Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000127808
Ethics application status
Approved
Date submitted
20/01/2012
Date registered
25/01/2012
Date last updated
30/01/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Preparing culturally competent physical education teachers: Can they increase the physical activity levels of Indigenous students participating in a Sporting Chance Program.
Scientific title
Preparing culturally competent physical education teachers: Can they increase the physical activity levels of Indigenous students participating in a Sporting Chance Program.
Secondary ID [1] 279769 0
NA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Academic deficits in extremely preterm children 285640 0
Condition category
Condition code
Reproductive Health and Childbirth 285827 285827 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Indigenous students from three secondary schools who participate in the Sporting Chance Program will be invited (n=80-90). Once per week, for a period 90-120 minutes, consenting participants will participate in a pre-service teacher-led 6-week intervention that will aim to increase their physical activity levels in those sessions, whilst meeting program outcomes. These sessions will be underpinned by the Social Cognitive Theory, and will include student choice of activities, goal setting, time to practice new sport/physical activity skills, pre-service teacher instruction, modelling, and feedback and social peer support/reinforcement.
Intervention code [1] 284091 0
Prevention
Comparator / control treatment
Indigenous students who did not consent to the intervention (but did consent to being assessed) will be considered the control.
Control group
Active

Outcomes
Primary outcome [1] 286338 0
The primary outcome of this trial is academic performance 2 years post intervention.
Academic outcome will be assessed using the Wide Range Achievement Test -4th edition (WRAT-4). The WRAT-4 includes subtests that assess reading (single word decoding), sentence comprehension, spelling and math computation. Additional information regarding literacy and numeracy, academic performance, grade repetition and integration assistance will be sought from parents and teachers.
Timepoint [1] 286338 0
2 years post intervention commencement
Secondary outcome [1] 295632 0
Working memory will be assessed subtests from the Working Memory Test Battery for Children (WMTB-C):
- Verbal short-term memory will be assessed with Digit Recall and Word List Recall which requires the child to immediately recall verbal information.
- Visual-spatial short-term memory will be assessed with Block Recall and Mazes Memory which involves the child to immediately recall visual-spatial information. A subtest from the Automated Working Memory Assessment (AWMA) known as Mister X will also be used to assess visuo-spatial working memory.
- Verbal working memory will be assessed with Backward Digit Recall which involves the child to recall sequences of digits in the reverse order to that presented.
- Visual-spatial working memory will be assessed with Backward Block Recall which involves the child to recall sequences of tapped blocks in the reverse order to that presented.
Timepoint [1] 295632 0
2 weeks, 12 months and 24 months post-intervention commencement

Eligibility
Key inclusion criteria
Indigenous students attending three of the eligible secondary schools who are currently participating in the Sporting Chance Program.
Minimum age
11 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not currently participating in the Sporting Chance Program at the three eligible secondary schools.

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)
Those participants who are invited and consent to participate in the program and assessments will be placed in the intervention group. Those who do not consent to participate in the program, but do consent to be involved in the assessments, will be placed in an active control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
They will not be randomised.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284555 0
Government body
Name [1] 284555 0
National Health and Medical Research Council
Country [1] 284555 0
Australia
Primary sponsor type
Individual
Name
Dr Louisa Peralta
Address
Rm 448, Building A35
Parramatta Rd
Faculty of Education and Social Work
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 283476 0
None
Name [1] 283476 0
Address [1] 283476 0
Country [1] 283476 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286535 0
Royal Children's Hospital (RCH) Human Research Ethics Committee (HREC)
Ethics committee address [1] 286535 0
Ethics committee country [1] 286535 0
Australia
Date submitted for ethics approval [1] 286535 0
06/02/2012
Approval date [1] 286535 0
14/09/2011
Ethics approval number [1] 286535 0

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

Contacts
Principal investigator
Name 33662 0
Address 33662 0
Country 33662 0
Phone 33662 0
Fax 33662 0
Email 33662 0
Contact person for public queries
Name 16909 0
Dr Louisa Peralta
Address 16909 0
Rm 448, Building A35
Faculty of Education and Social Work
The University of Sydney
NSW 2006
Country 16909 0
Australia
Phone 16909 0
+ 61 2 9036 5399
Fax 16909 0
Email 16909 0
[email protected]
Contact person for scientific queries
Name 7837 0
Dr Louisa Peralta
Address 7837 0
Rm 448, Building A35
Faculty of Education and Social Work
The University of Sydney
NSW 2006
Country 7837 0
Australia
Phone 7837 0
+61 2 9036 5399
Fax 7837 0
Email 7837 0
[email protected]

No information has been provided regarding IPD availability


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.