Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000018516
Ethics application status
Approved
Date submitted
10/01/2006
Date registered
11/01/2006
Date last updated
29/11/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Electronic Games to Aid Motivation to Exercise (eGAME) Pilot Phase
Scientific title
A pilot study to test the feasibility of a large randomised controlled trial to assess the effectiveness of active video games to increase physical activity and decrease body mass in children.
Secondary ID [1] 273468 0
HRC
Universal Trial Number (UTN)
Trial acronym
eGAME
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy children (Childrens' body mass and physical activity) 979 0
Condition category
Condition code
Public Health 1054 1054 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will compare the effect of an active video game upgrade (EyeToy) of PlayStation2 to standard PlayStation2 video gaming. Specifically, participants will be randomly allocated to an an active video upgrade for a period of 12 weeks. A repeated measures design will ensure participants are assessed at 3 time points over the 12 weeks of the study.
Intervention code [1] 831 0
Behaviour
Comparator / control treatment
The control group will not receive the upgrade and will continue to play their current library of non-active games.
Control group
Active

Outcomes
Primary outcome [1] 1409 0
The primary outcome of the study is a decrease in body mass.
Timepoint [1] 1409 0
Height and weight will be assessed at baseline and at the end of study (12-weeks).
Secondary outcome [1] 2495 0
Changes in levels of physical activity.
Timepoint [1] 2495 0
Participants will self-report physical activity (previous 7 days) at baseline and weeks 6 and 12.
Secondary outcome [2] 2496 0
Objective measures of physical activity (using an accelorometer).
Timepoint [2] 2496 0
Assessed at baseline and weeks 6 and 12.

Eligibility
Key inclusion criteria
Pilot Study • Is a child aged between 10 and 14 years• Owns a video gaming console (Playstation2)• Able to give written informed assent to participate in the study• Parent or guardian/caregiver over the age of 18 years able to provide written informed consent• Must be able to communicate in English
Minimum age
10 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants are ineligible if they:• Own and play PlayStation EyeToy video games• Have participated in a previous phase of the study • Have a medical condition which limits their ability to exercise safely.

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)
Randomisation will be performed centrally through the central CTRU service and reserachers will telephone the centre for allocation sequence
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence generation is performed through SAS and is stratified according to gender
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 256 0
New Zealand
State/province [1] 256 0

Funding & Sponsors
Funding source category [1] 1151 0
Government body
Name [1] 1151 0
Health Research Council of New Zealand
Country [1] 1151 0
New Zealand
Primary sponsor type
University
Name
Clinical Trials Research Unit
Address
Private Bag 92019, Auckland Mailing Centre Auckland, NZ
Country
New Zealand
Secondary sponsor category [1] 1013 0
None
Name [1] 1013 0
None
Address [1] 1013 0
Country [1] 1013 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2474 0
Auckland
Ethics committee address [1] 2474 0
Ethics committee country [1] 2474 0
New Zealand
Date submitted for ethics approval [1] 2474 0
Approval date [1] 2474 0
Ethics approval number [1] 2474 0

Summary
Brief summary
Twenty children were randomised: 10 received an active video game upgrade package and 10 received no intervention. Follow-up data were available for all study participants (100%). On average, study participants were 12 (SD 1.5) years of age and 40% were female. Their mean baseline BMI was 19.7 (SD 3.6) kg/m2 and they played an average of 80 (SD 72) minutes of electronic games per day.
Video game playing

Over the 12-week intervention period, children in the intervention group spent less total time playing all video games compared to those in the control group (54 versus 98 minutes/day [difference = -44 minutes/day, 95% CI [-92, 2]], p = 0.06). Children in the intervention group also tended to spend more time playing active video games compared to those in the control group (41 compared with 27 minutes/day [difference = 14 minutes/day, 95% CI [-15, 43], p = 0.3). The average time spent playing inactive games in the intervention group was significantly lower compared to the control group (47 versus 99 minutes/day [difference = -52 minutes/day, 95% CI [-101, -2]], p = 0.04).
Physical activity levels

On average participants provided 12.1 hours (SD 1.4) of activity count data per day. Physical activity (counts per minute) measured with an accelerometer was higher in the active video game intervention group compared to the control group (mean difference at 6 weeks = 194 counts/min [95% C.I. 32, 310], p = 0.04, and at 12 weeks = 48 counts/min [95% C.I. -153, 187], p = 0.6). There were no significant differences in time spent in moderate and vigorous physical activities between the two groups as measured by accelerometer (p > 0.4), record (p > 0.3), or mean PAQ-C (p > 0.3) scores. When all activity time was combined (light, moderate, and vigorous), boys were more active than girls (p < 0.05).
Waist circumference and BMI

Encouraging trends in the intervention group towards reductions in weight and waist circumference were observed. The mean difference in body weight between groups from baseline to 12 weeks was -0.13 kg (95% C.I. -1.97, 1.7), p = 0.9, while the mean difference in waist circumference between groups from baseline to 12 weeks was -1.4 cm (95% C.I. -2.68, -0.04), p = 0.04. However, the pilot study was not adequately powered to detect differences in anthropometric outcomes.
Trial website
Trial related presentations / publications
Ni Mhurchu, C., Maddison, R., Jull, A., Jiang, Y., Prapavessis, H., Rodgers, A. (2008). From Couch Potatoes to Jumping Beans: A Pilot Study of the Effect of Active Video Games on Physical Activity in Children. International Journal of Behavioural Nutrition and Physical Activity, 5:8 (7 February 2008).

Maddison, R., Ni Mhurchu, C., Jull, A., Jiang, Y., Prapavessis, H., Rodgers, A. (2007). Energy Expended Playing Video Console Games: An Opportunity to Increase Children’s Physical Activity? Pediatric Exercise Science, 19(3); 334-343.
Public notes

Contacts
Principal investigator
Name 35368 0
Address 35368 0
Country 35368 0
Phone 35368 0
Fax 35368 0
Email 35368 0
Contact person for public queries
Name 10020 0
Cliona NiMhurchu
Address 10020 0
Clinical Trials Reserach Unit
School of Population Health
University of Auckland
Private Bag 92109
Auckland
Country 10020 0
New Zealand
Phone 10020 0
+64 9 3737599 ext. 84494
Fax 10020 0
+64 9 3731710
Email 10020 0
[email protected]
Contact person for scientific queries
Name 948 0
Ralph Maddison
Address 948 0
Clinical Trials Reserach Unit
School of Population Health
University of Auckland
Private Bag 92109
Auckland
Country 948 0
New Zealand
Phone 948 0
+64 9 3737599 ext. 84767
Fax 948 0
+64 9 3731710
Email 948 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
No additional documents have been identified.