Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000602325
Ethics application status
Approved
Date submitted
13/04/2017
Date registered
27/04/2017
Date last updated
2/07/2019
Date data sharing statement initially provided
2/07/2019
Date results provided
2/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of the ACTI-BREAK program to improve academic and physical activity related outcomes in Victorian primary school children
Scientific title
The ACTI-BREAK program: a pilot cluster randomised controlled trial of the effect of a primary school active break program on classroom behaviour and academic achievement
Secondary ID [1] 291581 0
None
Universal Trial Number (UTN)
U1111-1194-9033
Trial acronym
ACTI-BREAK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical activity in children 302739 0
Condition category
Condition code
Public Health 302254 302254 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A behavioural intervention targeting increasing academic and physical activity outcomes in children in Years 3 and 4 attending 3 x middle socio-economic position Government primary schools across Melbourne, Australia. The ACTI-BREAK program encourages teachers to implement 5-minute moderate-intensity active breaks 3 times daily in their classrooms for 6 weeks. Scheduling of active breaks will be determined by teachers delivering the program.

The ACTI-BREAK activities were selected to be of moderate physical activity intensity, age appropriate and include a variety (n=30) of active break options with suggested modifications for easier or more challenging activities. ACTI-BREAK activities incorporate drama (e.g. jog on the spot as if a big scary bear is chasing you), games (e.g. musical chairs), following instructions (e.g. when the music stops, touch 10 chairs in a row), and technology/websites (e.g. GoNoodle and YouTube). An important element of the ACTI-BREAK program is that the activities do not require any set up and only use equipment already available in classrooms (e.g. music).

Teacher training session
At each intervention school, all teachers of Years 3 and 4 will participate in a one-off 45-minute face-to face training session approximately one week prior to implementing the ACTI-BREAK program. The session will be conducted on school grounds at a convenient time for teachers and will be delivered by the researcher who is a qualified and experienced primary school teacher. The training session is designed to inspire and equip the teachers with the necessary skills and knowledge to be able to implement the ACTI-BREAK program in their classrooms. This training session will include a rationale for adding active breaks to the classroom routine, current research evidence highlighting the potential positive effect of active breaks on academic-related outcomes, explanation of the ACTI-BREAK program and what they are required to do, and demonstrations of a range of the ACTI-BREAK activities. At the completion of the training session, teachers will be provided with intervention materials including the ACTI-BREAK program prompt cards, and classroom timers.

Intervention fidelity
Teachers will be required to complete logs of the ACTI-BREAKS they complete over the duration of the intervention. Children will also wear accelerometers mid-way through the intervention (week 3) and at the end of the intervention (week 6). Accelerometer data will be compared with teacher logs of ACTI-BREAKS completed during week 3, and week 6 of the intervention to monitor whether the ACTI-BREAKS are conducted at suitable physical activity intensity (moderate physical activity intensity).
Intervention code [1] 297647 0
Behaviour
Intervention code [2] 297809 0
Lifestyle
Comparator / control treatment
A current practice control arm consisting of grade 3 and 4 classes at 3 schools of similar socio-economic position will form the comparison group. These schools will continue with their usual teaching practices.
Control group
Active

Outcomes
Primary outcome [1] 301622 0
Reading achievement
Reading achievement will be assessed using the Wheldall Assessment of Reading Passages (WARP) Test. This curriculum-based measure, designed for the Australian school context, is designed to track reading fluency of students in Years 2 to 5, and involves children reading for 1-minute from a 200 word passage. The number of words read correctly in that minute is a measure of the student’s level of reading fluency. Reading fluency has been shown to be a powerful predictor of reading performance, with meta-analytic results showing a strong correlation between curriculum-based measures of reading fluency and other standardised tests of reading performance (r=0.67). The WARP Test includes a set of 3 initial assessment passages and a set of 10 progress monitoring passages. On advice from the instrument author, the progress monitoring passages were chosen for the current study, as they can be expected to be sensitive to change over the 6-week intervention period. The 10 progress-monitoring passages correlate very highly to each other in terms of reading difficulty (r=0.95-0.98). Thus, to eliminate potential learning effects, a different passage will be administered at baseline and end intervention, and were chosen based on advice from the author. A researcher with a primary school teaching qualification and experience will administer this test individually to each student with parent consent, at baseline and end of intervention.
Timepoint [1] 301622 0
Baseline and end of intervention (week 6)
Primary outcome [2] 301665 0
Mathematics achievement
Achievement in mathematics will be assessed using the Westwood One Minute Tests of Basic Number Facts, reproduced with permission from the Australian Council for Educational Research. This tool consists of four One Minute Basic Number Facts Tests, designed for the Australian school context. Each test has 33 items that focus on one of each of the following number operations: addition, subtraction, multiplication and division. This test has good test-retest reliability (0.88 to 0.94 depending on age level). To ensure alignment with the Year 3 and 4 curriculum early in the school year, and therefore potential to observe improvement, the subtraction test was chosen for this study. A researcher with a primary school teaching qualification and experience will administer this test to the whole class at baseline and end of intervention. Only data from students with parent consent will be used in the analyses.
Timepoint [2] 301665 0
Baseline and end of intervention (week 6)
Secondary outcome [1] 333479 0
Physical activity
Waist-worn ActiGraph accelerometers will be used to provide an objective measure of physical activity across the school day. The ActiGraph accelerometer is commonly used in studies involving children and has documented evidence of validity and reliability for measuring children’s moderate- to vigorous- physical activity. Accelerometers will be worn during waking hours for 7 consecutive days at baseline, mid-intervention (intervention group only) and end of the intervention period (week 6). Measures will be taken in last week of the intervention, rather than post intervention as the intervention is intended to have acute effects.
Participants’ physical activity will be included for analysis if they wear the accelerometer for at least five school hours on at least one school day, as used in similar studies. Freedson cut-points will be used to classify physical activity as light, moderate or vigorous. Data will be collected in 15-second epochs and non-wear time will be defined at 20 minutes of consecutive zero’s.
Timepoint [1] 333479 0
Baseline, mid (week 3; intervention schools only) and end of intervention (week 6)
Secondary outcome [2] 334208 0
Classroom behaviour (individual)
Information will be collected on student classroom behaviour at the individual level for those students with parent consent, As classroom behaviour can vary as a function of time of day, each class teacher will be required to record all observations of classroom behaviour at a consistent time each day. Classroom behaviour at the individual level will be measured using a tool adopted from the Direct Behaviour Rating Scale. The Direct Behaviour Rating Scale is a hybrid of direct observation and behaviour rating scales, and provides a valid measure of classroom behaviour, when compared with direct observation (r = 0.81 to 0.87). This observation tool requires teachers to indicate for each child, on a scale from 1 (0%) to 10 (100%), the percentage of time they are academically engaged (i.e. listening to the teacher, writing, looking at instructional materials, etc.) during the observation period.

Teachers at intervention and control schools will be required to observe behaviour during a 10-minute observation period during a seated lesson at 3 time points at baseline and again at the end (week 6) of the intervention. In addition, teachers at intervention schools will be required to record observations of behaviour during a 10-minute observation period immediately before and immediately after participation in an ACTI-BREAK at three time points during week 3 of the intervention. This pre-post measure will enable the acute effect of active breaks on classroom behaviour to be explored.

Timepoint [2] 334208 0
Baseline, mid (week 3; intervention schools only) and end of intervention (week 6)
Secondary outcome [3] 334209 0
Classroom behaviour (group)
Information will be collected on student classroom behaviour at the whole class level (no identifying information will be retained). Behaviour at the whole class level will be measured using a modified version of the Classroom Behaviour and Assets Survey-Teacher (CBAST), which is designed to efficiently provide a snapshot of the teacher’s perception of the behaviour of a whole class of students. A modified version of this tool has been used in similar studies. For the current study, teachers will be required to indicate the proportion of the class displaying on-task behaviour (as defined in the individual behaviour assessment tool), during the observation period. Response options include: 0 (0 students), 1 (1–2 students), 2 (a few students), 3 (about ¼ of the class), 4 (about ½ of the class), 5 (about ¾ of the class), 6 (most of the class), and 7 (all of the class).

Teachers at intervention and control schools will be required to observe behaviour during a 10-minute observation period during a seated lesson at 3 time points at baseline and again at the end (week 6) of the intervention. In addition, teachers at intervention schools will be required to record observations of behaviour during a 10-minute observation period immediately before and immediately after participation in an ACTI-BREAK at three time points during week 3 of the intervention. This pre-post measure will enable the acute effect of active breaks on classroom behaviour to be explored.
Timepoint [3] 334209 0
Baseline, mid (week 3; intervention schools only) and end of intervention (week 6)

Eligibility
Key inclusion criteria
Participants will be children in Years 3 or 4 at participating schools
Minimum age
7 Years
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded from analyses if they have a diagnosed behaviour or learning disorder

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)
Schools will be randomly selected and enrolled in the study.Teachers of Year 3 and 4 classes will be enrolled in the study, and all students in these classes will be invited to participate in the study. Random allocation to intervention or control group at the school level will occur after enrolment in the study but prior to baseline measures. Allocation concealment will be carried out via computer program, by a researcher who has no involvement with schools or participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All statistical analysis will be conducted using Stata 14.0. Multilevel mixed-effects linear regression models will be used to assess the impact of group (intervention vs. control) on achievement scores in reading and mathematics, mean percent of time in on-task behaviour, and physical activity level at the end of the intervention, each adjusted for baseline levels of the corresponding variable and clustering by class. The fixed effect of school will be added to the model to account for the unit of randomisation. All analyses will be stratified by sex. Alpha levels will be set at p<0.05. As this is a pilot study, the intervention will not be adequately powered to detect small changes between groups. Instead, trends in the associations will be investigated. Analyses will be conducted both on the intention-to-treat approach, and per protocol analysis (using data from fidelity checks).


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/02/2017
Date of last participant enrolment
Anticipated
15/05/2017
Actual
17/05/2017
Date of last data collection
Anticipated
30/06/2017
Actual
30/06/2017
Sample size
Target
400
Accrual to date
Final
374
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 296104 0
University
Name [1] 296104 0
Deakin University
Country [1] 296104 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
School of Exercise and Nutrition Sciences, Faculty of Health
221 Burwood Hwy, BURWOOD VIC 3125
Country
Australia
Secondary sponsor category [1] 294962 0
None
Name [1] 294962 0
Address [1] 294962 0
Country [1] 294962 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297325 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 297325 0
Ethics committee country [1] 297325 0
Australia
Date submitted for ethics approval [1] 297325 0
25/01/2016
Approval date [1] 297325 0
21/03/2016
Ethics approval number [1] 297325 0
2016-020
Ethics committee name [2] 297378 0
Victorian Department of Education and Training
Ethics committee address [2] 297378 0
Ethics committee country [2] 297378 0
Australia
Date submitted for ethics approval [2] 297378 0
22/01/2016
Approval date [2] 297378 0
22/03/2016
Ethics approval number [2] 297378 0
2016_002962

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

Contacts
Principal investigator
Name 73714 0
Miss Amanda Watson
Address 73714 0
Institute for Physical Activity and Nutrition
School of Exercise and Nutrition Sciences, Faculty of Health
221 Burwood Highway, Burwood, VIC 3125
Country 73714 0
Australia
Phone 73714 0
+61 3 92468383 ext. 95320
Fax 73714 0
Email 73714 0
[email protected]
Contact person for public queries
Name 73715 0
Amanda Watson
Address 73715 0
Institute for Physical Activity and Nutrition
School of Exercise and Nutrition Sciences, Faculty of Health
221 Burwood Highway, Burwood, VIC 3125
Country 73715 0
Australia
Phone 73715 0
+61 3 92468383 ext. 95320
Fax 73715 0
Email 73715 0
[email protected]
Contact person for scientific queries
Name 73716 0
Kylie Hesketh
Address 73716 0
Institute for Physical Activity and Nutrition
School of Exercise and Nutrition Sciences, Faculty of Health
221 Burwood Highway, Burwood, VIC 3125
Country 73716 0
Australia
Phone 73716 0
+61 3 92446812
Fax 73716 0
Email 73716 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2712Study protocolWatson A, Timperio A, Brown H, Hesketh KD. A primary school active break programme (ACTI-BREAK): study protocol for a pilot cluster randomised controlled trial. Trials. 2017;18(1):433.https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2163-5 



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA pilot primary school active break program (ACTI-BREAK): Effects on academic and physical activity outcomes for students in Years 3 and 4.2019https://dx.doi.org/10.1016/j.jsams.2018.09.232
N.B. These documents automatically identified may not have been verified by the study sponsor.