Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618002034213
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 provided
19/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Active breaks in the classroom to improve thinking skills
Scientific title
Classroom-based active breaks for typically developing children's cognitive enhancement
Secondary ID [1] 296863 0
None
Universal Trial Number (UTN)
U1111-1225-4552
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sedentary behaviour 309609 0
Cognitive functions 309610 0
Condition category
Condition code
Mental Health 308429 308429 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ARM 1
Brief name: cognitively challenging active breaks.

Short description: teachers and children assigned to this group performed cognitively challenging active breaks in their classroom, twice a day for 5-6 weeks. The breaks were designed to last 4-5min. They consisted of physically active games combined with a cognitive task intended to challenge one or more executive functions (i.e., response inhibition, working memory and/or cognitive flexibility) of the participants.

ARM 2
Brief name: non-cognitively-challenging (or ‘simple’) active breaks
Short description: teachers and children assigned to this group performed non-cognitively-challenging active breaks in their classroom, twice a day for 5-6 weeks. The breaks were designed to last 4-5min and had similar intensity but low cognitive demand compared to Arm 1.

ARM 1 and ARM 2
Procedures: Three mainstream primary schools were recruited at convenience from greater Melbourne to participate in the study. Five classrooms (Grades 1 and 2), out of nine from two schools, were randomly assigned to Arm 1; the remaining four classrooms were assigned to Arm 2.
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 seven activities (different sets for each arm), designed to last between four and five minutes, and to use them to break up children’s 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 trial was conducted in October-December 2017 (school Term 4).

Activities: Arm 1 was required to perform the following activities: i) "My Clock is Late!" – an imitation of a coordination sequence with a time delay between teacher and children (Tomporowski, McCullick & Pesce, 2015); ii) "Silent ball Q&A" – children toss a ball to each other, each time the thrower asks a question to which the catcher has to answer; iii) "Simon says…" – Children perform the actions that are preceded by 'Simon says…', but do nothing in absence of that phrase; iv) "Robot remote control" – a stimulus-response game that requires children remember and perform the appropriate positions/actions associated to each of the teacher’s prompts; v) "One, two, three…star (+ moon, + sun)" – a game that requires children to quickly respond to the stimuli provided by the curator of the game (Tomporowski et al., 2015); vi) "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); vii) "Dance off!" – children dance over a music track and freeze their position every time the music stops.
Arm 2 was required to perform the following activities: 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) "Let’s dance!" – children dance for the duration of a fun music track.

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, 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] 312418 0
Prevention
Intervention code [2] 312419 0
Lifestyle
Intervention code [3] 312420 0
Behaviour
Comparator / control treatment
Control arm
One of the recruited schools (six classes – grade 1 and 2) 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. Please note that we could not randomly allocate this condition. One of the consenting schools agreed to participate in the study only if assigned to the passive control, because perceived that the trial could be too demanding for teachers.
Control group
Active

Outcomes
Primary outcome [1] 308419 0
Response inhibition was measured using a computer-based Go/No-Go task
Timepoint [1] 308419 0
baseline and 5-6 weeks after intervention commencement
Primary outcome [2] 308420 0
The proportion of oxy-/deoxy-haemoglobin in the prefrontal neocortex (i.e., brain activity) was measured via Artinis® single sensor functional Near-Infrared Spectroscopy (fNIRS), while performing a letter Go/No-Go task (i.e., click for all letters except 'X')
Timepoint [2] 308420 0
baseline and 5-6 weeks after intervention commencement
Primary outcome [3] 308421 0
Working memory score was measured using the iPad-based NIH Toolbox List Sorting Working Memory Test
Timepoint [3] 308421 0
baseline and 5-6 weeks after intervention commencement
Secondary outcome [1] 354913 0
Sitting time was measured with activPAL™ inclinometers (activity monitors)
Timepoint [1] 354913 0
baseline, 3 weeks and 5-6 weeks after intervention commencement. At each time point, children wore the inclinometers for two school days that did not inlcude physical education or school sports.
Secondary outcome [2] 354914 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] 354914 0
baseline, 3 weeks and 5-6 weeks after intervention commencement
Secondary outcome [3] 354915 0
Children’s enjoyment of the active breaks was assessed using a modified version of the Physical Activity Enjoyment Survey (PACES)
Timepoint [3] 354915 0
at 6 weeks after intervention commencement
Secondary outcome [4] 354916 0
Perceived physical exertion assessed using a pictorial scale for physical exertion
Timepoint [4] 354916 0
at 6 weeks after intervention commencement
Secondary outcome [5] 354917 0
Perceived mental effort assessed using a pictorial scale for mental exertion
Timepoint [5] 354917 0
at 6 weeks after intervention commencement

Eligibility
Key inclusion criteria
Children in Grade 1 and 2 mainstream schools
Minimum age
6 Years
Maximum age
9 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central ransomisation by computer (only intervention arms).
The allocation to intervention conditions was randomised: the classrooms of two schools were randomly assigned to cognitively challenging active breaks (Arm 1) or to non-cognitively-challenging active breaks (Arm 2). The school allocated to the control group was consented to participate after the randomisation was completed, therefore the passive control was not randomly allocated.
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 - only intervention arms)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Other
Other design features
Quasi-randomised allocation
Three mainstream primary schools consented to participate in the study. Five classrooms (Grades 1 and 2), out of nine from two schools, were randomly assigned to intervention Arm 1; the remaining four classrooms were assigned to intervention Arm 2. One of the consenting schools agreed to participate in the study only if assigned to the passive control; therefore, this study condition could not be randomly allocated.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All data will be processed and analysed using MATLAB (brain activity), 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, working memory, and brain activity) 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. Brain activity will be adjusted for the related cognitive performance. The sample size determination was based on previous studies; a power calculation was not conducted as this was a pilot study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
26/10/2017
Date of last participant enrolment
Anticipated
Actual
6/11/2017
Date of last data collection
Anticipated
Actual
21/12/2017
Sample size
Target
132
Accrual to date
Final
153
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 300644 0
Government body
Name [1] 300644 0
Department of Education and Training of Victoria
Country [1] 300644 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] 301121 0
None
Name [1] 301121 0
Address [1] 301121 0
Country [1] 301121 0
Other collaborator category [1] 280463 0
University
Name [1] 280463 0
Italian University of Sport and Movement 'Foro Italico'
Address [1] 280463 0
Via dei Robilant, 1, 00135 Rome
Country [1] 280463 0
Italy
Other collaborator category [2] 280464 0
Charities/Societies/Foundations
Name [2] 280464 0
Research Institute for Neuroscience, Education and Didactics, Patrizio Paoletti Foundation
Address [2] 280464 0
Via Cristoforo Cecci 2C, 06081 Santa Maria degli Angeli – Assisi (PG)
Country [2] 280464 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301433 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 301433 0
Ethics committee country [1] 301433 0
Australia
Date submitted for ethics approval [1] 301433 0
21/11/2016
Approval date [1] 301433 0
25/01/2017
Ethics approval number [1] 301433 0
2016-382

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

Contacts
Principal investigator
Name 86978 0
A/Prof Lisa Barnett
Address 86978 0
Deakin University – Institute for Physical Activity and Nutrition, Faculty of Health
221 Burwood Highway, Burwood VIC 3125
Country 86978 0
Australia
Phone 86978 0
+61 3 9244 6177
Fax 86978 0
Email 86978 0
[email protected]
Contact person for public queries
Name 86979 0
Emiliano Mazzoli
Address 86979 0
Deakin University – School of Health and Social Development, Faculty of Health
221 Burwood Highway, Burwood VIC 3125
Country 86979 0
Australia
Phone 86979 0
+61392468383 Ext.: 95393
Fax 86979 0
Email 86979 0
[email protected]
Contact person for scientific queries
Name 86980 0
Emiliano Mazzoli
Address 86980 0
Deakin University – School of Health and Social Development, Faculty of Health
221 Burwood Highway, Burwood VIC 3125
Country 86980 0
Australia
Phone 86980 0
+61392468383 Ext.: 95393
Fax 86980 0
Email 86980 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
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 it could be 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?




Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseBreaking up classroom sitting time with cognitively engaging physical activity: Behavioural and brain responses.2021https://dx.doi.org/10.1371/journal.pone.0253733
N.B. These documents automatically identified may not have been verified by the study sponsor.