ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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]

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)

Condition category

Condition code

Public Health

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]

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]

The primary outcome of the study is a decrease in body mass.

Timepoint [1]

Height and weight will be assessed at baseline and at the end of study (12-weeks).

Secondary outcome [1]

Changes in levels of physical activity.

Timepoint [1]

Participants will self-report physical activity (previous 7 days) at baseline and weeks 6 and 12.

Secondary outcome [2]

Objective measures of physical activity (using an accelorometer).

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health Research Council of New Zealand

Address [1]

Level 3, 110 Stanley Street, Auckland, New Zealand
Postal Address PO Box 5541, Wellesley Street, Auckland, New Zealand
Phone 64 9 303 5200
Fax 64 9 377 9988

Country [1]

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]

None

Name [1]

None

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Auckland

Ethics committee address [1]

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Cliona NiMhurchu

Address

Clinical Trials Reserach Unit
School of Population Health
University of Auckland
Private Bag 92109
Auckland

Country

New Zealand

Phone

+64 9 3737599 ext. 84494

Fax

+64 9 3731710

c.nimhurchu@ctru.auckland.ac.nz

Contact person for scientific queries

Name

Ralph Maddison

Address

Clinical Trials Reserach Unit
School of Population Health
University of Auckland
Private Bag 92109
Auckland

Country

New Zealand

Phone

+64 9 3737599 ext. 84767

Fax

+64 9 3731710

r.maddison@ctru.auckland.ac.nz

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically