Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000279224
Ethics application status
Approved
Date submitted
9/03/2009
Date registered
15/05/2009
Date last updated
14/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does access to electronic games decrease physical activity in children?
Scientific title
Among children, does access to electronic games decrease physical activity?
Secondary ID [1] 259977 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insufficient physical activity 4440 0
Condition category
Condition code
Other 4708 4708 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
Public Health 5033 5033 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3 conditions, each of 8 weeks duration, children proceed directly from one condition to the next - with a balanced order across participants:
1) no electronic games - children have no home access to electronic game consoles and are requested to avoid other electronic game playing
2) traditional input electronic games - children are provided with a PlayStation2 console, game pad input device and a rangae of non violent games, amount of game playing is at family's discretion with guideline of a maximum of 2 hours per day leisure screen time
3) active input electronic games, children are provided with a PlayStation2 console and EyeToy and dancemat input devices and a range of non violent games, amount of game playing is at family's discretion with guideline of a maximum of 2 hours per day leisure screen time
Intervention code [1] 4186 0
Lifestyle
Comparator / control treatment
no electonic games - electronic games console removed from house and children asked to avoid all electronic game playing
Control group
Active

Outcomes
Primary outcome [1] 5576 0
physical activity - as assessed by Actical accelerometers worn for one week on both wrist and hip. This provides the amount of time at sedentary, light, moderate and vigorous levels of physical activity
Timepoint [1] 5576 0
at end of each 8 week condition
Secondary outcome [1] 9395 0
energy expenditure - as assessed by Doubly Labelled Water (DLW) technique - dose of DLW given and urine samples collected for 11 days
Timepoint [1] 9395 0
at end of each 8 week condition
Secondary outcome [2] 9396 0
self-perceived competence - assessed using self report Harter's Self Perception Profile for Children (Harter 1985)
Timepoint [2] 9396 0
at end of each 8 week condition
Secondary outcome [3] 9397 0
attitudes to technology - assesse using self-report for 'flow' (Webster et al 1993), 'ease of use' and 'usefulness of technology' (Dean et al 1998)
Timepoint [3] 9397 0
at end of each 8 week condition
Secondary outcome [4] 9398 0
motor competence - assessed by the Movement Assessment Battery for Children (MABC) version 2 (Henderson et al 2007)
Timepoint [4] 9398 0
at end of each 8 week condition
Secondary outcome [5] 9399 0
adiposity - assessed by body fat estimates from DLW, waist girth and body mass index (BMI) (age and gender adjusted z-scores)
Timepoint [5] 9399 0
at end of each 8 week condition
Secondary outcome [6] 9400 0
other leisure activities - assessed by self-report 7 day diary based on previous day physical activity recall (PDPAR) (Anderson et al. 2005)
Timepoint [6] 9400 0
at end of each 8 week condition

Eligibility
Key inclusion criteria
range of motor competence
range of electronic game experience
Minimum age
10 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
physical or psychological impairments which would interfere with their ability to participate in trial

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)
sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Elligible volunteers participate in all three conditions. Order is balanced across participants
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/04/2009
Actual
1/05/2009
Date of last participant enrolment
Anticipated
Actual
7/06/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 4633 0
Government body
Name [1] 4633 0
National Health and Medical Research Council
Country [1] 4633 0
Australia
Primary sponsor type
University
Name
Curtin University of Technology
Address
GPO Box U1987
Perth 6846
Country
Australia
Secondary sponsor category [1] 4177 0
None
Name [1] 4177 0
Address [1] 4177 0
Country [1] 4177 0
Other collaborator category [1] 604 0
University
Name [1] 604 0
The University of Queensland
Address [1] 604 0
St Lucia
Queensland
4072
Country [1] 604 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6671 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 6671 0
Ethics committee country [1] 6671 0
Australia
Date submitted for ethics approval [1] 6671 0
06/03/2009
Approval date [1] 6671 0
16/03/2009
Ethics approval number [1] 6671 0
HR131/2006

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

Contacts
Principal investigator
Name 29368 0
Prof Leon Straker
Address 29368 0
School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987
Perth WA 6845
Australia
Country 29368 0
Australia
Phone 29368 0
+61 8 9266 3634
Fax 29368 0
Email 29368 0
[email protected]
Contact person for public queries
Name 12615 0
Professor Leon Straker
Address 12615 0
School of Physiotherapy
Curtin University of Technology
GPO Box U1987
Perth WA 6845
Country 12615 0
Australia
Phone 12615 0
+61 8 9266 3634
Fax 12615 0
Email 12615 0
[email protected]
Contact person for scientific queries
Name 3543 0
Professor Leon Straker
Address 3543 0
School of Physiotherapy
Curtin University of Technology
GPO Box U1987
Perth WA 6845
Country 3543 0
Australia
Phone 3543 0
+61 8 9266 3634
Fax 3543 0
Email 3543 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
EmbaseRationale, design and methods for a randomised and controlled trial to investigate whether home access to electronic games decreases children's physical activity.2009https://dx.doi.org/10.1186/1471-2458-9-212
EmbaseTeaching our children to sit or be active? Sedentary behavior, light activity and moderate/vigorous activity at and away from school.2012https://dx.doi.org/10.1016/j.jsams.2012.11.680
N.B. These documents automatically identified may not have been verified by the study sponsor.