Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000662965
Ethics application status
Approved
Date submitted
19/10/2008
Date registered
29/06/2011
Date last updated
4/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of an interactive technology physical activity intervention in 8-12 year old children
Scientific title
A randomised crossover trial to determine the effectiveness of an interactive technology physical activity intervention compared to providing national physical activity guidelines information in children aged 8-12 years - pilot
Secondary ID [1] 262529 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity prevention 3843 0
type 2 diabetes prevention 3844 0
Condition category
Condition code
Public Health 268325 268325 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will undergo a crossover of two interventions in random order: i. provided with national physical activity guidelines pamphlet giving information about why physical activity is important, minimum activity guidelines of 60min/day and maximum electronic media guidelines of 2 hours, types of physical activities and where to get more information; ii. the same guidelines were used for participants to use the ipod to measure and monitor their daily and weekly progress towards these physical activity goals for 4 weeks. They captured the activity using an ipod and uploaded it to a website. The website and the ipod provided immediate feedback on activity progress towards the goal. There was no washout as both the intervention and control conditions were exposing participants to physical activity based on the national physical activity guidelines, just using different mechanisms.
Intervention code [1] 3570 0
Other interventions
Comparator / control treatment
national physical activity guideline information was provided in the form of the downloadable brochure available on the website. Participants were advised to meet the weekly guidelines for a 4-week period.
Control group
Active

Outcomes
Primary outcome [1] 4937 0
Amount of daily/weekly physical activity completed. Measured via an ipod, accelerometer, questionnaire
Timepoint [1] 4937 0
after 4 weeks and 8 weeks
Primary outcome [2] 4938 0
a process evaluation on the ease of use of the technology and any difficulties experienced examined via questionnaire.
Timepoint [2] 4938 0
after 4 weeks and 8 weeks
Secondary outcome [1] 8323 0
habitual physical activity and sedentary behaviour measured via questionnaire asking about transport to school, tv and computer use, lunchtime activities and perception of amount of physical activity.
Timepoint [1] 8323 0
after 4 weeks and 8 weeks
Secondary outcome [2] 8324 0
anthropometric measures (height, weight, body mass index, waist circumference). Measured using stadiometer, scales and tape measure
Timepoint [2] 8324 0
after 4 weeks and 8 weeks

Eligibility
Key inclusion criteria
8-12 years
Minimum age
8 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
cognitive impairment preventing understanding of the intervention instructions and use of technology. physical inability to walk

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)
After baseline testing, concealed randomised cross-over. Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated randomisation stratified for gender
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4024 0
University
Name [1] 4024 0
RMIT University
Country [1] 4024 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
Plenty Road, Bundoora, VIC 3083
Country
Australia
Secondary sponsor category [1] 3617 0
None
Name [1] 3617 0
Address [1] 3617 0
Country [1] 3617 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6104 0
RMIT Human Ethics Committee
Ethics committee address [1] 6104 0
GPO Box 2476 V
melbourne
VIC 3001
Ethics committee country [1] 6104 0
Australia
Date submitted for ethics approval [1] 6104 0
Approval date [1] 6104 0
15/09/2008
Ethics approval number [1] 6104 0
HREC 34/08

Summary
Brief summary
a pilot study to determine if 8-12 year olds are able to use a technology based physical activity intervention to increase activity levels and work towards individualised goals each week compared with usual public health information available in the form of a pamphlet.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29049 0
Address 29049 0
Country 29049 0
Phone 29049 0
Fax 29049 0
Email 29049 0
Contact person for public queries
Name 12206 0
Dr Amanda Benson
Address 12206 0
Plenty Road
RMIT University
Bundoora, VIC 3083
Country 12206 0
Australia
Phone 12206 0
+61 3 99257677
Fax 12206 0
Email 12206 0
[email protected]
Contact person for scientific queries
Name 3134 0
Dr Amanda Benson
Address 3134 0
Plenty Road
RMIT University
Bundoora, VIC 3083
Country 3134 0
Australia
Phone 3134 0
+61 3 99257677
Fax 3134 0
Email 3134 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.