Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000838819
Ethics application status
Approved
Date submitted
13/05/2021
Date registered
30/06/2021
Date last updated
30/06/2021
Date data sharing statement initially provided
30/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of physical activity breaks in secondary school mathematics lessons
Scientific title
Investigating the impact of cognitively demanding physical activity breaks on time spent on task in secondary school mathematics lessons
Secondary ID [1] 304216 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Muscular fitness 321914 0
Cognition 321915 0
Condition category
Condition code
Public Health 319640 319640 0 0
Health promotion/education
Neurological 319932 319932 0 0
Studies of the normal brain and nervous system
Musculoskeletal 319933 319933 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Cognitively demanding resistance training breaks.
Why: Delivering resistance training breaks while also performing a cognitive task is aiming to determine if students who participate in this type of intervention see benefits to on-task behaviour in the mathematics classroom as an acute response.
What: The intervention is delivered via video and requires students to answer a mathematics question, responding with the correct answer by performing the linked resistance training exercise. Examples of body weight exercises included in the intervention are: table push ups, squats to a chair, tricep dips on a chair. An example of a video that will be used in the intervention can be found here - https://vimeo.com/manage/videos/540482591
Who provided: The video was produced by working with experts from the fitness industry, specifically strength trainers with expertise in delivering resistance training activities to adolescents. At the point of delivery, it will be classroom mathematics teachers who play the video to the class and supervise the safety of their students. A 3 hour training session is delivered to all teachers involved in the study where key elements of safety, motivation and technique are explained. The procedure for delivery is for students to enter the classroom and place their bag safely out of the way (this is clearly indicated on a safety video at the beginning of the study). The teacher will then ask the class if any students are unwell or suffering from an injury. At this point, the teacher makes a decision based on outlined scenarios discussed in training to either modify the student's workload or exempt them from that session. The video is then played and students participate in the workout. The Tabata style has students exercise for 20 seconds and resting for 10 seconds repeated 8 times. The total video time is 6 minutes. At the completion of the video, students return to their seat and begin class work.
How: The intervention is provided to the class of Year 10 students as a group at the beginning of each mathematics lesson for 6 weeks (A total of 36 sessions). The video links are to be provided on the following webpage. Currently in progress - https://www.canva.com/design/DAEZReid3e0/CRCrCAgbig6L9g1poK6Udg/view
Where: The intervention will occur in a standard Highschool mathematics classroom. No movement to furniture is required and students perform all exercises using only the desk and chair.
When and how much: Each video lasts for 6 minutes with a total workout time of 4 minutes. The video is delivered at the beginning of each mathematics lesson (3 times per week) for a total of 6 weeks.
Tailoring: Tailoring can occur for students who are injured. Eg a student with a broken arm can modify exercises to complete another exercise that does not utilise the use of their arm e.g. lunges. All modifications are discussed in the teacher training session.
Modifications: No modifications are intended.
How well - planned: Planned fidelity checks are to occur weekly by myself - the lead investigator. A structured set of questions outline a fidelity check ensuring continuity to the delivery of the videos across schools.
Intervention code [1] 320553 0
Behaviour
Intervention code [2] 320554 0
Lifestyle
Comparator / control treatment
The comparator/control arm for this study will be used. Students in the same level mathematics class will continue with their normal classroom practice (no treatment given) as a control measure. They will enter the classroom, have the roll marked and proceed with normal learning activities. The only formal requirements for this group is that they
a) Do not perform any physical activity in the first 6 minutes of the lesson
b) do not complete any non calculator skill work in the first 6 minutes.
Control group
Active

Outcomes
Primary outcome [1] 327506 0
Time spent on-task during mathematics lessons will be observed using momentary time sampling, reported as a percentage of time.

This observational tool has been adapted from the “Behaviour Observation of students in schools and the Applied Behaviour Analysis for Teachers”. All students will be observed in 15-sec intervals on a rotational basis over a 30-min period in the allocated mathematics time slot. Two observations per school at each time point will be included.
Timepoint [1] 327506 0
Assessments at baseline and baseline+6 weeks
Secondary outcome [1] 395436 0
Muscular fitness - Upper body

To assess this outcome the 90-degree push-up test on metronome till fatigue will be used.
Timepoint [1] 395436 0
Assessments at baseline and baseline+6 weeks
Secondary outcome [2] 395437 0
Academic achievement

Progress in Mathematics outcomes for each child will be assessed by the class teacher before and after the program using the “ACER Progressive Mathematics achievement test” which will be provided by the research team.
Timepoint [2] 395437 0
Assessments at baseline and baseline+6 weeks
Secondary outcome [3] 395438 0
Student perception of the experience.

A randomly selected group of 6 students will participate in focus groups offering their feedback from a participant’s viewpoint. The session will last 30 minutes and will be recorded. The questions used have been designed specifically for this study and will provide qualitative data to determine feasibility, specifically:
Acceptability - The extent to which the program is considered suitable, satisfying, or attractive to program participants.
Practicality - The extent to which the program can be delivered using existing resources.
Timepoint [3] 395438 0
Assessments at baseline+6 weeks
Secondary outcome [4] 395439 0
Teacher perception of the experience.

At the completion of the study, teachers will participate in a short interview, seeking their perception of the experience of delivering the study. The interview will last 30 minutes, be recorded, and is delivered one on one. The questions used have been designed specifically for this study and will provide qualitative data to determine feasibility, specifically:
Acceptability - The extent to which the program is considered suitable, satisfying, or attractive to program participants.
Practicality - The extent to which the program can be delivered using existing resources.
Timepoint [4] 395439 0
Occurring at a suitable time within 2 weeks of the completion of the study.
Secondary outcome [5] 396643 0
Student engagement

Questionnaires specifically designed for the study will be used to assess students’ perceptions of novelty, motivation and attitudes towards mathematics.

The following scale response is provided to students
Strongly disagree Disagree Neutral Agree Strongly Agree
To answer the following questions:
1. The videos at the start of the Mathematics lessons are enjoyable.
2. I like the videos as a way of beginning my Mathematics lesson.
3. The non calculator numeracy tasks were challenging and promoted learning
4. I find it easier to concentrate after completing a 6 minute videos.
5. I look forward to participating in the Strength in Numbers videos.
6. Strength in Numbers videos have improved my learning in Mathematics.
7. I have enjoyed this change to my normal Mathematics lesson.
Timepoint [5] 396643 0
Baseline +6weeks
Secondary outcome [6] 396644 0
Muscular fitness - Core strength

plank hold test till fatigue.
Timepoint [6] 396644 0
Assessments at baseline and baseline+6 weeks
Secondary outcome [7] 396645 0
Muscular fitness - lower leg

30-second squat test for maximum repetitions
Timepoint [7] 396645 0
Assessments at baseline and baseline+6 weeks

Eligibility
Key inclusion criteria
Students participating in the study must be in year 10 at an NSW high school.
Minimum age
14 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Any acute or chronic condition that would limit the ability of the patient to participate in the study
• Parents have refused to give consent

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)
Sealed envelopes
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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Our sample size calculations were estimated using data from previous studies that examined the effect of activity breaks on students’ on-task behaviour in schools (Myrto F Mavilidi et al., 2020; M.F. Mavilidi et al., 2021). To ensure 80% power to detect a 30% improvement in the primary outcome (i.e., percentage of lesson spent on-task), we require 34 participants for a non-clustered trial (two-tailed, p <.05). However, consistent with CONSORT guidelines, we adjusted our power calculations for the clustering of effects at the class level (Campbell, Elbourne, & Altman, 2004) using the following correction factor [1 + (m-1) x ICC]. Where m = students per class and ICC = the intra-class correlation coefficient for the primary outcome. Assuming a class size of 18 participating students per class, and an ICC of 0.4, the correction factor is 7.8 [i.e., 1 + (18-1) x 0.4]. Therefore, our required sample is 265 students (i.e., 7.8 x 34) consisting of 16 classes (i.e., 8 classes in the intervention and 8 classes in control groups). Our power calculation does not include school level clustering, which is typically negligible after adjustment for class level clustering (Lonsdale et al., 2013; M.F. Mavilidi et al., 2021).

Statistical analyses will be conducted using linear mixed models in IBM SPSS (version 24). The model will include time, group and the group-by-time interaction as fixed effects. To account for the clustered nature of the data (i.e. students located in classes and schools), the mixed models included random intercepts for class and school. Cohen’s d will be calculated to provide a measure of effect size.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
28/06/2021
Date of last participant enrolment
Anticipated
2/07/2021
Actual
Date of last data collection
Anticipated
27/08/2021
Actual
Sample size
Target
265
Accrual to date
130
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 34026 0
2320 - Maitland
Recruitment postcode(s) [2] 34028 0
2284 - Booragul
Recruitment postcode(s) [3] 34029 0
2289 - Kotara
Recruitment postcode(s) [4] 34030 0
2321 - Lochinvar
Recruitment postcode(s) [5] 34031 0
2290 - Gateshead

Funding & Sponsors
Funding source category [1] 308592 0
Charities/Societies/Foundations
Name [1] 308592 0
Hunter Medical Research Institute
Country [1] 308592 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Dr, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 309450 0
University
Name [1] 309450 0
University of Newcastle, Priority research centre for physical activity and nutrition
Address [1] 309450 0
ATC Building, University Dr, Callaghan NSW 2308
Country [1] 309450 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308527 0
HUMAN RESEARCH ETHICS COMMITTEE - University of Newcastle
Ethics committee address [1] 308527 0
Ethics committee country [1] 308527 0
Australia
Date submitted for ethics approval [1] 308527 0
24/11/2019
Approval date [1] 308527 0
06/05/2020
Ethics approval number [1] 308527 0
H-2019-0415

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

Contacts
Principal investigator
Name 111018 0
Mrs Katie Robinson
Address 111018 0
HPE Building
University of Newcastle
Callaghan Dr, Callaghan NSw 2308
Country 111018 0
Australia
Phone 111018 0
+61412578572
Fax 111018 0
Email 111018 0
[email protected]
Contact person for public queries
Name 111019 0
Katie Robinson
Address 111019 0
HPE Building
University of Newcastle
Callaghan Dr, Callaghan NSw 2308
Country 111019 0
Australia
Phone 111019 0
+61412578572
Fax 111019 0
Email 111019 0
[email protected]
Contact person for scientific queries
Name 111020 0
Katie Robinson
Address 111020 0
HPE Building
University of Newcastle
Callaghan Dr, Callaghan NSw 2308
Country 111020 0
Australia
Phone 111020 0
+61412578572
Fax 111020 0
Email 111020 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
Participants are under the age of 18 and although all information is de-identified, ethical approval was received on the basis that no raw data would be made public. Sufficient data analysis will be provided in future publications.


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.