Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000910303
Ethics application status
Approved
Date submitted
17/06/2017
Date registered
21/06/2017
Date last updated
20/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Pau te Hau: Curriculum-based high-intensity interval training for young adolescents
Scientific title
Health effects of curriculum-based high intensity interval training for young adolescents
Secondary ID [1] 292219 0
None
Universal Trial Number (UTN)
U1111-1198-0573
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aerobic fitness 303713 0
Condition category
Condition code
Public Health 303087 303087 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This cluster-randomised controlled trial will be conducted within intermediate level schools in Auckland – one low decile (1-3) and one high decile (8-10) - in order to determine provisional efficacy and feasibility of delivery in different settings. Total number of participants is therefore expected to be 80-100 school students subject to recruitment rate. Two classes will be recruited from each school; one will be randomly allocated to HIIT, and the other to a control group who will continue with usual practice Physical Education class delivery. Assessments will be conducted at baseline and post intervention period (~10 weeks). The primary outcome measure will be aerobic fitness. Secondary outcome measures will include a range of physiological outcomes, body composition, muscular fitness, cognitive function, and psychological wellbeing. Additionally, participants’ attitudes to, and perceptions of exercise will be assessed, and the teachers’ perceptions of their competence and willingness to continue delivery of HIIT will be determined. Teachers will receive resources and a professional development session (with approximately 4 ongoing brief feedback sessions throughout the term) to deliver the intervention, which will consist of brief HIIT sessions to fit within two PE periods per week. The sessions will be designed to be deliverable in a variety of settings such that specialist space is not required, and with minimal, portable equipment. Specific aspects related to Level 4 Health and Physical Education Curriculum in New Zealand will be incorporated into succinct discussions after sessions. Analysis will account for moderators (i.e.., decile, initial fitness level, score on the strengths and difficulties questionnaire, classification of weight status) and relative efficacy.
The single pre-intervention one-day teacher professional development session and ongoing brief feedback throughout the intervention will contribute towards the 12 practising teacher criteria requirements for maintenance of teacher registration within NZ. They will address the latest evidence on the benefits of HIIT across all outcomes in order to enhance teacher buy-in and understanding. Importantly, teachers will learn to deliver the HIIT using the SAAFE principles developed by Lubans and colleagues, within an Aotearoa New Zealand context. A written HIIT resource will then be provided to teachers, along with brief videos of exercises to be used. They will also receive a 'class-pack' of heart rate monitors. Teachers will be encouraged to complete an action plan and identify barriers and solutions to facilitate the integration of HIIT into their PE lessons.
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
Teachers will deliver sessions to student participants in class.
Members of the research team will deliver the professional development to the intervention class teachers in person.
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 85% of predicted heart rate maximum as a guideline intensity towards the end of each work phase.
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. The questions will be developed in conjunction with the teachers. Specific NZ Health and Physical Education Level 4 Curriculum learning area strands, achievement objectives, and key competencies addressed will include:
Movement concepts and motor skills strand, and achievement objectives:
• Movement skills through the process of acquisition of exercise competency
• Positive attitudes though the aspects of resilience and perseverance.
Personal Health and Physical Development strand, and achievement objectives:
• Managing self and sense of responsibility for incorporating regular and enjoyable physical activity into personal lifestyle to enhance wellbeing.

NUMBER OF TIMES FOR INTERVENTION DELIVERY
Over one school term (8-10 weeks), 16-20, 10-15 minute sessions in total will be delivered in class by the teachers.
LOCATION
All HIIT sessions will be delivered in school (Year 8 level) during usual Physical Education 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. No strategy will be employed to enhance adherence as it is reliant on usual attendance to class.
Intervention code [1] 298380 0
Lifestyle
Comparator / control treatment
Usual Physical Education (PE) Curriculum delivery at Year 8.
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.
Control group
Active

Outcomes
Primary outcome [1] 302470 0
Aerobic fitness using the PACER multi-stage fitness test, and also for comparative purposes a sub-maximal cycle ergometer workload / heart rate relationship test. That is, 1-3 incremental (35 Watts) stage cycle with heart rate recorded.
Timepoint [1] 302470 0
End of intervention - one school term (approximately 9 weeks)
Secondary outcome [1] 336104 0
Body composition (muscle mass, fat, visceral fat mass) using dual-energy x-ray absorptiometry (DEXA) and bio-electrical impedance analysis for comparative purposes.
Timepoint [1] 336104 0
End of intervention - one school term (approximately 9 weeks)
Secondary outcome [2] 336105 0
LDL via blood analysis on a Roche Modular Diagnostics Instrument at the AUT Roche Diagnostics Laboratory. Blood will be drawn via standard venepuncture procedures after an overnight fast by trained and experienced phlebotomists
Timepoint [2] 336105 0
End of intervention - one school term (approximately 9 weeks)
Secondary outcome [3] 336106 0
Muscular fitness using well-established procedures: 90° push-up to failure, a modified pull-up (supine pull), a body mass squat, and grip strength.
Timepoint [3] 336106 0
End of intervention - one school term (approximately 9 weeks)
Secondary outcome [4] 336107 0
The International Fitness Scale (IFIS) for youth to determine self-perceived physical fitness using a 5 question, 5 point scale response survey. This will be used in conjunction with a newly developed six item HIIT self efficacy measure.

Sanchez-Lopez M, Martinez-Vizcaino V, Garcia-Hermoso A, Jimenez-Pavon D, Ortega FB. Construct validity and test-retest reliability of the International Fitness Scale (IFIS) in Spanish children aged 9-12 years. Scandinavian Journal of Medicine and Science in Sports
Timepoint [4] 336107 0
End of intervention - one school term (approximately 9 weeks)
Secondary outcome [5] 336108 0
Executive function: The Trail Making Test (TMT) is a measure of visual attention, speed, scanning, speed of processing and mental flexibility and has been validated in youth. The TMT involves a two part visual task in which participants are required to draw a line from one point to the next as quickly as possible. Lower scores indicate greater cognitive performance,
Timepoint [5] 336108 0
End of intervention - one school term (approximately 9 weeks)
Secondary outcome [6] 336109 0
Psychological well-being: The Warwick-Edinburgh Mental Wellbeing Scale is a 7-item questionnaire. Participants respond on a 5-point scale that best describes the frequency with which they experience thoughts such as "I’ve been feeling optimistic about the future" over the last 2 weeks.
Timepoint [6] 336109 0
End of intervention - one school term (approximately 9 weeks)
Secondary outcome [7] 336110 0
Autonomous motivation for exercise using the Behavioural Regulations in Exercise Questionnaire – Version 2 (BREQ-2) (Markland & Tobin, 2004). The BREQ-2 includes sub-scales for intrinsic and identified regulations, and the mean of these sub-scales is calculated to create an autonomous motivation variable.
Timepoint [7] 336110 0
End of intervention - one school term (approximately 9 weeks)
Secondary outcome [8] 336126 0
HDL via blood analysis on a Roche Modular Diagnostics Instrument at the AUT Roche Diagnostics Laboratory. Blood will be drawn via standard venepuncture procedures after an overnight fast by trained and experienced phlebotomists
Timepoint [8] 336126 0
End of intervention - one school term (approximately 9 weeks)
Secondary outcome [9] 336127 0
Glucose via blood analysis on a Roche Modular Diagnostics Instrument at the AUT Roche Diagnostics Laboratory. Blood will be drawn via standard venepuncture procedures after an overnight fast by trained and experienced phlebotomists
Timepoint [9] 336127 0
End of intervention - one school term (approximately 9 weeks)
Secondary outcome [10] 336128 0
Insulin via blood analysis on a Roche Modular Diagnostics Instrument at the AUT Roche Diagnostics Laboratory. Blood will be drawn via standard venepuncture procedures after an overnight fast by trained and experienced phlebotomists
Timepoint [10] 336128 0
End of intervention - one school term (approximately 9 weeks)
Secondary outcome [11] 336130 0
Triglycerides via blood analysis on a Roche Modular Diagnostics Instrument at the AUT Roche Diagnostics Laboratory. Blood will be drawn via standard venepuncture procedures after an overnight fast by trained and experienced phlebotomists
Timepoint [11] 336130 0
End of intervention - one school term (approximately 9 weeks)
Secondary outcome [12] 336131 0
Total cholesterol via blood analysis on a Roche Modular Diagnostics Instrument at the AUT Roche Diagnostics Laboratory. Blood will be drawn via standard venepuncture procedures after an overnight fast by trained and experienced phlebotomists
Timepoint [12] 336131 0
End of intervention - one school term (approximately 9 weeks)
Secondary outcome [13] 336132 0
In order to specifically address the acceptability of intervention, separate interviews will be conducted with student participants and teachers. ‘Student Voice’ will be heard through small group interviews to be conducted with student participants post intervention period. Focus group discussions are regularly used with children and youth as they are generally more comfortable discussing matters in groups. These group discussions will be semi-structured with a casual approach that will be adapted for the specific age group targeted to ensure the discussion is more engaging for this cohort. The main focus of these group discussions is to enable the participants to express their views in regards to HIIT itself as well as their views, preferences, and perspectives toward vigorous activity in general and if that changed over the course of the intervention. Discussions will be conducted at the school and will recorded and transcribed verbatim by members of the research team. Transcripts will then be coded and thematically analysed and the key themes identified will be organized into higher and lower level themes.

Individual interviews with teachers will be conducted post intervention to determine their impressions and experiences with intervention delivery, and solicit reflective feedback on possible future implementation and sustainability of the HIIT programme in their school.
Timepoint [13] 336132 0
End of intervention - one school term (approximately 9 weeks)
Secondary outcome [14] 336133 0
Classroom behaviour. The classroom behaviour questionnaire is a 25-item questionnaire, divided into 5 sub-scales with established reliability and validity to be completed by teachers.
Timepoint [14] 336133 0
End of intervention - one school term (approximately 9 weeks)
Secondary outcome [15] 336134 0
Psychological ill-being. Using the validated Strength and Difficulties Questionnaire.
Timepoint [15] 336134 0
End of intervention - one school term (approximately 9 weeks)
Secondary outcome [16] 336189 0
Weight in kg by scale
Timepoint [16] 336189 0
End of intervention - one school term (approximately 9 weeks)
Secondary outcome [17] 336191 0
Teacher perceptions of competence and willingness to continue the HIIT sessions in futture via interview
Timepoint [17] 336191 0
End of intervention - one school term (approximately 9 weeks)

Eligibility
Key inclusion criteria
All students in Year 8 able to participate in normal Physical Eduction class activity
Minimum age
12 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unable to participate in normal Physical Education class acitivity

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)
Randomisation is to be conducted post baseline assessments by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Type of endpoint/s
Statistical methods / analysis
Linear and generalised linear mixed models will be used to assess appropriately adjusted effects of the intervention on outcome measures at completion. Subgroups considered for analysis will consist in gender and dichotomised school decile and initial fitness level. Missing baseline data will be multiply imputed; missing outcome data will not be imputed, based on a missing-at-random assumption, but sensitivity analyses will be carried out to inform the discussion regarding any possible attrition bias. This trial being pragmatic in intent and design, all efficacy analyses will be based on a strictly interpreted intention to treat analysis set, with per protocol analyses being treated as sensitivity analyses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/03/2018
Actual
12/03/2018
Date of last participant enrolment
Anticipated
Actual
12/04/2018
Date of last data collection
Anticipated
Actual
6/07/2018
Sample size
Target
80
Accrual to date
Final
85
Recruitment outside Australia
Country [1] 8994 0
New Zealand
State/province [1] 8994 0
Auckland

Funding & Sponsors
Funding source category [1] 296760 0
Government body
Name [1] 296760 0
Health Research Council NZ
Country [1] 296760 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
Private Bag 92006
Auckland 1020
Country
New Zealand
Secondary sponsor category [1] 295742 0
Government body
Name [1] 295742 0
Health Research Council NZ
Address [1] 295742 0
Level 3 - ProCARE Building, Grafton Mews, at 110 Stanley Street (GPS: 50 Grafton Road), Grafton, Auckland 1010
Country [1] 295742 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297987 0
Health and Disabilities Ethics Committees
Ethics committee address [1] 297987 0
Ethics committee country [1] 297987 0
New Zealand
Date submitted for ethics approval [1] 297987 0
22/06/2017
Approval date [1] 297987 0
19/09/2017
Ethics approval number [1] 297987 0
17/NTB/167

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

Contacts
Principal investigator
Name 75662 0
Dr Nigel Harris
Address 75662 0
AUT Millennium
17 Antares Place
Mairangi Bay
Auckland 0632
Country 75662 0
New Zealand
Phone 75662 0
+6421608870
Fax 75662 0
Email 75662 0
[email protected]
Contact person for public queries
Name 75663 0
Nigel Harris
Address 75663 0
AUT Millennium
17 Antares Place
Mairangi Bay
Auckland 0632
Country 75663 0
New Zealand
Phone 75663 0
+6421608870
Fax 75663 0
Email 75663 0
[email protected]
Contact person for scientific queries
Name 75664 0
Nigel Harris
Address 75664 0
AUT Millennium
17 Antares Place
Mairangi Bay
Auckland 0632
Country 75664 0
New Zealand
Phone 75664 0
+6421608870
Fax 75664 0
Email 75664 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
SourceTitleYear of PublicationDOI
EmbaseFeasibility and Provisional Efficacy of Embedding High-Intensity Interval Training Into Physical Education Lessons: A Pilot Cluster-Randomized Controlled Trial.2021https://dx.doi.org/10.1123/pes.2020-0255
N.B. These documents automatically identified may not have been verified by the study sponsor.