Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000113358
Ethics application status
Approved
Date submitted
22/12/2016
Date registered
23/01/2017
Date last updated
18/01/2019
Date data sharing statement initially provided
18/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating the effectiveness of the Active Team mobile phone application in increasing physical activity
Scientific title
Active Team - a randomized controlled trial evaluating the efficacy of an online social networking intervention to increase physical activity in physically inactive Australian adults.
Secondary ID [1] 290163 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 300214 0
Condition category
Condition code
Public Health 300155 300155 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active Team is gamified physical activity intervention delivered via mobile phone application (app). The app utilises online social networking platform, Facebook, to connect users to at least two of their existing friends, who form a team. During the 100 day intervention, participants are provided with a pedometer and the Active Team app. They are encouraged to wear the pedometer for all waking hours and aim to take at least 10,000 steps per day. The app also contains social and gamified features, such as the ability for team members to challenge each other to walking-based challenges or send virtual gifts to one another. Server logs of page views and activity in the app will be used to determine engagement with the app.
Intervention code [1] 295917 0
Behaviour
Intervention code [2] 296920 0
Lifestyle
Comparator / control treatment
Active control condition: Participants allocated to this condition utilise a basic version of the Active Team mobile phone application. As in the intervention condition, participants are provided with a pedometer to measure their step counts which they are encouraged to record in the app’s calendar function. Unlike in the intervention condition, however, the basic app does not contain any social or gamification features.

Wait list control: participants in this condition are wait listed for the duration of the study. These participants are given the opportunity to access the intervention after they have completed the 9 month follow up assessment.
Control group
Active

Outcomes
Primary outcome [1] 299648 0
Objective physical activity (GENEActiv accelerometer worn 24h a day for 7 days.)
Timepoint [1] 299648 0
Baseline, 3 months post baseline, and 9 month follow up
Secondary outcome [1] 327743 0
Quality of life (SF-12)
Timepoint [1] 327743 0
Baseline, 3 months post baseline, and 9 month follow up
Secondary outcome [2] 327744 0
Anxiety and depression (Depression Anxiety Stress scale)
Timepoint [2] 327744 0
Baseline, 3 months post-intervention, and 9 month follow up
Secondary outcome [3] 327745 0
Physical activity self-efficacy (Plotnikoff MPEES self-efficacy scale)
Timepoint [3] 327745 0
Baseline, 3 months post baseline, and 9 month follow up
Secondary outcome [4] 327746 0
Subjective physical activity (Active Australia survey)
Timepoint [4] 327746 0
Baseline, 3 months post baseline, and 9 month follow up
Secondary outcome [5] 327747 0
Engagement with the intervention (usage data collected from phone application)
Timepoint [5] 327747 0
3 months post baseline
Secondary outcome [6] 327748 0
Wellbeing (PERMA plus scale)
Timepoint [6] 327748 0
Baseline, 3 months post-baseline
Secondary outcome [7] 327856 0
Sleep duration and subjective sleep quality (Pittsburgh Sleep Quality Index)
Timepoint [7] 327856 0
Baseline, 3 months post baseline, and 9 month follow up
Secondary outcome [8] 330955 0
physical activity outcome expectations (Plotnikoff MPEES expectations scale)
Timepoint [8] 330955 0
Baseline, 3 months post baseline, and 9 month follow up

Eligibility
Key inclusion criteria
Eligible participants:
1. Are aged between 18 - 65 years old
2. Reside in Australia
3. Own a smartphone
4. Use Facebook at least once per week
5. Are English-language proficient
6. Currently perform less than 150 minutes of physical activity per week
7. Are able to recruit at least two Facebook friends to also participate in the study (forming the participants 'team')
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Affected by a medical condition or disability that precludes them from performing walking-based physical activity

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants are allocated to conditions based on an allocation schedule that is held by an independent allocation officer (an administrative staff member), who has no direct involvement with the study. Following the enrollment of a team of participants into the study, the researchers will contact the allocation officer who will randomly allocate those participants into one of the three conditions. Researchers will not have direct access to the allocation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization will be used. The allocation officer will generate randomly sequenced blocks (of random length), using a random number generator website (random.org).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis that was used to determine minimum sample size:
The G power statistical program was used to calculate minimum sample size to detect a significant difference (alpha=0.01, beta=0.2) with a small to moderate effect size if one exists. This analysis indicated that a minimum sample size of 440 is required.

Statistical analysis that will be used to analyse results:
All statistical analysis will be conducted using the Statistical Package for the Social Sciences (SPSS) v21.
Primary analysis: the SPSS mixed models function will be used to assess the direction and statistical significance of changes in objective physical activity and secondary outcomes (quality of life, mental health, and constructs of social cognitive theory) between the three time points (baseline, 3 months, and 9 months).

Secondary analysis: mediation analysis will be used to determine the effect of user engagement with the intervention, on intervention efficacy.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
9/12/2016
Date of last participant enrolment
Anticipated
1/09/2017
Actual
22/12/2017
Date of last data collection
Anticipated
22/09/2018
Actual
31/10/2018
Sample size
Target
440
Accrual to date
Final
444
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 294497 0
Government body
Name [1] 294497 0
National Health and Medical Research Council
Country [1] 294497 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
Corner of North Terrace & Frome Rd, Adelaide South Australia 5000
Country
Australia
Secondary sponsor category [1] 293394 0
None
Name [1] 293394 0
Address [1] 293394 0
Country [1] 293394 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295965 0
University of South Australia Human Research Committee
Ethics committee address [1] 295965 0
Ethics committee country [1] 295965 0
Australia
Date submitted for ethics approval [1] 295965 0
01/04/2015
Approval date [1] 295965 0
01/04/2016
Ethics approval number [1] 295965 0
0000033967

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68910 0
Dr Carol Maher
Address 68910 0
University of South Australia, North Terrace & Frome Rd, Adelaide SA 5000
Country 68910 0
Australia
Phone 68910 0
+61 8 830 22315
Fax 68910 0
Email 68910 0
[email protected]
Contact person for public queries
Name 68911 0
Carol Maher
Address 68911 0
University of South Australia, North Terrace & Frome Rd, Adelaide SA 5000
Country 68911 0
Australia
Phone 68911 0
+61 8 830 22315
Fax 68911 0
Email 68911 0
[email protected]
Contact person for scientific queries
Name 68912 0
Carol Maher
Address 68912 0
University of South Australia, North Terrace & Frome Rd, Adelaide SA 5000
Country 68912 0
Australia
Phone 68912 0
+61 8 830 22315
Fax 68912 0
Email 68912 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Anyone who wishes to access it.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Access subject to approvals by Principal Investigator.


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseUser Engagement and Attrition in an App-Based Physical Activity Intervention: Secondary Analysis of a Randomized Controlled Trial.2019https://dx.doi.org/10.2196/14645
EmbaseA Social Networking and Gamified App to Increase Physical Activity: Cluster RCT.2020https://dx.doi.org/10.1016/j.amepre.2019.09.009
EmbaseExamining social-cognitive theory constructs as mediators of behaviour change in the active team smartphone physical activity program: a mediation analysis.2021https://dx.doi.org/10.1186/s12889-020-10100-0
N.B. These documents automatically identified may not have been verified by the study sponsor.