Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001555448
Ethics application status
Approved
Date submitted
7/11/2016
Date registered
10/11/2016
Date last updated
29/11/2019
Date data sharing statement initially provided
29/11/2019
Date results information initially provided
29/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Using personalised physical activity advice in combination with Fitbit activity trackers
Scientific title
Examining the effectiveness of computer-tailored advice in combination with activity trackers (Fitbit) for increasing physical activity
Secondary ID [1] 290479 0
None
Universal Trial Number (UTN)
Trial acronym
TaylorTrack study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 300852 0
overweight/obesity 300890 0
Condition category
Condition code
Public Health 300673 300673 0 0
Health promotion/education
Diet and Nutrition 300710 300710 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be recruited, predominantly via social media, e-mail and random cold calling and randomised into one of 4 intervention groups.

Group 1a – Text-based computer-tailored physical activity program with self-reported physical activity
Group 1b – Video-based computer-tailored physical activity program with self-reported physical activity
Group 2a – Text-based computer-tailored physical activity program with wrist-worn physical activity tracker
Group 2b – Video-based computer-tailored physical activity program with wrist-worn physical activity tracker

All groups 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 feedback. The feedback will (either delivered as text on a webpage or as a personalised online video; and either supported by an activity tracker (Fitbit) or not)..

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 3 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 5-10 minutes to read.
- Each tailored feedback video will last between 5-10 minutes.

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.
Intervention code [1] 296336 0
Lifestyle
Intervention code [2] 296337 0
Behaviour
Comparator / control treatment
No control group; the main aim is to test whether the effectiveness of the personalised feedback is increased by also providing participants with a physical activity tracker (Fitbit)
Control group
Active

Outcomes
Primary outcome [1] 300099 0
Change in physical activity measured through the Active Australia Survey
Timepoint [1] 300099 0
Assessed at baseline, 1 and 3 months
Primary outcome [2] 300100 0
Credibility and acceptability of the intervention assessed through a number of questionnaires (Fitbit use (survey designed for this study), Physical activity acceptability (survey designed for this study), Fitbit Integration (survey designed for this study), Systems Usability Scale),
Timepoint [2] 300100 0
Assessed at 1 and 3 months
Primary outcome [3] 300111 0
Engagement with the intervention assessed through website usage statistics
Timepoint [3] 300111 0
Continuous ongoing measurement from the time participants use the website the first time to the end of the study at 3 months post-baseline.
Secondary outcome [1] 329045 0
Change in Sleep assessed through 6 questions. This survey was designed specifically for this study as questions were taken from 3 different sources:

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 [1] 329045 0
Assessed at baseline, 1 and 3 months
Secondary outcome [2] 329074 0
Intervention feasibility (this is a process evaluation assessing for example: how many technical issues there were with the use of Fitbit, as well as how easy/hard participant recruitment was). All this will be assessed through information that is automatically fed back to the research team (e.g. participant reports technical issue, this is logged on a spreadsheet; recruitment: the cost, amount of effort and time needed to recruit participants; information about recruitment is logged in a spreadsheet)
Timepoint [2] 329074 0
3 months post-baseline
Secondary outcome [3] 329075 0
Change in sitting time assessed using the workforce sitting questionnaire
Timepoint [3] 329075 0
Assessed at baseline, 1 and 3 months
Secondary outcome [4] 329076 0
Change in self-regulation strength

Survey taken from: Saelens et al. (2000). Use of self-management strategies in a 2-year cognitive behavioural intervention to promote physical activity. Behavior Therapy, 31:365-379.
Timepoint [4] 329076 0
Assessed at baseline and 3 months
Secondary outcome [5] 329137 0
Mediators and moderators of intervention outcomes: demographics, Internet usage (survey designed for this study), technology usage (survey designed for this study), Internet Self-efficacy Scale
Timepoint [5] 329137 0
Assessed at baseline only

Eligibility
Key inclusion criteria
Eligible people will be adults with Internet access and a smartphone, who speak and read English, live anywhere in Australia, are insufficiently active, and have not used an activity tracker in the past year and have a BMI between 25 and 40. With regards to physical activity, participants will be eligible if they are not doing at least in 150 minutes of moderate intensity physical activity per week (insufficiently active), and can safely increase activity levels according to the Physical Activity Readiness Questionnaire (PARQ).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Under 18 years of age
- BMI Under 25
- Without regular access to Internet and smartphone
- 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 will be asked to complete an online registration form which details whether or not the are eligible and their contact information. Or they will be cold called and eligibility was assessed directly on the phone.

Once eligibility is assessed, participants are asked to complete an online baseline survey.

Once baseline data is complete, participants will be enrolled into the study and randomised.

The person who will determine if a subject was eligible for inclusion in the trial will be unaware, when this decision is made, to which group the subject will be allocated. Therefore allocation will be concealed.

The method of concealment is central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization.com will be used generate a random sequence determining which participant would be allocated to what group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this is a pilot study, demonstrating proof of concept is deemed more important over conducting a fully powered trail.
Repeated measure ANOVAs with intention to treat or Linear Mixed Models will be applied to assess significant differences between groups for the different outcomes measures..

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/11/2016
Actual
14/11/2016
Date of last participant enrolment
Anticipated
Actual
21/12/2016
Date of last data collection
Anticipated
Actual
21/03/2017
Sample size
Target
200
Accrual to date
Final
243
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 294896 0
Charities/Societies/Foundations
Name [1] 294896 0
National Heart Foundation of Australia
Country [1] 294896 0
Australia
Primary sponsor type
University
Name
Central Queensland University
Address
Centre for Physical Activity Studies (CPAS)
Building 18, CQUniversity Australia
Bruce Highway
Rockhampton, QLD, 4702
Country
Australia
Secondary sponsor category [1] 293733 0
None
Name [1] 293733 0
none
Address [1] 293733 0
none
Country [1] 293733 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296274 0
CQUniversity Human Research Ethics Committee
Ethics committee address [1] 296274 0
Office of Research
Building 361, Ibis Avenue
CQUniversity Australia
Rockhampton, QLD, 4702
Ethics committee country [1] 296274 0
Australia
Date submitted for ethics approval [1] 296274 0
12/08/2016
Approval date [1] 296274 0
20/09/2016
Ethics approval number [1] 296274 0
H16/08-227

Summary
Brief summary
Physical inactivity is responsible for the second largest chronic disease burden in Australia (6.6%) and costs the health care system $1.6 billion every year. Over 85% of Australians have access to the Internet, and while most users have embraced the advantages of fast broadband connections, little research has investigated how this can be used for health promotion. More recently, there has been a large uptake of advanced activity trackers (e.g. Fitbit) that provide accurate information about personal activity levels. The vast reach and low cost of innovative web-based interventions can contribute significantly to promote physical activity and prevent chronic disease on a population level.

Current web-based interventions often fail to engage participants long enough to achieve long-term behaviour change and health benefits. As such, innovative approaches, in tune with how people use the Internet today, are needed. Based on our previous research we aim to demonstrate that highly personalised (e.g. tailored to age, gender, activity levels and self-efficacy) physical activity advice that is based on feedback from an advanced activity tracker is more credible, engaging and effective to increase physical activity when compared to personalised physical activity advice that is based on a self-report measure (e.g., the Active Australia Survey).

Study aims are:
To study the effectiveness of the computer-tailored physical activity intervention supported with Fitbit activity monitors relative to a computer-tailored physical activity intervention without Fitbit support (4 group, 3 month randomised trial) on:
a. The primary outcome measure of change in physical activity.
b. The secondary outcome measures: credibility and acceptability of the personalised advice, the engagement with the intervention (assessed through website usage statistics) and intervention feasibility.
Trial website
www.taylortrack.org.au
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 70230 0
Prof Corneel Vandelanotte
Address 70230 0
Building 18
CQUniversity Australia
Rockhampton, QLD, 4702
Country 70230 0
Australia
Phone 70230 0
+61 7 4923 2183
Fax 70230 0
Email 70230 0
[email protected]
Contact person for public queries
Name 70231 0
Prof Corneel Vandelanotte
Address 70231 0
Building 18
CQUniversity Australia
Rockhampton, QLD, 4702
Country 70231 0
Australia
Phone 70231 0
+61 7 4923 2183
Fax 70231 0
Email 70231 0
[email protected]
Contact person for scientific queries
Name 70232 0
Prof Corneel Vandelanotte
Address 70232 0
Building 18
CQUniversity Australia
Rockhampton, QLD, 4702
Country 70232 0
Australia
Phone 70232 0
+61 7 4923 2183
Fax 70232 0
Email 70232 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Vandelanotte C, Duncan MJ, Maher CA, Schoeppe S, R... [More Details] 371793-(Uploaded-27-11-2019-12-22-08)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.