Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000356864
Ethics application status
Approved
Date submitted
26/01/2021
Date registered
30/03/2021
Date last updated
7/04/2024
Date data sharing statement initially provided
30/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Pau te Hau - Training Teachers to Deliver High Intensity Interval Training (HIIT) to School Students
Scientific title
The effect of high intensity interval training on school students' cardiorespiratory fitness
Secondary ID [1] 303166 0
None
Universal Trial Number (UTN)
U1111-1259-8382
Trial acronym
Linked study record
This follows from feasibility issues addressed in ACTRN12617000910303

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 320286 0
Mental Wellbeing 320438 0
Condition category
Condition code
Public Health 318257 318257 0 0
Other public health
Mental Health 318707 318707 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This research is defined in two phases: Phase 1 is a cluster-randomised controlled trial. Phase 2 is the Implementation phase. Phase 1 involves working with school teachers (students age 8-13) to train them to deliver an exercise programme (high intensity interval training) intervention in their class as part of their physical education curriculum delivery. We then conduct a cluster-randomised controlled trial over one school term (9 weeks) to determine the effect of the intervention on a range of outcomes on the student participants in comparison to usual practice physical education. We will also seek feedback from the teachers and participating school students on their perceptions of the exercise. The control group classes from different schools would simply continue with their standard physical education curriculum delivery.
The training module consists of sessions regarding the research on HIIT, how to use the app and heart rate monitors provided, how to incorporate curriculum components, and explanation of the Maori components. The module is comprised of a series of workshop activities including interactive learning, and lectures. All the training occurs on one day.

In Phase 2, we will then follow-up with a further one year of schools implementing the exercise as they see fit (or not), and subsequently conduct an evaluation of that implementation phase in terms of the extent and nature of the teachers’ use of the exercise in their classes. We won’t collect any data from the student participants in the implementation phase, only the teachers. There are no new specific exercises prescribed in this phase.

The cluster-randomised controlled trial will be conducted within 14-16 intermediate and primary level schools. Total number of participants is therefore expected to be 850 school students.
The schools will be randomly allocated to either high intensity interval training (HIIT) intervention, or control who will continue with usual practice Physical Education (PE) class delivery. Assessments will be conducted at baseline and post intervention period (9 weeks).

WHO
The professional development session will be delivered by the research team (all full-time academic staff members, PhD’s) to the teachers of the intervention class. The HIIT sessions will be delivered by the teachers to the participant students in class.
INTERVENTION MODE
The HIIT sessions delivered by the teachers will be structured to fit within 10-15 minutes, twice per week, and involve a variety of work to rest ratios based on existing HIIT protocols. Participants will wear heart rate monitors and have their de-identified heart rate displayed on screen for them to target at least 90% of predicted heart rate maximum as a guideline intensity towards the end of each work phase. The sessions will be deliverable in a variety of settings such that specialist space is not required, and with no requisite equipment. Our matauranga Maori approach to HIIT sessions will be designed around cultural narratives and histories, such as the discovery of Aotearoa by Kupe, or the ascension of Tane through the 12 heavens to provide cultural context. These narratives facilitate cultural relevance and provide innovative opportunities to utilise Maori knowledge in a contemporary education setting and integrate cultural aspects of the curriculum into exercise sessions. The format of sessions will require a setting specific approach, and some variation in delivery is inevitable given different teacher delivery. Brief reflective questions at the end of each HIIT session will prompt critical thinking around the participant’s own relationship with vigorous physical activity and how that evolves over the course of the intervention period.
NUMBER OF TIMES FOR INTERVENTION DELIVERY
Over one school terms (9 weeks), ~18 sessions in total will be delivered in class by the teachers. The adherence to this frequency, and the target intensity is via a report that is uploaded to the researchers via the heart rate monitoring app provided.
LOCATION
All HIIT sessions will be delivered in school (Year 5-8 level) during usual PE class times. The professional development session will be delivered to the teachers involved with the intervention class at the University facility of the research team.
ADHERENCE
Will be assessed via recording of class attendance, and heart rates achieved by participants. No strategy will be employed to enhance adherence as it is reliant on usual attendance to class.
The physical activity levels and classroom behaviour sampling are not sub-studies.
The physical activity levels will be assessed in a group randomly selected by excel random function, and incorporated as an outcome measure for the main trial. The classroom behaviour sub-sample are also randomly selected within the intervention group by excel randomisation function. The observations are used to describe the acute effects of the intervention, within the main cluster-randomised controlled trial.
Intervention code [1] 319516 0
Treatment: Other
Comparator / control treatment
Usual Physical Education (PE) Curriculum delivery. (over the same duration as intervention - 18 weeks)
Given that each different school has a unique approach to meeting curriculum requirements, the usual PE programme control groups will inevitably be somewhat varied, but the intention is to compare relative efficacy of HIIT with the current programme as it is. Normal PE at this level involves twice weekly class sessions of 1-2 hours in length, covering introductory sports skills, some game based activities, and at times, a component of ' fitness' subject to individual teacher determination. Heart rate during a sample of sessions will be recorded, and the total number of PE sessions delivered during the 18 week period reported by the school. Schools have a set structure with a specific timetable so this information is well identified.
Control group
Active

Outcomes
Primary outcome [1] 326247 0
Cardiorespiratory (aerobic) fitness assessed with the commonly used Progressive Aerobic Cardiovascular Endurance Run (PACER). BEEP test 15m shuttle
Timepoint [1] 326247 0
Baseline and post- Phase 1 intervention (9 weeks post commencement of intervention)
Secondary outcome [1] 390729 0
Mental wellbeing- Stirling Children’s Wellbeing Scale (SCWBS; Liddle & Carter, 2015) is a 15 item questionnaire. The SCWBS was developed and validated in children aged 8-15 years. The scale uses a strengths-based approach. It holistically measures emotional and psychological wellbeing and was designed to measure the effectiveness of wellbeing interventions in children and adolescents.
Timepoint [1] 390729 0
Baseline and post- Phase 1 intervention (9 weeks post commencement of intervention)
Secondary outcome [2] 390734 0
Physical activity. In a randomly selected sub-sample (25%), the well validated Axivity™ AX3 accelerometer units will be used to objectively assess activity patterns for the duration of one school week. The daily and total counts will be registered with the average time spent in vigorous physical activity. The AX3 device will be worn on the non-dominant wrist for 24 hours a day for seven days including a weekend day.
Timepoint [2] 390734 0
Baseline and post- Phase 1 intervention (9 weeks post commencement of intervention)
Secondary outcome [3] 390745 0
Student voice: Small group interviews will be conducted with student participants post intervention period. These group discussions will be semi-structured with a casual approach to engage this cohort. Recorded transcripts will then be coded and thematically analysed. These interviews seek perceptions of student participants on their willingness to participate, satisfaction with program, or perceived barriers / dislikes.
Timepoint [3] 390745 0
Baseline and post- Phase 1 intervention (9 weeks post commencement of intervention)
Secondary outcome [4] 390747 0
Teacher perceptions of competence and willingness to continue the HIIT sessions in future via interview. This is a composite outcome.
Timepoint [4] 390747 0
Baseline and post- Phase 1 intervention (9 weeks post commencement of intervention)
Secondary outcome [5] 390750 0
On-task behaviour. In a randomly selected four schools the acute effect of the intervention on students’ behaviour in the classroom will be observed mid-intervention using established methods. During each 30 min observation period, research assistants will assess the on-task and off-task behaviour of six randomly selected students (5 min per student). A composite score is assigned. On-task behaviour includes times when the child is actively engaged in an academic activity (eg, reading, writing or performing the designated task) or passively engaged (ie, sitting quietly and listening to the teacher). Off-task behaviour includes times when the student is not engaged in the designated task and can be classified as off-task motor (ie, walking around the class), off-task verbal (ie, talking) or off-task passive (ie, passively not attending to the assigned academic activity). Time spent on-task and off-task during the lesson will be expressed as a percentage of total lesson time. A digital stopwatch will be used.
Timepoint [5] 390750 0
Mid-intervention
Secondary outcome [6] 393227 0
Implementation extent
Timepoint [6] 393227 0
In phase 2, Implementation
The total number of sessions delivered by schools will be assessed via a report generated by app usage reporting.

Eligibility
Key inclusion criteria
All students in Year 5 - Year 8 able to participate in normal Physical Eduction class activity
Minimum age
8 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To estimate the effect of the intervention, mixed effects regression models will be used, with adjustment for baseline and with school as a random effect. Both standardised and unstandardised effect sizes will be calculated with 95% confidence intervals (CI), and p-values.
Per-protocol analyses will be carried out for those schools who meet the compliance and session criteria, with a random effect for classes nested within schools. Exploratory subgroup analyses will be carried out for the fitness outcomes as specified a priori for sex, Maori ethnicity, and maturity index.
Intraclass correlation coefficients will be calculated for all outcomes. As a sensitivity analysis, effects of the intervention will be estimated with adjustment for baseline, sex, age, ethnicty, and BMI z-score.
All statistical analysis will be undertaken in Stata 17.0 (StataCorp, Texas).

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
12/04/2021
Actual
5/04/2021
Date of last participant enrolment
Anticipated
7/04/2023
Actual
7/04/2023
Date of last data collection
Anticipated
6/09/2024
Actual
Sample size
Target
850
Accrual to date
Final
785
Recruitment outside Australia
Country [1] 23392 0
New Zealand
State/province [1] 23392 0
Auckland

Funding & Sponsors
Funding source category [1] 307573 0
Government body
Name [1] 307573 0
Health Research Council New Zealand
Country [1] 307573 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
17 Antares Place, Rosedale, Auckland, 0632
Country
New Zealand
Secondary sponsor category [1] 308364 0
None
Name [1] 308364 0
Address [1] 308364 0
Country [1] 308364 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307632 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 307632 0
Ethics committee country [1] 307632 0
New Zealand
Date submitted for ethics approval [1] 307632 0
22/10/2020
Approval date [1] 307632 0
07/12/2020
Ethics approval number [1] 307632 0
20/NTB/280
Ethics committee name [2] 307706 0
Auckland University of Technology Ethics Committee
Ethics committee address [2] 307706 0
Ethics committee country [2] 307706 0
New Zealand
Date submitted for ethics approval [2] 307706 0
01/10/2020
Approval date [2] 307706 0
18/12/2020
Ethics approval number [2] 307706 0
20/429

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

Contacts
Principal investigator
Name 107934 0
Prof Nigel k Harris
Address 107934 0
Auckland University of Technology
17 Antares Place, Rosedale, Auckland, 0632
Country 107934 0
New Zealand
Phone 107934 0
+6499219999
Fax 107934 0
Email 107934 0
nigel.harris@aut.ac.nz
Contact person for public queries
Name 107935 0
Dr Nigel Harris
Address 107935 0
Auckland University of Technology
17 Antares Place, Rosedale, Auckland, 0632
Country 107935 0
New Zealand
Phone 107935 0
+649219999
Fax 107935 0
Email 107935 0
nigel.harris@aut.ac.nz
Contact person for scientific queries
Name 107936 0
Dr Nigel Harris
Address 107936 0
Auckland University of Technology
17 Antares Place, Rosedale, Auckland, 0632
Country 107936 0
New Zealand
Phone 107936 0
+649219999
Fax 107936 0
Email 107936 0
nigel.harris@aut.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified efficacy outcomes
When will data be available (start and end dates)?
After all analyses and dissemination are complete until 5 years after publication
Available to whom?
By request from researchers
Available for what types of analyses?
Meta-analyses
How or where can data be obtained?
By email request to Principal Investigator
nigel.harris@aut.ac.nz


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.