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Trial registered on ANZCTR


Trial ID
ACTRN12615000057583
Ethics application status
Approved
Date submitted
17/10/2014
Date registered
22/01/2015
Date last updated
27/03/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
TaylorActive - A Randomised Controlled Trial (RCT) investigating the effectiveness of tailored videos in promoting physical activity via the Internet.
Scientific title
TaylorActive - A randomised controlled trial investigating the effectiveness of a video tailored intervention delivered via the Internet to promote physical activity for Australian adults.
Secondary ID [1] 285498 0
Nil.
Universal Trial Number (UTN)
Trial acronym
TaylorActive
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 293288 0
Condition category
Condition code
Public Health 293557 293557 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be recruited, predominantly via social media, and randomised into one of three intervention groups.

The three intervention groups will consist of the 'Control' group, the 'Text' group and the 'Video' group.

The 'Text' group will have access to the TaylorActive website, and be asked to complete 8 modules on a weekly/fortnightly basis, in order to receive personally tailored text feedback.

The 'Video' group will have access to the TaylorActive website, and be asked to complete 8 modules on a weekly/fortnightly basis, in order to receive personally tailored video feedback.

The TaylorActive website is minimal and includes:
- A homepage - highlighting the 'Text' and 'Video' groups modules and action plans.
- A library - includes up to 25 articles.
- A 5 star rating for each feedback page and library article.
- A Report an issue section.
- A account page where participants can update their details.

The 8 modules will include and give tailored feedback on the following information:

Module 1 (Week 1)
- Overview of the TaylorActive Project.
- General questions: name, height, weight, gender, age.
- Module relevant questions: current physical activity levels, goal choice, self-efficacy regarding participating in physical activity.
- Physical activity guidelines for chosen goal provided.
- Current activity level (tailored to chosen goal)
- Setting a small goal to achieve before next week.

Module 2 (Week 2)
- Review small physical activity goal provided last week.
- Goal setting and Action Plans

Module 3 (Week 3)
- Review physical activity for prior week.
- Benefits related to exercise.
- Boosting your confidence.

Module 4 (Week 4)
- Review physical activity for prior week.
- Opportunity to change goal.
- Confidence, Motivation and Positive thinking.

Module 5 (Week 6)
- Review physical activity at week 6 with that at week 1.
- Habits.
- Relapse Prevention - Barriers to following through.

Module 6 (Week 8)
- Review physical activity for prior fortnight.
- Opportunity to change goal.
- Social Support.

Module 7 (Week 10)
- Review physical activity for prior fortnight.
- Active Lifestyle.
- Active Environments.

Module 8 (Week 12)
- Review physical activity for prior fortnight.
- Summary of activity over TaylorActive Project.
- Success Stories.
- Wrap up the program, highlighting some of the skills learnt.

Other information:
- The TaylorActive feedback is provided by Physical Activity Researchers.
- The TaylorActive intervention will span a 9 month period for all participants.
- Each participant gets the opportunity to choose a male and female 'Taylor' to provide their tailored feedback.
- Each module should take between 5-10 minutes to complete the questions.
- Each tailored feedback text should take between 3-5 minutes to read.
- Each tailored feedback video will last between 2-3 minutes.
- Each module will also have a fun element at the end - this fun element will be different in each module.

The website will record each time a participant logs in to the TaylorActive site, how many web pages they visit and how long they are on the website for.

Participants will be sent emails to visit the website and complete the TaylorActive Modules and Action Plans. Up to 3 reminders will be sent for each module to be completed.

All participants will maintain access to the TaylorActive website after the initial 12 week tailored program is completed, for the entire duration of the 9 month program.
Intervention code [1] 290438 0
Lifestyle
Intervention code [2] 290439 0
Behaviour
Comparator / control treatment
Participants in the 'Control' group will only have access to the TaylorActive website Library, and will not have access to any modules or tailored feedback.

The TaylorActive Library will include up to 25 articles, including articles related to stating motivated, how to start getting physical activity and including some physical activity schedule. Some of the articles are titled: Keeping Positive, Getting Motivated, Getting started walking, Making the time to be active, Resistance training schedule, Moving from walking to running.

The Control Group will have access to the website for the entire 9 months of the TaylorActive Project.
Control group
Active

Outcomes
Primary outcome [1] 293374 0
Physical Activity - measured by Actigraph wear time and Active Australia Questionnaire.
Timepoint [1] 293374 0
0, 3 and 9 months
Secondary outcome [1] 310887 0
Correlates of physical activity - Attitudes towards regular physical activity.

Attitude towards regular physical activity (6 items)
6 items from Rhodes et al (2010) were used to assess attitudes towards regular physical activity – three items assessing instrumental aspects of attitudes ( PA will be beneficial, useful, and wise) and three items assessing affective aspects of attitude (PA will be enjoyable, pleasant and exciting) were used.
Timepoint [1] 310887 0
0, 3 and 9 months.
Secondary outcome [2] 311122 0
Quality of Life - measured by SF-12 Questionnaire
Timepoint [2] 311122 0
0, 3 and 9 months.
Secondary outcome [3] 311125 0
Participant Engagement and Retention - measured by System Usability Scale and Satisfaction, Physical Advice Acceptability.
Timepoint [3] 311125 0
0, 3 and 9 months.
Secondary outcome [4] 311129 0
Influence of moderators on intervention effectiveness - measured by demographics, PANES, delivery-mode usability, Learning Style, Internet usage, Internet Self-efficacy, Technology Use, Usefulness, Physical Activity Intentions, Motivation and Self-Report Behavioural Automaticity Index.

PANES - Sallis, J.F., Kerr, J., Carlson, J.A., Norman, G.J., Saelens, B.E., Durant, N., and Ainsworth, B.E. (2010). Evaluating a brief self-report measure of neighborhood environments for physical activity research and surveillance: Physical activity neighborhood environment scale (PANES). Journal of Physical Activity and Health, 7, 533-540.

Delivery Mode Usability - Corneel Vandelanotte, Mitch J Duncan, Ronald C Plotnikoff, W Kerry Mummery. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 29.02.2012.

Learning Style - Based on the 3 groups of the TaylorActive Project (Control, Text and Video).

Internet Usage - Rodgers WM, Selzler A, Vandelanotte C, Stickland MK (in press). Adapting to the medium and the message: Willingness and confidence of COPD patients to use electronic devices for health information management. The European Health Psychologist. Blank, Groselj (2014). Dimensions of Internet use: amount, variety, and types. Information, Communication & Society.

Internet Self-Efficacy - http://onlinelibrary.wiley.com/doi/10.1111/j.1083-6101.2000.tb00110.x/full

Technology Use - Rodgers WM, Selzler A, Vandelanotte C, Stickland MK (in press). Adapting to the medium and the message: Willingness and confidence of COPD patients to use electronic devices for health information management. The European Health Psychologist. Blank, Groselj (2014). Dimensions of Internet use: amount, variety, and types. Information, Communication & Society.

Usefulness - Based on the goals of the 12 week TaylorActive Project.

Motivation - Based on the goals of the 12 week TaylorActive Project.

Physical Activity Intentions - (Courneya et al., 1999; Courneya, 1994; Rhodes & Courneya, 2003)

Self-Report Behavioural Automaticity Index - Gardner, Abraham, Lally, & de Bruijn (2012). Towards parsimony in habit measurement: Testing the convergent and predictive validity of an automaticity subscale of the Self-Report Habit Index. International Journal of Behavioral Nutrition and Physical Activity.
Timepoint [4] 311129 0
0, 3 and 9 months.
Secondary outcome [5] 311228 0
Depression Scale - measured by Depression, Anxiety and Stress Scale (DASS 21).
Timepoint [5] 311228 0
0, 3 and 9 months.
Secondary outcome [6] 311229 0
Workforce Sitting Questionnaire
Timepoint [6] 311229 0
0, 3 and 9 months.
Secondary outcome [7] 311230 0
Sleep, measured by a combination of questions:
Q 1-4: 2nd page, 2nd paragraph http://www.cdc.gov/mmwr/PDF/wk/mm6008.pdf
Q5: http://ps.psychiatryonline.org/article.aspx?articleid=1671298
Q6: PSQI http://www.sleep.pitt.edu/content.asp?id=1484
Timepoint [7] 311230 0
0, 3 and 9 months.
Secondary outcome [8] 311231 0
Text Group Only Questions - Physical Activity advice acceptability.

Hinchliffe & Mummery, 2008; Vandelanotte & De Bourdeaudhuij, 2003; Vandelanotte et al., 2004.
Timepoint [8] 311231 0
3 months.
Secondary outcome [9] 311232 0
Video Group Only Questions - Physical activity advice acceptability.

Hinchliffe & Mummery, 2008; Vandelanotte & De Bourdeaudhuij, 2003; Vandelanotte et al., 2004.
Timepoint [9] 311232 0
3 months.
Secondary outcome [10] 312364 0
Video Group only Questions - Website Usability.

Hinchliffe & Mummery, 2008; Vandelanotte & De Bourdeaudhuij, 2003; Vandelanotte et al., 2004.
Timepoint [10] 312364 0
3 months.
Secondary outcome [11] 312365 0
Text Group Only Questions - Website Usability.

Hinchliffe & Mummery, 2008; Vandelanotte & De Bourdeaudhuij, 2003; Vandelanotte et al., 2004.
Timepoint [11] 312365 0
3 months
Secondary outcome [12] 312366 0
Correlates of physical activity - Perceived Behavioural Control.

Perceived behavioural control was assessed using 3 items from Rhodes et al (2010).
Timepoint [12] 312366 0
0, 3 and 9 months.
Secondary outcome [13] 312385 0
Correlates of physical activity - Subjective Norm

Subjective norm was assessed using 3 items. 2 items from Rhodes (2010) measuring the injunctive component of subjective norm, and one items from Trinh et al (2012) assessing the descriptive component of subjective norm (‘“I think that over the next month, most people who are important to me will themselves participate regularly in PA).
Timepoint [13] 312385 0
0, 3 and 9 months.
Secondary outcome [14] 312386 0
Correlates of Physical Activity - Intentions

Intentions were assessed using 2 items from Rhodes et al (2010).
Timepoint [14] 312386 0
0, 3 and 9 months.
Secondary outcome [15] 312387 0
Correlates of Physical Activity - Action Planning

Planning was measured using four items rated using a 7-point Likert scale ranging from 1 (no plans) to 7 (detailed plans) (Conner, 2010; Trinh, 2012). The items were: (1) “I have made plans concerning ‘when’ I am going to engage in regular PA over the next month;” (2) “I have made plans concerning ‘where’ I am going to engage in regular PA over the next month;” (3) “I have made plans concerning ‘what’ kind of regular PA I am going to engage in over the next month;” and (4) “I have made plans concerning ‘how’ I am going to get to a place to engage in regular PA over the next month.”
Timepoint [15] 312387 0
0, 3 and 9 months.

Eligibility
Key inclusion criteria
Participants will be screened by a member of the research team, both online and in a phone conversation and meet the following criteria to be included in the TaylroActive study.

- Over 18 years of age
- Broadband Internet Access
- Speak, read and write English
- BMI above 17.5
- Say NO to all Physical Activity Readiness Questionnaire questions, or have doctors approval to participate in physical activity.

Participants will be deemed healthy volunteers by completing the eligibility screening assessment.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Under 18 years of age
- BMI Under 17.5
- Without regular access to Broadband Internet
- Have a condition where physical activity is contraindicated

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)
Interested participants are asked to complete an online registration form which details whether or not the are eligible and their contact information.

Once eligibility is assessed, participants will be sent an email from the TaylorActive Project Office about when the office will next be in contact. All participants will be contacted by phone (at their designated time) by the Project Office, and will be asked to confirm all eligibility questions, including their answers to the PARQ, and confirm their contact details.

Participants will then be sent an Actigraph, a participant information sheet, a consent form, an Actigraph information sheet, Actigraph log sheet and their personal TaylorActive schedule.

During the time when the participant is wearing the Actigraph, they will be called by the Population Research Laboratory (PRL) to complete their Computer Assisted Telephone Interview (CATI) survey.

Once the Actigraph data and survey data are complete, participants will be enrolled and randomised into the TaylorActive Project.

Allocations is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization.com was used to determine how the 510 participants would be allocated to the three intervention groups.
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
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 290100 0
Government body
Name [1] 290100 0
National Health and Medical Research Council of Australia (NHMRC)
Address [1] 290100 0
Level 1
16 Marcus Clarke Street
Canberra, ACT, 2601

GPO Box 1421
Canberra, ACT, 2601
Country [1] 290100 0
Australia
Primary sponsor type
University
Name
CQUniversity
Address
Centre for Physical Activity Studies (CPAS)
Building 18, CQUniversity Australia
Bruce Highway
Rockhampton, QLD, 4702
Country
Australia
Secondary sponsor category [1] 288806 0
University
Name [1] 288806 0
University of Newcastle
Address [1] 288806 0
Priority Research Centre in Physical Activity in Nutrition
University Drive
University of Newcastle
Callaghan, NSW, 2308
Country [1] 288806 0
Australia
Other collaborator category [1] 278203 0
University
Name [1] 278203 0
University of Alberta
Address [1] 278203 0
Faculty of Physical Education and Recreation
W1-34 Van Vliet Centre
University of Alberta
Edmonton, AB, T6G 2H9
Country [1] 278203 0
Canada

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291808 0
Human Research Ethics Committee
Ethics committee address [1] 291808 0
Office of Research
Building 361, Ibis Avenue
CQUniversity Australia
Rockhampton, QLD, 4702
Ethics committee country [1] 291808 0
Australia
Date submitted for ethics approval [1] 291808 0
15/07/2014
Approval date [1] 291808 0
22/08/2014
Ethics approval number [1] 291808 0
H14/07-163

Summary
Brief summary
TaylorActive is a physical activity project for Australian adults. This project is investigating the effectiveness of tailored videos in promoting physical activity using the Internet.
Trial website
www.tayloractive.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51050 0
A/Prof Corneel Vandelanotte
Address 51050 0
Building 18
CQUniversity Australia
Rockhampton, QLD, 4702
Country 51050 0
Australia
Phone 51050 0
+61 07 4923 2183
Fax 51050 0
Email 51050 0
c.vandelanotte@cqu.edu.au
Contact person for public queries
Name 51051 0
Ms Cindy Hooker
Address 51051 0
Building 18
CQUniversity Australia
Rockhampton, QLD, 4702
Country 51051 0
Australia
Phone 51051 0
+61 07 4930 6537
Fax 51051 0
Email 51051 0
c.hooker@cqu.edu.au
Contact person for scientific queries
Name 51052 0
A/Prof Corneel Vandelanotte
Address 51052 0
Building 18
CQUniversity Australia
Rockhampton, QLD, 4702
Country 51052 0
Australia
Phone 51052 0
+61 07 4923 2183
Fax 51052 0
Email 51052 0
c.vandelanotte@cqu.edu.au