Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000729628
Ethics application status
Approved
Date submitted
22/06/2014
Date registered
8/07/2014
Date last updated
14/07/2021
Date data sharing statement initially provided
14/07/2021
Date results provided
14/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of high intensity interval training (HIIT) on physical and psycho-social outcomes in low-active adolescents
Scientific title
The impact of high intensity interval training on physical and psycho-social outcomes in low active adolescents
Secondary ID [1] 284853 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical Inactivity 291215 0
Psychological Well-being 291216 0
Condition category
Condition code
Public Health 291558 291558 0 0
Health promotion/education
Mental Health 291559 291559 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to evaluate the impact of an innovative and time efficient 'High Intensity Interval Training' school-based program to increase fitness (e.g., cardio-respiratory fitness, muscular strength) and improve psychological well-being e.g., physical self-description, executive function) amongst adolescents. The proposed project will involve the development of a 3-arm intervention (Group A: High Intensity Interval Training; Group B: Body Weight Exercise Program; Group C: Wait List Control) to encourage students to participate short sessions of intense exercise. The proposed intervention may assist in reducing rates of obesity and improving physical, social and emotional well-being in Australian adolescents.
We aim to recruit approximately 60 year 9-10 students from one secondary school in the Newcastle region. It has been determined that 20 participants per group would provide adequate power to detect statistically significant effects, assuming a drop-out of 15%.
An information session will be delivered by a member of the research team and delivered during school hours. The session will outline the intervention and requirements of the students. Students will be given the opportunity to ask questions regarding the program during this session.
Eligible students, will be asked to complete both physiological and psychological assessments at baseline and post-intervention.
The ‘High Intensity Interval Training’ intervention will include an evidence-based and innovative approach to improve fitness and psychological well-being amongst year 9-10 students. The 'High Intensity Interval Training' intervention will include face-to-face activity sessions delivered by trained Physical Education teachers, on campus during recess and lunch breaks. Participants will participate in 3 sessions delivered on a weekly basis.
At the conclusion of the intervention, students will be provided with a range of resources to promote continued participation in self-directed 'High Intensity Interval Training' sessions (e.g., Smart Phone Apps, websites, a booklet of workouts, etc).


The High Intensity Interval Training group will receive cardio based exercises (e.g., running, jumping jacks, jumping rope) administered on a group basis, during 3 weekly session of 8 minute each (for a total of 8 weeks). Intensity will be examined via heart rate monitors (e.g., 80%+ maximum heart rate target).

The Body Weight Exercise Program group will receive cardio plus muscular strength exercises (e.g., push ups, squat jumps, walking lunges) administered on a group basis, during 3 weekly session of 8 minute each (for a total of 8 weeks). Intensity will be examined via heart rate monitors (e.g., 60%+ maximum heart rate target).

Strategies used to monitor adherence include: student enjoyment and participation in the program (e.g., pre and post session feelings state), and session attendance during the 8 weeks.
Intervention code [1] 288826 0
Lifestyle
Comparator / control treatment
The program will be replicated for the wait list control group once the intervention and all follow-up assessments have been completed with all groups. The wait-list control group will receive the High Intensity Interval Training program during term 4 (approximately 3 weeks post-intervention) at school, during school hours (i.e., sessions will be conducted during recess and lunch breaks, using school-based facilities, three days per week).
Control group
Active

Outcomes
Primary outcome [1] 291516 0
Cardio-respiratory fitness: assessed by 20 m multistage fitness test (Leger and Lambert 1982)
Timepoint [1] 291516 0
Baseline and one week post-intervention
Secondary outcome [1] 306942 0
Physical activity: assessed using GeneACTIV accelerometers and the physical activity screen (Scott., et al., under review).
Timepoint [1] 306942 0
Baseline and one week post-intervention
Secondary outcome [2] 306943 0
Muscular Strength: assessed using 90-degree push-up test (Cooper Institute for Aerobics Research 2004), and standing long jump
Timepoint [2] 306943 0
Baseline and one week post-intervention
Secondary outcome [3] 306947 0
Physical self-description: assessed by Global physical self-concept scale (Marsh, Richards et al. 1994)
Timepoint [3] 306947 0
Baseline and one week post-intervention
Secondary outcome [4] 306948 0
Psychological well-being/executive function: assessed by The Physical Self Description Questionnaire (Marsh, 1996); The Kessler Psychological Distress Scale (K6) (Kessler, Andrews et al. 2002) and The Trail Making Test (Reitan & Wolfson, 2004)
Timepoint [4] 306948 0
Baseline and one week post-intervention
Secondary outcome [5] 306949 0
Body Mass Index (BMI) & BMI-z score: assessed by Height and Weight (Centers for Disease Control & Prevention 1996)
Timepoint [5] 306949 0
Baseline and one week post-intervention
Secondary outcome [6] 309411 0
Well-being: assessed using the flourishing and positive and negative feelings scale (Diener., et al, 2009)
Timepoint [6] 309411 0
Baseline and one week post intervention
Secondary outcome [7] 309412 0
Behavioural regulation in exercise: this will be assessed using the Behavioural Regulation in Exercise Questionnaire (Markland & Tobin, 2004)
Timepoint [7] 309412 0
Baseline and one week post-intervention

Eligibility
Key inclusion criteria
Eligibility: students enrolled in years 9-10
Minimum age
15 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students will be ineligible if they do not provide parental consent to participate.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be sourced from one school in the Newcastle area. The school principal will be sent an information statement describing the study and a consent letter. If the principal declines the study invitation, another school in the Newcastle area will be contacted.

Once a school has been successfully recruited, participants will be provided with study information via: announcements at school assembly, announcements during PE lessons and provision of an information statement.

All students in year 9-10 will be invited to participate in the study.

Students will be invited to an information session at the school describing the study. At this session, interested students will be provided with an Information Letter detailing the intervention, the anticipated benefits, their required commitment level, and a Consent Form.

Participants will enter the study voluntarily. This will be explained to students at the school announcements sessions. Consent will be sought from both parent and child if interested in participating.

Participants will be aware of each other's intervention condition allocation, as concealing this information is not feasible in an exercise trial conducted within a school setting (at one school).

Therefore, allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Once baseline testing has been completed, students will be randomly allocated to one of the three study arms using a computer based random number-producing algorithm. This method ensures an equal chance of allocation to each group.
(i) High Intensity Interval Training;
(ii) Body Weight Exercise Program;
(iii) Wait List Control.

Assessors will be blinded to allocation at baseline and post test (assessors will not be aware of participants' groups at post test).
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
Wait list control design: participants assigned to the control group will receive the intervention following post-intervention assessments, in term 4, 2014.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analyses of the primary and secondary outcomes will be conducted with linear mixed models using IBM SPSS Statistics for Windows, Version 20.0 (2010 SPSS Inc., IBM Company Armonk, NY) and alpha levels will be set at p < 0.05. The models will be used to assess the impact of treatment (HIIT or BWEP or control), time (treated as categorical levels baseline and post-intervention) and the group-by-time interaction, these three terms forming the base model. The models will be specified to adjust for the clustered nature of the data and will include all randomised participants in the analysis.

Power calculations were based on change in the primary outcome of cardio-vascular fitness (multi-stage shuttle test (Leger and Lambert 1982)). Based on a previous study (Eather et al., 2014) a between-group difference of 10 laps was considered achievable, assuming a standard deviation of 9, 80% power with alpha levels set a 0.05. It was determined that 20 participants per group would provide adequate power to detect statistically significant effects, assuming a drop-out of 15%.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/07/2014
Actual
15/07/2014
Date of last participant enrolment
Anticipated
31/07/2014
Actual
31/07/2014
Date of last data collection
Anticipated
Actual
12/12/2014
Sample size
Target
60
Accrual to date
Final
65
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 288768 0
Self funded/Unfunded
Name [1] 288768 0
A/Prof David Lubans
Country [1] 288768 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
The University of Newcastle (UoN)
University Drive
Callaghan NSW 2308
Australia
Country
Australia
Secondary sponsor category [1] 287464 0
Individual
Name [1] 287464 0
A/Prof David Lubans
Address [1] 287464 0
Priority Research Centre in Physical Activity & Nutrition
Level 3 ATC
The University of Newcastle (UoN)
University Drive
Callaghan NSW 2308
Australia
Country [1] 287464 0
Australia
Secondary sponsor category [2] 287465 0
Individual
Name [2] 287465 0
Prof Ron Plotnikoff
Address [2] 287465 0
Priority Research Centre in Physical Activity & Nutrition
Level 3 ATC
The University of Newcastle (UoN)
University Drive
Callaghan NSW 2308
Australia
Country [2] 287465 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290607 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 290607 0
Ethics committee country [1] 290607 0
Australia
Date submitted for ethics approval [1] 290607 0
28/02/2014
Approval date [1] 290607 0
22/05/2014
Ethics approval number [1] 290607 0
H-2014-0083

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

Contacts
Principal investigator
Name 46378 0
A/Prof David Lubans
Address 46378 0
Priority Research Centre for Physical Activity and Nutrition Level 3 ATC
Building The University of Newcastle (UoN)
University Drive
Callaghan NSW
2308
Country 46378 0
Australia
Phone 46378 0
+61 2 4921 2049
Fax 46378 0
+61 2 4921 2084
Email 46378 0
[email protected]
Contact person for public queries
Name 46379 0
David Lubans
Address 46379 0
Priority Research Centre for Physical Activity and Nutrition Level 3 ATC
Building The University of Newcastle (UoN)
University Drive
Callaghan NSW
2308
Country 46379 0
Australia
Phone 46379 0
+61 2 4921 2049
Fax 46379 0
+61 2 4921 2084
Email 46379 0
[email protected]
Contact person for scientific queries
Name 46380 0
David Lubans
Address 46380 0
Priority Research Centre for Physical Activity and Nutrition Level 3 ATC
Building The University of Newcastle (UoN)
University Drive
Callaghan NSW
2308
Country 46380 0
Australia
Phone 46380 0
+61 2 4921 2049
Fax 46380 0
+61 2 4921 2084
Email 46380 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All primary and secondary data.
When will data be available (start and end dates)?
Data are available upon request and will be available for a minimum of 5 years after publication.
Available to whom?
Researchers with ethics approval
Available for what types of analyses?
Meta-analysis
How or where can data be obtained?
Contact David Lubans - [email protected]


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
EmbasePreliminary efficacy and feasibility of embedding high intensity interval training into the school day: A pilot randomized controlled trial.2015https://dx.doi.org/10.1016/j.pmedr.2015.11.001
N.B. These documents automatically identified may not have been verified by the study sponsor.