Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000292976
Ethics application status
Approved
Date submitted
23/02/2020
Date registered
4/03/2020
Date last updated
4/03/2020
Date data sharing statement initially provided
4/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Commercial App Use on Physical Activity
Scientific title
The Impact of Strava on Physical Activity: A Pilot Randomised Controlled Trial
Secondary ID [1] 300626 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 316395 0
Condition category
Condition code
Public Health 314662 314662 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to examine the effect of an intervention incorporating a commercially available app (Strava) on physical activity behaviour. Strava is a widely used, free app that enables individuals to track and monitor their physical activity behaviour. This study also seeks to isolate the value of the social features of Strava in facilitating physical activity, by examining the use of the Strava community and an existing social media platform (Facebook).

A pilot randomised controlled trial will be conducted, with participants randomly allocated to one of three conditions: 1) Strava only (and use of the Strava community), 2) Strava + Facebook (and use of the Strava community), 3) waitlisted control condition. Participants in all three conditions will be provided with an Information Sheet about the Australian Physical Activity Guidelines, and provided with a goal of engaging in 30 minutes of at least moderate-intensity physical activity (e.g., activity that makes you feel out of breathe, for example brisk walking, swimming, jogging, cycling) on at least five days per week (The Department of Health, 2019). Participants allocated to the Strava only and Strava + Facebook conditions will be guided through the installation of Strava on their smartphone, and will also be provided with a brief overview of how to use the various features of Strava, including the Strava community (connecting with other users within Strava). Participants in the Strava + Facebook condition will be shown how to share tracked physical activity from Strava to Facebook, and asked to do so for the duration of the study. They will also be provided with information related to the benefits of sharing tracked physical activity to Facebook. Intervention engagement will be measured by monitoring participants’ Strava accounts and personal Facebook accounts.
Intervention code [1] 316951 0
Behaviour
Comparator / control treatment
Participants allocated to the control condition will be given an Information Sheet about the Australian Physical Activity Guidelines, and will be provided with a goal of engaging in 30 minutes of at least moderate-intensity physical activity (e.g., activity that makes you feel out of breathe, for example brisk walking, swimming, jogging, cycling) on at least five days per week (The Department of Health, 2019). These participants will be guided through the downloading of Strava and provided with information for its use after completing the 6-month follow-up assessment.

Control group
Active

Outcomes
Primary outcome [1] 322984 0
Accelerometer-derived physical activity (light, moderate and vigorous) using the GeneActiv wrist-worn triaxial accelerometer (worn 24 hours a day for 7 days).
Timepoint [1] 322984 0
Baseline, 8-weeks (final week of intervention), 3 and 6 month post baseline follow-ups.
Primary outcome [2] 322985 0
Self-reported engagement in physical activity (duration, frequency and type of physical activity) using an open-ended response format following Prichard and Tiggemann (2008).
Timepoint [2] 322985 0
Baseline, 8-weeks (final week of intervention), 3 and 6 month post baseline follow-ups.
Secondary outcome [1] 380426 0
Social support for physical activity assessed using the Social Support for Exercise Behaviors Scale.
Timepoint [1] 380426 0
Baseline, 8-weeks (final week of intervention), 3 and 6 month post baseline follow-ups.
Secondary outcome [2] 380427 0
Physical activity self-efficacy measured using the Physical Activity Self-efficacy Scale.
Timepoint [2] 380427 0
Baseline, 8-weeks (final week of intervention), 3 and 6 month post baseline follow-ups.
Secondary outcome [3] 380428 0
Physical activity motivations using the Behavioral Regulation in Exercise Questionnaire.
Timepoint [3] 380428 0
Baseline, 8-weeks (final week of intervention), 3 and 6 month post baseline follow-ups.
Secondary outcome [4] 380429 0
Trait social comparison assessed using the Iowa-Netherlands Comparison Orientation Measure.
Timepoint [4] 380429 0
Baseline
Secondary outcome [5] 380430 0
Trait competitiveness using the Revised Competitiveness Index.
Timepoint [5] 380430 0
Baseline
Secondary outcome [6] 380431 0
Ten-Item Personality Inventory (TIPI)
Timepoint [6] 380431 0
Baseline
Secondary outcome [7] 380432 0
Narcissism Personality Inventory (NPI-13)
Timepoint [7] 380432 0
Baseline
Secondary outcome [8] 380433 0
Intervention engagement measured by monitoring participants’ Strava accounts and personal Facebook accounts.
Timepoint [8] 380433 0
Participants’ Strava and personal Facebook accounts will be examined by the researchers on a weekly basis during the intervention phase, and for a one week period at both the 3 and 6 month post baseline follow-ups.
Secondary outcome [9] 380434 0
Feasibility of the intervention assessed by asking participants to report on the acceptability of the intervention on items developed for the present study.
Timepoint [9] 380434 0
At completion of the intervention (8 weeks).

Eligibility
Key inclusion criteria
Aged 18 years and over
Live independently (without assistance) in Metropolitan Adelaide
Possess a smartphone (iPhone or Android)
Use Facebook regularly (on at least 4 days per week)
Insufficiently active (not currently achieving the Australian guidelines of 150 minutes of moderate-to-vigorous physical activity per week)
Not currently using a physical activity app and sharing the tracked data to the app community (other app users) or social media platforms (e.g., Facebook, Instagram)  
Have not used Strava in the past 12 months
Fluent in English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Existing medical conditions for which individuals have been advised by a doctor to avoid physical activity.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation using computerised sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation
We aim to recruit a sample size of n = 102 calculated using G*Power 3.1 software, based on the following parameters: a moderate effect size (Cohen’s f) of 0.25, 3 groups, 4 repeated measures, an alpha level of 0.05 and 80% power.

Statistical analyses
All analyses will follow intention to treat principles. Linear mixed models will be used to determine changes in the primary (physical activity) and secondary outcomes (e.g., social support, self-efficacy) over the four time points (baseline, 8-weeks, 3 months and 6 months). The feasibility data will be descriptively analysed. Data will be analyzed using IBM Statistical Package for the Social Sciences (SPSS) version 25. Alpha will be set at 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/03/2020
Actual
Date of last participant enrolment
Anticipated
10/08/2020
Actual
Date of last data collection
Anticipated
8/03/2021
Actual
Sample size
Target
102
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 305047 0
University
Name [1] 305047 0
Flinders University
Country [1] 305047 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Flinders University
GPO Box 2100
Adelaide, SA 5001
Country
Australia
Secondary sponsor category [1] 305412 0
None
Name [1] 305412 0
Address [1] 305412 0
Country [1] 305412 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305437 0
Social and Behavioural Research Ethics Committee (SBREC)
Ethics committee address [1] 305437 0
Ethics committee country [1] 305437 0
Australia
Date submitted for ethics approval [1] 305437 0
18/11/2019
Approval date [1] 305437 0
09/12/2019
Ethics approval number [1] 305437 0
8525

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

Contacts
Principal investigator
Name 100382 0
Ms Jasmine Petersen
Address 100382 0
Flinders University
GPO Box 2100
Adelaide, SA 5001
Country 100382 0
Australia
Phone 100382 0
+61 8 82013713
Fax 100382 0
Email 100382 0
[email protected]
Contact person for public queries
Name 100383 0
Jasmine Petersen
Address 100383 0
Flinders University
GPO Box 2100
Adelaide, SA 5001
Country 100383 0
Australia
Phone 100383 0
+61 8 82013713
Fax 100383 0
Email 100383 0
[email protected]
Contact person for scientific queries
Name 100384 0
Jasmine Petersen
Address 100384 0
Flinders University
GPO Box 2100
Adelaide, SA 5001
Country 100384 0
Australia
Phone 100384 0
+61 8 82013713
Fax 100384 0
Email 100384 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.