ANZCTR - Registration

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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]

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

Condition category

Condition code

Public Health

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]

Behaviour

Intervention code [2]

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]

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]

At baseline and at 3 months and 1 year

Secondary outcome [1]

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]

At baseline and at 3 months and 1 year

Secondary outcome [2]

Internet engagement will be measured through the number of hits that a user registers and the mean session duration.

Timepoint [2]

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]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

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]

University

Name [1]

CQUniversity

Address [1]

Institute for Health and Social Science Research
CQUniversity
Rockhampton
Queensland
4702

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Western Sydney Human Research Ethics committee

Ethics committee address [1]

Human Ethics Officer
University of Western Sydney
Locked Bag 1797
Penrith
NSW
2751

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

06/12/2010

Ethics approval number [1]

H8767

Ethics committee name [2]

CQUniversity Human Research Ethics committee

Ethics committee address [2]

Office of Research
CQUniversity
CQ Mail Centre
Rockhampton
QLD
4702

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

04/02/2011

Ethics approval number [2]

H11/01-005

Summary

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. 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 efficacy of the intervention is initially being tested in the in a randomised control trial (RCT). The RCT is investigating efficacy, adherence and behaviour change in a rigorous, controlled setting with high internal validity. The RCT has been registered separately (ACTRN12611000157976).
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.

Trial website

www.10000steps.org.au

Trial related presentations / publications

Protocol paper:
WALK 2.0: Examining the effectiveness of Web 2.0 features to increase physical activity in a 'real world' setting: an ecological trial (10/2014) DOI: 10.1136/bmjopen-2014-006374

Public notes

Contacts

Principal investigator

Name

Prof Gregory Kolt

Address

School of Science and Health University of Western Sydney Locked Bag 1797 Penrith NSW 2751

Country

Australia

Phone

+61246203747

Fax

g.kolt@uws.edu.au

Contact person for public queries

Name

Gregory Kolt

Address

School of Science and Health University of Western Sydney Locked Bag 1797 Penrith NSW 2751

Country

Australia

Phone

+61246203747

Fax

+61246203710

g.kolt@uws.edu.au

Contact person for scientific queries

Name

Gregory Kolt

Address

School of Science and Health University of Western Sydney Locked Bag 1797 Penrith NSW 2751

Country

Australia

Phone

+61246203747

Fax

+61246203710

g.kolt@uws.edu.au

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

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Documents added automatically

No additional documents have been identified.

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