Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000766112
Ethics application status
Approved
Date submitted
13/05/2019
Date registered
22/05/2019
Date last updated
13/10/2021
Date data sharing statement initially provided
22/05/2019
Date results provided
13/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Kick-Smart: Promoting academic achievement, fitness and well-being in primary school-aged children
Scientific title
An Investigation into the Teaching & Learning of Martial Arts on children's academic performance, physical fitness, and social and emotional well-being
Secondary ID [1] 298135 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health 312671 0
Physical Inactivity 312672 0
Condition category
Condition code
Mental Health 311171 311171 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 311417 311417 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All children in a selected Stage 3 (Years 5 and 6) class will participate in the program, while children in another Stage 3 class will act as a control group, however, only children from whom a parental consent form has been provided will be involved in the data collection aspects of this research. The program will combine a curriculum-based program with the integration of physical activity and martial arts at school delivered in PE and School Sport time. The control class will continue with their usual PE and Sport lessons. The program will run for six weeks starting week 2 of term 3, 2019. This research will be conducted as a feasibility trial. Data to test the potential effectiveness of the intervention will be collected from students in both intervention and control classes during Term 3, 2019. The control class will receive a condensed delivery of the intervention in weeks 8-10. Classes will be randomised after baseline data collection. Both classes class have equal chance of being selected for either group.
During the program, students (in the test class) will engage in two, 1-hour sessions each week, which will include activities and techniques from a range of martial arts including Karate, Boxing, Taekwon-Do and Pankration/MMA. This will include learning basic punches and kicks and practicing them on pads, as well as basic self-defence techniques. The students will not be striking each other at any point, however in some classes, controlled physical contact will be necessary. For example:
• Students will learn how to escape simple grabs such as a wrist grab. This will require students to practice this with a partner by holding their partner’s wrist and the other to apply the escape technique.
The martial arts program will also include discussions and activities that aim to develop a better understanding of various character/ethic topics such as courage, self-control and teamwork.
Additionally, the content from this project meets many Stage 3 requirements for the NSW Mathematics and the NSW PDHPE syllabi. Mr Burt, and members of the research team, qualified to administer the assessment, will be involved in the delivery of all assessments and the observations of pupils. Follow up data will be collected in week 8 of Term 3. Class teacher for the control class will continue with regular class duties and activities. The class teacher for the test class will be required to be present to supervise their class during each Kick-Smart session and manage any behaviour issues during this time.
The intervention will be administered by Mr Louis Burt, who is the University PhD research Student. Mr Burt is a qualified primary school teacher, as well as an accredited martial arts instructor with 19 years martial arts experience.
Teachers’ consent should be received in order to be able to deliver the program in their classes and collect data.
Children will complete a range of assessments at baseline (Week 1, Term 3) and follow up (Week 8, Term 3).
Intervention code [1] 314511 0
Behaviour
Comparator / control treatment
The control class will continue with regular PE lessons and school sport activities.
‘Regular PE lessons’ refers to the individual school’s programmed unit of work that follows the NSW PDHPE Syllabus ( https://educationstandards.nsw.edu.au/wps/portal/nesa/k-10/learning-areas/pdhpe/pdhpe-k-10-2018 ).
Control group
Active

Outcomes
Primary outcome [1] 319940 0
Children’s social and emotional well-being as a composite outcome, assessed using the Stirling Children's Well-being Scale (SCWBS).
Timepoint [1] 319940 0
All Baseline Data collected the week prior to the commencement of the trial. All post-treatment date collected the week following the completion of the 6 week program.
The tool used to assess this outcome will be the Stirling Children's Well-being Scale (SCWBS)
Primary outcome [2] 320097 0
Children’s on-task behaviour within lessons. A momentary time sampling template will be used to assess on task behaviour.
Timepoint [2] 320097 0
A momentary time sampling template will be used to assess on task behaviour during a mathematics lesson, which the class teacher will be teaching, in Week 1 of Term 3, which is the week prior to the beginning of the intervention. This process will be completed again in Week 9 of Term 3, which is the week after the completion of the intervention.
Secondary outcome [1] 369949 0
Cognition: Student’s cognition will be assessed using the following two measures.
The NIH Toolbox Flanker Inhibitory Control and Attention Test measures both attention and inhibitory control using an IPad. Students are required to focus on a specific stimulus whilst inhibiting attention to the stimuli flanking it. To achieve this, students are presented with a row of arrows pointing different directions. Students are then required to choose one of two buttons on the screen that corresponds to the direction in which the middle arrow is pointing. Students are presented with four practices questions prior to beginning the examination.
The NIH Toolbox Dimensional Change Sort Test measures attention and cognitive flexibility. Students are presented with two dimensions (either shape or colour) and are required to answer a series of bivalent test pictures according to one of the two dimensions (the dimensions are interchangeable). Students are given thee practice trials which are directly followed by the examination
Timepoint [1] 369949 0
All Baseline Data collected the week prior to the commencement of the trial. All post-treatment date collected the week following the completion of the 6 week program.
Secondary outcome [2] 369950 0
Academic performance: Children’s academic performance in Mathematics will be measured using the One Minute Basic Fact test.
Timepoint [2] 369950 0
All Baseline Data collected the week prior to the commencement of the trial. All post-treatment date collected the week following the completion of the 6 week program.
Secondary outcome [3] 369951 0
Physical activity across the whole week: Students will wear the accelerometers across the whole week (Monday to Friday). Raw data from the accelerometer will be screened and analysed using Meter plus software which allows for time specific analysis to accurately analyse lesson- and school-time physical activity and sedentary behaviour.
Timepoint [3] 369951 0
All Baseline Data collected the week prior to the commencement of the trial. All post-treatment date collected the week following the completion of the 6 week program.

Eligibility
Key inclusion criteria
All NSW Primary Schools are eligible to participate in the program. All Stage 3 classes within these schools are eligible to participate.
Minimum age
10 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Must not be outside the minimum and maximum age brackets.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on a previous feasibility trials (EASY MINDS and Fit4fun) conducted by the CI's (Dr Riley, Dr Eather) this number is manageable and sufficient to test the feasibility of the project in Phase 1 of the Intervention (one small feasibility trial of 40 children)

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2019
Actual
1/07/2019
Date of last participant enrolment
Anticipated
22/07/2019
Actual
12/09/2019
Date of last data collection
Anticipated
13/09/2019
Actual
30/09/2020
Sample size
Target
40
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 35531 0
2287 - Fletcher

Funding & Sponsors
Funding source category [1] 302663 0
University
Name [1] 302663 0
University of Newcastle
Country [1] 302663 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Dr, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 302755 0
None
Name [1] 302755 0
Address [1] 302755 0
Country [1] 302755 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303286 0
University of Newcastle - Human Research Ethics Committee
Ethics committee address [1] 303286 0
Ethics committee country [1] 303286 0
Australia
Date submitted for ethics approval [1] 303286 0
02/04/2019
Approval date [1] 303286 0
06/06/2019
Ethics approval number [1] 303286 0
H-2019-0057

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

Contacts
Principal investigator
Name 93134 0
Dr Narelle Eather
Address 93134 0
University of Newcastle
University Drive, Callaghan NSW, 2308
Country 93134 0
Australia
Phone 93134 0
+61 2 4921 6232
Fax 93134 0
Email 93134 0
[email protected]
Contact person for public queries
Name 93135 0
Narelle Eather
Address 93135 0
University of Newcastle
University Drive, Callaghan NSW, 2308
Country 93135 0
Australia
Phone 93135 0
+61 2 4921 6232
Fax 93135 0
Email 93135 0
[email protected]
Contact person for scientific queries
Name 93136 0
Narelle Eather
Address 93136 0
University of Newcastle
University Drive, Callaghan NSW, 2308
Country 93136 0
Australia
Phone 93136 0
+61 2 4921 6232
Fax 93136 0
Email 93136 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1988Study protocol    377519-(Uploaded-03-05-2019-14-13-32)-Study-related document.docx
1989Informed consent form    377519-(Uploaded-03-05-2019-14-13-54)-Study-related document.docx



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.