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Trial registered on ANZCTR


Registration number
ACTRN12618002035202
Ethics application status
Approved
Date submitted
12/12/2018
Date registered
19/12/2018
Date last updated
19/12/2018
Date data sharing statement initially provided
19/12/2018
Date results information initially provided
19/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Active breaks in the classroom to improve thinking skills of non-typically developing children
Scientific title
Classroom-based active breaks for non-typically developing children's cognitive enhancement
Secondary ID [1] 296866 0
None
Universal Trial Number (UTN)
U1111-1225-4654
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sedentary behaviour 310779 0
Cognitive functions
310780 0
Condition category
Condition code
Mental Health 309461 309461 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: active breaks

Short description: teachers, and children, assigned to this group performed active breaks in their classroom to break up prolonged sitting twice a day (between 9:00 am and 11:00 am and between 11:30 am and 1:00 pm) for 5-6 weeks. The breaks were designed to last 4-5min.

Procedures: two special primary schools were recruited at convenience from greater Melbourne to participate in the study. Two classrooms (primary section), out of three from two schools, were randomly assigned the intervention; the remaining classroom acted as a control.

All teachers attended a one-off 20-min training on how to conduct active breaks in the classroom, including the rationale for research and a practical demonstration of the breaks. Teachers were asked to select the active breaks from a specific repertoire of 12 activities with a mixed level of cognitive demand (low-high), to help them select the ones that best suited children’s motor skills and cognitive abilities. The following activities were proposed: i) "Quick fit!" – a simple imitation of a movement sequence; ii) "Silent ball!" – children try to toss a light ball to each other without talking, making sounds or dropping the ball; iii) "As if…" – children enact the actions described in the sentences read by the teacher; iv) "Fitness dice" – children perform the activity associated with the result from a dice roll; v) "Over, Under, Around and Through" – children form lines of four/five and go over, under, around and through imaginary or real objects following their leader; vi) "3-speed car" – children pretend to be cars travelling at different speeds as suggested by the teacher; vii) "It’s a Zoo in Here!" – children pretend to be the animals called out by the teacher; viii) "Happy routine" – a simple routine of movements and streches; ix) "Simon says…" – Children perform the actions that are preceded by 'Simon says…', but do nothing in absence of that phrase; x) "One, two, three…star" – a game that requires children to quickly respond to the stimuli provided by the curator of the game (Tomporowski, McCullick & Pesce, 2015); xi) "Crazy traffic lights" – children are required to move or stop according to the visual signs presented by the teacher, disregarding the inconsistent verbal cues that the teacher will sometimes provide (Tomporowski et al., 2015); xii) "Dance off!" – children dance over a music track and freeze their position every time the music stops. The trial was conducted in February-March 2018 (school Term 1).

Resources: teachers were provided with an hard copy of a manual, including a description of the activities, specific instructions to be followed for each session, an activity log to record teacher’s daily progress, and suggestions on additional resources and equipment that could be used, as well as some equipment (i.e., a light-weight ball, visual cards, action prompts, dices and music).

Program deliverer(s): one researcher conducted the face-to-face trainings for teachers involved in the trial; teachers who completed the training implemented face-to-face active breaks with their children in the classroom.

Adaptations: the suggested teaching progression allowed teachers to modify the active breaks to match children’s skills. This was possible by applying at least one of the following: segmentation, modulation of interlimb coordination demand, and adjustments in the ratio between repetition and change. For example, teachers could break down the task to a fewer number of movement types (segmentation), simplify the type of motor tasks performed – e.g., jumping instead of hopping – (modulation of coordination demand) or increase the number of repetitions of each movement to allow children to have more time to synchronise with the whole group (adjustments in the ratio between repetition and change).

Adherence: the following strategies helped researchers to control for the fidelity to the program:
i) teachers were asked to complete an activity log to record the number and type of active breaks performed on each trial day; ii) one-on-one interviews were conducted with teachers at the end of the trial. Some of the interview questions related to fidelity to the program; iii) researchers incidentally observed teachers’ implementation of active breaks during in-class observations of children’s time on-task; iv) children’s sitting time collected at mid-trial was also considered as one measure of teacher’s adherence to the program.
Intervention code [1] 313140 0
Prevention
Intervention code [2] 313141 0
Lifestyle
Intervention code [3] 313142 0
Behaviour
Comparator / control treatment
One of the recruited classrooms acted as a control group. Teachers in the control group were not involved in any training sessions and were asked to continue with the usual school activities.
Control group
Active

Outcomes
Primary outcome [1] 308422 0
Response inhibition was measured using a computer-based Go/No-Go task.
Timepoint [1] 308422 0
baseline and 5-6 weeks after intervention commencement
Primary outcome [2] 308423 0
Inhibition control (interference) and attention score was measured with the iPad-based NIH Toolbox Flanker Inhibitory Control and Attention Test (composite score).
Timepoint [2] 308423 0
baseline and 5-6 weeks after intervention commencement
Primary outcome [3] 308424 0
Working memory score was measured using the iPad-based NIH Toolbox List Sorting Working Memory Test.
Timepoint [3] 308424 0
baseline and 5-6 weeks after intervention commencement
Secondary outcome [1] 354925 0
Sitting time measured with activPAL™ inclinometers (activity monitors). At each time point, children wore the inclinometers for two school days that did not inlcude physical education or school sports.
Timepoint [1] 354925 0
baseline, 3 weeks and 5-6 weeks after intervention commencement.
Secondary outcome [2] 354926 0
Time on-task was measured via systematic classroom observations. This required a researcher to sit quietly in a corner of the classroom for an hour and to observe six consenting children (selected at random) following the promps coming from a previously recorded audio file. Each child was observed for 10 seconds, after which the observed behaviour was noted down (5 seconds). After four consecutive observation intervals the next child was observed.
Timepoint [2] 354926 0
baseline, 3 weeks and 5-6 weeks after intervention commencement.

Eligibility
Key inclusion criteria
Children with neurodevelopmental disorder in primary special schools
Minimum age
8 Years
Maximum age
12 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Having a visual or auditory impairment. This would have not allowed the researchers to measure most of the primary outcomes, as the selected measures are not designed for children with these types of impairments. Having a physical impairment that does not allow children to participate to the breaks would also constitute an exclusion criterion.

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)
Central randomisation by computer using random.org.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
All data will be processed and analysed using Stata 15.0 and R. Linear regressions will be conducted to investigate the effects of the study condition on sitting/stepping. Regression/mixed models will be used to investigate the effects of sitting/stepping on each cognitive (response inhibition, interference/attention, and working memory) and behavioural (time 0n-task) outcomes. Each model will include the study condition and its interaction with sitting/stepping as predictors. All models will be adjusted for age and sex. The sample size determination was based on previous studies; a power calculation was not conducted as this was a pilot study.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 301436 0
Government body
Name [1] 301436 0
Department of Education and Training of Victoria
Address [1] 301436 0
2 Treasury Pl, East Melbourne VIC 3002
Country [1] 301436 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Melbourne Burwood Campus, 221 Burwood Highway, Burwood, VIC 3125
Country
Australia
Secondary sponsor category [1] 301122 0
None
Name [1] 301122 0
Address [1] 301122 0
Country [1] 301122 0
Other collaborator category [1] 280465 0
University
Name [1] 280465 0
Italian University of Sport and Movement 'Foro Italico'
Address [1] 280465 0
Via dei Robilant, 1, 00135 Rome
Country [1] 280465 0
Italy
Other collaborator category [2] 280466 0
Charities/Societies/Foundations
Name [2] 280466 0
Research Institute for Neuroscience, Education and Didactics, Patrizio Paoletti Foundation
Address [2] 280466 0
Via Cristoforo Cecci 2C, 06081 Santa Maria degli Angeli – Assisi (PG)
Country [2] 280466 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302170 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 302170 0
221 Burwood Highway, Burwood, VIC 3125
Ethics committee country [1] 302170 0
Australia
Date submitted for ethics approval [1] 302170 0
21/11/2016
Approval date [1] 302170 0
25/01/2017
Ethics approval number [1] 302170 0
2016-382

Summary
Brief summary
The aim of this study is to understand the impact of classroom-based active breaks on sitting time, cognitive functioning, brain activity and on-task behaviour in children with neurodevelopmental disorder.
Trial website
Trial related presentations / publications
Public notes
This project was funded by the Department of Education and Training of Victoria.

Contacts
Principal investigator
Name 89362 0
A/Prof Lisa Barnett
Address 89362 0
Deakin University – Institute for Physical Activity and Nutrition, Faculty of Health
221 Burwood Highway, Burwood Victoria 3125
Country 89362 0
Australia
Phone 89362 0
+61 3 9244 6177
Fax 89362 0
Email 89362 0
lisa.barnett@deakin.edu.au
Contact person for public queries
Name 89363 0
Mr Emiliano Mazzoli
Address 89363 0
Deakin University – School of Health and Social Development, Faculty of Health
221 Burwood Highway, Burwood Victoria 3125
Country 89363 0
Australia
Phone 89363 0
+61 3 9246 8383 Ext: 95393
Fax 89363 0
Email 89363 0
emiliano.mazzoli@deakin.edu.au
Contact person for scientific queries
Name 89364 0
Mr Emiliano Mazzoli
Address 89364 0
Deakin University – School of Health and Social Development, Faculty of Health
221 Burwood Highway, Burwood Victoria 3125
Country 89364 0
Australia
Phone 89364 0
+61 3 9246 8383 Ext: 95393
Fax 89364 0
Email 89364 0
emiliano.mazzoli@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data were collected for the purpose of this study. Researchers will report the findings in summary of the findings to key stakeholder organisations and participants, in appropriate peer-reviewed publications and in a PhD thesis. As approved by the Ethics committee and consented by the participants, the use of the data is specific to this project. In accordance with the National Health and Medical Research Council (NHMRC) and Deakin University recommendations, the data will be kept for five years from the date of last publication, after which they will be destroyed. Although possible, the use of this data for future research might require additional consent to be sought with participants.
What supporting documents are/will be available?
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 739 0
Ethical approval
Citation [1] 739 0
Link [1] 739 0
Email [1] 739 0
Other [1] 739 0
Type [2] 740 0
Informed consent form
Citation [2] 740 0
Link [2] 740 0
Email [2] 740 0
Other [2] 740 0
Plain Language Statement brochure to parents/guardians
Type [3] 741 0
Informed consent form
Citation [3] 741 0
Link [3] 741 0
Email [3] 741 0
Other [3] 741 0
Consent form to parents/guardians
Type [4] 742 0
Informed consent form
Citation [4] 742 0
Link [4] 742 0
Email [4] 742 0
Other [4] 742 0
Plain Language Statement and consent form to school principal
Type [5] 743 0
Informed consent form
Citation [5] 743 0
Link [5] 743 0
Email [5] 743 0
Other [5] 743 0
Plain Language Statement and consent form to teachers
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Yes
Other publication details
Citation type [1] 745 0
Report
Citation/DOI/link/details [1] 745 0
This was prepared to report the preliminary results of the study to key stakeholder organisations and participants.
Attachments [1] 745 0
Results – basic reporting
Results – plain English summary