Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000632493
Ethics application status
Approved
Date submitted
10/12/2007
Date registered
12/12/2007
Date last updated
29/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Electronic Games to Aid Motivation to Exercise (eGAME)
Scientific title
Active Video Games to Improve Body Composition and Physical Activity in Children
Secondary ID [1] 253532 0
HRC 07-077B
Universal Trial Number (UTN)
Trial acronym
eGAME
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight/obese 2620 0
Condition category
Condition code
Public Health 2736 2736 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active video games (Sony EyeToy). Children will receive an upgrade to their existing gaming hardware. Observation over 6 months will establish use of the upgrade as well as associated changes to physical activity levels and body composition.
Intervention code [1] 2355 0
Behaviour
Comparator / control treatment
No active video games will be given. Children will continue with their existing gaming hardware. Standard treatment.
Control group
Active

Outcomes
Primary outcome [1] 3625 0
Change in BMI - Body Mass Index (kg/m2, z-score and centile) from baseline to 3 and 6 months.
Timepoint [1] 3625 0
Baseline, 3 months and 6 months.
Secondary outcome [1] 6070 0
Percent body fat (%)
Timepoint [1] 6070 0
Baseline, 3 months and 6 months.
Secondary outcome [2] 6071 0
Waist circumference (cm)
Timepoint [2] 6071 0
Baseline, 3 months and 6 months.
Secondary outcome [3] 6072 0
Physical fitness measured in VO2Max (ml/kg/min)
Timepoint [3] 6072 0
Baseline, 3 months and 6 months.
Secondary outcome [4] 6073 0
Physical Activity Questionnaire for Children score (self-report physical activity levels)
Timepoint [4] 6073 0
Baseline, 3 months and 6 months.
Secondary outcome [5] 6074 0
Average daily time spent in light to vigorous activities (minutes) as measured via accelerometry
Timepoint [5] 6074 0
Baseline, 3 months and 6 months.
Secondary outcome [6] 6075 0
Average daily time spent in active video games (minutes) (self-report)
Timepoint [6] 6075 0
Baseline, 3 months and 6 months.
Secondary outcome [7] 6076 0
Average daily time spent in non-active video games (minutes) (self-report)
Timepoint [7] 6076 0
Baseline, 3 months and 6 months.

Eligibility
Key inclusion criteria
Potential participants will be eligible to participate if they are =10 and <15 years, live in the greater Auckland area, own PlayStation2 or 3, play video games for 2 or more hours per week and are overweight according to Cole international cut-off values.
Minimum age
10 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Potential participants will be excluded if they already own active video games or have a medical condition that would prohibit exercise.

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)
Interested participants who meet all criteria and for whom consent/assent has been granted will undergo baseline assessment.
Following baseline data collection, consented participants will be randomly assigned to either active video gaming intervention or the control group by the Clinical Trials Research Unit (CTRU) central randomisation service. The researcher will access the CTRU central randomisation service to determine the randomisation allocation. The allocation sequence for randomisation is concealed up to the point of randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be stratified by sex (female and male) and preferred self-identified ethnicity (Maori, Pacific, and non-Maori non-Pacific) using stratified blocked randomisation with variable block sizes (multiple of 2).
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
330
Accrual to date
Final
Recruitment outside Australia
Country [1] 712 0
New Zealand
State/province [1] 712 0
Auckland

Funding & Sponsors
Funding source category [1] 2873 0
Government body
Name [1] 2873 0
Health Research Council
Country [1] 2873 0
New Zealand
Primary sponsor type
University
Name
Ralph Maddison
Address
Clinical Trials Research Unit (CTRU)
University of Auckland
Private Bag 92019
Auckland
Country
New Zealand
Secondary sponsor category [1] 2590 0
University
Name [1] 2590 0
Cliona Ni Mhurchu
Address [1] 2590 0
Clinical Trials Research Unit (CTRU)
University of Auckland
Private Bag 92019
Auckland
Country [1] 2590 0
New Zealand
Other collaborator category [1] 101 0
University
Name [1] 101 0
Andrew Jull
Address [1] 101 0
Clinical Trials Research Unit (CTRU)
University of Auckland
Private Bag 92019
Auckland
Country [1] 101 0
New Zealand
Other collaborator category [2] 102 0
University
Name [2] 102 0
Harry Prapavessis
Address [2] 102 0
School of Kinesiology
University of Western Ontario
Thames Hall/3M centre
London
Ontario N6A 3K7
Country [2] 102 0
Canada
Other collaborator category [3] 103 0
University
Name [3] 103 0
Yannan Jiang
Address [3] 103 0
Clinical Trials Research Unit (CTRU)
University of Auckland
Private Bag 92019
Auckland
Country [3] 103 0
New Zealand
Other collaborator category [4] 104 0
University
Name [4] 104 0
Anthony Rodgers
Address [4] 104 0
Clinical Trials Research Unit (CTRU)
University of Auckland
Private Bag 92019
Auckland
Country [4] 104 0
New Zealand
Other collaborator category [5] 105 0
University
Name [5] 105 0
Stephen Vander Hoorn
Address [5] 105 0
Clinical Trials Research Unit (CTRU)
University of Auckland
Private Bag 92019
Auckland
Country [5] 105 0
New Zealand
Other collaborator category [6] 106 0
University
Name [6] 106 0
David Schaff
Address [6] 106 0
Pacific Health
University of Auckland
Private Bag 92019
Auckland
Country [6] 106 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4813 0
Northern Y Ethics Committee
Ethics committee address [1] 4813 0
3rd floor, BNZ building
354 Victoria St
PO Box 1031
Hamilton
Ethics committee country [1] 4813 0
New Zealand
Date submitted for ethics approval [1] 4813 0
Approval date [1] 4813 0
31/10/2007
Ethics approval number [1] 4813 0
NTY/07/09/099

Summary
Brief summary
The main objective of this study is to determine the effects of active video games over 6 months on: body mass index (BMI), percent body fat, waist circumference, cardio-respiratory fitness, and physical activity levels in children.
Trial website
Trial related presentations / publications
Feasibility, design and conduct of a pragmatic randomized controlled trial to reduce overweight and obesity in children: The electronic games to aid motivation to exercise (eGAME) study
Ralph Maddison, Louise Foley, Cliona Ni Mhurchu, Andrew Jull, Yannan Jiang, Harry Prapavessis, Anthony Rodgers, Stephen Vander Hoorn, Maea Hohepa and David Schaaf BMC Public Health 2009, 9:146 (19 May 2009)

http://www.biomedcentral.com/1471-2458/9/146
Public notes

Contacts
Principal investigator
Name 28237 0
Address 28237 0
Country 28237 0
Phone 28237 0
Fax 28237 0
Email 28237 0
Contact person for public queries
Name 11394 0
Louise Foley
Address 11394 0
Clinical Trials Research Unit (CTRU)
University of Auckland
Private Bag 92019
Auckland
Country 11394 0
New Zealand
Phone 11394 0
64 9 3737599 x 84612
Fax 11394 0
Email 11394 0
[email protected]
Contact person for scientific queries
Name 2322 0
Ralph Maddison
Address 2322 0
Clinical Trials Research Unit (CTRU)
University of Auckland
Private Bag 92019
Auckland
Country 2322 0
New Zealand
Phone 2322 0
64 9 3737599 x 84767
Fax 2322 0
Email 2322 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
Dimensions AIActive video games: the mediating effect of aerobic fitness on body composition2012https://doi.org/10.1186/1479-5868-9-54
N.B. These documents automatically identified may not have been verified by the study sponsor.