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Trial registered on ANZCTR


Registration number
ACTRN12620001221943
Ethics application status
Approved
Date submitted
6/08/2020
Date registered
16/11/2020
Date last updated
22/10/2021
Date data sharing statement initially provided
16/11/2020
Date results provided
16/11/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A feasibility trial of EMU (Education, Movement and Understanding): A primary school-based Indigenous games program targeting health, well-being and academic achievement in children.
Scientific title
A feasibility trial of EMU (Education, Movement and Understanding): A primary school-based Indigenous games program targeting health, well-being and academic achievement in children.
Secondary ID [1] 301962 0
'Nil known'
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 - i.e., Cardio respiratory fitness 318521 0
Mental health 318522 0
Condition category
Condition code
Cardiovascular 316523 316523 0 0
Normal development and function of the cardiovascular system
Mental Health 316524 316524 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 316885 316885 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
EMU (Education, Movement and Understanding) means “be happy” and is a 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 activity (PA) program in the community/at school. The EMU program will specifically target the development of a positive learning environment through positive teaching practices.
The EMU program will be delivered by an experienced and qualified teacher (member of the research team) over an 8-week period (2 × 60 min sessions per week). Both members delivering the sessions have a minimum of 5 years teaching experience in schools. Face to face delivery will be provided for stage 2 and/or stage 3 teachers and their students (i.e., 4 teachers; 100 children) from two Government primary schools in the Hunter Region (Awabakal, Grinagai, Wonaruah, Worimi and Darkinung Country, in New South Wales, Australia, ) with student enrolments of > 20% Aboriginal students, will be invited to participate in this pilot study.
The initial feasibility trial of EMU will see the development of the curriculum resource (EMU) in consultation with Aboriginal teachers, students and community members; and the running of the study delivered by the research team over a school term in Awabakal Country (Hunter Region, NSW, Australia).
Optional delivery of sessions either during, or directly after school sport. Teachers to evaluate the research team on their delivery of such sessions which include the below:
• Aboriginal games
• Cultural theme
• Specific social-emotional concept
• Key numeracy or literacy focus (spelling and procedural fluency).
Teachers will supervise the delivery of the content (performed by a researcher who is PDHPE trained).

Detailed lesson plans will be provided to the usual teachers and can be discussed with the researchers i.e., regarding how best to deliver the content in the future after the trial.
Consequently, face-to-face teaching will be provided/witnessed and opportunities to question teaching strategies will be provided between the researchers and usual teachers. There is no maximum number of children included per group, a typical class may have up to 30 students. The research team has created detailed lesson plans that will be provided to the usual teachers (not the students). Opportunities to input in to these lesson plans will be offered to the community, school staff before commencing EMU. Rolls will be taken by the usual teacher and/or researcher to monitor adherence to the intervention (as well as being a part of the typical practices in Department Schools).
Draft schedule:
Week 1a
Gorri
Aboriginal people
Underarm/overarm throw
Self-acceptance
Spelling

Week 1b

Buroinjin Kabi Kabi
Catch
Diversity
Addition

Week 2a1
Keen-tan
Dreaming
Jump & catch
Resilience
Grammar

Week 2 b

Marn-grook
Kick
Identity
Subtraction

Week 3a

Millim-baeyeetch
Identity / sporting identity
Kick & catch
Belonging
Punctuation

Week 3 b

Puldjungi
Throw & catch
Mindfulness
Multiplication

Week 4a

Purlja
Language
Kick & throw
Trust
Spelling

Week 4 b

Arrkene Irreme
Strike
Relationships
Division

Week 5a

Jumpinpin
Community spirit
Catch
courage
Grammar

Week 5b

Merkai
Strike
Respect
Addition and subtraction

Week 6a

Apwerte
Family
Rolling
Integrity
Punctuation

Week 6 b

Wana
Strike, roll, catch
Self-control
Multiplication and division

Week 7 a

Kalq
Connectedness
Strike
Loyalty
RECAP


Week 7b

Koollche
Rolling, locomotor skills
Teamwork
RECAP

Week 8a

Tabloid
Cultural pride
All FMS
Honesty
RECAP

Week 8b

Tabloid
ALL FMS
Perseverance
RECAP
Primary Outcomes
Intervention code [1] 318253 0
Behaviour
Comparator / control treatment
No control group i.e., an initial feasibility trial
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324658 0
(i) Primary outcome 1: Fidelity and quality: Three lesson observations per class will be conducted during the program period using a semi-structured observation checklist (Using the MASTER Framework). The 'semi-structured observation checklist' was designed specifically for this study and requires the teachers to record/comment on the delivery in terms of levels of support provided to students, perceived activity levels, witnessed enjoyment etc.
Timepoint [1] 324658 0
Term 4 i.e., December, 2020

Fidelity checks conducted during one session week 3, 5, 7
Primary outcome [2] 324988 0
(ii) Primary outcome 2: Dosage: We would like the teachers to complete a logbook detailing the number of sessions they delivered (and reflect on each session).
Timepoint [2] 324988 0

Term 4 i.e., December, 2020

Instructor to complete a register every session for the 8 weeks (16 sessions planned).
Primary outcome [3] 324989 0
(iii) Primary outcome 3: Responsiveness: We would like teachers to evaluate the EMU resources and EMU lessons. Similarly, we would like students to evaluate the EMU program using both qualitative and quantitative measures. Semi-structured interviews will be conducted with the research team and teachers in addition to the previously mentioned semi-structured checklist. The interview will provide opportunity for feedback in addition to identifying strengths and limitations witnessed in the delivery of EMU from a teachers perspective. The 'semi-structured observation checklist' was designed specifically for this study and requires the teachers to record/comment on the delivery in terms of levels of support provided to students, perceived activity levels, witnessed enjoyment etc.
Timepoint [3] 324989 0
Term 4 i.e., December, 2020

teacher evaluation conducted week 10 term 4 2020 - after program has been delivered
Secondary outcome [1] 385346 0
1. School-based PA: PA will be recorded using a three item PA survey item by Prochaska JJ, Sallis JF, Long B. A physical activity screening measure for use with adolescents in primary care. Archives of pediatrics & adolescent medicine. 2001;155(5):554-9.
Timepoint [1] 385346 0
Term 4, 2020
Week 1 = baseline assessment (before 8 week intervention)
Week 10= follow-up assessment (after 8 week intervention)
Secondary outcome [2] 386462 0
2. Cardiorespiratory fitness: 20m shuttle run test
Timepoint [2] 386462 0
Term 4, 2020
Week 1 = baseline assessment (before 8 week intervention)
Week 10= follow-up assessment (after 8 week intervention)
Secondary outcome [3] 386463 0
3. Well-being: The Stirling Children’s Well-being Scale
Timepoint [3] 386463 0
Term 4, 2020
Week 1 = baseline assessment (before 8 week intervention)
Week 10= follow-up assessment (after 8 week intervention)
Secondary outcome [4] 386464 0
4. Academic Achievement: Progress in Mathematics/English outcomes using stage appropriate progressive achievement tests (spelling, mathematics).
Timepoint [4] 386464 0
Term 4, 2020
Week 1 = baseline assessment (before 8 week intervention)
Week 10= follow-up assessment (after 8 week intervention)
Secondary outcome [5] 386465 0
5. Enjoyment of sport: Adapted Physical Activity Children’s Enjoyment Scale
Timepoint [5] 386465 0
Term 4, 2020
Week 1 = baseline assessment (before 8 week intervention)
Week 10= follow-up assessment (after 8 week intervention)
Secondary outcome [6] 386466 0
6. Psychological health: Self-Perception Profile for Children
Timepoint [6] 386466 0
Term 4, 2020
Week 1 = baseline assessment (before 8 week intervention)
Week 10= follow-up assessment (after 8 week intervention)
Secondary outcome [7] 386467 0
7. Concepts of well-being, enjoyment, psychological health, learning environment: Artwork assessment (Created by the Research team)

(combined outcome)
Timepoint [7] 386467 0
Term 4, 2020
Week 1 = baseline assessment (before 8 week intervention)
Week 10= follow-up assessment (after 8 week intervention)

Eligibility
Key inclusion criteria
Stage 2 and/or stage 3 teachers and their students (i.e., 4 teachers; 100 children) from two primary schools in the Hunter Region (Awabakal, Grinagai, Wonaruah, Worimi and Darkinung Country) with student cohorts of > 20% Aboriginal students, will be invited to participate in the program. All upper-primary school students aged 9-12 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
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
N/A

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Non-randomized trial.

A descriptive analysis was conducted to assess retention, recruitment, adherence and satisfaction among participants.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
12/10/2020
Date of last participant enrolment
Anticipated
Actual
13/11/2020
Date of last data collection
Anticipated
18/12/2020
Actual
18/12/2020
Sample size
Target
100
Accrual to date
Final
115
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 30906 0
2300 - Newcastle
Recruitment postcode(s) [2] 30907 0
2320 - Rutherford

Funding & Sponsors
Funding source category [1] 306386 0
Other Collaborative groups
Name [1] 306386 0
Hunter Medical Research Institute
Country [1] 306386 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Hunter Medical Research Institute
Address
Lot 1, Kookaburra Cct, New Lambton Heights NSW 2305
Country
Australia
Secondary sponsor category [1] 306889 0
None
Name [1] 306889 0
Address [1] 306889 0
Country [1] 306889 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306583 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 306583 0
Ethics committee country [1] 306583 0
Australia
Date submitted for ethics approval [1] 306583 0
26/06/2020
Approval date [1] 306583 0
28/07/2020
Ethics approval number [1] 306583 0
H-2020-0057

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

Contacts
Principal investigator
Name 104370 0
Dr Narelle Eather
Address 104370 0
Faculty of Education & Arts, HPE310, HPE building.
C/O The University of Newcastle, University Drive, Callaghan NSW 2308, Australia,
Country 104370 0
Australia
Phone 104370 0
+61 24921 2049
Fax 104370 0
N/A
Email 104370 0
[email protected]
Contact person for public queries
Name 104371 0
Narelle Eather
Address 104371 0
Faculty of Education & Arts, HPE310, HPE building.
C/O The University of Newcastle, University Drive, Callaghan NSW 2308, Australia,
Country 104371 0
Australia
Phone 104371 0
+61 24921 2049
Fax 104371 0
N/A
Email 104371 0
[email protected]
Contact person for scientific queries
Name 104372 0
Narelle Eather
Address 104372 0
Faculty of Education & Arts, HPE310, HPE building.
C/O The University of Newcastle, University Drive, Callaghan NSW 2308, Australia,
Country 104372 0
Australia
Phone 104372 0
+61 24921 2049
Fax 104372 0
N/A
Email 104372 0
[email protected]

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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo N/A

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3500Plain language summaryNo N/A
4802Study results articleYes Eather, N., Riley, N., Babic, M., Bennie, A., Mayn... [More Details]

Documents added automatically
No additional documents have been identified.