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Trial registered on ANZCTR


Registration number
ACTRN12617001383358
Ethics application status
Approved
Date submitted
15/09/2017
Date registered
28/09/2017
Date last updated
30/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility of embedding stage appropriate High Intensity Interval Training (HIIT) encompassing syllabus linked mathematics content within the
school week for students in Early Stage 1 to Stage 3 (6-12 years).
Scientific title
Making Maths a HIIT at School - Does High Intensity Interval Training (HIIT) combined with syllabus linked mathematics content (Stage 1 to Stage 3, ages 6-12 years) impact on children's: fitness levels, achievement and attitude towards maths, and on task behaviour?
Secondary ID [1] 292479 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Children's physical fitness 304103 0
On task behaviour (engagement) 304104 0
Condition category
Condition code
Public Health 303437 303437 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Making Maths a HIIT at School is an eight-week physically active mathematics intervention. This is a pilot study using a convenience sample suitable for testing the feasibility of the program for use in the whole school (across K-6). There will be a control school. This will be a whole of school approach with all eligible participants completing baseline assessments and follow-up measures conducted immediate post-intervention. The Intervention School will receive (3x 10 minutes per week) Mathematics sessions facilitated by UoN Researchers for the first 4 weeks (with teachers observing and researchers available pre and post each session to answer any questions/discuss content of the sessions) that incorporate HIIT and then 4 weeks with teachers running the sessions either in the school playground or in the school hall (weather dependent). The UoN researchers administering the intervention all have PhDs in Education and experience running programs involving children and physical activity. The program will focus on children’s individual mathematics skills. This will involve children being active whilst learning their multiplication tables, counting in patterns, adding numbers and subtracting numbers. Example physical activities include skipping, shuttle runs, frog jumps and some game based activities such as 'rob the nest'. The sessions will run at the start of the school day on a Monday, Wednesday and Thursday. Given this is a whole of school approach with significant teacher involvement, the activities will be adapted to suit the needs of the students. This could include the make-up of the groups for activities, such as the size of groups if rotating through activity 'stations', also age range will be a consideration, The mathematical content/language used will be, where possible, consistent with the the mathematical content/language being covered in-class in the respective year level.. Some basic sports equipment will be supplied to the school for use in the program, including such things as skipping ropes, numbered bean bags, agility ladders and cones.
Random fidelity checks will be performed by the research team to assess program adherence. Teachers will not be provided with the days that fidelity checks are to be performed but were aware that a member of the research team would be attending the sessions on at least 2 occasions during weeks 5-8.
Intervention code [1] 298984 0
Behaviour
Comparator / control treatment
The control school (matched based on demographic and size) during the intervention will not receive any treatment and will continue on with their regular classes taught by their class teacher(s).
Control group
Active

Outcomes
Primary outcome [1] 303211 0
Physical fitness
(age adapted Yo-Yo intermittent recovery run test; Standing jump test; basketball throw test).
Timepoint [1] 303211 0
Baseline (week before intervention started)
Post intervention (immediately after the 8 week intervention)
Secondary outcome [1] 338255 0
On task behaviour
(observed using a momentary time sampling procedure. Students will be chosen at random and will be observed in 15 second intervals over a 30 minute period)
Timepoint [1] 338255 0
Baseline (week before intervention)
Mid Program (week 4)
Post intervention (immediately after the 8 week intervention)
Secondary outcome [2] 338256 0
Student mathematics self-efficacy
(modified (stage appropriate) version of the Programme for International Assessment (PISA) scales)
Timepoint [2] 338256 0
Baseline (week before intervention)
Post intervention (immediately after the 8 week intervention)
Secondary outcome [3] 338832 0
Basic mathematics facts assessment: measured using the Individual Basic Facts Assessment Tool (IBFA).
Timepoint [3] 338832 0
Baseline (week before intervention)
Post intervention (immediately after the 8 week intervention)
Secondary outcome [4] 338956 0
Student mathematics self-concept
(Programme for International Assessment (PISA) scales)
Timepoint [4] 338956 0
Baseline (week before intervention)
Post intervention (immediately after the 8 week intervention)
Secondary outcome [5] 338957 0
Student mathematics anxiety
(modified (stage appropriate) version of the Programme for International Assessment (PISA) scales)
Timepoint [5] 338957 0
Baseline (week before intervention)
Post intervention (immediately after the 8 week intervention)
Secondary outcome [6] 338967 0
Student mathematics interest
(Programme for International Assessment (PISA) scales)
Timepoint [6] 338967 0
Baseline (week before intervention)
Post intervention (immediately after the 8 week intervention)

Eligibility
Key inclusion criteria
Whole of school approach
Be attending the primary school (K-6)
Minimum age
5 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
All students in the class(s) will participate in the program, however, only the students who provide signed consent letters will contribute to the study data.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
quasi-experimental (Non-Equivalent Groups Design)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analyses of quantitative data will be completed using IBM SPSS software and alpha levels will be set at p < 0.05. All variables will be checked for normality. Independent samples t-tests will be used to compare differences between groups at baseline. Linear mixed models will be fitted to compare intervention and the control group for continuous variables. Group (intervention or control), time (baseline and 8 weeks) and group-by-time interaction will be assessed as fixed effects within the model. Potential gender effects will be explored using a group-by-time-by-gender interaction term in the mixed model. Differences of means and 95% confidence intervals (CIs) will be determined using the linear mixed models. Analyses will include all participants. Cohen (1988)'s d will be used to determine effect sizes (d = (M1 – M2) / pooled standard deviation), and chi-squared tests for categorical variables.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
19/07/2017
Date of last participant enrolment
Anticipated
Actual
21/07/2017
Date of last data collection
Anticipated
22/09/2017
Actual
22/09/2017
Sample size
Target
87
Accrual to date
Final
84
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 297532 0
Government body
Name [1] 297532 0
Catholic Schools Office
Country [1] 297532 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive, Callaghan, NSW, 2308
Country
Australia
Secondary sponsor category [1] 296538 0
None
Name [1] 296538 0
Address [1] 296538 0
Country [1] 296538 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298229 0
Newcastle University Human Ethics Committee
Ethics committee address [1] 298229 0
Ethics committee country [1] 298229 0
Australia
Date submitted for ethics approval [1] 298229 0
09/03/2017
Approval date [1] 298229 0
26/06/2017
Ethics approval number [1] 298229 0
H-2017-0072

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

Contacts
Principal investigator
Name 76410 0
Dr Adam Lloyd
Address 76410 0
The University of Newcastle
University Drive, Callaghan, NSW 2308
Country 76410 0
Australia
Phone 76410 0
+61249854253
Fax 76410 0
Email 76410 0
adam.lloyd@newcastle.edu.au
Contact person for public queries
Name 76411 0
Adam Lloyd
Address 76411 0
The University of Newcastle
University Drive, Callaghan, NSW 2308
Country 76411 0
Australia
Phone 76411 0
+61249854253
Fax 76411 0
Email 76411 0
adam.lloyd@newcastle.edu.au
Contact person for scientific queries
Name 76412 0
Adam Lloyd
Address 76412 0
The University of Newcastle
University Drive, Callaghan, NSW 2308
Country 76412 0
Australia
Phone 76412 0
+61249854253
Fax 76412 0
Email 76412 0
adam.lloyd@newcastle.edu.au

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.