Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000544370
Ethics application status
Approved
Date submitted
29/03/2017
Date registered
18/04/2017
Date last updated
12/03/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Embedding High Intensity Interval Training (HIIT) into the school day: The Burn 2 Learn pilot trial for senior school students
Scientific title
A scalable intervention for increasing vigorous physical activity among older adolescents: The Burn 2 Learn pilot trial.
Secondary ID [1] 291512 0
Nil known
Universal Trial Number (UTN)
Trial acronym
B2L
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health (i.e., psychological distress) 302596 0
cardiovascular disease 302597 0
Type 2 diabetes 302598 0
Condition category
Condition code
Cardiovascular 302118 302118 0 0
Normal development and function of the cardiovascular system
Mental Health 302119 302119 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 302120 302120 0 0
Health promotion/education

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

1) Accredited teacher professional learning workshop: 1 x full day (5 hours) workshop was conducted for intervention group teachers identified and recruited as Burn 2 Learn 'school champions. The workshop provided a rationale for the intervention, including up to date evidence of the benefits of vigorous physical activity for cognitive and mental health, as well as the roles and responsibilities of school champions.

2) Introductory seminar: was delivered to Principals and teachers (20 min) by the research team. The seminars focused on the latest evidence regarding physical activity, fitness and academic achievement. The seminar included video files with testimonies from experts in physical activity and cognition.

3) Interactive seminar: Students participated in an interactive/practical training workshop (2 hours) delivered at the study schools by members of the research team. The workshop included program familiarisation, safety considerations and session delivery.

4) School-based activity sessions: The model of intervention delivery shifted from a peer-led model, with recruited 'peer-leaders' (i.e., students) organising and delivering the school-based exercise sessions, to a teacher-facilitated but student self-directed model. Instead of peer leaders organising exercise sessions during out-of-class time (i.e., lunch, before school etc), teachers were asked to facilitate the exercise sessions during scheduled lesson time. During these periods, teachers offered the opportunity to students and assisted them where necessary. However, the exercise sessions were self-directed by students. Our decision to move to in-class exercise session delivery was made before we started the program, but after the recruitment of participants (N= 68). Schools were encouraged to schedule 3 x sessions/week for 14 weeks. Each session will last 15-20 minutes (including warm-up and cool down). The sessions involved students participating in High Intensity Interval Training (HIIT), that incorporates a combination of aerobic (e.g., shuttle runs, jumping jacks, boxing, dancing) and muscle strengthening exercises (e.g., push-ups, squat jumps and walking lunges), organized into between 8-16 intervals (30 seconds work, 30 seconds rest; 1:1 work to rest ratio). HIIT sessions included variety and choice of activities within sessions to enhance motivation. Students selected from pre-designed HIIT workouts including boxing, dance, running, resistance training and sport-based HIIT (e.g., soccer, touch football and basketball). It was not mandatory for students to attend the sessions. Students' attendance at the activity sessions was tracked using heart rate monitors, which were synced to a smartphone/tablet using Bluetooth technology. The OnBeat smartphone/tablet application (app) was used to monitor students' heart rate during sessions.

5) Parents of intervention group students received 2 x e-newsletters containing information on the benefits of physical activity for academic performance and mental health and strategies to support their children, using the Skoolbag app and Facebook.

6) Equipment and resources: Schools were provided with an equipment pack to assist in the delivery of the Burn 2 Learn program (~$2500 AUD) - 1 x iPad, 1 x heart rate monitor/student, Bluetooth speaker and B2L session cards (i.e., describing the various HIIT workouts).
Intervention code [1] 297583 0
Lifestyle
Intervention code [2] 297584 0
Prevention
Intervention code [3] 297585 0
Behaviour
Comparator / control treatment
Usual practice control - Students will participate in usual school activities and external sports and exercise. Students allocated to the control condition will receive the intervention following the final assessments.
Control group
Active

Outcomes
Primary outcome [1] 301570 0
Cardio-respiratory fitness: Assessed using the PACER 20m shuttle run test (laps)
Timepoint [1] 301570 0
Baseline, 14 weeks post-baseline assessments
Secondary outcome [1] 333089 0
Time spent (i.e., minutes) in vigorous physical activity: Assessed using GT9X Link accelerometers and Evensen cut-points to determine activity intensity. Accelerometers will be worn on 7 consecutive days for 24 hours per day (even when bathing, swimming and sleeping).
Timepoint [1] 333089 0
Baseline, 14 weeks post-baseline assessments
Secondary outcome [2] 333090 0
Muscular fitness: Timed push-up test (upper body) and standing long jump test (lower body)
Timepoint [2] 333090 0
Baseline, 14 weeks post-baseline assessments
Secondary outcome [3] 333091 0
Body composition: Waist circumference (central adiposity); height and weight for Body Mass Index (total adiposity)
Timepoint [3] 333091 0
Baseline, 14 weeks post-baseline assessments
Secondary outcome [4] 333092 0
Cognitive control: Computer administered tests - Eriksen Flanker task (inhibition) and serial n-back task (working memory).
Timepoint [4] 333092 0
Baseline, 14 weeks post-baseline assessments
Secondary outcome [5] 333093 0
Psychological distress: Assessed using the validated Strengths and Difficulties questionnaire (Goodman et al. 1997)
Timepoint [5] 333093 0
Baseline, 14 weeks post-baseline assessments
Secondary outcome [6] 333094 0
Perceived stress: Assessed using the validated Perceived Stress Scale (Cohen et al. 1983)
Timepoint [6] 333094 0
Baseline, 14 weeks post-baseline assessments
Secondary outcome [7] 333095 0
Autonomous motivation for physical activity: Assessed using the validated Behavioural Regulations in Exercise Questionnaire - version 2 (BREQ-2) (Markland and Tobin, 2004)
Timepoint [7] 333095 0
Baseline, 14 weeks post-baseline assessments
Secondary outcome [8] 333106 0
Basic psychological needs satisfaction: Assessed using the validated Adolescent Psychological Need Support in Exercise Questionnaire (Emm-Collison et al. 2016)
Timepoint [8] 333106 0
Baseline, 14-weeks post-baseline assessments

Eligibility
Key inclusion criteria
Study participants must be in Grade 11 at consenting schools
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 baseline assessments. Therefore, group allocation is concealed from study team members determining participant eligibility and enrollment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will occur at the school-level by an independent researcher not involved in the present trial using a simple coin toss procedure.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Study will employ a wait-list control procedure, in which the control group will receive the intervention following the final assessment period.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations have been based on estimated effect sizes for the primary outcome of cardio-respiratory fitness assessed using the PACER 20m shuttle run test (outcome = laps completed). Assuming an adjusted mean difference between groups of 5 laps with a standard deviation of change of 7 laps, and intervention:control participant ratio of 1:1, the required sample size to achieve 80% power with alpha level p <.05 is 32 students per group (or 64 students total). To account for an expected drop-out rate of 10% at 14-weeks, the sample size was inflated to 40 students per group, or a total study sample of 80 students.

Analyses of the primary and secondary outcomes will be conducted using linear mixed models SAS V 9.1 (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 to Learn or control), time (treated as categorical with levels baseline and 15 weeks) and the group-by-time interaction, using a random intercept to account for the repeated measures for each participant. 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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/04/2017
Actual
30/03/2017
Date of last participant enrolment
Anticipated
5/05/2017
Actual
5/05/2017
Date of last data collection
Anticipated
25/08/2017
Actual
1/09/2017
Sample size
Target
80
Accrual to date
Final
68
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 296002 0
Government body
Name [1] 296002 0
National Health and Medical Research Council (NHMRC)
Country [1] 296002 0
Australia
Funding source category [2] 296206 0
Government body
Name [2] 296206 0
NSW Department of Education
Country [2] 296206 0
Australia
Primary sponsor type
Individual
Name
David R. Lubans
Address
University of Newcastle, Priority Research Centre for Physical Activity and Nutrition, Level 3, ATC building, University Drive, Callaghan, NSW, 2308
Country
Australia
Secondary sponsor category [1] 294907 0
None
Name [1] 294907 0
Address [1] 294907 0
Country [1] 294907 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297262 0
University of Newcastle Human Research Ethics Comittee
Ethics committee address [1] 297262 0
University Drive, Callaghan, NSW, 2308
Ethics committee country [1] 297262 0
Australia
Date submitted for ethics approval [1] 297262 0
30/11/2016
Approval date [1] 297262 0
21/03/2017
Ethics approval number [1] 297262 0
H-2016-0424
Ethics committee name [2] 297280 0
State Education Research Education Process (SERAP)
Ethics committee address [2] 297280 0
Locked Bag 53, Darlinghurst, NSW, 1300
Ethics committee country [2] 297280 0
Australia
Date submitted for ethics approval [2] 297280 0
13/03/2017
Approval date [2] 297280 0
Ethics approval number [2] 297280 0

Summary
Brief summary
The purpose of this trial is to evaluate the impact of the Burn 2 Learn (B2L) intervention on students' cardio-respiratory fitness and secondary outcomes (muscular fitness, body composition, vigorous physical activity, cognitive control, motivation, basic needs satisfaction and psychological health). Our primary hypothesis is that students allocated to the intervention condition will experience improved cardio-respiratory fitness relative to students allocated to the control condition by the primary study end point (14 weeks post-baseline). We aim to recruit 80 grade 11 students from two schools (x40 per school) who will be randomly allocated (by school) to received the B2L intervention or participate in usual practice (control group to receive the intervention after the final assessments). The B2L intervention will involve students participating in 2-3 sessions per week of High Intensity Interval Training (HIIT) for 14 weeks, delivered at school by peer leaders (trained grade 11 students). To facilitate the intervention, 2 x teachers will be recruited as school champions and will attend a one-day professional learning workshop. Peer leaders (x 5-10 students) will be identified and recruited from the intervention school. Peer leaders and students will participate in a 2 hour workshop delivered by the research team. The HIIT sessions will involve a variety of engaging exercises and will occur for 15-20 minutes at a time. The intervention school will receive an equipment pack (heart-rate monitors, iPad, Bluetooth speaker, exercise cards) to facilitate session delivery. To gain support from the home environment, parents of study participants will receive 2 x eNewsletters via Facebook or the Skoolbag app during the study period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73506 0
Prof David R. Lubans
Address 73506 0
University of Newcastle, Priority Research Centre for Physical Activity and Nutrition, Level 3, ATC building, University Drive, Callaghan, NSW, 2308
Country 73506 0
Australia
Phone 73506 0
+61 2 4921 2049
Fax 73506 0
Email 73506 0
david.lubans@newcastle.edu.au
Contact person for public queries
Name 73507 0
Prof David R. Lubans
Address 73507 0
University of Newcastle, Priority Research Centre for Physical Activity and Nutrition, Level 3, ATC building, University Drive, Callaghan, NSW, 2308
Country 73507 0
Australia
Phone 73507 0
+61 2 4921 2049
Fax 73507 0
Email 73507 0
david.lubans@newcastle.edu.au
Contact person for scientific queries
Name 73508 0
Prof David R. Lubans
Address 73508 0
University of Newcastle, Priority Research Centre for Physical Activity and Nutrition, Level 3, ATC building, University Drive, Callaghan, NSW, 2308
Country 73508 0
Australia
Phone 73508 0
+61 2 4921 2049
Fax 73508 0
Email 73508 0
david.lubans@newcastle.edu.au

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

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