Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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
ACTRN12622000534785
Ethics application status
Approved
Date submitted
23/03/2022
Date registered
5/04/2022
Date last updated
20/03/2023
Date data sharing statement initially provided
5/04/2022
Date results provided
20/03/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing the Feasibility and Effect of Co-designing High-Intensity Interval Training with Students and Teachers
Scientific title
Assessing the Feasibility and Effect of Co-designing High-Intensity Interval Training with Students and Teachers
Secondary ID [1] 306344 0
None
Universal Trial Number (UTN)
Trial acronym
Making a HIIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 325562 0
Cognitive Function 325794 0
Condition category
Condition code
Public Health 322934 322934 0 0
Health promotion/education
Mental Health 322935 322935 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study includes a high-intensity interval training (HIIT) intervention during health and physical education (HPE) class using HIIT workouts co-designed by students, teachers, and researchers. Most school-based HIIT interventions have had little to no input from end-users on the HIIT workouts (e.g., included exercises and interval lengths) used in the intervention. Using self-determination theory to guide the creation of the HIIT workouts, we aim to increase the autonomy, competence, and relatedness students feel while completing these workouts by involving them as co-designers. We are also interested in the effect of the co-designed workouts on several outcomes.

There are three arms:
1) Co-designers - involved in the creation of the HIIT workouts and partake in HIIT workouts during the intervention
2) HIIT only - not involved in the creation of the HIIT workouts but partake in HIIT workouts during the intervention
3) Control - not involved in the creation of the HIIT workouts and continue normal HPE lessons during the intervention

Classes will be assigned to the arms based on school and teacher input. Each school will involve all three arms of the study.

Prior to using the HIIT workouts, the workouts will be co-designed by those involved in Group 1. Students will complete approximately 6 lessons focused on problem identification (barriers and facilitators), upskilling (learning about heart rate and trying different pre-made HIIT workouts, design (in groups of 3 – 5 students, create a 5 minute workout), and modification (based on heart rate data and feedback from their peers, teacher, and a researcher, students can modify their workouts as needed) in an iterative process. The lesson length will vary based on class time between schools, but can range between 50 and 70 minutes. The lessons will be conducted throughout a single school term across a minimum of 3 weeks. However, the exact schedule for each class will be determined collectively by teachers and researchers to suit individual class needs.

The intervention will be 8 weeks in length during weeks 2 - 9 of one 10-week school term. During the intervention, students in arms 1 and 2 will complete HIIT workouts in their HPE lessons. The HIIT workouts will be 10 minutes in length and will be co-designed with researchers, teachers, and students in Arm 1 prior to the intervention. The HIIT workouts will be delivered by teachers either in the school hall, field, or outdoor courts pending where the HPE lessons take place. We will aim to complete 2 x 10-minute HIIT workouts each week for 8 weeks. However, this will be tailored to each participating school to match their needs and changes in delivery will be documented for each involved class. The HIIT workouts will contain a variety of exercises and each one will be different due to the co-designed nature. Exercises that may be included are sprints, squats, skipping, and shadow boxing.

Intervention adherence and fidelity will be assessed using 1) the number of HIIT workouts delivered by teachers; 2) the number of HIIT workouts attended by students; and 3) students' heart rate throughout the HIIT workout. Students will be encouraged to have a heart rate equal or above 80% throughout each 10-minute HIIT workout.
Intervention code [1] 322776 0
Prevention
Comparator / control treatment
The control group will continue with their normal health and physical education (HPE) lessons during the intervention, which are delivered in line with the Australian HPE curriculum, and do not involve HIIT workouts.
Control group
Active

Outcomes
Primary outcome [1] 330348 0
Cardiorespiratory Fitness (20 m shuttle run test)
Timepoint [1] 330348 0
Baseline (the week prior the intervention) and the week after the 8-week intervention (post-intervention)
Secondary outcome [1] 405902 0
Antisaccade task. The number of correctly identified target letters will be used as the outcome variable from the antisaccade task.
Timepoint [1] 405902 0
Baseline (the week prior the intervention) and the week after the 8-week intervention (post-intervention)
Secondary outcome [2] 405903 0
Muscular Fitness (Standing Long Jump - centimetres jumped from starting line)
Timepoint [2] 405903 0
Baseline (the week prior the intervention) and the week after the 8-week intervention (post-intervention)
Secondary outcome [3] 405904 0
Motivation toward HIIT using the Perceived locus of control questionnaire containing 20 questions on a 7-point Likert scale
Timepoint [3] 405904 0
Baseline (after the first HIIT workout) and after the last HIIT workout in week 8
Secondary outcome [4] 405905 0
Enjoyment of HIIT using the PACES questionnaire that includes 16 questions on a 5-point Likert scale
Timepoint [4] 405905 0
Baseline (after the first HIIT workout) and after the last HIIT workout in week 8
Secondary outcome [5] 405906 0
Self-efficacy toward HIIT using the self-efficacy questionnaire for HIIT that has 6 questions on a 10-point Likert scale
Timepoint [5] 405906 0
Baseline (after the first HIIT workout) and after the last HIIT workout in week 8
Secondary outcome [6] 405907 0
Autonomy during HIIT using 5 questions on a 7-point Likert scale
Timepoint [6] 405907 0
Baseline (after the first HIIT workout) and after the last HIIT workout in week 8
Secondary outcome [7] 407964 0
Visual Array Task as described in Draheim et al 2021 (Journal of Experimental Psychology: General). The outcome variable of interest from the visual array task is the capacity score (k), which provides a measure of working memory capacity. It is calculated from N × ("Hits" + "Correction" + "Rejections" -1), where N is the set-size for that array.
Timepoint [7] 407964 0
Baseline (the week prior the intervention) and the week after the 8-week intervention (post-intervention)
Secondary outcome [8] 407965 0
Competence during HIIT using 5 questions on a 7-point Likert scale
Timepoint [8] 407965 0
Baseline (after the first HIIT workout) and after the last HIIT workout in week 8
Secondary outcome [9] 407966 0
Relatedness during HIIT using 5 questions on a 7-point Likert scale
Timepoint [9] 407966 0
Baseline (after the first HIIT workout) and after the last HIIT workout in week 8

Eligibility
Key inclusion criteria
Student study participants must be in Year 7 or 8 at consenting schools, and enrolled in a participating class.

Teacher study participants must be an HPE teacher leading one of the participating classes in the study
Minimum age
10 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students will be excluded if they: 1) have a health or medical condition that would preclude participation in vigorous physical activity; 2) are not able to understand the study procedures; or 3) have an injury that prevents them from participating in HPE class.

Study design
Purpose of the study
Prevention
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/03/2021
Date of last participant enrolment
Anticipated
30/04/2022
Actual
1/04/2022
Date of last data collection
Anticipated
24/06/2022
Actual
1/07/2022
Sample size
Target
250
Accrual to date
Final
308
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 310699 0
University
Name [1] 310699 0
QUEX Institute of Excellence
Country [1] 310699 0
Australia
Funding source category [2] 310877 0
Charities/Societies/Foundations
Name [2] 310877 0
Sports Medicine Australia
Country [2] 310877 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
School of Human Movement and Nutrition Sciences
The University of Queensland
Brisbane Qld 4072 Australia
Country
Australia
Secondary sponsor category [1] 312392 0
None
Name [1] 312392 0
Address [1] 312392 0
Country [1] 312392 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310283 0
The University of Queensland Human Research Ethics Committee, Low and Negligible Risk Ethics Sub-Committee
Ethics committee address [1] 310283 0
Ethics committee country [1] 310283 0
Australia
Date submitted for ethics approval [1] 310283 0
Approval date [1] 310283 0
22/10/2020
Ethics approval number [1] 310283 0
2020002444

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

Contacts
Principal investigator
Name 117114 0
Dr Michalis Stylianou
Address 117114 0
School of Human Movement and Nutrition Sciences
The University of Queensland
Brisbane 4072
QLD
Country 117114 0
Australia
Phone 117114 0
+61 7 3365 6982
Fax 117114 0
Email 117114 0
m.stylianou@uq.edu.au
Contact person for public queries
Name 117115 0
Stephanie Duncombe
Address 117115 0
School of Human Movement and Nutrition Sciences
The University of Queensland
Brisbane 4072
QLD
Country 117115 0
Australia
Phone 117115 0
+61 7 3365 6982
Fax 117115 0
Email 117115 0
s.duncombe@uq.net.au
Contact person for scientific queries
Name 117116 0
Stephanie Duncombe
Address 117116 0
School of Human Movement and Nutrition Sciences
The University of Queensland
Brisbane 4072
QLD
Country 117116 0
Australia
Phone 117116 0
+61 7 3365 6982
Fax 117116 0
Email 117116 0
s.duncombe@uq.net.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
In the informed consent form participants were told "data will only be accessed by members of the research team"


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15357Ethical approval  s.duncombe@uq.net.au Two amendments were approved for this ethics appli... [More Details]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMaking a HIIT: study protocol for assessing the feasibility and effects of co-designing high-intensity interval training workouts with students and teachers.2022https://dx.doi.org/10.1186/s12887-022-03440-w
N.B. These documents automatically identified may not have been verified by the study sponsor.