Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000293268
Ethics application status
Approved
Date submitted
20/02/2018
Date registered
27/02/2018
Date last updated
3/11/2021
Date data sharing statement initially provided
8/02/2019
Date results provided
3/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Embedding High Intensity Interval Training (HIIT) into the school day: The 'Burn 2 Learn' program for senior school students
Scientific title
A scalable intervention for increasing vigorous physical activity among older adolescents: The ‘Burn 2 Learn’ cluster randomised controlled trial.
Secondary ID [1] 293060 0
Nil known
Universal Trial Number (UTN)
Trial acronym
B2L
Linked study record
The clinical trials registration number for the Burn 2 Learn pilot trial is: ACTRN12617000544370

Health condition
Health condition(s) or problem(s) studied:
Mental health (i.e., psychological distress) 304988 0
Cardiovascular disease 304989 0
Type 2 diabetes 304990 0
Condition category
Condition code
Cardiovascular 304311 304311 0 0
Normal development and function of the cardiovascular system
Mental Health 304312 304312 0 0
Studies of normal psychology, cognitive function and behaviour
Metabolic and Endocrine 304313 304313 0 0
Normal metabolism and endocrine development and function
Public Health 304314 304314 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Burn 2 Learn intervention will involve the following intervention components and implementation strategies:

1) Intervention components:
i) Professional learning: 1 x one-day (i.e., 5 hours) professional learning workshop will be provided to two teachers per intervention school who agree to act as 'school champions' and facilitate the Burn 2 Learn program in their school. The workshop will be delivered by members of the research team (i.e., the Principal Investigator and certain Chief Investigators), and will cover information and current evidence on the impact of vigorous physical activity and cardio-respiratory fitness on cognitive functioning and academic performance as well as adolescent mental health. Teachers will participate in practical exercise sessions, where they will be taught about high intensity interval training (HIIT), and they will also be shown how to use the 'Burn 2 Learn' resources (i.e., HIIT task cards, smartphone application etc). A condensed online version of the workshop will be provided for any teachers that could not attend the face-to-face workshop.
ii) Interactive student seminar: Participating students will attend 1 x interactive seminar (i.e., 2.5 hours) delivered by a trained 'school champion', but supported by a member of the research team (present on the day of delivery). The interactive seminar will provide an overview of the Burn 2 Learn program and will address relevant information regarding physical activity, mental health and cognition, using a PowerPoint presentation and embedded videos designed specifically for this project. During this introductory session, students will participate in a practical HIIT session using the Burn 2 Learn smartphone application (hereafter referred to as the ‘B2L app’) and commercial heart-rate monitors.
iii) School-based exercise sessions: Sessions will be run at school during curricular time, supported by program resources and the B2L app. Schools will be encouraged to offer a minimum of 2 exercise sessions/week across 2 school terms (i.e., 16 weeks) during regularly scheduled lessons, and each exercise session will last approximately 10-15 minutes in duration. In addition, students will be encouraged to complete additional sessions before or after school, during recess or lunch, and during free/study periods using the B2L app. Students will also be encouraged to continue the exercise sessions during their 2-week school holidays, which falls around the middle of the intervention period. The sessions will involve a combination of aerobic (e.g., shuttle runs, jumping jacks, boxing, dancing) and body weight muscle-strengthening exercises (e.g., push-ups, squat jumps and walking lunges), and have been designed to be fun and engaging as well as vigorous in nature. Students will be able to select from pre-designed HIIT workouts, which may be delivered for between 8-16 intervals (30 seconds work, 30 seconds rest; 1:1 work to rest ratio). A shorter option (i.e., 8 intervals; 20 seconds work, 10 seconds rest; 2:1 work to rest ratio; 4 minutes) will also be provided for when time constraints preclude a longer session. HIIT sessions will include variety and choice of activities to enhance motivation, and will be student self-directed. The school champions (i.e., classroom teachers) will facilitate exercise sessions, but are not expected to guide/deliver the sessions themselves. Students' attendance at the activity sessions will be tracked using the B2L app and via teacher recording.
iv) Smartphone app: A smartphone app has been developed to enable students to complete the sessions at school and home. Android and iOS versions of the app are available. The app includes: (i) descriptions and depictions of exercise sessions, (ii) options for 'solo' or 'group' sessions (for up to 6 users per device), (iii) timer, audible prompts and display of heart rate using Bluetooth-synced commercial heart rate monitors (WAHOO brand) during HIIT sessions, (iv) personalised reports outlining heart rate (i.e., in bpm and % of maximum) achieved overall, and during each work interval across the session, (v) display of HIIT session log on app dashboard to aid self-monitoring and goal setting.
v) Parental e-newsletter: Parents of intervention group students will receive two e-newsletters containing information on the benefits of physical activity for academic performance and mental health and strategies to support their children’s participation in physical activity during school holiday periods. The e-newsletters will include video content, and will be emailed to parents, unless there is a preferred parental contact method provided by the school.
2) Implementation strategies:
i) Recruitment of school champions: 2 x teachers/school will be recruited as school champions. These teachers will attend the NSW Education Standards Authority (NESA) accredited professional learning workshop, and will facilitate the delivery of the B2L program during curricular time in their school. These school champions will also liaise with the research team to organise data collection, will deliver the interactive seminar for students (with support from the research team) and will act as advocates for the B2L program in their schools.
ii) Delivery of tailored presentation to school faculty: The school champions will design a tailored presentation (approx.. 10 minutes), scaffolded by pre-designed program resources (i.e., videos, presentation slides), to be delivered to school faculty during a regularly scheduled staff meeting. The purpose if this strategy is to inform staff of the objectives and details of the B2L program, and to promote a supportive school climate.
iii) Provision of equipment and resources: Schools will be provided with a small equipment pack to assist in the delivery of the Burn 2 Learn program (~AUD2500) including: 1 x heart rate monitor/student, 1 x Bluetooth speaker for playing music during sessions, Burn 2 Learn Technique cards (i.e., describing key components to perform each exercise) and Burn 2 Learn HIIT session cards (i.e., describing the various HIIT workouts), a small assortment of sports equipment (e.g., balls, cones).

Measurement of on-task behavior: Schools will be invited to participate in a sub-study to determine the acute effect of the B2L intervention on students’ behaviour in the classroom. Classroom observations will be conducted by trained research assistants at baseline and mid-intervention (week 5 to 8) using established methods (Alberto & Troutman, 2003; Riley, Lubans, Holmes, & Morgan, 2016). During each 30 minute observation period (starting 5-mins after students enter the classroom), research assistants will assess the on- and off-task behaviour of six randomly selected students (5 min per student). For each lesson, two observers will randomly select 12 students (i.e., six boys and six girls) and the order in which they are observed (teachers and students will not know who is being observed). Observers will listen to an MP3 audio file via headphones, which will inform them when to observe and record (in 15-sec intervals). After each 10-sec interval, the observers will record the student`s behaviour by circling an appropriate code (i.e., actively engaged, passively engaged, off-task motor, off-task verbal or off-task passive) using an observation sheet. After 15 seconds, the observer will then focus on the next student and repeat this process five times until the six students have been observed 20 times. On-task behaviour includes times when the child is actively engaged in an academic activity (e.g., reading, writing, or performing the designated task) or passively engaged (i.e., 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 (i.e., walking around the class), off-task verbal (i.e., talking) or off-task passive (i.e., passively not attending to the assigned academic activity). Time spent on- and off-task during the lesson will be expressed as a percentage of total lesson time. Two trained research assistants will be responsible for conducting all observations and inter-rater reliability scores will be established in the training phase.

Assessors will be consisted of trained research staff who will observe students' on-task behavior during their lessons. Before assessments, they will participate in a 2-hour training to help them measure reliably and accurately measure on-task behavior.

Vitality scale: The concept of subjective vitality refers to the state of feeling alive and alert--to having energy available to the self. Vitality is considered an aspect of eudaimonic well-being (Ryan & Deci, 2001), as being vital and energetic is part of what it means to be fully functioning and psychologically well. The vitality scale consisting of 6-items will be distributed and completed by students at the beginning and at the end of the lesson (at two time points: baseline and post-test).
Intervention code [1] 299302 0
Lifestyle
Intervention code [2] 299303 0
Behaviour
Intervention code [3] 299304 0
Prevention
Comparator / control treatment
The study will employ a 'wait-list' control design. Participants randomly allocated to the control group will continue with usual school practice (i.e., normal curricular lessons) for the duration of the intervention period. Schools allocated to control will then receive the intervention following final study assessments (i.e., the following year).
Control group
Active

Outcomes
Primary outcome [1] 303790 0
Cardio-respiratory fitness: Assessed using the PACER 20m shuttle run test (outcome=laps)
Timepoint [1] 303790 0
Baseline, 6-month post-baseline assessments (primary timepoint) & 12-month post-baseline assessments
Secondary outcome [1] 340152 0
Time spent (i.e., mean minutes) in moderate-to-vigorous physical activity: Assessed using wrist-worn ActiGraph GT9X Link accelerometers. Accelerometers will be worn on the non-dominant wrist for 7 consecutive days for 24 hours per day (even when bathing, swimming and sleeping).
Timepoint [1] 340152 0
Baseline, 6-month post-baseline and 12-month post-baseline assessments
Secondary outcome [2] 340153 0
Muscular fitness: 90 degree push-up test (upper body) and standing long jump test (lower body)
Timepoint [2] 340153 0
Baseline, 6-month post-baseline and 12-month post-baseline assessments
Secondary outcome [3] 340154 0
Body composition: Height will be assessed using a portable stadiometer and weight will be assessed using a portable digital scale. Body Mass Index (BMI) will be assessed using the standard formula (Weight [kg]/Height [m]2).
Timepoint [3] 340154 0
Baseline, 6-month post-baseline and 12-month post-baseline assessments
Secondary outcome [4] 340155 0
Cognitive control: Computer administered tests - Eriksen Flanker task (inhibition) and serial n-back task (working memory).
Timepoint [4] 340155 0
Baseline, 6-month post-baseline and 12-month post-baseline assessments
Secondary outcome [5] 340157 0
Psychological distress: Assessed using the validated Strengths and Difficulties questionnaire (Goodman et al. 1997)
Timepoint [5] 340157 0
Baseline, 6-month post-baseline and 12-month post-baseline assessments
Secondary outcome [6] 340158 0
Perceived stress: Assessed using the validated Perceived Stress Scale (Cohen et al. 1983)
Timepoint [6] 340158 0
Baseline, 6-month post-baseline and 12-month post-baseline assessments
Secondary outcome [7] 340160 0
Autonomous motivation for Exercise: Assessed using the intrinsic and identified subscales from the validated Behavioural Regulations in Exercise Questionnaire - version 2 (BREQ-2) (Markland and Tobin, 2004)
Timepoint [7] 340160 0
Baseline, 6-month post-baseline and 12-month post-baseline assessments
Secondary outcome [8] 340161 0
Mental wellbeing: Assessed using the validated Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) (Clark et al., 2011)
Timepoint [8] 340161 0
Baseline, 6-month post-baseline and 12-month post-baseline assessments
Secondary outcome [9] 340162 0
Basic psychological needs satisfaction (from peers and teachers): Assessed using the validated Adolescent Psychological Need Support in Exercise Questionnaire (Emm-Collison et al. 2016).
Timepoint [9] 340162 0
Baseline, 6-month post-baseline and 12-month post-baseline assessments
Secondary outcome [10] 340163 0
Stress: objectively assessed by analysis of cortisol build-up in hair shaft among a sub-sample of approximately 200 students stratified by sex (i.e., 50% of the recruited students from cohort 1)
Timepoint [10] 340163 0
Baseline and 6-month post-baseline assessments
Secondary outcome [11] 342663 0
Brain structure and function, assessed using magnetic resonance imaging (MRI) in a sub-sample of approximately 60 students (i.e., 30 students per school from 2 schools; 1 x intervention group, 1 x control group) identified as being in the bottom 50% of students in their school for cardio-respiratory fitness (based on their baseline PACER shuttle run test result). We will explore the following: (i) Structural MRI (i.e., Hippocampus, frontal regions/Prefrontal Cortex, Anterior Cingulate Cortex, Basal Ganglia ); (ii) Functional MRI (i.e., resting state activation of the Default Mode, Cognitive Control, and Saliency networks, and activation of the Hippocampus and Prefrontal Cortex regions); (iii) Spectroscopy (i.e., gamma-Aminobutyric acid [GABA], Glutamate, Adenosine Tri-Phosphate [ATP] and metabolites - to assess inhibition/excitation and metabolic activity, respectively, within the Hippocampus and frontal regions/Prefrontal Cortex).
Timepoint [11] 342663 0
Baseline and 6-months post-baseline assessments
Secondary outcome [12] 343344 0
Self-efficacy for High Intensity Interval Training (HIIT): Assessed using a scale developed specifically for this study
Timepoint [12] 343344 0
Baseline, 6-month post-baseline and 12-month post-baseline assessments
Secondary outcome [13] 343442 0
Perceived fitness: Assessed using the International Fitness Scale (IFIS) (Sanchez-Lopez et al. 2015)
Timepoint [13] 343442 0
Baseline, 6-month post-baseline and 12-month post-baseline assessments
Secondary outcome [14] 343595 0
Time spent (i.e., mean minutes) in vigorous physical activity: Assessed using wrist-worn ActiGraph GT9X Link accelerometers. Accelerometers will be worn on the non-dominant wrist for 7 consecutive days for 24 hours per day (even when bathing, swimming and sleeping).
Timepoint [14] 343595 0
Baseline, 6-month post-baseline and 12-month post-baseline assessments
Secondary outcome [15] 366624 0
on-task behavior

Percentage of time spent in on-task behavior will be measured using a time momentary sampling strategy. After each 10-sec interval, the observers will record the student`s behaviour by circling an appropriate code (i.e., actively engaged, passively engaged, off-task motor, off-task verbal or off-task passive) using an observation sheet. After 15 seconds, the observer will then focus on the next student and repeat this process five times until the six students have been observed 20 times. On-task behaviour includes times when the child is actively engaged in an academic activity (e.g., reading, writing, or performing the designated task) or passively engaged (i.e., 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 (i.e., walking around the class), off-task verbal (i.e., talking) or off-task passive (i.e., passively not attending to the assigned academic activity).

Timepoint [15] 366624 0
Baseline and post-test (will be conducted during week 5 and week 8)
Secondary outcome [16] 366625 0
Vitality measure

Students will fill their answers on a 6-item questionnaire with 7-point Likert Scale.
Timepoint [16] 366625 0
Baseline and post-test (will be conducted during week 5 and week 8)

Eligibility
Key inclusion criteria
Study participants must be in Grade 11 at consenting schools, and enrolled in the class of a recruited 'school champion'.
Minimum age
15 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students that have a health or medical condition that would preclude participation in vigorous physical activity will be excluded.

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)
Allocation to control or intervention groups will be conducted following recruitment and baseline assessments, using central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following recruitment, pairs of schools will be matched based on the following key characteristics: geographic location (i.e., region, rural/urban, coastal/inland), school area-level socio-economic status (i.e., using the Socio-Economic Indexes For Areas [SEIFA] Index of Relative Socio-Economic Disadvantage), and schools' student population educational advantage (i.e., using the Index of Community Socio-Educational Advantage [ICSEA]). Schools will be randomised by an independent researcher using a computer-based random number generator, such that one school from each pair will be allocated to the intervention condition and the remaining school will be allocated to the control condition. Using this approach, each school will have an equal chance of being allocated to the intervention condition, whilst maintaining an appropriate balance of school characteristics across the two conditions.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
The intervention will occur across two separate cohorts. Cohort 1 (10 schools; 5 intervention and 5 control) will be assessed for baseline measures during 2018, whereas Cohort 2 (10 schools; 5 intervention and 5 control) will be assessed for baseline measures during 2019.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: Power calculations were based on the primary outcome of cardio-respiratory fitness (CRF), assessed using the Progressive Aerobic Cardiovascular Endurance Run (PACER) test. Baseline post-test correlation (r=.90) and standard deviation (SD=29) values were obtained from our pilot trial, and conservative ICC values of .20 and .03 were used to account for clustering at the class- and school-levels, respectively (Heo & Leon, 2008). To detect a clinically meaningful baseline-adjusted between-group difference of 6 laps with 80% power at a 5% significance level will require 280 students per treatment group (i.e., 2 classes of 14 students from each of 10 schools). Inflating the sample size to 18 students per class, or 360 students per treatment arm (i.e., total sample of 720 students) allows for a potential drop-out rate of 20% at our primary study endpoint (i.e., 6-months).

Analyses of the primary and secondary outcomes will be conducted using linear mixed models SAS V9.1 (SAS Institute Inc, Cary, NC), with alpha levels set at p<0.05. The models will be used to assess the impact of treatment (Burn 2 Learn or control), time (treated as categorical with levels baseline, 6 months & 12 months) and the group-by-time interaction, using random effects to account for the clustered nature of the data. Although randomisation will occur at the school level, our statistical analyses will be adjusted for the clustering of effects at the class level, as students from each school are nested in classes. Previous school-based studies have demonstrated that clustering at the school-level is negligible after adjusting for clustering at the class-level. However, we will test this assumption and additionally adjust our analyses for school-level clustering if required (i.e., if ICC for school is greater than .05, following adjustment for class). Several potential moderators of intervention effects will be explored using interaction tests. Subgroup analyses will be conducted for the following variables if the significance of the group-by-moderator interaction is less than or equal to .10. Socio-economic status (Low, Medium, High), Sex (male, female), baseline weight status (not overweight, overweight/obese), baseline psychological distress (using the cut-offs within the Strengths and Difficulties Questionnaire), and baseline cardio-respiratory fitness (using FITNESSGRAM healthy fitness standards)

Compared to complete case analyses, mixed models include available data for all participants in the analysis and are thus both more efficient and robust to bias. Mixed model analyses are consistent with the intention-to-treat principle, assuming the data are missing at random. The validity of this assumption will be explored by assessing relationships between missingness and observed values of covariates and previous outcomes. Sensitivity analyses will also be conducted using a 'last observation carried forward' imputation approach and a complete-case analysis. In addition to our primary analysis (i.e., intention-to-treat) and sensitivity analyses, we will also conduct two per-protocol analyses (i.e., at the class and student levels, respectively). After consideration of typical school disruptions (i.e., sports carnivals, excursions, exams etc), we estimate that a minimum of 28 exercise sessions offered during the school day is achievable for schools and sufficient to observe effects for our primary outcome at the primary end point (i.e., 6-months). Therefore, our class-level per-protocol analysis will include only students from classes in which at least 28 school-based sessions were offered. For our student-level per-protocol analysis, we will include only those students who achieved an average heart-rate of 80% of their age-predicted maximum across the intervention period (up until our primary endpoint), using data drawn from the B2L smartphone app.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/03/2018
Actual
13/03/2018
Date of last participant enrolment
Anticipated
13/04/2020
Actual
2/04/2019
Date of last data collection
Anticipated
30/04/2021
Actual
30/04/2020
Sample size
Target
720
Accrual to date
Final
670
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 297684 0
Government body
Name [1] 297684 0
National Health and Medical Research Council
Country [1] 297684 0
Australia
Funding source category [2] 298727 0
Government body
Name [2] 298727 0
New South Wales Department of Education
Country [2] 298727 0
Australia
Primary sponsor type
Individual
Name
David Lubans
Address
Level 3, ATC building
University Drive
Callaghan, NSW, 2308
Country
Australia
Secondary sponsor category [1] 297899 0
None
Name [1] 297899 0
Address [1] 297899 0
Country [1] 297899 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298756 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 298756 0
Ethics committee country [1] 298756 0
Australia
Date submitted for ethics approval [1] 298756 0
05/12/2016
Approval date [1] 298756 0
13/03/2017
Ethics approval number [1] 298756 0
H-2016-0424
Ethics committee name [2] 299671 0
NSW Department of Education: School Policy and Information Management
Ethics committee address [2] 299671 0
Ethics committee country [2] 299671 0
Australia
Date submitted for ethics approval [2] 299671 0
01/03/2017
Approval date [2] 299671 0
28/04/2017
Ethics approval number [2] 299671 0
SERAP2017116

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

Contacts
Principal investigator
Name 78126 0
Prof David Lubans
Address 78126 0
Level 3, ATC Building
University Drive
Callaghan, NSW, 2308
Country 78126 0
Australia
Phone 78126 0
+61249212049
Fax 78126 0
Email 78126 0
[email protected]
Contact person for public queries
Name 78127 0
David Lubans
Address 78127 0
Level 3, ATC Building
University Drive
Callaghan, NSW, 2308
Country 78127 0
Australia
Phone 78127 0
+61249212049
Fax 78127 0
Email 78127 0
[email protected]
Contact person for scientific queries
Name 78128 0
David Lubans
Address 78128 0
Level 3, ATC Building
University Drive
Callaghan, NSW, 2308
Country 78128 0
Australia
Phone 78128 0
+61249212049
Fax 78128 0
Email 78128 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


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
EmbaseSchool-based physical activity intervention for older adolescents: Rationale and study protocol for the Burn 2 Learn cluster randomised controlled trial.2019https://dx.doi.org/10.1136/bmjopen-2018-026029
N.B. These documents automatically identified may not have been verified by the study sponsor.