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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.
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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.
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Secondary ID [1]
301962
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'Nil known'
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Universal Trial Number (UTN)
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Trial acronym
EMU (Education, Movement and Understanding).
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Physical fitness - i.e., Cardio respiratory fitness
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Mental health
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Condition category
Condition code
Cardiovascular
316523
316523
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0
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Normal development and function of the cardiovascular system
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Mental Health
316524
316524
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0
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Studies of normal psychology, cognitive function and behaviour
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Public Health
316885
316885
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0
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Health promotion/education
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
318253
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Behaviour
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Comparator / control treatment
No control group i.e., an initial feasibility trial
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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(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.
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Assessment method [1]
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Timepoint [1]
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Term 4 i.e., December, 2020
Fidelity checks conducted during one session week 3, 5, 7
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Primary outcome [2]
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(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).
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Assessment method [2]
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Timepoint [2]
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Term 4 i.e., December, 2020
Instructor to complete a register every session for the 8 weeks (16 sessions planned).
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Primary outcome [3]
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(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.
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Assessment method [3]
324989
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Timepoint [3]
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Term 4 i.e., December, 2020
teacher evaluation conducted week 10 term 4 2020 - after program has been delivered
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Secondary outcome [1]
385346
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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.
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Assessment method [1]
385346
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Timepoint [1]
385346
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Term 4, 2020
Week 1 = baseline assessment (before 8 week intervention)
Week 10= follow-up assessment (after 8 week intervention)
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Secondary outcome [2]
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2. Cardiorespiratory fitness: 20m shuttle run test
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Assessment method [2]
386462
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Timepoint [2]
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Term 4, 2020
Week 1 = baseline assessment (before 8 week intervention)
Week 10= follow-up assessment (after 8 week intervention)
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Secondary outcome [3]
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3. Well-being: The Stirling Children’s Well-being Scale
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Assessment method [3]
386463
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Timepoint [3]
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Term 4, 2020
Week 1 = baseline assessment (before 8 week intervention)
Week 10= follow-up assessment (after 8 week intervention)
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Secondary outcome [4]
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4. Academic Achievement: Progress in Mathematics/English outcomes using stage appropriate progressive achievement tests (spelling, mathematics).
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Assessment method [4]
386464
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Timepoint [4]
386464
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Term 4, 2020
Week 1 = baseline assessment (before 8 week intervention)
Week 10= follow-up assessment (after 8 week intervention)
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Secondary outcome [5]
386465
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5. Enjoyment of sport: Adapted Physical Activity Children’s Enjoyment Scale
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Assessment method [5]
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Timepoint [5]
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Term 4, 2020
Week 1 = baseline assessment (before 8 week intervention)
Week 10= follow-up assessment (after 8 week intervention)
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Secondary outcome [6]
386466
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6. Psychological health: Self-Perception Profile for Children
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Assessment method [6]
386466
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Timepoint [6]
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Term 4, 2020
Week 1 = baseline assessment (before 8 week intervention)
Week 10= follow-up assessment (after 8 week intervention)
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Secondary outcome [7]
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7. Concepts of well-being, enjoyment, psychological health, learning environment: Artwork assessment (Created by the Research team)
(combined outcome)
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Assessment method [7]
386467
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Timepoint [7]
386467
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Term 4, 2020
Week 1 = baseline assessment (before 8 week intervention)
Week 10= follow-up assessment (after 8 week intervention)
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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.
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Minimum age
9
Years
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Maximum age
12
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
N/A
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
N/A
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
Non-randomized trial.
A descriptive analysis was conducted to assess retention, recruitment, adherence and satisfaction among participants.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
12/10/2020
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Date of last participant enrolment
Anticipated
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Actual
13/11/2020
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Date of last data collection
Anticipated
18/12/2020
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Actual
18/12/2020
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Sample size
Target
100
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Accrual to date
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Final
115
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment postcode(s) [1]
30906
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2300 - Newcastle
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Recruitment postcode(s) [2]
30907
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2320 - Rutherford
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Funding & Sponsors
Funding source category [1]
306386
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Other Collaborative groups
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Name [1]
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Hunter Medical Research Institute
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Address [1]
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Lot 1, Kookaburra Cct, New Lambton Heights NSW 2305
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Country [1]
306386
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Australia
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Primary sponsor type
Other Collaborative groups
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Name
Hunter Medical Research Institute
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Address
Lot 1, Kookaburra Cct, New Lambton Heights NSW 2305
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Country
Australia
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Secondary sponsor category [1]
306889
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None
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Name [1]
306889
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Address [1]
306889
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Country [1]
306889
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
306583
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The University of Newcastle Human Research Ethics Committee
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Ethics committee address [1]
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The University of Newcastle Human Research Ethics Committee. The University of Newcastle, University Drive, Callaghan NSW 2308, Australia,
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Ethics committee country [1]
306583
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Australia
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Date submitted for ethics approval [1]
306583
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26/06/2020
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Approval date [1]
306583
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28/07/2020
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Ethics approval number [1]
306583
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H-2020-0057
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Summary
Brief summary
The EMU (meaning “be happy”) 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.
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Trial website
No trial website is available
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Trial related presentations / publications
N/A
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Public notes
N/A
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Contacts
Principal investigator
Name
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Dr Narelle Eather
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Address
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Faculty of Education & Arts, HPE310, HPE building.
C/O The University of Newcastle, University Drive, Callaghan NSW 2308, Australia,
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Country
104370
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Australia
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Phone
104370
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+61 24921 2049
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Fax
104370
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N/A
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Email
104370
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[email protected]
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Contact person for public queries
Name
104371
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Narelle Eather
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Address
104371
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Faculty of Education & Arts, HPE310, HPE building.
C/O The University of Newcastle, University Drive, Callaghan NSW 2308, Australia,
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Country
104371
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Australia
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Phone
104371
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+61 24921 2049
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Fax
104371
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N/A
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Email
104371
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[email protected]
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Contact person for scientific queries
Name
104372
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Narelle Eather
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Address
104372
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Faculty of Education & Arts, HPE310, HPE building.
C/O The University of Newcastle, University Drive, Callaghan NSW 2308, Australia,
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Country
104372
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Australia
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Phone
104372
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+61 24921 2049
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Fax
104372
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N/A
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Email
104372
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Current Study Results
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Plain language summary
No
N/A
Update to Study Results
Doc. No.
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
3500
Plain language summary
No
N/A
4802
Study results article
Yes
Eather, N., Riley, N., Babic, M., Bennie, A., Mayn...
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No additional documents have been identified.
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