Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000861752
Ethics application status
Approved
Date submitted
3/06/2022
Date registered
17/06/2022
Date last updated
7/04/2024
Date data sharing statement initially provided
17/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Identifying strategies to support implementation of the Resistance Training for Teens (RT for Teens) school-based health-related fitness program for adolescents
Scientific title
Optimising the implementation of the Resistance Training for Teens program in secondary schools
Secondary ID [1] 305947 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is the next phase of the state-wide dissemination study ACTRN12621000352808.

Health condition
Health condition(s) or problem(s) studied:
Poor health-related fitness 324542 0
Physical inactivity 324543 0
Psychological well-being 324544 0
Sedentary behaviour 324545 0
Obesity 324546 0
Condition category
Condition code
Public Health 322011 322011 0 0
Health promotion/education
Diet and Nutrition 322012 322012 0 0
Obesity
Mental Health 322013 322013 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In a recent cluster randomised controlled trial (RCT) delivered in New South Wales (NSW) government schools, we demonstrated that the ‘Resistance Training for Teens’ (RT for Teens) intervention improved adolescents’ muscular fitness, body composition and RT skill competency (e.g., squat, lunge and push-up technique).

In the current project, we will partner with the NSW Department of Education (DoE) and five Local Health Districts (LHDs) to evaluate strategies to support the implementation of the RT for Teens program in NSW government and non-government secondary schools. Using findings from our previous RCT and dissemination studies, we have adapted our implementation support strategies to optimise reach, dose delivered, fidelity, sustainability, and impact. The aim of our proposed study is to assess the effect of three implementation support models (i.e., Low, Moderate and High) on the implementation (i.e., reach, effectiveness, dose delivered, fidelity, adoption, sustainability, impact and cost) of the RT for Teens program in NSW schools. To achieve this aim, we will conduct a hybrid type III implementation-effectiveness cluster RCT in 90 schools to determine the most effective and cost-effective RT for Teens implementation model.

One teacher from each school will attend the RT for Teens professional learning workshop, provided by members of the RT for Teens design team from University of Newcastle, and serve as the “School Champion”. School Champions will attend 1 full day face-to-face training and be provided with curricular materials, including units of work, lesson plans, assessments task, technique and workout cards. The workshop will occur in Term 2 (2023), while the RT for Teens program can be delivered from Term 2 until Term 4 (2023). The School Champions will train the other teachers of their school who will also deliver the program to the students. This training (delivered by the School Champions to other teachers in school) include a 2-hour workshop and will be scheduled during Term 2 (2023) prior start of the program. The attendance of the School Champion workshop will be monitored by the Project Manager (i.e., by using an attendance list) and the teachers are required to complete an Action Plan to support implementation in their school, this plan will be evaluated by the Project Manager to ensure it is of high quality. In addition, app analytics will be accessed to monitor students' participation in the practical sessions.

In addition to the teacher workshop, the Medium and High support groups will both include on-going support from external change agents (i.e., LHD Project Officers). Contact includes guidance via email, phone or face-to-face, depending teachers' preferences. Furthermore, Project Officers will observe one or two teachers per school who deliver an RT for Teens session and provide feedback to teachers on the structure of the RT for Teens session. The SAAFE observation checklist will be used to determine intervention fidelity and a brief checklist will be completed after each school meeting. This approach is consistent with the existing NSW health model for supporting the implementation of healthy eating and physical activity programs in schools. Project Officers from 5 LHDs will work directly with School Champions to facilitate implementation of the RT for Teens program. The 'High' support group will also receive a basic resistance training equipment pack valued at approximately $1000 AUD.

The RT for Teens program includes the following:

Resistance training (RT) sessions: Teachers will be trained to deliver the RT for Teens sessions. The 8-week program will utilise the following structured format: i) Warm-up (~5 mins); ii) GymFit (~20-25 mins); iii) Workout Of the Day (WOD)/GameFit/FunFit (~10-15 mins); and iv) StretchFit (i.e., a cool down including static stretching) (~5 mins). Within the 8-week implementation period, teachers will be encouraged to deliver approximately one session (theory and practice) per week.

Theory lessons: Teachers are provided with 8 x 40 min theory lessons designed by the research team to align with the Australian Curriculum for health and physical education (HPE) and the Australian Physical Literacy Framework. They will be delivered during health lessons, with content covering: (i) introduction to RT, (ii) self-assessment of fitness, motivation and monitoring, (iii) fitness and eHealth technologies, (iv) principles of training and RT program design, (v) social media, physical activity and body image, (vi) Yoga, Pilates and other muscle-strengthening activity, (vii) nutrition myths and recommendations, and (viii) community-based opportunities for RT.

Access to a smartphone app: Students and teachers will be able to access the RT for Teens app. Note: only students that provided their consent (i.e., opt-in) will be able to use the app. The app includes: a fitness testing feature – whereby students are able to use criterion-referenced standards to develop self-assessment skills; skill testing – a function for evaluating competence in six specific RT movements; and workouts – a library of pre-designed bodyweight resistance training workouts organised by difficulty (with a custom workout generator).

Teachers will be encouraged to implement the full program including all sessions, but can still participate in the program when teaching part of the intervention. Teacher logbooks will be consulted by the research team after the implementation period to collect data on what sessions have been delivered by the teachers.

Students fitness results (e.g., number of push-ups until fatigue) will be recorded through the smartphone app (students) or tablet app version (teachers). Data on level of intensity during the RT for Teens sessions will not be collected as the prior focus of the project is on implementation.

Students will not be asked to engage in additional RT exercises outside of school hours or outside this program, but they will be encouraged to get familiar with RT, feel confident about it and include it in their own exercise schedule after participation.
Intervention code [1] 322339 0
Lifestyle
Intervention code [2] 322340 0
Prevention
Intervention code [3] 322341 0
Behaviour
Comparator / control treatment
The 'Low' support group (i.e., usual care in delivering the RT for Teens program) will act as a control group because this is the professional development model typically used by the NSW DoE. This is often referred to as the “train and forget” model because schools are not provided with on-going support.

Schools/teachers in this group will still deliver the RT for Teens program, participate in the one-day school champion workshop and the school champion will be requested to deliver the 2-hour workshop for the other teachers (but without ongoing support/equipment pack).
Control group
Active

Outcomes
Primary outcome [1] 329768 0
Our primary outcome is Reach, including the proportion of Year 9 and 10 students that participate in the RT for Teens program. This information will be collected using consents for participation and teacher logbooks (i.e., class lists). Participation (%) will be defined as the number of Year 9 and 10 students who have participated in the program divided by the total number of students in Year 9 and 10 at the study schools. All data related to this outcome will be assessed as a composite outcome.
Timepoint [1] 329768 0
Consents for participation will be collected at baseline (before intervention, during the teacher workshop). Outcomes will be assessed at baseline, 6-month and 18-month follow-up.
Secondary outcome [1] 403710 0
Dose delivered: The number of RT for Teens sessions delivered to students (including practical sessions and theory lessons). We have prepared a checklist for teachers to keep track of the delivered sessions with the number of students in class (practical and theoretical separately).
Timepoint [1] 403710 0
6-month and 18-month follow-up (post-intervention commencement).
Secondary outcome [2] 403711 0
Fidelity: Project Officers will observe about two teachers per school who deliver an RT for Teens session (~120 observations), for the High and Moderate group (60 schools) and will use the 'Supportive, Active, Autonomous, Fair, and Enjoyable' (SAAFE) observation checklist to determine intervention fidelity.
Timepoint [2] 403711 0
During the 8-week intervention period
Secondary outcome [3] 403712 0
Sustainability: The extent to which the program has become embedded within the school setting will be determined by interviewing the School Champions at follow-up, by a 30-minute semi-structured one-on-one interview with a member of the research team. In addition, the school champion will complete the Program Sustainability Assessment Tool (with only the items for Environmental support (n=5) and Organizational capacity (n=5)). This feedback will be assessed as a composite secondary outcome.
Timepoint [3] 403712 0
18-month follow-up (post-intervention commencement)
Secondary outcome [4] 403713 0
Impact: Impact outcomes will be collected by students using the RT for Teens smartphone app (note: only if they provided their opt-in consent) or teachers using the tablet version of the app (the latter applies only when students don't have access to a smartphone). The current version of the app allows students to enter their own results for fitness, RT skill competency and participation in muscle-strengthening activity. Students can view animated images to get familiar with the performance criteria for each specific RT skill (i.e., Squat, Push-ups, Lunge, Overhead Press, Suspended row, front support with chest touches). in the MY TECHNIQUE screen, students can see an overview of their six skills and current scores (rated with help from a peer, teacher, or can self-assess using the video). Upper body and torso muscular endurance will be assessed using the validated 90° push-up and plank tests, respectively. All the above mentioned measures will be assessed as a composite secondary outcome.
Timepoint [4] 403713 0
During the 8-week intervention period, after completing of each practical RT session of the RT for Teens program.
Secondary outcome [5] 403714 0
Cost: We will conduct a within-trial economic evaluation, from the perspective of the Education Sector, assessing cost-effectiveness of the RT for Teens program across the three trial arms.

Costs comprise intervention and implementation costs (not evaluation costs); the latter varies in intensity between trial arms. The opportunity cost of teacher, and other staff, time will also be costed at pro-rata salary levels for intervention and implementation activities. An incremental cost-effectiveness ratio (ICER) will assess the additional costs and additional effectiveness between trial arms. A probability sensitivity analysis will assess statistical uncertainty in the ICER, and a value of information analysis will assess the value of undertaking future research to further optimise implementation. A budget impact analysis will then estimate the total financial impact for the NSW DoE and Ministry of Health (MoH) from investing in the most cost-effective implementation model for scale-up across Australia. Central to our proposal is generating data to guide policy makers’ future decisions. To estimate RT for Teens value we will compare the incremental cost per participant with benefit achieved at the participant level across each group.
Timepoint [5] 403714 0
After all participating schools have implemented the intervention.
Secondary outcome [6] 403715 0
Acceptability: Perceptions among the delivery team that a given intervention is agreeable, palatable, or satisfactory.
This outcome will be assessed via an online questionnaire for the teachers who delivered the RT for Teens program.
Items from a validated questionnaire will be used, designed to assess the Acceptability of Intervention Measure (AIM) (Weiner et al., 2017).

Weiner, B. J., Lewis, C. C., Stanick, C., Powell, B. J., Dorsey, C. N., Clary, A. S., ... & Halko, H. (2017). Psychometric assessment of three newly developed implementation outcome measures. Implementation Science, 12(1), 1-12.
Timepoint [6] 403715 0
6-month and 18-month follow-up (post-intervention commencement).
Secondary outcome [7] 410692 0
Adaptability: Extent to which an intervention can be adapted, tailored, refined, or reinvented to meet local needs.
This outcome will be assessed via an online questionnaire for the teachers who delivered the RT for Teens program.
Items from the validated Program Sustainability Assessment Tool (PSAT) questionnaire will be used (Hall et al., 2021).

H Hall, A., Shoesmith, A., Shelton, R. C., Lane, C., Wolfenden, L., & Nathan, N. (2021). Adaptation and Validation of the Program Sustainability Assessment Tool (PSAT) for Use in the Elementary School Setting. International journal of environmental research and public health, 18(21), 11414.
Timepoint [7] 410692 0
6-month and 18-month follow-up (post-intervention commencement).
Secondary outcome [8] 410693 0
Feasibility: Perceptions among the delivery team that an intervention can be successfully used or carried out within a given organization or setting.
This outcome will be assessed via an online questionnaire for the teachers who delivered the RT for Teens program.
Items from a validated questionnaire will be used, designed to assess the Feasibility of Intervention Measure (FIM) (Weiner et al., 2017).

Weiner, B. J., Lewis, C. C., Stanick, C., Powell, B. J., Dorsey, C. N., Clary, A. S., ... & Halko, H. (2017). Psychometric assessment of three newly developed implementation outcome measures. Implementation Science, 12(1), 1-12.
Timepoint [8] 410693 0
Baseline and at 6-month and 18-month follow-up (post-intervention commencement).
Secondary outcome [9] 410694 0
Compatibility (appropriateness): Extent to which an intervention fits with the mission, priorities, and values of organizations or settings.
This outcome will be assessed via an online questionnaire for the teachers who delivered the RT for Teens program.

Items from a validated questionnaire will be used, designed to assess the Intervention Appropriateness Measure (IAM) (Weiner et al., 2017).

Weiner, B. J., Lewis, C. C., Stanick, C., Powell, B. J., Dorsey, C. N., Clary, A. S., ... & Halko, H. (2017). Psychometric assessment of three newly developed implementation outcome measures. Implementation Science, 12(1), 1-12.
Timepoint [9] 410694 0
Baseline and at 6-month and 18-month follow-up (post-intervention commencement).
Secondary outcome [10] 410695 0
Culture: Organizations’ norms, values, and basic assumptions around selected health outcomes.
This outcome will be assessed via an online questionnaire for the teachers who delivered the RT for Teens program.

Items from a previous study will be used and will be slightly adjusted to the current study (Kennedy et al., 2020).

Kennedy, S. G., Leahy, A. A., Smith, J. J., Eather, N., Hillman, C. H., Morgan, P. J., ... & Lubans, D. R. (2020). Process evaluation of a school-based high-intensity interval training program for older adolescents: the burn 2 learn cluster randomised controlled trial. Children, 7(12), 299.
Timepoint [10] 410695 0
Baseline and at 6-month and 18-month follow-up (post-intervention commencement).
Secondary outcome [11] 410696 0
Dose (satisfaction): Delivery team’s satisfaction with an intervention and with interactions with the support system.
This outcome will be assessed via an online questionnaire for the teachers who delivered the RT for Teens program.

Items from a previous study will be used and will be slightly adjusted to the current study (Kennedy et al., 2020).

Kennedy, S. G., Leahy, A. A., Smith, J. J., Eather, N., Hillman, C. H., Morgan, P. J., ... & Lubans, D. R. (2020). Process evaluation of a school-based high-intensity interval training program for older adolescents: the burn 2 learn cluster randomised controlled trial. Children, 7(12), 299.
Timepoint [11] 410696 0
Baseline and at 6-month and 18-month follow-up (post-intervention commencement).
Secondary outcome [12] 410697 0
Complexity: Perceptions among the delivery team that a given intervention is relatively difficult to understand and use; number of different intervention components.
This outcome will be assessed via an online questionnaire for the teachers who delivered the RT for Teens program.

Items from a previous study will be used and will be slightly adjusted to the current study (Carlson et al., 2017).

Carlson JA, Engelberg JK, Cain KL, et al. Contextual factors related to implementation of classroom physical activity breaks. Transl Behav Med 2017;7:581–92.
Timepoint [12] 410697 0
Baseline and at 6-month and 18-month follow-up (post-intervention commencement).
Secondary outcome [13] 410698 0
Self-efficacy: Delivery team’s belief in its ability to execute courses of action to achieve implementation goals.
This outcome will be assessed via an online questionnaire for the teachers who delivered the RT for Teens program.

Items from several previous studies will be used and slightly adjusted to the current study (Kennedey et al., 2020; Morgan & Bourke, 2008; Keyworth et al., 2020).

Kennedy, S. G., Leahy, A. A., Smith, J. J., Eather, N., Hillman, C. H., Morgan, P. J., ... & Lubans, D. R. (2020). Process evaluation of a school-based high-intensity interval training program for older adolescents: the burn 2 learn cluster randomised controlled trial. Children, 7(12), 299.

Morgan, P., & Bourke, S. (2008). Non-specialist teachers' confidence to teach PE: the nature and influence of personal school experiences in PE. Physical Education and Sport Pedagogy, 13(1), 1-29.

Keyworth, C., Epton, T., Goldthorpe, J., Calam, R., & Armitage, C. J. (2020). Acceptability, reliability, and validity of a brief measure of capabilities, opportunities, and motivations (“COM-B”). British journal of health psychology, 25(3), 474-501
Timepoint [13] 410698 0
Baseline and at 6-month and 18-month follow-up (post-intervention commencement).
Secondary outcome [14] 410819 0
Teachers' perceptions of the RT for Teens program.
This outcome will be assess via a 30-minute semi-structured one-on-one interview with a member of the research team.

Interview items from a previous study on RT for Teens will be used and slightly adapted to the current program (Kennedy et al., 2018).

Kennedy, S. G., Smith, J. J., Hansen, V., Lindhout, M. I., Morgan, P. J., & Lubans, D. R. (2018). Implementing resistance training in secondary schools: an exploration of teachers' perceptions. Translational Journal of the American College of Sports Medicine, 3(12), 85-96.
Timepoint [14] 410819 0
at 6-month and 18-month follow-up (post-intervention commencement).
Secondary outcome [15] 410822 0
Stakeholders' perceptions of the RT for Teens program.

The final phase of this project will focus on engagement with key stakeholders in VIC, QLD and WA to guide national dissemination. This outcome will be assessed via a series of semi-structured face-to-face (or virtual if more feasible) focus groups with key stakeholders and authorities in the education and health sectors. The details of this focus group (e.g., time and discussion items) will be determined in the final phase of the RCT, once the follow-up data collection has been finalized for cohort 2.

In each state, focus group participants will include: (i) Executive directors: Government and non-government health and education authorities, (ii) School leaders: Secondary school principals and HPE head of departments who are responsible for school-based program decisions, and (iii) Teachers: Secondary school HPE teachers. Focus group data will be recorded, transcribed and entered into NVIVO software for inductive thematic analysis. Data from the focus groups will be used to investigate state-based parameters and pragmatic considerations for national dissemination.
Timepoint [15] 410822 0
Once the 18-month follow-up (post-intervention commencement) data collection has been completed.

Eligibility
Key inclusion criteria
The intervention will target students in Year 9 and 10 in secondary schools in NSW. All government (n = 367) and non-government (n = 140) secondary schools will be eligible to participate. The study will start in Term 2 (2023) and finish in Term 1 (2025). Teachers who have previously attended an RT for Teens professional learning workshop will still be eligible to participate in the study.
Minimum age
13 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
n/a

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)
Randomisation will be undertaken using a random number producing algorithm by an independent statistical analysis service- Clinical Research Design, Information Technology and Statistical Support (CREDITSS) from Hunter Medical Research Institute.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be stratified by type and location of schools, using a random number producing algorithm by an independent statistical analysis service- Clinical Research Design, Information Technology and Statistical Support (CREDITSS) from Hunter Medical Research Institute. Within one week of attending the workshop, schools will be contacted via email and their group allocation will be explained.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative analyses: Analyses of the primary (program reach) and secondary (implementation and impact) outcomes will be conducted using logistic mixed models for dichotomous outcomes, and ordinal or linear mixed effects regression models for continuous outcomes, with alpha levels set at p<0.025 for the comparisons of the Moderate and High support arms against the Low support arms. If the p-values for the differences between the Moderate and High support arms with the Low support arm reach this threshold, the Moderate and High support arms will be compared at a 5% significance threshold. For student level outcomes, statistical analyses will be adjusted for the clustering of effects at the class level, as students from each school are nested in classes. Although clustering at the school level is negligible after adjusting for clustering at the class level, we will test this assumption and adjust our analyses for school-level clustering if required. For teacher-level outcomes, clustering will be accounted for at the school-level. Secondary schools in NSW include an average eight Year 9 and 10 classes/school (~30 students/class).

Qualitative analyses: Audio recordings from the semi structured interviews will be de-identified and professionally transcribed. Transcriptions will be imported into NVivo 12 (QSR International, 2018) for data analysis. We ascribe to framework analysis, an approach we deem appropriate for qualitative studies with specific questions that address specific aims. Inductive thematic analysis will be used to create a broad framework for initial coding. Secondary coding will be completed by two researchers independently and inter-coder reliability will later be assessed to ensure consistency. Further analysis of refined coding will then be completed to identify key themes. The CIs will undertake a series of semi-structured face-to-face (or virtual if more feasible) focus groups with key stakeholders and authorities in the education and health sectors. In each state, focus group participants will include: (i) Executive directors: Government and non-government health and education authorities, (ii) School leaders: Secondary school principals and HPE head of departments who are responsible for school-based program decisions, and (iii) Teachers: Secondary school HPE teachers. Focus group data will be recorded, transcribed and entered into NVIVO software for inductive thematic analysis. Data from the focus groups will be used to investigate state-based parameters and pragmatic considerations for national dissemination.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
27/02/2023
Actual
26/02/2023
Date of last participant enrolment
Anticipated
16/06/2023
Actual
7/03/2024
Date of last data collection
Anticipated
28/04/2025
Actual
Sample size
Target
7800
Accrual to date
Final
5220
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 310289 0
University
Name [1] 310289 0
National Health & Medical Research Council (NHMRC) Partnership Projects 2021
Country [1] 310289 0
Australia
Primary sponsor type
Individual
Name
Prof David Lubans
Address
Centre for Active Living & Learning (CALL)
Level 3 ATC building
University of Newcastle
University Drive
Callaghan, NSW 2308, Australia
Country
Australia
Secondary sponsor category [1] 311396 0
Individual
Name [1] 311396 0
Prof Heather McKay
Address [1] 311396 0
University of British Columbia, Faculty of Medicine
Diamond Health Care Centre
11th Floor - 2775 Laurel Street
Vancouver, BC Canada V5Z 1M9
Country [1] 311396 0
Canada
Secondary sponsor category [2] 311402 0
Individual
Name [2] 311402 0
Dr Jordan Smith
Address [2] 311402 0
Centre for Active Living & Learning (CALL)
Level 3 ATC building
University of Newcastle
University Drive
Callaghan, NSW 2308, Australia
Country [2] 311402 0
Australia
Secondary sponsor category [3] 311403 0
Individual
Name [3] 311403 0
Prof Philip Morgan
Address [3] 311403 0
Centre for Active Living & Learning (CALL)
Level 3 ATC building
University of Newcastle
University Drive
Callaghan, NSW 2308, Australia
Country [3] 311403 0
Australia
Secondary sponsor category [4] 311404 0
Individual
Name [4] 311404 0
Dr Rachel Sutherland
Address [4] 311404 0
Hunter New England Population Health,
Postal address:
Locked Bag 1
New Lambton NSW 2305
Australia
Country [4] 311404 0
Australia
Secondary sponsor category [5] 311405 0
Individual
Name [5] 311405 0
Prof Dawn Penney
Address [5] 311405 0
School of Education,
Edith Cowan University
2 Bradford Street
Mount Lawley WA 6050
Australia
Country [5] 311405 0
Australia
Secondary sponsor category [6] 311406 0
Individual
Name [6] 311406 0
Dr Sarah Kennedy
Address [6] 311406 0
Western Sydney University
Second Ave, Kingswood NSW 2747
Australia
Country [6] 311406 0
Australia
Secondary sponsor category [7] 311407 0
Individual
Name [7] 311407 0
Dr Joseph Scott
Address [7] 311407 0
University of the Sunshine Coast, School of Education
90 Sippy Downs Dr, Sippy Downs QLD 4556
Australia
Country [7] 311407 0
Australia
Secondary sponsor category [8] 311408 0
Individual
Name [8] 311408 0
Prof Jo Salmon
Address [8] 311408 0
Deakin University, Faculty of Health
221 Burwood Highway, Burwood, Victoria 3125
Australia
Country [8] 311408 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309954 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 309954 0
Ethics committee country [1] 309954 0
Australia
Date submitted for ethics approval [1] 309954 0
02/12/2021
Approval date [1] 309954 0
31/05/2022
Ethics approval number [1] 309954 0
H-2021-0418
Ethics committee name [2] 312810 0
Department of Education - SERAP
Ethics committee address [2] 312810 0
Ethics committee country [2] 312810 0
Australia
Date submitted for ethics approval [2] 312810 0
22/11/2022
Approval date [2] 312810 0
15/12/2022
Ethics approval number [2] 312810 0
2022215
Ethics committee name [3] 312811 0
NSW Health Ethics (REGIS)
Ethics committee address [3] 312811 0
Ethics committee country [3] 312811 0
Australia
Date submitted for ethics approval [3] 312811 0
28/02/2023
Approval date [3] 312811 0
02/03/2023
Ethics approval number [3] 312811 0
2023/ETH00052

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

Contacts
Principal investigator
Name 115974 0
Prof David Lubans
Address 115974 0
Centre for Active Living & Learning (CALL)
University of Newcastle
University Drive Callaghan NSW 2308
Country 115974 0
Australia
Phone 115974 0
+61 02 49212049
Fax 115974 0
Email 115974 0
david.lubans@newcastle.edu.au
Contact person for public queries
Name 115975 0
David Lubans
Address 115975 0
Centre for Active Living & Learning (CALL)
University of Newcastle
University Drive Callaghan NSW 2308
Country 115975 0
Australia
Phone 115975 0
+61 02 49212049
Fax 115975 0
Email 115975 0
david.lubans@newcastle.edu.au
Contact person for scientific queries
Name 115976 0
David Lubans
Address 115976 0
Centre for Active Living & Learning (CALL)
University of Newcastle
University Drive Callaghan NSW 2308
Country 115976 0
Australia
Phone 115976 0
+61 02 49212049
Fax 115976 0
Email 115976 0
david.lubans@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.