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Trial registered on ANZCTR


Registration number
ACTRN12617000681358
Ethics application status
Approved
Date submitted
4/05/2017
Date registered
12/05/2017
Date last updated
26/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Physical Activity for Everyone (PA4E1) Implementation Trial: supporting secondary schools in low-income communities to prevent the decline in adolescent physical activity.
Scientific title
Implementation trial of a multi-component physical activity intervention in disadvantaged secondary schools: Physical Activity for Everyone (PA4E1)
Secondary ID [1] 291860 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
PA4E1
Linked study record
ACTRN12612000382875

Health condition
Health condition(s) or problem(s) studied:
physical inactivity 303134 0
overweight and obesity 303135 0
Condition category
Condition code
Public Health 302584 302584 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Schools allocated to the intervention condition will implement a multi-component physical activity intervention (PA4E1). Secondary schools will be supported to implement seven practices to enhance physical activity opportunities within the school environment. Practices span the domains of the Health Promoting Schools Framework:
1. Curriculum practices: teach practical physical education (PE) lessons using practices to enhance PE quality and increase student moderate-to-vigorous physical activity (MVPA) levels, development of personal physical activity plans for students, and a ten-week enhanced sport program; 2. School environment practices: regular scheduled and supervised recess and lunchtime physical activity opportunities, and the development of a school physical activity policy;
3. Community and parental practices: school promotion of physical activity to families, and promotion and engagement of community physical activity providers.
Schools will be provided with support to implement practices over two years using strategies outlined below.

A PA4E1 efficacy/ effectiveness trial involving 10 secondary schools (5 intervention, 5 control) (ACTRN 12612000382875) showed the program delivered over two years resulted in an improvement in daily minutes of MVPA and a reduction in adiposity. Schools were supported to implement the seven physical activity practices with six support strategies, including location of a change agent within the schools one day per week.

This implementation trial will involve scaling up the intervention to a larger number of schools. Several amendments to the support strategies to better suit implementation in a larger number of schools have been made based on: i) literature reviews; ii) focus groups with school executives and PE teachers involved in the effectiveness trial; and iii) observations of secondary school PA practices identifying further barriers and enablers to practice implementation which were then addressed by an expert advisory group applying the Theoretical Domains Framework and selecting appropriate, evidence based implementation support strategies and delivery modes (e.g. face to face, telephone support, online learning, apps). The implementation trial will consist of seven support strategies:

1. Establishment of an in-school champion – Instead of the external consultant model used in the initial PA4E1 trial, an existing in-school teacher will be appointed by the school executive to be the program champion. This influential teacher will be allocated half a day per week for 24 months to lead the planning and implementation of the physical activity (PA) practices within the school (funding to allow this release is provided by the project).
2. Obtaining executive and leadership support - As per the initial PA4E1 trial, a school sport and PA committee will lead and oversee the implementation of the intervention within each school.
3. Teacher professional learning - The face-to-face training offered in the PA4E1 effectiveness trial to all PE teachers will be replaced by accredited education sector courses where these are available. Representatives from each school will participate in professional learning in three areas: 1) a course on enhancing PA by developing a policy/procedure that provides students with opportunity to participate in 150 minutes/week PA (12 month on-line course, approx 1 x 1 hour modules per month for 12 months, combination of practical and theory based learning run through Department of Education (DOE), School Sport Unit – accredited. Templates to assist schools in developing a school physical activity policy will be provided); 2) a course covering delivery of an enhanced school sport program (1 day face to face training offered through the DOE School Sport Unit, accredited. Training notes and resources required to deliver the enhanced school sport program such as circuit cards will be provided to participants. It is anticipated that 3-4 staff from each school will attend the training course to enable delivery at the school level. Training courses will be scheduled by the DOE School Sport Unit, across NSW, with school booking in to the most convenient location.); and 3) training on enhancing activity in practical PE lesson (specifically developed for trial and delivered through an Online Portal). Teachers will be asked to complete 2 short modules/presentations (15 minutes per module) per school term over the first year of intervention. Online training will be supplemented with group discussions at PE staff meetings following each online training). Via the in-school program champion, PE and other teachers will be provided with facilitated online training in the PA components relevant to their role, e.g. delivering active PE lessons and implementing personal physical activity plans in to their lesson.
4. Tools and resources – Based on the PA4E1 trial, physical activity equipment (e.g. balls) will be provided to the intervention schools, and curriculum materials (e.g. templates for personal PA plans), sport program manuals, and sample policies and planning templates will be provided through an Online Portal developed specifically for the program.
5. Prompts and reminders - The school champion and Project Support Officer (see below) will provide prompts to schools and teaching staff to undertake intervention strategies. Prompts will also be built into school communication processes through the Online Portal and documents such as electronic calendar reminders and agenda items in meetings.
6. Implementation support - Each school will receive support from health district staff for the duration of the intervention (Project Support Officer). At least monthly contacts (via email, telephone or in person) will support schools to develop their sport and physical activity procedures (this support was not provided in initial trial).
7. Implementation performance monitoring and feedback - School PA policies and practices will be audited termly by Health District support staff through the Online Portal, with feedback reports regarding implementation progress towards compliance being provided. The school champion will be prompted to develop an action plan for the following term to meeting the PA4E1 program targets.
Intervention code [1] 297976 0
Prevention
Intervention code [2] 297977 0
Lifestyle
Comparator / control treatment
The control group will be offered a lower dose intervention at the completion of the trial period. Schools in the control group will complete the study measures and continue delivering usual PE lessons, school sport and other physical activity programs and practices during the intervention period. PA4E1 program materials will be made available to these schools following completion of the study.
Control group
Active

Outcomes
Primary outcome [1] 302001 0
The primary trial outcome will be whether or not the school implements at least four of the seven PA practices. Measures of the seven school PA practices will be undertaken at all schools via telephone interview surveys of Head PE teachers. Observational verification of practice implementation and an audit of documents relevant to the practices will also be undertaken.
Timepoint [1] 302001 0
The primary outcome will be compared between groups at 12 months and 24 months
Secondary outcome [1] 334498 0
School level measures: Whether each school meets each of the seven physical activity practices (as measured by telephone interview surveys of Head PE teachers). Observational verification of practice implementation and an audit of documents relevant to the practices will also be undertaken.


Timepoint [1] 334498 0
Baseline, 12 months and 24-months after intervention commencement
Secondary outcome [2] 334509 0
Student level measures will be undertaken in a subsample of schools (30 schools, 15 schools per group). These are:
- Physical activity -mean minutes of student moderate-to-vigorous physical activity (MVPA) per day) assessed via accelerometers (Actigraph GT9X-BT or GT3X+) worn on the wrist. Students will be asked to wear accelerometers for 7 days.

Timepoint [2] 334509 0
12 months and 24 months after intervention commencement
Secondary outcome [3] 334510 0
- Objectively measured student height and adiposity, including, weight, Body Mass Index (BMI),BMI z-score, % body fat). Percentage body fat will be assessed by the DXA method using the Tanita DC-430MA Body Composition Analyser (Tanita Corporation, Tokyo, Japan).
Timepoint [3] 334510 0
12 months and 24 months after intervention commencement
Secondary outcome [4] 334511 0
- Cost and Cost-effectiveness. The cost and incremental costs associated with the implementation of the physical activity intervention and support strategies will be calculated as those costs additional to the costs of usual physical activity practices of schools. The total cost of implementing the intervention will be estimated from a societal perspective. Resource use categories will include personnel costs, materials and printing. Personnel costs included opportunity costs for the delivery of strategies by school staff and community sport and fitness providers. Project records relating to intervention delivery, including costs, will be kept throughout the trial.
Timepoint [4] 334511 0
12 month and 24 months after intervention commencement

Eligibility
Key inclusion criteria
Schools: Secondary Department of Education (DOE) and Catholic schools, that enrol students in Grades 7-10, are located in socio-economically disadvantaged communities (ranked in the bottom 50% of NSW suburbs based on the SEIFA Index of Relative Socioeconomic Disadvantage), are not fully selective/sports/performing arts/agriculture/boarding schools, and are not participating in other major whole school physical activity intervention studies/initiatives, and have the capacity to release a teacher to implement the intervention (school champion). In addition, only co-educational schools will be eligible for student level measures.
Minimum age
11 Years
Maximum age
14 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students with severe intellectual or physical disabilities will be excluded from eligibility for student measurement

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The study region spans four Local Health Districts in New South Wales, Australia, namely Central Coast, Hunter New England, Mid North Coast and South Western Sydney. Secondary schools within the study region that meet the following criteria will be considered eligible: Government and Catholic schools, that enrol students in Grades 7-10; classified as being disadvantaged by the SEIFA Index of Relative Socioeconomic Disadvantage (suburb in lower 50% of NSW); are not fully selective/sports/performing arts/agriculture/boarding schools; are not participating in other major whole school physical activity intervention studies/initiatives and have the capacity to release a teacher to implement the intervention (school champion role).

All eligible secondary schools will be invited to participate in the study.. The list of schools will be put in random order for contact within their strata using a random number function in Microsoft Excel by a statistician not involved in contacting schools or in the study delivery. The list will be stratified by local health district and school sector. A letter inviting schools to be involved in the project, detailing all levels of potential involvement dependent upon allocation will be sent to schools. Approximately one week after the invitation letter is sent, School Principals will be contacted by phone by a member of the research team and invited to participate in the study. A face-to-face meeting will be offered with both the Principal and the Head PDHPE teacher to outline the requirements of the study and gain consent. The Principals of co-educational schools will be asked to provide separate consent for student level measures.

Consenting schools will be randomised to intervention or control conditions using a random number function in micro-soft excel by a statistician not involved in contacting schools or in the study delivery. Block randomisation (1:1) will be undertaken within strata based on local health district (4 districts) and sector (Government, Catholic). Principals will be notified of their allocation following baseline collection of primary outcomes. Schools consenting to student level data will be selected at random for participation in this aspect, within their strata and notified of involvement when notified of group allocation.

PE staff will be provided with study information and consent letters that outline the purpose of the study and level of involvement.

Allocation will not be known by Principals, PE teachers or research staff at the time of baseline data collection.

Parents of students in the relevant Grade in 30 schools (15 per arm) participating in study measurement will be provided an information package and a consent form asking for their child to participate in the study measurement. The letter will describe the study, but will not indicate to which group the school has been allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Secondary schools will be randomly allocated to the intervention or control condition using a computerised random number function in Microsoft Excel. Consenting schools will be randomised to intervention or control conditions using a random number function in Microsoft Excel by a statistician not involved in contacting schools or in the study delivery. Block randomisation (1:1) will be undertaken within strata based on local health district (4 districts) and sector (Government, Catholic).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Wait list control design. Participants assigned to the control group will receive a lower dose intervention at the completion of the study.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Student and school characteristics will be summarised separately for intervention and control schools. The analysis will follow the intention to treat principles, with multiple imputation the primary method of dealing with missing data. Per protocol analyses will also be performed.

Differences between treatment groups in the primary outcome at 12 months and 24-months (collected from 49 schools recruited to the implementation intervention) will be assessed using logistic regression models (a separate analysis conducted at both time-points), the stratification variables will be included in the models as covariates.

For secondary student level outcomes (collected from a nested sample of students attending 30 schools; n=1200 students), analysis of minutes of MVPA per day (overall, and within school hours) will be undertaken using a linear mixed model (LMM ), including a school-level random intercept to model the clustering (30 clusters, 15 intervention and 15 control). Separate analysis will be conducted at 12 and 24-months.

The target sample is 49 secondary schools recruited to the school physical activity implementation intervention, with secondary outcome measures collected in a nested sample of 30 randomly selected secondary schools (n=1200 students).

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7935 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 15902 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 296360 0
Government body
Name [1] 296360 0
NSW Ministry of Health – Translational Research Grant
Address [1] 296360 0
Locked Mail Bag 961
North Sydney NSW 2059
Country [1] 296360 0
Australia
Funding source category [2] 300249 0
Charities/Societies/Foundations
Name [2] 300249 0
Cancer Council NSW
Address [2] 300249 0
153 Dowling St
Woolloomooloo NSW 2011
(PO Box 572 Kings Cross NSW 1340)
Country [2] 300249 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Population Health
Address
Locked Bag 10
Wallsend NSW 2287
Country
Australia
Secondary sponsor category [1] 295300 0
University
Name [1] 295300 0
University of Newcastle
Address [1] 295300 0
Callaghan Campus
University Drive Callaghan NSW 2308
Country [1] 295300 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297590 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 297590 0
Hunter New England Health
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 297590 0
Australia
Date submitted for ethics approval [1] 297590 0
22/09/2016
Approval date [1] 297590 0
03/11/2016
Ethics approval number [1] 297590 0
11/03/16/4.05
Ethics committee name [2] 297591 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 297591 0
Callaghan Campus
University Drive Callaghan NSW 2308
Ethics committee country [2] 297591 0
Australia
Date submitted for ethics approval [2] 297591 0
11/10/2016
Approval date [2] 297591 0
08/11/2016
Ethics approval number [2] 297591 0
TBA
Ethics committee name [3] 297592 0
Aboriginal Health and Medical Research Ethics Committee
Ethics committee address [3] 297592 0
Level 3, 66 Wentworth Ave
SURRY HILLS, NSW 2010
PO Box 1565
Strawberry Hills, NSW 2012
Ethics committee country [3] 297592 0
Australia
Date submitted for ethics approval [3] 297592 0
23/09/2016
Approval date [3] 297592 0
23/04/2017
Ethics approval number [3] 297592 0
Ref 1216/16
Ethics committee name [4] 297593 0
State Education Research Approvals Process (for all DoE schools)
Ethics committee address [4] 297593 0
Locked Bag 53
Darlinghurst NSW 1300
Ethics committee country [4] 297593 0
Australia
Date submitted for ethics approval [4] 297593 0
10/11/2016
Approval date [4] 297593 0
21/12/2016
Ethics approval number [4] 297593 0
SERAP 2011111
Ethics committee name [5] 297594 0
Broken Bay Diocese (for Catholic schools in Central Coast LHD)
Ethics committee address [5] 297594 0
Caroline Chisholm Centre
Building 2, 423 Pennant Hills Road (PO Box 967)
Pennant Hills, NSW 2120 (1715)
Ethics committee country [5] 297594 0
Australia
Date submitted for ethics approval [5] 297594 0
23/11/2016
Approval date [5] 297594 0
22/01/2017
Ethics approval number [5] 297594 0
NA
Ethics committee name [6] 297595 0
Lismore Diocese (for Catholic schools in Mid Coast LHD)
Ethics committee address [6] 297595 0
3 Dawson St (PO Box 158)
Lismore NSW 2480
Ethics committee country [6] 297595 0
Australia
Date submitted for ethics approval [6] 297595 0
17/11/2016
Approval date [6] 297595 0
10/02/2017
Ethics approval number [6] 297595 0
NA
Ethics committee name [7] 297596 0
Armidale Diocese (for Catholic schools in the New England part of Hunter New England LHD)
Ethics committee address [7] 297596 0
Unit 2, 131 Barney St
ARMIDALE, NSW 2350
Ethics committee country [7] 297596 0
Australia
Date submitted for ethics approval [7] 297596 0
21/11/2016
Approval date [7] 297596 0
22/12/2016
Ethics approval number [7] 297596 0
NA
Ethics committee name [8] 297597 0
Diocese of Maitland-Newcastle Catholic Schools Office (for Catholic schools in the Hunter part of Hunter New England LHD)
Ethics committee address [8] 297597 0
PO Box 714
Newcastle NSW 2300
Ethics committee country [8] 297597 0
Australia
Date submitted for ethics approval [8] 297597 0
08/11/2016
Approval date [8] 297597 0
21/12/2016
Ethics approval number [8] 297597 0
NA

Summary
Brief summary
To address adolescent PA, Physical Activity 4 Everyone (PA4E1) is a multi-component secondary school PA intervention recently trialled in New South Wales (NSW), Australia in a study involving 10 disadvantaged secondary schools (5 intervention schools, 5 control schools). The program involved schools implementing seven PA strategies, which schools were supported to implement. The intervention delivered over two years resulted in significant improvements in adolescents’ daily minutes of moderate-to-vigorous physical activity (MVPA) and adiposity at 24 months. The program was cost-effective and acceptable to stakeholders. There is currently little evidence to guide the successful scale-up of effective programs, such as PA4E1, to a larger number of secondary schools. Without adequate implementation ‘at scale’ of such programs, their benefits cannot be realised. A larger trial of the PA4E1 intervention will be conducted in secondary schools located in disadvantaged areas in four NSW Local Health Districts.

The primary aim of this study is to assess the effectiveness of the intervention in increasing school implementation of seven practices designed to facilitate student PA levels (PA practices). The effectiveness of the intervention in improving adolescent PA and preventing adiposity, and its cost effectiveness in doing so, will also be assessed in a sub-sample of schools (secondary outcome).
The study will employ a cluster randomised controlled trial (RCT) design (24 intervention schools and 25 control schools). An implementation support intervention adapted for scale up from the support provided to schools in the PA4E1 effectiveness trial has been designed using the Theoretical Domains Framework (TDF). A nested sample of 30 schools (15 per group) will collect student level measures to assess the secondary outcomes.
Trial website
NA
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 74538 0
Prof John Wiggers
Address 74538 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW Australia 2287
Country 74538 0
Australia
Phone 74538 0
+61 2 4924 6247
Fax 74538 0
+61 2 49246215
Email 74538 0
john.wiggers@hnehealth.nsw.gov.au
Contact person for public queries
Name 74539 0
Ms Rachel Sutherland
Address 74539 0
Hunter New England Population Health
Locked Bag 10
Wallsend NSW Australia 2287
Country 74539 0
Australia
Phone 74539 0
+61 2 4924 6133
Fax 74539 0
+61 2 49246215
Email 74539 0
rachel.sutherland@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 74540 0
Ms Rachel Sutheland
Address 74540 0
Hunter New England Population Health
Locked Bag 10
Wallsend NSW Australia 2287
Country 74540 0
Australia
Phone 74540 0
+61 2 49246133
Fax 74540 0
+61 2 49246215
Email 74540 0
rachel.sutherland@hnehealth.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary