ANZCTR - Registration

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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]

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

Condition category

Condition code

Public Health

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]

Behaviour

Intervention code [2]

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]

Average daily step count. Measured over five days with an activity monitor (Actigraph GT3X)

Timepoint [1]

Baseline, 3 Months, 12 months and 18 months

Primary outcome [2]

Anthropometric data (Height, weight, BMI, waist circumference)

Timepoint [2]

Baseline, 3 Months, 12 months and 18 months

Secondary outcome [1]

Website engagement (number of visits, duration of visits)

Timepoint [1]

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]

4700

Recruitment postcode(s) [2]

2560

Recruitment postcode(s) [3]

2570

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

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]

University

Name [1]

CQUniversity

Address [1]

Institute for Health and Social Science Research
CQUniversity
Rockhampton
Queensland
4702

Country [1]

Australia

Other collaborator category [1]

Government body

Name [1]

Queensland Health

Address [1]

GPO Box 48
Brisbane
Queensland
4001

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Western Sydney University Human Research Ethics committee

Ethics committee address [1]

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

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/11/2010

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]

31/01/2011

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 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.

Trial website

Trial related presentations / publications

Rosenkranz RR, Duncan MJ, Caperchione CM, et al. Validity of the Stages of Change in Steps instrument (SoC-Step) for achieving the physical activity goal of 10,000 steps per day. 2015;15:1197.

DOI: 10.1186/s12889-015-2539-y

Vandelanotte C, Stanton R, Rebar AL, et al. Physical activity screening to recruit inactive randomized controlled trial participants: how much is too much? Trials 2015;16(1):446.

DOI: 10.1186/s13063-015-0976-7

Caperchione CM, Duncan MJ, Rosenkranz RR, et al. Recruitment, screening, and baseline participant characteristics in the WALK 2.0 study: A randomized controlled trial using Web 2.0 applications to promote physical activity. 2016;2:25-33.

DOI: 10.1016/j.conctc.2015.12.004

Public notes

Contacts

Principal investigator

Name

Prof Gregory Kolt

Address

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

Country

Australia

Phone

+61246203747

Fax

+61246203710

g.kolt@westernsydney.edu.au

Contact person for public queries

Name

Gregory Kolt

Address

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

Country

Australia

Phone

+61246203747

Fax

+61246203710

g.kolt@westernsydney.edu.au

Contact person for scientific queries

Name

Professor Gregory Kolt

Address

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

Country

Australia

Phone

+61246203747

Fax

+61246203710

g.kolt@westernsydney.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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Physical activity screening to recruit inactive randomized controlled trial participants: How much is too much?.	2015	https://dx.doi.org/10.1186/s13063-015-0976-7
Embase	Validity of the Stages of Change in Steps instrument (SoC-Step) for achieving the physical activity goal of 10,000 steps per day.	2015	https://dx.doi.org/10.1186/s12889-015-2539-y
Embase	Recruitment, screening, and baseline participant characteristics in the WALK 2.0 study: A randomized controlled trial using web 2.0 applications to promote physical activity.	2016	https://dx.doi.org/10.1016/j.conctc.2015.12.004
Embase	Associations between quality of life and duration and frequency of physical activity and sedentary behaviour: Baseline findings from the WALK 2.0 randomised controlled trial.	2017	https://dx.doi.org/10.1371/journal.pone.0180072
Embase	The effectiveness of a web 2.0 physical activity intervention in older adults - a randomised controlled trial.	2018	https://dx.doi.org/10.1186/s12966-017-0641-5

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically