Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000253909
Ethics application status
Approved
Date submitted
7/03/2011
Date registered
8/03/2011
Date last updated
7/04/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
WALK 2.0: Using Web 2.0 applications to promote health related physical activity
Scientific title
Comparing a Web 1.0 and 2.0 promotion website on retention and physical activity levels in low-active adults: An Ecological trial
Secondary ID [1] 259671 0
nil
Universal Trial Number (UTN)
U111-1119-1755
Trial acronym
Walk 2.0
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical Inactivity 261241 0
Condition category
Condition code
Public Health 259387 259387 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The efficacy of the web 2.0 physical activity intervention will be tested initially in a randomised controlled trial (ACTRN12611000157976). The ecological trial will complement the randomised controlled trial by providing additional information about the recruitment and retention capabilities of the intervention using a self-selected sample of real-world users of an existing health promotion website. Since 2007, the 10,000 Step website has averaged approximately 1,000 new registrants per month. During the recruitment phase of the ecological trial, all individuals who register, of their own impetus, with the online program will be presented with an option to participate in the study and provide informed consent.

The primary intervention group will receive access to an interactive website with web 2.0 content including streams, social media connectivity and other innovative content. 1447 participants will be recruited to this group.

Participants' interactions with the website will be monitored for the duration of the project (1 year). Time spent interacting with the website is self-selected and internet engagement (number of hits, session duration) will be monitored and, combined with self-reported physical activity patterns, used to examine utility of the site in promoting physical activity.
Intervention code [1] 258099 0
Behaviour
Intervention code [2] 264172 0
Lifestyle
Comparator / control treatment
The comparison group will receive access to an existing website with web 1.0 content. This website will consist of basic features allowing participants to record their physical activity, access health information and communicate with other users of the web 1.0 platform via a forum. 1447 participants will be recruited to this group.

Participants' interactions with the website will be monitored for the duration of the project (1 year). Time spent interacting with the website is self-selected and internet engagement (number of hits, session duration) will be monitored and, combined with self-reported physical activity patterns, used to examine utility of the site in promoting physical activity.
Control group
Active

Outcomes
Primary outcome [1] 262221 0
The primary outcome measure will be physical activity, measured by the Active Australia survey instrument and completed by means of an online administration to all trial participants.
Timepoint [1] 262221 0
At baseline and at 3 months and 1 year
Secondary outcome [1] 273349 0
The secondary outcome measure will be self reported Body Mass Index (BMI). Information regarding height and weight will be collected from all trial participants by means of online survey.
Timepoint [1] 273349 0
At baseline and at 3 months and 1 year
Secondary outcome [2] 273454 0
Internet engagement will be measured through the number of hits that a user registers and the mean session duration.
Timepoint [2] 273454 0
At baseline and at 3 months (as a minimum) and 1 year.

Eligibility
Key inclusion criteria
Volunteers will be eligible to participate in the study if:

1) they are ambulatory
2) they are able to read and/or speak English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Volunteers will be excluded from participating in the study if:

1) they are engaged in more than 150 minutes of moderate physical activity on 5 or more days of the week.
2) they are under 18 years of age

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants involved in the Walk 2.0 RCT (ACTRN12611000157976) will not be allocated to either condition in this study. The ecological trial will be conducted using a self-selected sample of real-world users of an existing health promotion website. Since 2007, the 10,000 Step website has averaged approximately 1,000 new registrants per month. During the recruitment phase of the ecological trial all individuals who register, on their own impetus, with the online program will be presented with an option to participate in the study and provide informed consent. On electing to participate, users will be randomly allocated to the intervention (Web 2.0) or comparator (Web 1.0) groups by computer generated algorithm.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking 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
1/10/2011
Actual
27/11/2012
Date of last participant enrolment
Anticipated
30/06/2014
Actual
30/06/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
2894
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258558 0
Government body
Name [1] 258558 0
National Health and Medical Research Council
Country [1] 258558 0
Australia
Primary sponsor type
University
Name
University of Western Sydney
Address
School of Science & Health University of Western Sydney Locked Bag 1797 Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 257696 0
University
Name [1] 257696 0
CQUniversity
Address [1] 257696 0
Institute for Health and Social Science Research
CQUniversity
Rockhampton
Queensland
4702
Country [1] 257696 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260530 0
University of Western Sydney Human Research Ethics committee
Ethics committee address [1] 260530 0
Ethics committee country [1] 260530 0
Australia
Date submitted for ethics approval [1] 260530 0
Approval date [1] 260530 0
06/12/2010
Ethics approval number [1] 260530 0
H8767
Ethics committee name [2] 260531 0
CQUniversity Human Research Ethics committee
Ethics committee address [2] 260531 0
Ethics committee country [2] 260531 0
Australia
Date submitted for ethics approval [2] 260531 0
Approval date [2] 260531 0
04/02/2011
Ethics approval number [2] 260531 0
H11/01-005

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

Contacts
Principal investigator
Name 32266 0
Prof Gregory Kolt
Address 32266 0
School of Science and Health University of Western Sydney Locked Bag 1797 Penrith NSW 2751
Country 32266 0
Australia
Phone 32266 0
+61246203747
Fax 32266 0
Email 32266 0
[email protected]
Contact person for public queries
Name 15513 0
Gregory Kolt
Address 15513 0
School of Science and Health University of Western Sydney Locked Bag 1797 Penrith NSW 2751
Country 15513 0
Australia
Phone 15513 0
+61246203747
Fax 15513 0
+61246203710
Email 15513 0
[email protected]
Contact person for scientific queries
Name 6441 0
Gregory Kolt
Address 6441 0
School of Science and Health University of Western Sydney Locked Bag 1797 Penrith NSW 2751
Country 6441 0
Australia
Phone 6441 0
+61246203747
Fax 6441 0
+61246203710
Email 6441 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.