Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000403538
Ethics application status
Approved
Date submitted
7/02/2024
Date registered
3/04/2024
Date last updated
3/04/2024
Date data sharing statement initially provided
3/04/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
EMU (Education, Movement and Understanding): A school-based Indigenous games program targeting cultural appreciation in children, and improvements in their physical activity and fitness levels, health and well-being, and academic achievement at school.
Scientific title
EMU (Education, Movement and Understanding): A school-based Indigenous games program targeting cultural appreciation in children, and improvements in their physical activity and fitness levels, health and well-being, and academic achievement at school.
Secondary ID [1] 311490 0
NIL
Universal Trial Number (UTN)
Trial acronym
EMU (Education, Movement and Understanding).
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical fitness 332817 0
Mental Health 332818 0
Condition category
Condition code
Cardiovascular 329533 329533 0 0
Normal development and function of the cardiovascular system
Mental Health 329534 329534 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 329535 329535 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention:

EMU (Education, Movement and Understanding) is a curriculum program designed to enhance the health and well-being of children, and their numeracy and literacy levels, through participation in an enjoyable and engaging physical education program at school. The EMU program will specifically target the development of a positive learning environment through positive teaching practices.


Aim The primary of this study is to evaluate the feasibility of training teachers to deliver the EMU program in primary schools within the Awabakal and Worimi regions of Newcastle.

Our secondary aim is to examine the impact of the EMU program on cultural understanding and appreciation, physical and mental health and wellbeing, and literacy and numeracy attainment in the children involved.


Informed by the positive findings of the 2020 EMU study this larger trial will involve 10 schools (5 schools; 10 teachers; 250 children x 2 years) and be evaluated using a randomised controlled trial (CRCT) in the Awabakal and Worimi areas of Newcastle.
Year 1 (2023-4): Program Development
Year 2 (2024): Phase 1 CRCT
Year 3 (2025): Phase 2 CRCT and evaluation.
Participants
Stage 3 teachers and their students from Government primary schools in the Awabakal and Worimi areas of Newcastle with student cohorts of >20% identified as Indigenous descent will be invited to participate. All primary schools are required to include Indigenous cultural perspectives and content in all Key Learning Areas (including physical education, mathematics, and English); but Stage 3 (Grades 5 & 6) is the ideal stage to increase engagement in classes via high quality learning opportunities, and to consolidate and extend key movement skills and core literacy and numeracy skills. In this second and larger EMU study, participating teachers and their students will be randomly assigned to either the EMU group (teacher receives professional learning) or the active control group (who will receive the program in following year)- which will be independently randomized at the school level. To ensure implementation success the research team will follow constructs from the Consolidated Framework for Implementation Research (adapted for schools) and Ngaa- bi-nya Aboriginal and Torres Strait Islander program evaluation framework - and ensure all aspects of the trial conforms with Consolidated Standards of Reporting Trials guidelines and Indigenous community needs/wants.

Timeline: EMU Professional Learning Program for Teachers will be conducted on one full day in the school week prior to program implementation at their school and conducted at the University of Newcastle. The day will be set once recruitment is finalized and schools provide information on availability.

Who will administer the EMU program:
The EMU professional learning program will involve training teachers who completed the EMU training workshop to deliver the supplied EMU program over an 8-week period (2 × 60 min sessions per week) to their stage 3 classes.


The EMU professional learning program will include the following components:
(i) 6 hours of teacher professional learning (delivered via interactive and online sessions)
(ii) equipment and resources pack (e.g., chalk, buckets, large dice, balls ,various bats, basketballs, skipping ropes, lettered beanbags, target mats and numbered flexi domes),
(iii) teacher handbook containing 16-detailed lesson plans,
(iv) zoom and discussion sessions providing implementation strategy support.
(v) mentor support from the Aboriginal liaison officer (member of the research team)

The primary objective of the EMU study relates to program feasibility as a teacher training and curriculum program. As outlined by Durlak and Dupree (2008), we will evaluate the below aspects of implementation, with the trial will be deemed successful if EMU is delivered as intended and rated highly on fidelity and quality scores; and teacher / student mean overall program satisfaction greater than or equal to 4 out of 5 (on a 5-point scale ranging from 1=Poor to 5=Excellent).
(i) Fidelity and quality: two lesson observations per class will be conducted during the program using a semi- structured observation checklist (MASTER Framework),
(ii) Dosage: teachers will complete a logbook detailing (and reflecting on) delivered sessions,
(iii) Responsiveness: teachers will evaluate the EMU workshop, resources and lessons; and students will evaluate EMU program using both qualitative and quantitative measures, and
iv) Adaptation: teacher will describe how they modified the program resources via a logbook/register.
Intervention code [1] 327939 0
Behaviour
Comparator / control treatment
The wait list control group will continue with their normal lessons until the treatment group has implemented the EMU program and follow-up assessments have been completed. It is anticipated that the control group will receive the EMU training in Term 3 2024
Control group
Active

Outcomes
Primary outcome [1] 337327 0
(i) Primary outcome 1: Fidelity and quality
Timepoint [1] 337327 0
: School Term 2 2024 Fidelity checks conducted by research team 2 x per school
Primary outcome [2] 337328 0
Responsiveness:
Timepoint [2] 337328 0
School Term 2 2024 Teacher complete a register every session for the 8 weeks (16 sessions planned).
Primary outcome [3] 337329 0
Dosage
Timepoint [3] 337329 0
School Term 2 2024 Teacher complete a register every session for the 8 weeks (16 sessions planned).
Secondary outcome [1] 431462 0
Cardiorespiratory fitness
Timepoint [1] 431462 0
Term 2, 2024 Week 1 = baseline assessment (before 8 week intervention) Week 10= follow-up assessment (after 8 week intervention)
Secondary outcome [2] 431463 0
Mental Health: Physical Self Perceptions
Timepoint [2] 431463 0
Term 2, 2024 Week 1 = baseline assessment (before 8 week intervention) Week 10= follow-up assessment (after 8 week intervention)
Secondary outcome [3] 431464 0
Wellbeing
Timepoint [3] 431464 0
Term 2, 2024 Week 1 = baseline assessment (before 8 week intervention) Week 10= follow-up assessment (after 8 week intervention)
Secondary outcome [4] 431465 0
Academic Achievement:
Timepoint [4] 431465 0
Term 2, 2024 Week 1 = baseline assessment (before 8 week intervention) Week 10= follow-up assessment (after 8 week intervention)
Secondary outcome [5] 431466 0
Enjoyment of Sport
Timepoint [5] 431466 0
Term 2, 2024 Week 1 = baseline assessment (before 8 week intervention) Week 10= follow-up assessment (after 8 week intervention)

Eligibility
Key inclusion criteria
Stage 3 teachers and their students (i.e., 20 teachers; 400 children) from 10 primary schools in the Hunter Region (Awabakal, and Worimi Country) with student cohorts of > 20% Aboriginal students, will be invited to participate in the program. All upper-primary school students aged 10-12 years old, will be invited to participate in the study. However, only students/participants who provide written informed consent will complete physical measures and participant questionnaires.
Minimum age
9 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will occur after baseline assessment (5 schools to EMU group and 5 wait list control) - using an sequence generating excel file and an independent researcher
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A descriptive analysis will be conducted to assess retention, recruitment, adherence and satisfaction among participants. A descriptive analysis was conducted to assess retention, recruitment, adherence and satisfaction among participants.

Health outcomes will be assessed using Linear Mixed Models

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
19/02/2024
Date of last participant enrolment
Anticipated
5/04/2024
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
420
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 315776 0
Commercial sector/Industry
Name [1] 315776 0
Port Waratah Coal Services
Country [1] 315776 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
Country
Australia
Secondary sponsor category [1] 317900 0
None
Name [1] 317900 0
Address [1] 317900 0
Country [1] 317900 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314636 0
The University of Newcastle Human Ethics
Ethics committee address [1] 314636 0
The University of Newcastle, Callaghan NSW 2308
Ethics committee country [1] 314636 0
Australia
Date submitted for ethics approval [1] 314636 0
12/09/2023
Approval date [1] 314636 0
24/10/2023
Ethics approval number [1] 314636 0
H-2020-0057

Summary
Brief summary
The EMU program is designed to enhance the health and well-being of children, and their numeracy and literacy levels, through participation in an enjoyable and engaging PA program in the community/at school. The EMU program will specifically target the development of a positive learning environment through positive teaching practices i.e., through Aboriginal/Indigenous games. The overall aim of this study is to evaluate the impact of the EMU program on PA levels, well-being outcomes, and literacy and numeracy attainment in a sample of primary school-aged children. We hypothesise that students may receive various benefits to a variety of health outcomes i.e., resulting from participation in EMU.
Phase 1 - pilot (completed)
Phase 2 = train the teacher
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132238 0
A/Prof Narelle Eather
Address 132238 0
School of Education ATC305 The University of Newcastle, University Drive, Callaghan NSW 2308, Australia,
Country 132238 0
Australia
Phone 132238 0
+61 425302312
Fax 132238 0
Email 132238 0
narelle.eather@newcastle.edu.au
Contact person for public queries
Name 132239 0
Narelle Eather
Address 132239 0
School of Education ATC305 The University of Newcastle, University Drive, Callaghan NSW 2308, Australia,
Country 132239 0
Australia
Phone 132239 0
+61 425302312
Fax 132239 0
Email 132239 0
narelle.eather@newcastle.edu.au
Contact person for scientific queries
Name 132240 0
Narelle Eather
Address 132240 0
School of Education ATC305 The University of Newcastle, University Drive, Callaghan NSW 2308, Australia,
Country 132240 0
Australia
Phone 132240 0
+61 425302312
Fax 132240 0
Email 132240 0
narelle.eather@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
We do not have ethics approval - data will be de-identified


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.