two 1-h workshops on
separate days at each school. After the initial workshop,
teachers will complete eight online modules designed to
reinforce and extend knowledge and skills gained in the
initial workshop. During the workshop, mentors will
encourage teachers to complete the online modules in
small groups approximately once per month (e.g., at stage
meetings). This collaborative approach is intended to foster
development of an iPLAY community of practice within
each school [36]. However, modules can also be completed
independently.
At the end of the face-to-face workshop, each teacher will
create an individualized learning plan. The learning plan
will describe when each teacher intends to complete each
of eight modules. The website/app will suggest to teachers
that the learning plan accommodates at least one week
between modules. This one-week interval will allow
teachers time to implement and reflect on each teaching
strategy. Upon completion of each module, the website/app
will prompt teachers to reflect on their learning plan
and adjust target dates, as required. Teachers will also
have the ability to modify this learning plan at any
time i.e., without prompting. During the intervention,
teachers will be prompted via a notification on their
smartphone and/or an email when a new module is due
for completion (according to each teachers self-selected,
individualized learning plan).
Online learning activities will include brief instruc-
tional videos and engaging tasks that allow teachers to
understand the rationale behind each teaching strategy
[28]. Each module will be designed to take 30 min to
complete, but teachers will be able to stop and start
mid-module. Each module will include an action plan
Fig. 2 iPLAY Intervention Implementation Strategies
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task in which teachers will set implementation goals for
their PE and sport lessons. At the beginning of each
online module, teachers will reflect on their progress
towards goals set in the action plan from the previous
module. In addition to the website, professional learn-
ing will also be available via a smartphone app on both
iOS and Android platforms. In our recent professional
learning trial [28], 109 of 110 NSW teachers owned a
smartphone with one of these two operating systems.
Thus, we expect most teachers in the proposed study
will be able to access the app.
An iPLAY mentor will be assigned to each school and
will observe one 30-min PE or sport lesson delivered by
each consenting classroom teacher. Mentors will then
meet individually with each teacher for 30 min to
promote and guide self-reflection and provide feedback
concerning the observed lesson. Feedback from
mentors will be guided by an online observation check-
list that prompts mentors to discuss the SAAFE (Support-
ive, Active Autonomous, Fair and Enjoyable) teaching
principles [22], which are based on self-determination
theory tenets [37]. During this conversation, the classroom
teacher will answer reflective questions on the website/
app.
Recently introduced regulations in NSW mandate
that teachers engage in peer lesson observation. In
iPLAY, teachers will be observed by one of their peers
while they teach a 30-min PE or sport lesson. After-
wards, the pair will use a SAAFE checklist hosted on
the project website/app as the basis for a 30-min peer
discussion activity. As in the iPLAY mentoring
session, classroom teachers will answer reflective
questions on the website/app during the peer discus-
sion activity.
The final training component for teachers will involve a
30-min small group discussion led by one of their schools
iPLAY leaders. During this meeting teachers will use the
website/app to answer reflective questions regarding their
implementation of iPLAY components. These meetings
will likely take place during regularly scheduled Stage
Meetingsinvolving teachers from (i) Early Stage 1 and
Stage 1 Kindergarten, Years 1 and 2, (ii) Stage 2 Years
3 and 4 and (iii) Stage 3 Years 5 and 6.
Teachers who join a school after the iPLAY intervention
has started and/or miss the face-to-face workshop will be
able to complete an online version of that component.
They will complete all other aspects of the program as
usual unless they join the school after the iPLAY interven-
tion has finished and an iPLAY mentor is not available for
the lesson observation component. In this instance, iPLAY
leaders will be asked to facilitate this component.
Classroom teacher delivery Support for classroom
teachersimplementation of the curricular components
will include smartphone prompts, teaching resources, a
class activity monitoring system and the mentoring de-
scribed previously. The iPLAY smartphone app will pro-
vide reminders for teachers to implement strategies from
their action plan. Teachers will be able to choose the
interval for these reminders. The website and smartphone
app will allow teachers to download resources (e.g., lesson
plans, activity descriptions, and classroom movement
break videos) that support intervention implementation.
Also, when teachers set their action plan in each mod-
ule, the web-based platform will identify resources that
are specifically relevant to the skills/activities that the
teacher has planned for the coming weeks. Links to
these resources plus the action plan will be emailed to
the teacher.
In the original SCORES intervention, teachers used
Yamax digital pedometers (Yamax, Eagle Farm,
Australia) and an Excel spreadsheet with an evidence-
based algorithm [38, 39] to calculate the mean
proportion of time their students spent being active
during PE lessons. We have developed an activity
tracking system that provides this information instant-
aneously to teachers at the end of a lesson. The
system utilizes inexpensive pedometers ($20USD)
(SmartLAB Move ANT+ pedometer, HMM, Dossenheim,
Germany) that communicate wirelessly with a smart-
phone app. Each school will be provided with one
activity tracking system which includes 25 pedometers,
a smartphone pre-loaded with the app, and a carrying
case that includes a charging station. Mentors will
demonstrate the system to teachers in the school-based
workshops and provide clarification as required when
they observe each teachers lesson. An instructional
video will form part of one of the online modules. A
complete user manual will be available in the resource
section of the website. In the action plans that teachers
complete during online learning modules, they will be
asked to indicate how many times they plan to use the
physical activity monitoring system in their upcoming
lessons. They will also have the option to set a goal for
their studentsactivity levels during these monitored
lessons.
iPLAY leader training We will work with school prin-
cipals to recruit up to three iPLAY Leaders per school.
These teachers will deliver the non-curricular compo-
nents of the intervention (e.g., active playgrounds) and
support other teachers with their implementation of the
curricular components.
Each iPLAY leader will complete a series of four online
learning modules (30 mins × 4 modules = 2 hours)
designed to teach them how to implement the non-
curricular components of the intervention (see Table 1
for details).
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iPLAY leader delivery Once all leaders in a school have
completed the online training, the leaders will meet as a
group with their schoolsiPLAY mentor. The purpose of
this 1-h meeting will be to set implementation goals for
each non-curricular component and to determine the
specifics of how leaders will support classroom teachers
delivery of the curricular components (i.e., who will do
what and when). The iPLAY leadersimplementation
plan for each school will be recorded on the website. As
leaders make implementation progress in their schools,
they will log this information, including reflections on
facilitators and barriers.
In addition to recording their implementation of
the non-curricular components on the website/app,
leaders will be asked to meet with their schools
iPLAY mentor for one hour once per term to discuss
progress and set new implementation goals. This
meeting will also provide an opportunity for leaders
and mentors to discuss classroom teachersimple-
mentation of the curricular components. Checklists to
guide these meetings will be available on the website
and mentors will be responsible for ensuring these
are logged at the end of the meeting.
Finally, iPLAY leaders will facilitate at least one 30-min
small group discussion session (~10 teachers/group)
during which teachers in their school will reflect on their
implementation of iPLAY components. Mentors will
suggest to leaders that these meetings take place in
the final term of the intervention.
Implementation timeline
Within each cohort, the main iPLAY intervention will be
delivered in four phases that roughly equate to 3.5 school
terms (see Fig. 2), which is approximately 10 months. In
the RCT, the five iPLAY intervention schools from Cohort
1 will begin the intervention starting in August 2016
(Term 3), while Cohort 2 is scheduled for June 2017 (Term
2). In the scale-up implementation study, the 80 schools in
Cohort 1 will be divided into 4 groups that will begin
the intervention on a rolling basis Group 1 (June
2016 Term 2), Group 2 (August 2016 Term 3),
Group 3 (November 2016 Term 4) and Group 4 (March
2017 Term 1). A similar roll-out is scheduled for Cohort
2, starting in June 2017. See Fig. 3 for details.
Ongoing implementation
At the end of the main intervention period (3.5 school
terms = approximately 10 months), teachers will con-
tinue to have access to the iPLAY website and will have
the ability to set action plans and access resources as
often as they like. They can also re-visit online learning
modules. Finally, iPLAY leaders in each school will
havetheoptiontoleadupto4×30miniPLAY discus-
sions with classroom teachers each year. These
discussionswillfocusoniPLAY action planning and
will include discussion of facilitators and barriers to
implementation. Classroom teachers who participate
in these discussions and complete a reflection task and
an action plan via the website will earn up to an extra
two BOSTES registered professional learning hours per
year on top of the 14 h earned in the main iPLAY
intervention.
Cluster randomized controlled trial
We will conduct a cluster RCT with an allocation ratio of
1:1 (intervention : attention control) that conforms with
CONSORT guidelines [40]. We will perform assessments
at baseline, post-intervention (12 months after baseline)
and maintenance (24 months after baseline).
Attention control Arm
Teachers in the 10 schools allocated to the attention
control arm will be offered teacher professional learn-
ing designed to improve their delivery of the NSW
KindergartenYear 6 Science and Technology curricu-
lum. This program, known as My Scien ce, has been
shown to increase teacher confidence and student
engagement in science [41]. Teachers who complete
the My Science program will receive 10.5 h of BOSTES-
registered teacher professional learning credit. They will
also have the option to complete the iPLAY program at
the end of the study, and earn an additional 14 h of regis-
tered professional learning credit.
The primary purpose of employing an attention con-
trol intervention is to limit principalsand teachers
disappointment at not receiving the iPLAY interven-
tion, thereby increasing participation during data
collection at the post-intervention and maintenance
phases.
Participants
As noted previously, schools designated as Schools for
Specific Purposeswill not be eligible for the cluster
RCT. Schools that participated in the original SCORES
efficacy study will also be excluded from the cluster
RCT. All teachers in each school selected for the cluster
RCT will be invited to participate in the intervention,
but only students in Years 3 and 4 will complete out-
come assessments.
Procedure
Principals and teachers will provide written informed
consent to participate in the cluster RCT. Students will
provide assent and parents will provide written in-
formed consent for their child to participate. Trained
research assistants will collect all student level out-
comes in the cluster RCT. These data collectors will
not be informed of schoolsallocation to the
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intervention or control condition; however, due to the
use of social marketing within iPLAY schools (e.g., post-
ers), our ability to meaningfully blind these researchers
is significantly diminished. Despite this limitation, the
potential risk of bias for many measures in this study is
low (e.g., objective measures of physical activity) and
statisticians will be blinded to each schools allocation.
Primary outcome measure entire RCT sample
Cardiorespiratory fitness will be assessed using the 20 m
multistage fitness test [42], which has demonstrated
strong validity in studies worldwide [43] and is considered
to be the most appropriate field-based measure [44]. We
will measure cardiorespiratory fitness for all physically
able children in the cluster RCT.
Secondary outcome measures
Student level measures entire RCT sample
Student physical activity (objective measure) We will
measure studentsphysical activity behavior over a
period of eight days using GENEActiv accelerometers
(Activinsights, Cambridge, United Kingdom) worn on
the non-dominant wrist. GENEActiv accelerometers are
valid for children [45], and wrist-based accelerometry
may be more acceptable for children compared with
hip-worn monitors, resulting in greater compliance and
reducing missing data [46]. Data will be reduced using
evidenced-based, best-practice procedures at the time of
analysis. At present, this involves using the Euclidean
norm minus one (ENMO) method to apply cut-points
Fig. 3 iPLAY Randomised Controlled Trial and Implementation Study Timelines
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[45] to the data, providing estimates of time in different
intensities of activity (e.g., moderate vs. vigorous). Accel-
erometry data will be used to examine: (i) within school
activity, (ii) recess and lunch activity, (iii) after-school
activity, (iv) weekend activity and (v) total activity.
Anthropometry We will measure all studentsheight
and weight, using stadiometers (Surgical and Medical Prod-
ucts No. 26SM, Medtone Education Supplies, Melbourne,
Australia) and digital scales (UC-321, A&D Company LTD,
Tokyo, Japan), respectively. We will then calculate body
mass index (BMI) and BMI z-scores using the Centers for
Disease Control and Prevention methodology [47].
Student characteristics Students will self-report their
sex and date of birth. They will also indicate the country
in which they were born and the language they speak at
home. We will use this information to categorize stu-
dents into one of seven ethnic backgrounds (English,
European, Middle Eastern, Asian, African, South Pacific
or other), based on the Australian Bureau of Statistics
Standard Classification of Languages [48]. We will also
ask students to indicate if they are of Indigenous origin
(i.e., Aboriginal or Torres Strait Islander). We will assess
student-level socioeconomic status through the childs
self-reported home suburb, childrens perception of the
number of books in their home (as measured in Trends
in International Mathematics and Science Study) [49],
and a single-item question on perceived socioeconomic
status [50].
Student physical activity (self-report) We will measure
studentsactivity behaviors using single item measures
of (i) typical physical activity participation [51], (ii) phys-
ical activity participation last week [51], (iii) organized
sport participation in the past year with team and
individual sports measured separately [52] and (iv) active
commuting to school [52].
Teachersinterpersonal style during PE and school
sport We will use a 4-item scale to assess studentsper-
ceptions of their teachers support of studentspsycho-
logical needs. This will involve two items from an adapted
version of the Teacher as Social Context questionnaire
[53], one item adapted from the Health Care Climate
Questionnaire [54] and one item from the Controlling
Teacher Scale [55].
Student behavior, affect and cognition during PE and
school sport We will assess effort through three items, in-
cluding two items from the Student Engagement in School
questionnaire [56] and one item from the effort subscale of
the Intrinsic Motivation Inventory [57]. Enjoyment will be
assessed using three items adapted to PE and school sport
from the Student Engagement in School questionnaire.
Three items will be used to assess studentsconcentration
in the lessons [58]. Three items from the Use of Strategies
subscale of the Cognitive Processes Questionnaire in
Physical Education [59] will measure strategies students
employ when learning in PE and school sport.
Subjective well-being We will measure studentsper-
ceived well-being using 10 items from the WHOsHealth
Behavior in School-aged Children questionnaire [50].
Academic achievement We will work with NSW
BOSTES to obtain studentsYear3and5NAPLAN
numeracy and literacy standardized test scores [60].
Student level measures sub-sample
Within each school, we will randomly select one class to
form a sub-sample. We expect 18 students per class to
volunteer; therefore, the subsample will include approxi-
mately 360 children. Children in the sub-sample will
complete the following measures in addition to the pre-
viously described measures.
Fundamental movement skill competency
Studentsfundamental movement skill competence will
be measured using three object-control skills from the
Test of Gross Motor Development-2 [61]. From the 12
skills available, we selected the overarm throw, catch,
and kick due to their transferability into a variety of
different sports that are popular among Australian
children. Moreover, object control skills are most strongly
associated with physical activity levels in comparison to
locomotor and stability skills [62, 63].
Cognitive control
We will measure childrens working memory and inhib-
ition using a modified AX-Continuous Performance Task
(AX-CPT) [64]. The tests will be administered by trained
research assistants and completed by participants using a
computer. The AX-CPT requires participants to correctly
respond to target trials that occur when the letter X
(correct-probe) is immediately preceded by the letterA
(correct-cue). Non-target trials occur when probes are
letters other than X (collectively referred to asY)and/or
cues are letters other than A (referred to collectively asB).
Thus, participants encounter four types of trials: AX, AY,
BX, and BY [65].
Principal level measures entire sample (online
questionnaires)
Principal characteristics
Principals will self-report their demographic information
(age, sex, ethnicity, and number of years teaching).
Additionally, we will ask principals to declare if they have
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ever been accredited as a specialist PE teacher, and to
self-report their physical activity [51] and sport
participation [52].
School characteristics
Principals will complete items measuring the number of
classes, number of students per class, number of
employed teaching staff within their schools, number of
PE specialist teachers and bell times for the school (e.g.,
school start, recess, lunch, and school end times).
School physical activity
We will assess principalsperceptions of facilities, equip-
ment, time allocation, and support for physical education
in their school using 13 items from the NSW School
Physical Activity and Nutrition Survey [66]. A single-item
measure will be used to determine if schools currently
receive Sporting Schoolsfunding for external providers to
run sport programs within the school.
Teacher level measuresentire sample (online
questionnaires)
Teacher characteristics
As with principals, teachers will self-report their demo-
graphic information (date of birth, sex, ethnicity, and
number of years teaching). We will also ask teachers to
report the stage they are currently teaching, and their
current level of BOSTES accreditation. Additionally, we
will ask teachers to declare if they have ever been
accredited as a specialist PE teacher, and to self-report
their physical activity [51] and sport participation [52].
Teacher confidence
We will assess teacher confidence in teaching PE and
school sport, as well as other key learning areas (e.g.,
English, Mathematics, Science and Technology), by
adapting a measure of non-specialist primary teachers
confidence to teach PE [67].
Student conduct
A single item measure will be used to assess teachers
perceptions of their studentsbehavior [56].
Perceived student engagement
We will measure teachersperception of their students
engagement in PE and school sport lessons, as well as
other key learning areas (e.g., English, Mathematics,
Science and Technology) using an adapted version of
the Student Engagement in School Questionnaire [56].
Internet self-efficacy
An eight-item Internet self-efficacy scale will be used to
assess teachersbeliefs in their ability to utilize internet
tools [68].
Job satisfaction, burnout and absenteeism
Single-item measure of overall job satisfaction [69]
and burnout [70] will be used. Additionally, we will
seek permission from teachers to collect from their
principal the number of days absent from work due
to illness.
Statistical analyses and sample size We will test for
between-arm differences in changes in student outcomes
using linear mixed models with standard errors corrected
for clustering. We will analyze data according to intention
to treat principles (main analyses) and per-protocol princi-
ples (sensitivity analyses). We conducted a power analysis
using procedures appropriate for complex nested designs
[71]. In this analysis the effect size for between-arm differ-
ences in cardiorespiratory fitness (primary outcome) was
conservatively set to .35 (note: effect in our efficacy trial
was .54) with intraclass correlations based on our efficacy
trial [21] (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 childrens age, sex, 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 a
mixed modeling approach to explore moderation hypoth-
eses 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. We will also explore
potential moderating effects of principal and teacher
characteristics (e.g., specialist PE accreditation) on
student outcomes.
Per protocol analyses will investigate the influence of
iPLAY leadersand other teachersadoption and imple-
mentation of the intervention on student outcomes.
Adoption will focus on the proportion of intervention
training components completed (e.g., workshops attended
and online tasks completed), while implementation will
evaluate leadersand teachersutilization of strategies in
their schools (as per Table 1).
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 childrens physical activity and cardiorespiratory
fitness. Mediating effects will be estimated using a
cluster-bootstrapped based product-of-coefficients test
that is appropriate for cluster RCTs.
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Economic evaluation We will conduct an economic
evaluation to determine if iPLAY represents value-for-
moneymeasured incrementally against the attention
control arm. This allocative efficiency focus will deter-
mine 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, measurement and
valuation processes for the reference year 2018. The
incremental differences in costs will be combined with
the behavioral and biophysical 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
movement skill competency on overall well-being over
the lifetime of the cohort compared with usual practice.
A Markov model [72] consisting of health states
associated with different levels of physical activities/
movement skill competency will be used to accrue
costs and benefits over the time horizon. The long-term
improved outcome may translate into cost savings which
offset the increased cost associated with the implementa-
tion of iPLAY project. Simulation-modelling using the
@RISK software package will be used to calculate 95 %
uncertainty intervals around the epidemiological probabil-
ities and cost estimates.
Scale-up implementation evaluation
Running alongside the cluster RCT will be a scale-up
implementation study. This evaluation will be a multiple
cohort design, with all schools receiving the intervention.
Measurement will be guided by the RE-AIM framework
[73] and will occur at baseline, 12 and 24 months for each
cohort.
Participants and procedures
Participants will include principals, teachers and students
at government-funded primary schools in NSW. There
will be no exclusion criteria for principals or teachers
within these schools. To be included in the study at least
50 % of Stage 2 (Years 3 and 4) teachers must be willing
to participate in the program, at least one staff member
must be willing to be an iPLAY leader, and the principal
must provide consent for the program to run in the
school. All students who are enrolled in Years 3 or 4
(Stage 2) at baseline and who are able to participate in
physical activity will be eligible for the study, except for
students enrolled in Schools for Specific Purposes
(i.e., for students who require intensive levels of sup-
port). In these schools, teachers will be eligible to
participate in the study, but students will not be
asked to complete outcome assessments.
Principals and teachers will provide written informed
consent to participate in the scale-up implementation
study. Passive consent procedures will be used regarding
student participation; newsletters will be sent home and
will ask parents to indicate if they do not wish their
child to participate in the study.
Measures
Reach We will examine the extent to which participat-
ing schools are representative of the NSW population, in
terms of school size, SES, and location. Once a school is
recruited into the study we will employ a questionnaire
to ask the principal to identify the single most import-
ant reason for your decision to participate. At the end
of recruitment, we will purposively sample 100 schools
(according to size, SES, and location) that do not volun-
teer and follow-up by telephone to determine reasons
for non-participation.
Effectiveness We will conduct a reduced examination
of effectiveness in the scale-up implementation study
compared with the cluster RCT. Assessments will
include all questionnaires and standaridized tests of
numeracy and literacy from the cluster RCT. Other mea-
sures (e.g., 20 m multistage fitness test, accelerometers,
fundamental movement skills, and cognitive control) will
not be obtained in the scale-up implementation study.
Principals and teachers will complete online question-
naires. Classroom teachers will also administer an online
questionnaire to their students to complete self-report
measures. Questionnaires will be administered to princi-
pals, teachers, and students at baseline, post-intervention
(12 months) and maintenance (24 months).
Adoption We will examine the proportion of schools
from the NSW population that volunteer and participate
in the program. We will assess teacher level adoption by
examining the proportion of teachers who complete
each aspect of the training, including attendance at
face-to-face workshops and completion of online compo-
nents, as well as participation in mentor meetings, peer
observations and small group discussions.
Implementation We will monitor implementation as
per Table 1 (curricular and non-curricular components).
Maintenance Using the procedure described above,
we will re-examine effectiveness and implementation
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24 months after baseline. To further understand barriers
and facilitators to implementation, we will conduct semi-
structured interviews with purposively selected principals
(n=15), teachers (n=15) and students (n= 15). Sampling
will ensure that interview participants are drawn from
schools in which the intervention had strong effects, weak
effects and no effects. Thematic analysis of transcripts will
indicate ways to improve implementation prior to further
dissemination.
Statistical analyses
The scale-up implementation study will be assessed with a
focus on descriptive statistics concerning reach, adoption,
implementation, and maintenance. We will also use linear
regression to explore the impact of school and community
characteristics on program reach. We will use linear mixed
model analysis to examine changes in outcome variables
from baseline to 12-months and 24-months (i.e., effective-
ness). These effects will be estimated for the entire sample
as well as in key sub-populations (e.g., across teacher sex,
school average SES, teachers with high vs low internet self-
efficacy). Where possible, we will compare iPLAY schools
with expected values within the population (e.g., NAPLAN
scores in similar schools, physical activity participation)
from other data sources such as NSW School Physical Ac-
tivity and Nutrition Survey [66]. We will also compare out-
comes at 12 months (post-intervention) for Cohort 1 with
baseline levels for Cohort 2, taking advantage of the natural
experiment that is inherent in the design of the study.
Economic evaluation
The research question for economic evaluation of the
scale-up implementation study will be to assess, from
a societal perspective, the cost-outcome of scaling up
the iPLAY project(rolloutandimplementationto160
schools) in primary schools within NSW to assess
intervention affordability and sustainability.
The economic analysis will be a cost-outcome descrip-
tion as the one-arm design of the scale-up implementation
study does not include a control arm (which is necessary
for determination of comparative cost-effectiveness). The
primary economic analysis will comprise three compo-
nents: a cost analysis; an outcome analysis and the rela-
tionship between cost and outcomes for the intervention.
Costing of the intervention using opportunity cost princi-
ples will involve the following steps:
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).
In addition, variations in delivery costs of the iPLAY
intervention between participating schools will be identi-
fied in order to determine any factors that may impact
on the roll out of this program throughout NSW
primary schools and its adoption in other jurisdictions.
The economic outcomes for the scale-up implementation
study will be presented as total costs, average costs per
child and per school, separately from the intervention and
maintenance periods. The relationship between costs and
outcomes will be reported as average cost per outcome.
Discussion
Thepurposeofthisstudyistoevaluatetheextenttowhich
an existing, efficacious physical activity intervention can be
scaled-up and disseminated widely using online learning
methods alongside face-to-face implementation support. A
web-based delivery system is attractive as it may support
scaling-up and sustainability. However, little, if any, evi-
dence exists regarding the effectiveness of comprehensive
primary school-based physical activity interventions deliv-
ered using online methods. Using two concurrent studies,
and guided by the RE-AIM framework, our project will
help provide evidence on the effectiveness and cost-
effectiveness of teacher professional learning delivered
largely via the Internet to address the issue of physical in-
activity among primary school-aged children.
Abbreviations
BMI, body mass index; BOSTES, Board of Studies, Teaching and Educational
Standards; iPLAY, Internet-based Professional Learning to help teacher support
Activity in Youth; MVPA, moderate-to-vigorous physical activity; NAPLAN, National
Assessment Program Numeracy and Literacy; PE, Physical Education;
RCT, randomized controlled trial; RE-AIM, Reach Effectiveness Adoption
Implementation Maintenance; SCORES, Supporting ChildrensOutcomes
using Rewards, Exercise and Skills; SES, socioeconomic status; WHO,
World Health Organization
Acknowledgements
None.
Funding
This project is funded by a Partnership Project Grant from the National Health
and Medical Research Council (APP1114281) and a grant from the New South
Wales Department of Educations School Sport Unit. PP is supported by an
Lonsdale et al. BMC Public Health (2016) 16:873 Page 14 of 16
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
Australian Research Council Discovery Early Career Researcher Award
(DE140100080). JS is supported by a NHMRC Principal Research Fellowship
(APP1026216). MM is supported by a NHMRC Centre for Research Excellence
in Obesity Policy and Food Systems (APP1041020). DPC is supported by an
Australian Research Council Discovery Early Career Researcher Award
(DE140101588). DRL is supported by an Australian Research Council Future
Fellowship (FT140100399).
Availability of data and material
No data has been collected.
Authorscontributions
CL and DL conceived the idea for the study and led the design of all aspects.
CL and TS drafted the manuscript. TS, KC, MN, TH, MK, PM, AB, RC, LP, GK, and
JG contributed to the intervention development. TS, PP, JS, DV, MM, RP, DG, DC
and LG contributed to the study design. HM provided advice on study design
and implementation strategies. All authors edited the manuscript and approved
the final version prior to submission.
Authorsinformation
None.
Competing interests
The authors declare that they have no competing interests.
Consent for publication
Not applicable.
Ethics approval and consent to participate
Ethical approval for this study was provided by the Australian Catholic University
Human Research Ethics Committee (Ref:2014185 N) and the NSW Department of
Education (Ref: SERAP2014260). Principals, teachers and parents will provide
written consent in the cluster RCT. Students will provide written assent in the
cluster RCT. Principals and teachers will provide written consent in the scale-up
implementation study. Parents will have a written opportunity to decline
participation (i.e., opt out) in scale-up implementation study. Students will
provide oral assent in the scale-up implementation study.
Author details
1
Institute for Positive Psychology and Education, Australian Catholic University,
Edward Clancy Building 167-169 Albert St, Strathfield, NSW 2135, Australia.
2
Priority Research Centre for Physical Activity and Nutrition, School of Education,
University of Newcastle, Callaghan, NSW 2308, Australia.
3
Institute for Positive
Psychology and Education and School of Exercise Science, Australian Catholic
University, Edward Clancy Building 167-169 Albert St, Strathfield, NSW 2135,
Australia.
4
School of Exercise Science, Australian Catholic University, Edward
Clancy Building 167-169 Albert St, Strathfield, NSW 2135, Australia.
5
Physical
Activity Research Group, School of Human Health and Social Sciences, Central
Queensland University, Building 18, Yaamba Road, Rockhampton, QLD 4702,
Australia.
6
Institute for Physical Activity and Nutrition (IPAN), School of Exercise
and Nutrition Sciences, Deakin University, Geelong, Australia.
7
Deakin Health
Economics, Centre for Population Health Research, Faculty of Health, Deakin
University, Geelong, VIC, Australia.
8
Center for Hip Health and Mobility,
University of British Columbia, 7/F, 2635 Laurel Street, Vancouver, BC V5Z 1 M9,
Canada.
9
School of Science and Health, Western Sydney University, Locked Bag
1797, Penrith, NSW 2751, Australia.
10
School of Education, Australian Catholic
University, 250 Victoria Parade East, Melbourne, VIC 3002, Australia.
11
Faculty of
Education and Social Work, University of Sydney, Sydney, NSW 2006, Australia.
12
Early Start Research Institute, School of Education, University of Wollongong,
Wollongong, NSW 2522, Australia.
13
Teachers and Teaching Research Centre,
School of Education, University of Newcastle, Callaghan, NSW 2308, Australia.
Received: 8 June 2016 Accepted: 20 June 2016
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... Therefore, the school not only has a major responsibility to stimulate and promote healthy living in children, but also opens a wide time window to continuously and consequently integrate PA into children's everyday life (28). Several school-based PA interventions have been sucseccfully implemented in school-children of different age (17,(29)(30)(31)(32)(33)(34)(35)(36)(37). Results of the MOVI-Kids study for example indicated increased cardiorespiratory fitness and muscular strength and velocity after implementation of three 60 min PA sessions per week in 4-7 year old children after only a couple of months (36), and the Sogndal school-intervention study showed a reduction in a cardiovascular risk cluster score with a 60 min teacher controlled daily PA in elementary school children after 2 years (31,35). ...
Article
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Background Overweight/obesity in children and adolescents, largely arising due to increased food intake and reduced physical activity, is a major health concern. Physical activity (PA) integrated into learning has been shown to not only lead to improved health outcomes and wellbeing but also positively affect academic performance. The Health and Academic Performance with Happy Children (HAPHC) project aims at enhancing health and academic performance in elementary school children via implementation of a daily unit of Physical Activity Across the Curriculum (PAAC), which is carried out within the school setting. In this project, PA as an integrated part of learning will be evaluated and the learning material adapted for a large scale implementation across several European countries. Methods In three European countries (Austria, Slovenia, and Belgium), 12 primary schools in total will be recruited to act as either intervention or control school in a large intervention study, which applies the PAAC pedagogy during lectures. It is estimated that, at least 3,000+ children across the three countries will be recruited in this study. All teachers of intervention schools will receive training and materials/teaching equipment that will allow them to integrate a daily PA unit of 45 min over 3 years across the curriculum. In response to the daily PA intervention, the following primary outcomes will be assessed: changes in health related physiological factors, academic achievement, psycho-social aspects and wellbeing. Impact of Project The HAPHC project aims at promoting public health by increasing PA at an early age within the school setting and therewith preventing the increasing risk of non-communicable diseases across Europe. HAPHC project aims to develop knowledge and materials, which will ensure that the PAAC can be scalable to other European countries. Trial Registration Number ClinicalTrials.gov , identifier: NCT04956003.
... Our data comes from the 'Internet-based Professional Learning to help teachers support Activity in Youth' (iPLAY) cluster randomized controlled trial [20]. We collected data from primary school children starting in Grade 3 and 4 with follow-up data collection in the following two years (i.e., one-year follow-up and two-year follow-up). ...
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Background Reliable estimates of habitual sleep, physical activity, and sedentary time are essential to investigate the associations between these behaviours and health outcomes. While the number of days needed and hours/day for estimates of physical activity and sedentary time are generally known, the criteria for sleep estimates are more uncertain. The objective of this study was to identify the number of nights needed to obtain reliable estimates of habitual sleep behaviour using the GENEActiv wrist worn accelerometer. The number of days to obtain reliable estimate of physical activity was also examined. Methods Data was used from a two-year longitudinal study. Children wore an accelerometer for up to 8 days 24 h/day across three timepoints. The sample included 2,745 children (51 % girls) between the ages of 7-12-years-old (mean = 9.8 years, SD = 1.1 year) with valid accelerometer data from any timepoint. Reliability estimates were calculated for sleep duration, sleep efficiency, sleep onset, wake time, time in bed, light physical activity, moderate physical activity, moderate-to-vigorous physical activity, vigorous physical activity, and sedentary time. Results Intraclass correlations and the Spearman Brown prophecy formula were used to determine the nights and days needed for reliable estimates. We found that between 3 and 5 nights were needed to achieve acceptable reliability (ICC = 0.7) in sleep outcomes, while physical activity and sedentary time outcomes required between 3 and 4 days. Conclusions To obtain reliable estimates, researchers should consider these minimum criteria when designing their studies and prepare strategies to ensure sufficient wear time compliance.
... Evidence-based approaches using a single delivery setting: A straightforward approach to bridge the gap from a delivery setting to a separate behavior setting is assigning physical activity homework, which may boost motivation (albeit initially as controlled or extrinsic motivation) for MVPA. In the PE setting, some researchers have suggested the assignment of homework as a way to meet important objectives and standards, especially those related to maintaining an active lifestyle (Lonsdale, Sanders, et al., 2016). Among PE teachers, assigning homework may hold value as a means to spend class time on skill development instead of skill practice or MVPA, which could be done outside of classes (Hill, 2018). ...
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Full-text available
Despite clear evidence of the potential benefits gained by being physically active, children and adolescents (collectively youth) often fail to achieve the recommended daily 60 min of moderate-to-vigorous physical activity (MVPA). Focusing on youth physical activity in context provides the starting point for intervention design, but the design and implementation of effective interventions that leverage behavioral theory, evidence, and knowledge about settings remains a formidable challenge. This conceptual review aims to address critically relevant concepts, principles, and evidence from the literature to guide intervention design and implementation that target physical activity leader behavior toward reducing the problem of insufficient youth MVPA. The need to distinguish between the goals to increase MVPA within a setting and to increase youth overall/daily MVPA is emphasized. This review addresses the theoretical and practical considerations of interventions in settings where youth spend time each day. Included is an investigation of what gaps exist in current approaches to intervene through physical activity leaders in settings. Informed both by theory and extant evidence, potential solutions are discussed, including the synthesis of a novel theoretical framework to guide settings-based physical activity leader behavior interventions that address capabilities, opportunities, and motivations for physical activity behaviors across multiple setting levels.
... Data were drawn from a cluster randomised controlled trial of a school-based physical activity intervention. Details of the trial can be accessed elsewhere (Lonsdale et al., 2016). Briefly, schools which expressed interest in participating were stratified based on their socioeconomic status and geographic location (i.e., urban vs rural). ...
Article
Full-text available
Objectives To determine the impact of bushfires on children’s physical activity. Design Natural experiment comparing device-measured physical activity and air quality index data for schools exposed and not exposed to the Australian bushfires. Methods Participants were drawn from 22 schools participating in a cluster randomised controlled trial of a school-based physical activity intervention that coincided with the 2019 Australian bushfires. Students in Years 3 and 4 (8–10 years old) provided data. We used propensity score matching to match 245 exposed and 344 control participants. Main outcome measures Minutes of moderate and vigorous physical activity. Results The bushfires had minimal effect on children’s average weekly physical activity. Analysis of acute effects showed children maintained their levels of physical activity up to an estimated turning point of air quality index of 737.08 (95% CI = 638.63, 835.53), beyond which daily physical activity levels dropped sharply. Similar results were found for girls and boys and for children from low-to-average and higher socio-economic backgrounds. Conclusions Children’s physical activity was not strongly influenced by the presence of smoke and targeted public health advice during the bushfires might not have had the intended effect of reducing children’s outdoor physical activity. Only when air quality deteriorated to approximately 3.5 times the Air Quality index threshold (>200) deemed ‘hazardous’ by the Australian Department of Health did children’s physical activity decline. Public health agencies should re-evaluate the effectiveness of health messages during bushfires and develop strategies to mitigate risks to children’s health.
Article
Background: Physical activity among children and adolescents is associated with lower adiposity, improved cardio-metabolic health, and improved fitness. Worldwide, fewer than 30% of children and adolescents meet global physical activity recommendations of at least 60 minutes of moderate to vigorous physical activity per day. Schools may be ideal sites for interventions given that children and adolescents in most parts of the world spend a substantial amount of time in transit to and from school or attending school. Objectives: The purpose of this review update is to summarise the evidence on effectiveness of school-based interventions in increasing moderate to vigorous physical activity and improving fitness among children and adolescents 6 to 18 years of age. Specific objectives are: • to evaluate the effects of school-based interventions on increasing physical activity and improving fitness among children and adolescents; • to evaluate the effects of school-based interventions on improving body composition; and • to determine whether certain combinations or components (or both) of school-based interventions are more effective than others in promoting physical activity and fitness in this target population. Search methods: We searched CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, BIOSIS, SPORTDiscus, and Sociological Abstracts to 1 June 2020, without language restrictions. We screened reference lists of included articles and relevant systematic reviews. We contacted primary authors of studies to ask for additional information. Selection criteria: Eligible interventions were relevant to public health practice (i.e. were not delivered by a clinician), were implemented in the school setting, and aimed to increase physical activity among all school-attending children and adolescents (aged 6 to 18) for at least 12 weeks. The review was limited to randomised controlled trials. For this update, we have added two new criteria: the primary aim of the study was to increase physical activity or fitness, and the study used an objective measure of physical activity or fitness. Primary outcomes included proportion of participants meeting physical activity guidelines and duration of moderate to vigorous physical activity and sedentary time (new to this update). Secondary outcomes included measured body mass index (BMI), physical fitness, health-related quality of life (new to this update), and adverse events (new to this update). Television viewing time, blood cholesterol, and blood pressure have been removed from this update. DATA COLLECTION AND ANALYSIS: Two independent review authors used standardised forms to assess each study for relevance, to extract data, and to assess risk of bias. When discrepancies existed, discussion occurred until consensus was reached. Certainty of evidence was assessed according to GRADE. A random-effects meta-analysis based on the inverse variance method was conducted with participants stratified by age (children versus adolescents) when sufficient data were reported. Subgroup analyses explored effects by intervention type. Main results: Based on the three new inclusion criteria, we excluded 16 of the 44 studies included in the previous version of this review. We screened an additional 9968 titles (search October 2011 to June 2020), of which 978 unique studies were potentially relevant and 61 met all criteria for this update. We included a total of 89 studies representing complete data for 66,752 study participants. Most studies included children only (n = 56), followed by adolescents only (n = 22), and both (n = 10); one study did not report student age. Multi-component interventions were most common (n = 40), followed by schooltime physical activity (n = 19), enhanced physical education (n = 15), and before and after school programmes (n = 14); one study explored both enhanced physical education and an after school programme. Lack of blinding of participants, personnel, and outcome assessors and loss to follow-up were the most common sources of bias. Results show that school-based physical activity interventions probably result in little to no increase in time engaged in moderate to vigorous physical activity (mean difference (MD) 0.73 minutes/d, 95% confidence interval (CI) 0.16 to 1.30; 33 studies; moderate-certainty evidence) and may lead to little to no decrease in sedentary time (MD -3.78 minutes/d, 95% CI -7.80 to 0.24; 16 studies; low-certainty evidence). School-based physical activity interventions may improve physical fitness reported as maximal oxygen uptake (VO₂max) (MD 1.19 mL/kg/min, 95% CI 0.57 to 1.82; 13 studies; low-certainty evidence). School-based physical activity interventions may result in a very small decrease in BMI z-scores (MD -0.06, 95% CI -0.09 to -0.02; 21 studies; low-certainty evidence) and may not impact BMI expressed as kg/m² (MD -0.07, 95% CI -0.15 to 0.01; 50 studies; low-certainty evidence). We are very uncertain whether school-based physical activity interventions impact health-related quality of life or adverse events. Authors' conclusions: Given the variability of results and the overall small effects, school staff and public health professionals must give the matter considerable thought before implementing school-based physical activity interventions. Given the heterogeneity of effects, the risk of bias, and findings that the magnitude of effect is generally small, results should be interpreted cautiously.
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Physical education in primary school has recently received a significant boost through the implementation of mul-ticomponent and inter-institutional projects providing for the increase in the number of curricular hours and the implementation of various integrated measures aimed at development the time of motor commitment, interdisciplinary and transversal educational relationships. At the same time, these programs envisaged the teachers training and the development of partnerships with sports associations and local administrations. In Italy, regional programs are being carried out in which curricular physical education plays a central role and it's linked to other educational actions, such as education in correct eating habits and active transport/sustainable mobility. The second edition of the three-year regional project SBAM!, established by the Apulia Region, in collaboration with the Regional School Office, the Didactic Laboratory of Motor Activities of the University of Foggia, the Coni-Regional Committee, aimed at primary school children, has ended and the third edition is being planned. The following contribution presents a review on the multicomponent projects, carried out in various countries and the main cultural and methodological reference framework, which constitutes the integrating background of the Apulian project, focused on Physical Literacy. Recentemente in numerosi Paesi l'educazione fisica nella scuola primaria ha ricevuto un notevole impulso attraverso l'attuazione di progetti multicomponente ed inter-istituzionali che hanno previsto un aumento del numero di ore curriculari e l'attuazione di diverse misure, integrate, finalizzate allo sviluppo del tempo d'impegno motorio dei bambini e delle relazioni educative interdisciplinari e trasversali. Tali progetti, contestualmente, hanno previsto un piano di formazione degli insegnanti e lo sviluppo di partenariati con le Associazioni sportive e le Amministrazioni locali. In Italia sono in corso di svolgimento, interventi regionali in cui l'educazione fisica curriculare ha un ruolo centrale e di raccordo di altre azioni didattiche, quali l'educazione alle corrette abitudini alimentari e al trasporto attivo / mobilità sostenibile. In Puglia si è conclusa la seconda edizione del progetto regionale triennale SBAM! istituito dalla Regione Puglia, in collaborazione con l'Ufficio scolastico regionale,
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Objectives To determine if subpopulations of students benefit equally from school-based physical activity interventions in terms of cardiorespiratory fitness and physical activity. To examine if physical activity intensity mediates improvements in cardiorespiratory fitness. Design Pooled analysis of individual participant data from controlled trials that assessed the impact of school-based physical activity interventions on cardiorespiratory fitness and device-measured physical activity. Participants Data for 6621 children and adolescents aged 4–18 years from 20 trials were included. Main outcome measures Peak oxygen consumption (VO 2Peak mL/kg/min) and minutes of moderate and vigorous physical activity. Results Interventions modestly improved students’ cardiorespiratory fitness by 0.47 mL/kg/min (95% CI 0.33 to 0.61), but the effects were not distributed equally across subpopulations. Girls and older students benefited less than boys and younger students, respectively. Students with lower levels of initial fitness, and those with higher levels of baseline physical activity benefitted more than those who were initially fitter and less active, respectively. Interventions had a modest positive effect on physical activity with approximately one additional minute per day of both moderate and vigorous physical activity. Changes in vigorous, but not moderate intensity, physical activity explained a small amount (~5%) of the intervention effect on cardiorespiratory fitness. Conclusions Future interventions should include targeted strategies to address the needs of girls and older students. Interventions may also be improved by promoting more vigorous intensity physical activity. Interventions could mitigate declining youth cardiorespiratory fitness, increase physical activity and promote cardiovascular health if they can be delivered equitably and their effects sustained at the population level.
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Background Existing research on the costs associated with the design and deployment of eLearning in health professions education is limited. The relative costs of these learning platforms to those of face-to-face learning are also not well understood. The lack of predefined costing models used for eLearning cost data capture has made it difficult to complete cost evaluation. Objective The key aim of this scoping review was to explore the state of evidence concerning cost capture within eLearning in health professions education. The review explores the available data to define cost calculations related to eLearning. Methods The scoping review was performed using a search strategy with Medical Subject Heading terms and related keywords centered on eLearning and cost calculation with a population scope of health professionals in all countries. The search was limited to articles published in English. No restriction was placed on literature publication date. ResultsIn total, 7344 articles were returned from the original search of the literature. Of these, 232 were relevant to associated keywords or abstract references following screening. Full-text review resulted in 168 studies being excluded. Of these, 61 studies were excluded because they were unrelated to eLearning and focused on general education. In addition, 103 studies were excluded because of lack of detailed information regarding costs; these studies referred to cost in ways either indicating cost favorability or unfavorability, but without data to support findings. Finally, 4 studies were excluded because of limited cost data that were insufficient for analysis. In total, 42 studies provided data and analysis of the impact of cost and value in health professions education. The most common data source was total cost of training (n=29). Other sources included cost per learner, referring to the cost for individual students (n=13). The population most frequently cited was medical students (n=15), although 12 articles focused on multiple populations. A further 22 studies provide details of costing approaches for the production and delivery of eLearning. These studies offer insight into the ways eLearning has been budgeted and project-managed through implementation. Conclusions Although cost is a recognized factor in studies detailing eLearning design and implementation, the way cost is captured is inconsistent. Despite a perception that eLearning is more cost-effective than face-to-face instruction, there is not yet sufficient evidence to assert this conclusively. A rigorous, repeatable data capture method is needed, in addition to a means to leverage existing economic evaluation methods that can then test eLearning cost-effectiveness and how to implement eLearning with cost benefits and advantages over traditional instruction.
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Physical activity is associated with numerous health benefits in youth; however, these benefits could extend further than health, into education. Our aim was to systematically review and combine in meta-analyses evidence concerning the association between physical activity and the dimensions of school engagement, including behavior (e.g., time-on-task), emotions (e.g., lesson enjoyment), and cognition (e.g., self-regulated learning). We conducted meta-analyses using structural equation modeling on results from 38 studies. Overall, physical activity had a small, positive association with school engagement (d = .28, I2 = .86), 95% confidence interval [.12, .46]. This association was moderated by study design, with significant associations shown in randomized controlled trials but not in studies employing other designs. Risk of bias was also a significant effect moderator, as studies with a low risk of bias showed significant associations but not high risk of bias studies. Altogether, these results suggest that physical activity could improve school engagement.
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The 'how to' of scaling up public health interventions for maximum reach and outcomes is receiving greater attention; however, there remains a paucity of practical tools to guide those actively involved in scaling up processes in high-income countries. To fill this gap, the New South Wales Ministry of Health developed Increasing the scale of population health interventions: a guide (2014). The guide was informed by a systematic review of scaling up models and methods, and a two-round Delphi process with a sample of senior policy makers, practitioners and researchers actively involved in scaling up processes. Although it is a practical guide to assist health policy makers, health practitioners and others responsible for scaling up effective population health interventions, it can also be used by researchers in the design of research studies that are potentially suitable for scaling up, particularly where research-practice collaborations are involved. The guide is divided into four steps: step 1, 'scalability assessment', aims to determine if an intervention is scalable; step 2, 'developing a scale up plan', aims to develop a practical and workable scaling up plan that can be used to convince stakeholders there is a compelling case for action. Step 3, 'preparing for scale up', aims to identify ways of securing resources needed for going to scale, operating at scale, and building a foundation of legitimacy and support to sustain the scaling up effort through the implementation stage; and step 4, 'scaling up the intervention', involves putting the plan developed in step 2 into place. Although the guide is written as though the user is starting from the point of assessing the scalability of an intervention, later steps can be used by those already involved in scaling up to review their implementation processes. The guide is not intended to be prescriptive. Its purpose is to help policy makers, practitioners, researchers and other decision makers decide on appropriate methodological and practical choices, and balance what is desirable with what is feasible.
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This paper presents a conceptual model of key factors that characterize a socio-culturally targeted approach to physical activity intervention design and delivery.
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With the publication of the CONSORT statement there is now increased awareness of the need to adequately report the findings of randomised controlled trials. The CONSORT statement includes a checklist of items that should be addressed in the trial report. The original CONSORT statement was developed to ensure the appropriate reporting of parallel group randomised controlled trials in which individual participants are allocated to different intervention groups. In cluster randomised trials, however, groups of participants, rather than individuals, are randomly allocated to study groups. The process of allocating groups of participants raises additional reporting considerations and led to the publication of an extension to the CONSORT statement specifically for cluster randomised trials. In this paper we review the CONSORT extension to cluster randomised trials, outlining the special features of the cluster randomised trial which must be considered.