Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000157976
Ethics application status
Approved
Date submitted
7/02/2011
Date registered
9/02/2011
Date last updated
19/04/2016
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
Investigating the effect of a Web 2.0 physical activity intervention on physical activity levels in low activity older adults: A randomised controlled trial.
Secondary ID [1] 253455 0
nil
Universal Trial Number (UTN)
U1111-1119-1755
Trial acronym
WALK 2.0
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 261004 0
Condition category
Condition code
Public Health 259143 259143 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To determine the relative efficacy of web 2.0 in comparison to existing internet based interventions, the trial will consist of two intervention groups. Participants in both of these groups will receive a pedometer to monitor and record their daily coincidental physical activity regimen for the duration of the trial (eighteen months). 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. 168 participants will be recruited to this group. The comparative intervention group will receive access to an existing website without web 2.0 content. Participants will be able to contribute to forums and record their steps to the website, but will not have access to social media or innovative content. 168 participants will be recruited to this group. Participants will be able to access the website allocated to their intervention group for the duration of the project. 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 support the utility of the site in promoting physical activity. Objective outcome measures (Weight, BMI and Physical activity) will be collected three times over the course of the study (3 months, 12 months and 18 months). To assess physical activity objectively, participants will be asked to wear an activity monitor during waking hours for 5 days during the outcome measurements. Upon completing recruitment for the RCT, an Ecological trial of the websites will be conducted in 2890 voluntary participants. This study will test the recruitment and retention capabilities of the two interventions and the effect on physical activity levels and has been registered separately.
Intervention code [1] 257897 0
Behaviour
Intervention code [2] 257899 0
Lifestyle
Comparator / control treatment
Participants will receive a pedometer but will not have access to online content. Controls will be encouraged to use the pedometer to monitor and record daily incidental physical activity for the duration of the trial (eighteen months). Objective outcome measures (Weight, BMI and Physical activity regimen) will be collected three times over the course of the study (3 months, 12 months and 18 months). To assess physical activity, participants will be asked to wear an activity monitor during waking hours for 5 days.
Control group
Active

Outcomes
Primary outcome [1] 261995 0
Average daily step count. Measured over five days with an activity monitor (Actigraph GT3X)
Timepoint [1] 261995 0
Baseline, 3 Months, 12 months and 18 months
Primary outcome [2] 261996 0
Anthropometric data (Height, weight, BMI, waist circumference)
Timepoint [2] 261996 0
Baseline, 3 Months, 12 months and 18 months
Secondary outcome [1] 268928 0
Website engagement (number of visits, duration of visits)
Timepoint [1] 268928 0
at user login

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
3) live in the Rockhampton or Campbelltown local government area
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
3) they do not successfully complete the Physical Activity Readiness Questionnaire (PAR-Q) and gain medical clearance

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)
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
1/07/2011
Actual
26/03/2012
Date of last participant enrolment
Anticipated
Actual
22/07/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
504
Accrual to date
Final
504
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment postcode(s) [1] 3587 0
4700
Recruitment postcode(s) [2] 3588 0
2560
Recruitment postcode(s) [3] 3589 0
2570

Funding & Sponsors
Funding source category [1] 258370 0
Government body
Name [1] 258370 0
National Health and Medical research council
Country [1] 258370 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
School of Biomedical and Health Sciences
Western Sydney University
Locked Bag 1797
Penrith
NSW
2751
Country
Australia
Secondary sponsor category [1] 257519 0
University
Name [1] 257519 0
CQUniversity
Address [1] 257519 0
Institute for Health and Social Science Research
CQUniversity
Rockhampton
Queensland
4702
Country [1] 257519 0
Australia
Other collaborator category [1] 251778 0
Government body
Name [1] 251778 0
Queensland Health
Address [1] 251778 0
GPO Box 48
Brisbane
Queensland
4001
Country [1] 251778 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260345 0
Western Sydney University Human Research Ethics committee
Ethics committee address [1] 260345 0
Ethics committee country [1] 260345 0
Australia
Date submitted for ethics approval [1] 260345 0
04/11/2010
Approval date [1] 260345 0
06/12/2010
Ethics approval number [1] 260345 0
H8767
Ethics committee name [2] 260347 0
CQUniversity Human Research Ethics committee
Ethics committee address [2] 260347 0
Ethics committee country [2] 260347 0
Australia
Date submitted for ethics approval [2] 260347 0
31/01/2011
Approval date [2] 260347 0
04/02/2011
Ethics approval number [2] 260347 0
H11/01-005

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

Contacts
Principal investigator
Name 32121 0
Prof Gregory Kolt
Address 32121 0
School of Science and Health
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Country 32121 0
Australia
Phone 32121 0
+61246203747
Fax 32121 0
+61246203710
Email 32121 0
[email protected]
Contact person for public queries
Name 15368 0
Gregory Kolt
Address 15368 0
School of Science and Health
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Country 15368 0
Australia
Phone 15368 0
+61246203747
Fax 15368 0
+61246203710
Email 15368 0
[email protected]
Contact person for scientific queries
Name 6296 0
Professor Gregory Kolt
Address 6296 0
School of Science and Health
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Country 6296 0
Australia
Phone 6296 0
+61246203747
Fax 6296 0
+61246203710
Email 6296 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
EmbasePhysical activity screening to recruit inactive randomized controlled trial participants: How much is too much?.2015https://dx.doi.org/10.1186/s13063-015-0976-7
EmbaseValidity of the Stages of Change in Steps instrument (SoC-Step) for achieving the physical activity goal of 10,000 steps per day.2015https://dx.doi.org/10.1186/s12889-015-2539-y
EmbaseRecruitment, screening, and baseline participant characteristics in the WALK 2.0 study: A randomized controlled trial using web 2.0 applications to promote physical activity.2016https://dx.doi.org/10.1016/j.conctc.2015.12.004
EmbaseAssociations between quality of life and duration and frequency of physical activity and sedentary behaviour: Baseline findings from the WALK 2.0 randomised controlled trial.2017https://dx.doi.org/10.1371/journal.pone.0180072
EmbaseThe effectiveness of a web 2.0 physical activity intervention in older adults - a randomised controlled trial.2018https://dx.doi.org/10.1186/s12966-017-0641-5
N.B. These documents automatically identified may not have been verified by the study sponsor.