Trial from ANZCTR


Trial ID ACTRN12611000157976
Trial Status: Registered
Date Submitted: 7/02/2011
Date Registered: 9/02/2011
Prospectively registered

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Public title WALK 2.0: Using Web 2.0 applications to promote health related physical activity
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format Investigating the effect of a Web 2.0 physical activity intervention on physical activity levels in low activity older adults: A randomised controlled trial.
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Secondary ID [1] 253455 0
nil
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UTN U1111-1119-1755
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Trial acronym WALK 2.0
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Health condition(s) or problem(s) studied:
Physical inactivity 261004 0
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Condition category: Condition code:
Public Health Health promotion/education
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259143 259143 0 0

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Descriptions 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.
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Intervention Code:
Behaviour 257897 0
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Intervention Code:
Lifestyle 257899 0
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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.
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Control group Active
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Primary Outcome: Average daily step count. Measured over five days with an activity monitor (Actigraph GT3X) 261995 0
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Timepoint: Baseline, 3 Months, 12 months and 18 months 261995 0
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Primary Outcome: Anthropometric data (Height, weight, BMI, waist circumference) 261996 0
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Timepoint: Baseline, 3 Months, 12 months and 18 months 261996 0
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Secondary Outcome: Website engagement (number of visits, duration of visits) 268928 0
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Timepoint: at user login 268928 0
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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
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Minimum age 18 Years
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Maximum age No limit
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Gender Both males and females
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Healthy volunteers? Yes
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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
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Study type Interventional
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Purpose of the study Educational / counselling / training
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Not Applicable
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Anticipated date of first participant enrolment 1/07/2011
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Date of first participant enrolment 26/03/2012
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled 22/07/2013
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Target sample size 504
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Recruitment status Closed: follow-up continuing
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Recruitment in Australia

Recruitment state(s) NSW,QLD
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Postcode: 4700 3587 0
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Postcode: 2560 3588 0
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Postcode: 2570 3589 0
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Recruitment outside Australia

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Funding Source: Government body 258370 0
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Name: National Health and Medical research council 258370 0
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Address: National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
258370 0
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Country: Australia 258370 0
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Primary Sponsor University
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Name: University of Western Sydney
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Address: School of Biomedical and Health Sciences
University of Western Sydney
Locked Bag 1797
Penrith
NSW
2751
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Country: Australia
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Secondary Sponsor: University 257519 0
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Name: CQUniversity 257519 0
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Address: Institute for Health and Social Science Research
CQUniversity
Rockhampton
Queensland
4702
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Country: Australia 257519 0
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Other Collaborator: Government body 251778 0
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Name: Queensland Health 251778 0
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Address: GPO Box 48
Brisbane
Queensland
4001
251778 0
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Country: Australia 251778 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: University of Western Sydney Human Research Ethics committee 260345 0
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Address: Human Ethics Officer
University of Western Sydney
Locked Bag 1797
Penrith
NSW
2751
260345 0
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Country: Australia 260345 0
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Approval Date: 06/12/2010 260345 0
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Submitted Date: 04/11/2010 260345 0
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HREC: H8767 260345 0
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Ethics Committee name: CQUniversity Human Research Ethics committee 260347 0
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Address: Office of Research
CQUniversity
CQ Mail Centre
Rockhampton
QLD
4702
260347 0
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Country: Australia 260347 0
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Approval Date: 04/02/2011 260347 0
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Submitted Date: 31/01/2011 260347 0
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HREC: H11/01-005 260347 0
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Brief summary More than half of the Australian population do not meet the levels of physical activity recommended to achieve health benefits. The Internet has become an increasingly important communication tool and Internet based physical activity interventions which include innovative technology have the potential to reach large groups of individuals and contribute to the promotion of physical activity and behaviour change. Each year there is a proliferation of health-related and health-promotion websites, yet virtually no work has been done to study the utility and effectiveness of these population-targeted websites. This study will develop a website featuring Web 2.0 applications and evaluate the efficacy and utility of the website to promote physical activity in comparison to a conventional (Web 1.0) physical activity promotion website and a control group. The study will initially test the efficacy of the intervention in this randomised control trial (RCT). The RCT will investigate the efficacy, adherence and behaviour change in a rigorous, controlled setting with high internal validity.
Following the commencement of the RCT and an ecological trial (ET) will commence. The ET takes advantage of the unique 'real world' sample available to the research team through the existing 10,000 Steps website to evaluate engagement by users from the broader community. The ecological trial will be registered separately.
We expect that the current proposal will provide an increased understanding of the benefits of newer web-based technologies and applications in engaging and retaining participants on web-based physical activity promotion sites. This work has the potential to improve health outcomes from increased engagement/retention in physical activity.
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Trial website
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Trial related presentations / publications Kolt GS, Rosenkranz RR, Savage TN, Maeder AJ, Vandelanotte C, Duncan MJ, Caperchione CM, Tague R, Hooker C, Mummery WK: WALK 2.0 Study Protocol: Using Web 2.0 applications to promote health-related physical activity – A Randomised Controlled trial. BMC Public Health 2013, 13:436.
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Public Notes
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Principal Investigator
Title: Prof
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Name: Gregory Kolt
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Address: School of Science and Health University of Western Sydney Locked Bag 1797 Penrith NSW 2751
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Country: Australia
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Tel: +61246203747
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Fax: +61246203710
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Email: g.kolt@uws.edu.au
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Contact person for public queries
Title: Mr
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Name: Trevor Savage
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Address: School of Science and Health University of Western Sydney Locked Bag 1797 Penrith NSW 2751
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Tel: +61246203698
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Email: t.savage@uws.edu.au
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Contact person for scientific queries
Title: Prof
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Name: Professor Gregory Kolt
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Address: School of Science and Health University of Western Sydney Locked Bag 1797 Penrith NSW 2751
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Email: g.kolt@uws.edu.au
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Contact person responsible for updating information
Title:
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Name: Trevor Savage
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Address: School of Science and Health University of Western Sydney Locked Bag 1797 Penrith NSW 2751
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Country: Australia
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Tel: +61246203698
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Addition Cancer fields
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