Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000339651
Ethics application status
Approved
Date submitted
20/02/2014
Date registered
31/03/2014
Date last updated
31/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Increasing physical activity levels in the general population: Evaluating the benefit of a brief online coaching session in a web-based intervention that provides personalised physical activity advice.
Scientific title
Comparing the physical activity outcomes of a web-based physical activity intervention, 'My Activity Coach' with and without a brief online coaching session, in Australian adults.
Secondary ID [1] 281836 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The health consequences of physical inactivity (e.g. chronic disease) 288194 0
Condition category
Condition code
Public Health 288562 288562 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An 8 week web-based physical activity intervention with 4 modules of computer-tailored physical activity advice. Each module is delivered bi-weekly and has a duration of approximately 30 minutes. The modules deliver personalised physical activity advice based on the participant’s demographics, physical activity and psychosocial correlates of physical activity as assessed via a survey at the beginning of each module. The content of the modules is based on the theory of planned behaviour. Participants will also receive 4 brief online video coaching sessions with an activity coach. These coaching sessions will take place fortnightly, on alternate weeks to the modules and will be approximately 15minutes in duration. They will be delivered through an online video calling program of the participant’s choice (e.g. Skype, Google Hangout, Yahoo Messenger, FaceTime). Participants who fail to complete a module in the first 7 days of the fortnight will be given a follow-up phone call.
Intervention code [1] 286396 0
Behaviour
Intervention code [2] 288860 0
Lifestyle
Comparator / control treatment
There will be one comparator treatment group, and one wait-list control group which will make 3 groups in total. The comparator group (tailoring only group) will receive the same 8 week web-based physical activity intervention with 4 modules of computer-tailored physical activity advice as the main intervention group (coaching + tailoring group), but will not receive the brief online video coaching sessions. The wait-list control group will complete the research questionnaires (baseline, 9 weeks, 6 months and 12 months post intervention) before they are given access to complete the web-based physical activity intervention.
Control group
Active

Outcomes
Primary outcome [1] 288718 0
Physical Activity Behavior, measured by the Active Australia Questionnaire (AAQ).
Timepoint [1] 288718 0
Baseline, 9 weeks (post intervention), 6 months (follow up), 12 months (follow up)
Secondary outcome [1] 300828 0
Quality of Life, measured by the SF-12v2 Health Survey.
Timepoint [1] 300828 0
Baseline, 9 weeks (post intervention), 6 months (follow up), 12 months (follow up)
Secondary outcome [2] 300829 0
Constructs of Theory of Planned Behaviour including attitude, subjective norm, perceived behavioural control and intentions. These constructs will be measured using the items developed by (Rhodes, Hunt Matheson, & Mark, 2010). Additional items will be used to measure participants planning. These items were developed by (Trinh, Plotnikoff, Rhodes, North, & Courneya, 2012).
Timepoint [2] 300829 0
Baseline, 9 weeks (post intervention), 6 months (follow up), 12 months (follow up)
Secondary outcome [3] 307554 0
Intervention satisfaction will be assessed for participants in the coaching + tailoring and tailoring-only group. Participant’s satisfaction with components of the intervention including the questions, the tailored advice, website usability, the coaching sessions (for coaching + tailoring participants only) and the overall program will be assessed by 5, 19, 18, 9 and 17 items respectively. The majority of items are on a 5-point Likert scale where participants are asked to rate their agreement to statements about the components of the advice. The response options range from strongly agree to strongly disagree. Four open ended items will also be included in the sections on the tailored advice, website usability, the coaching session and the overall program to provide participants with the opportunity to describe 1) what they did like, 2) what they did not like, 3) any recommendations they have and 4) if they have any further comments about the components.
Timepoint [3] 307554 0
9 weeks (post intervention).
Secondary outcome [4] 307555 0
Intervention engagement and retention. Intervention engagement will be measured through participant’s adherence to the intervention modules, and web-site user statistics.
Timepoint [4] 307555 0
Intervention engagement and retention will be measured throughout the intervention period.

Eligibility
Key inclusion criteria
Residents of Mackay and Rockhampton Regions, Queensland, Australia.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-English speaking, Pregnant, under 18 years of age, currently meeting the physical activity guidelines, and at risk of injury or ill health from increasing physical activity (as assessed by the Physical Activity Readiness Questionnaire).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Online advertisements (Facebook, Google and community forums) and print advertisements (newspaper, leaflets and posters) will direct interested individuals to a recruitment page of the intervention website where they can find out more information about the study, and download the information sheet. If they wish to register they are invited to complete an online screening questionnaire which includes an online consent form. Participants who give their consent and are eligible to participate will be identified electronically by the computer software used to administer the surveys. A researcher will then randomly assign eligible participants to one of the three treatment groups. Participant's group assignment will not be disclosed until after they have completed the online baseline questionnaire. As the questionnaires are delivered online, the researchers are not involved in their administration.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated to one of the three groups based on the order of a computer-generated sequence (randomisation.com).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Intervention effects
Data will be analysed using intention to treat principles. Physical activity will be modelled using the using liner mixed models with random intercepts, the fixed effects of group (control, tailoring only, coaching + tailoring) and time (baseline, post-intervention, 6-months, 12-months), and a group by time interaction and will adjust for potential confounders including gender, age group and BMI if they are associated with physical activity and time.
Secondary analyses
The secondary analyses will be conducted using linear effects modelling to determine the effect of group and time on theory of planned behaviour constructs and quality of life. Linear mixed modelling will also be used to compare retention, satisfaction, adherence and web-site user statistics between groups. Multiple regression analyses will be conducted to assess TPB concepts including intention, attitude, subjective norm, perceived behavioural control and planning as mediators for physical activity changes. Descriptive statistics will be used to assess participant adherence and satisfaction of the brief online coaching session.
Sample Size
The sample size needed to detect any between group differences in the physical activity across the two time points was calculated from the sample size analysis determined by Cohen (1992). The alpha level was set to =0.05, so there is only a 5% chance of rejecting the null hypothesis. The power level was set to .80 which leaves a 20% chance of incorrectly rejecting the null hypothesis. The effect size was estimated to be small (.14) based on findings from a recent meta-analysis that the average effect size for web-based physical activity interventions is .14 (Davies et al., 2012b). An estimated attrition of 50% was also factored into the calculations based on the attrition of previous physical activity interventions of similar length. (Vandelanotte et al., 2007b). The analysis revealed that a sample size of 288, or 96 in each study arm, is required for the current study to detect any between group differences in physical activity across the two time points. (Davies et al., 2012b; Ferney et al., 2009) We will round up, and aim to recruit 100 participants in each study arm.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/04/2014
Actual
Date of last participant enrolment
Anticipated
7/11/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 286620 0
Government body
Name [1] 286620 0
National Health and Medical Research Council
Country [1] 286620 0
Australia
Primary sponsor type
University
Name
Central Queensland University
Address
Building No. 5
CQUniversity
CQMC
Rockhampton QLD 4702
Country
Australia
Secondary sponsor category [1] 285405 0
Individual
Name [1] 285405 0
Stephanie Alley
Address [1] 285405 0
Building No. 18
CQUniversity
CQMC
Rockhampton QLD 4702
Country [1] 285405 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288692 0
Human Research Ethics Commitee
Ethics committee address [1] 288692 0
Building No. 5
CQUniversity
CQMC
Rockhampton QLD 4702
Ethics committee country [1] 288692 0
Australia
Date submitted for ethics approval [1] 288692 0
30/03/2013
Approval date [1] 288692 0
02/08/2013
Ethics approval number [1] 288692 0
H13/04-044

Summary
Brief summary
Over half of Australians fail to reach the physical activity guidelines necessary to reduce the risk of cardiovascular disease, diabetes and cancer. Due to rising levels of chronic disease placing a significant burden on Australia’s health care and economy, there is a need for effective population-based physical activity interventions. The internet provides a practical platform to deliver physical activity interventions as it can reach large numbers of people at low cost. Whilst the short term effectiveness of web-based interventions has been established, participant engagement and retention into the intervention have been identified as problems affecting population-level reach and long term effectiveness. This project will measure the effectiveness of brief online coaching provided via Skype versus personally tailored advice alone will be examined in terms of improving website usage, retention and physical activity outcomes. Overall study findings will inform the next generation of web-based physical activity interventions effective in improving physical activity levels in a large range of Australians, and reducing the prevalence of disease in Australia.
Trial website
www.myactivitycoach.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37338 0
Mrs Stephanie Alley
Address 37338 0
Building No. 18
CQUniversity
CQMC
Rockhampton QLD 4702
Country 37338 0
Australia
Phone 37338 0
61749232263
Fax 37338 0
Email 37338 0
s.alley@cqu.edu.au
Contact person for public queries
Name 37339 0
Mrs Stephanie Alley
Address 37339 0
Building No. 18
CQUniversity
CQMC
Rockhampton QLD 4702
Country 37339 0
Australia
Phone 37339 0
61749232263
Fax 37339 0
Email 37339 0
s.alley@cqu.edu.au
Contact person for scientific queries
Name 37340 0
Mrs Stephanie Alley
Address 37340 0
Building No. 18
CQUniversity
CQMC
Rockhampton QLD 4702
Country 37340 0
Australia
Phone 37340 0
61749232263
Fax 37340 0
Email 37340 0
s.alley@cqu.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
SourceTitleYear of PublicationDOI
EmbaseWeb-Based Video-Coaching to Assist an Automated Computer-Tailored Physical Activity Intervention for Inactive Adults: A Randomized Controlled Trial.2016https://dx.doi.org/10.2196/jmir.5664
N.B. These documents automatically identified may not have been verified by the study sponsor.