Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000090516
Ethics application status
Approved
Date submitted
14/01/2015
Date registered
3/02/2015
Date last updated
13/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
iMove, iPlay: The physical implications of tablet computer use by young children
Scientific title
Movement of young children using tablet computers compared to free play and television: a within subject design
Secondary ID [1] 285969 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical activity 293901 0
sedentary behaviour 293902 0
musculoskeletal discomfort 293903 0
Condition category
Condition code
Musculoskeletal 294209 294209 0 0
Other muscular and skeletal disorders
Public Health 294210 294210 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
iPad2 (Apple, Cupertino, USA) with a range of age appropriate apps (including Peppa's Paintbox, and Playschool Playtime) and the apps will be selected based on a review and recommendation by the Australian Council on Children and the Media, will not include violence or gambling, and the name and description of the program and app will be given to parents for approval upon consent. The apps will be games designed for young children will include a pre-academic, or learning component. Children will complete the intervention individually (a single participant at a time). The iPad will be placed in the middle of the mat. Children will be instructed that they may move about the mat freely, but must stay on the mat. The research staff will supervise play for safety, but will not engage the child during play, with the exception of assistance being requested. The intervention condition will be a single 15 minute session. Between each condition, research staff with previous experience leading age-appropriate physical activities will lead an active dance break lasting for approximately 5 minutes.
Intervention code [1] 290945 0
Lifestyle
Intervention code [2] 291012 0
Behaviour
Comparator / control treatment
The iPad condition will be compared to two conditions which children will participate in individually: 1) traditional age appropriate toys to simulate free play environment with age-appropriate toys (e.g duplo blocks, arts & crafts, toy cars, puzzle), 2) television with a range of age appropriate programs. Prior to the toy condition, the research staff will introduce each toy and allow the child to ask any questions. Each condition will be a single 15 minutes session. Between each condition, research staff with previous experience leading age-appropriate physical activities will lead an active dance break lasting for approximately 5 minutes.
Control group
Active

Outcomes
Primary outcome [1] 293994 0
Physical Activity measured by actigraph accelerometers (hip & wrist) quantified as % of time spent in moderate to vigorous activity
Timepoint [1] 293994 0
During each 15 minute condition
Primary outcome [2] 293996 0
Muscle activity measured by surface myoelectric activity (sEMG) will be collected from the upper trapezius (UT) muscle. Mean and patterns of muscle activation (duration, breaks)
Timepoint [2] 293996 0
During each 15 minute condition
Primary outcome [3] 293997 0
Postural variation measured by Vicon (Oxford Metrics, inc., Oxford, U.K) three-dimensional motion analysis system, operated at 250Hz, will be utilised to collect participants’ head, trunk, and upper limb position, Mean and standard deviation of trunk, head, should, wrist angles
Timepoint [3] 293997 0
During each 15 minute condition
Secondary outcome [1] 312324 0
Gross Postures and postural variation measured through systematic observational coding of videotapes, % of time lying, sitting, standing
Timepoint [1] 312324 0
During each 15 minute condition

Eligibility
Key inclusion criteria
Participants will be included in the study if they are aged between 3 and 5 years and are able to complete the study protocol as outlined in the parent information sheet (including previous use of tablet computer as reported by parent).
Minimum age
3 Years
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they have a diagnosed disorder likely to impact their study participation, or illness around the time of data collection.

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)
Participants and their parents will complate all consent during an initial lab visit. Participants will participate in the three conditions in a balanced, randomized order.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization to the order of conditions will occur using a stratified block design, groups stratified by gender. Treatment order will be drawn from a selection of sealed envelopes with an equal number of possible treatment orders. Separate sets of sealed envelopes will be for boys and girls.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will be conducted using Stata/IC 13.0 for Windows (StataCorp LP, College Station TX, USA). Variables will be screened for normality using histograms and diagnostic measures, and non-normal variables will be transformed or analysed using non-parametric tests. Condition order effects will be tested and if significant, will be adjusted for in the model. Repeated measures, multilevel modelling will be used to test the difference in the dependent continuous variables (percentage of time in each physical activity intensity, trunk and head flexion angle means and standard deviations), and EMG activity between independent factor variables (three conditions).
The power calculation was based on two primary outcomes: physical activity from accelerometers and head and trunk angles from Vicon. Based upon the ICC of activity among preschool children of 0.81,21 a sample of 24 participants is needed to detect an effect size of 0.2 with resulting 85% power. A small effect size (Cohen’s d = 0.2) is assumed for studies on behavioural effects due to the subtleties of human performance. Straker et al. found an effect size of 0.25 in degrees of head flexion and 0.61 in trunk flexion when comparing tablet use to pen and paper use,(Straker et al., 2008) thus assuming a within subject correlation of 0.7, we would need 24 participants to detect this minimum difference with 80% power.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
27/01/2015
Date of last participant enrolment
Anticipated
30/04/2015
Actual
21/03/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 290552 0
University
Name [1] 290552 0
School of Physiotherapy and Exercise Science, Curtin University
Country [1] 290552 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
GPO Box U1987
Perth, Western Australia
6854
Country
Australia
Secondary sponsor category [1] 289246 0
None
Name [1] 289246 0
Address [1] 289246 0
Country [1] 289246 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292198 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 292198 0
Ethics committee country [1] 292198 0
Australia
Date submitted for ethics approval [1] 292198 0
Approval date [1] 292198 0
24/11/2014
Ethics approval number [1] 292198 0
RD-40-14

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

Contacts
Principal investigator
Name 54034 0
Dr Erin K Howie
Address 54034 0
Curtin University
GPO Box U1987
Perth, Western Australia
6854
Country 54034 0
Australia
Phone 54034 0
+61 8 9266 4660
Fax 54034 0
Email 54034 0
[email protected]
Contact person for public queries
Name 54035 0
Erin K Howie
Address 54035 0
Curtin University
GPO Box U1987
Perth, Western Australia
6854
Country 54035 0
Australia
Phone 54035 0
+61 8 9266 4660
Fax 54035 0
Email 54035 0
[email protected]
Contact person for scientific queries
Name 54036 0
Erin K Howie
Address 54036 0
Curtin University
GPO Box U1987
Perth, Western Australia
6854
Country 54036 0
Australia
Phone 54036 0
+61 8 9266 4660
Fax 54036 0
Email 54036 0
[email protected]

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

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseHead, trunk and arm posture amplitude and variation, muscle activity, sedentariness and physical activity of 3 to 5 year-old children during tablet computer use compared to television watching and toy play.2017https://dx.doi.org/10.1016/j.apergo.2017.05.011
N.B. These documents automatically identified may not have been verified by the study sponsor.