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- ecological trial
- pragmatic trial
- real-world trial
- randomised controlled trial
Despite the positive health benefits of physical activity, physical inactivity remains highly prevalent.1 To address this public health issue, population-based interventions that can effectively reach large numbers of people at low cost are needed.2 Numerous randomised controlled trials (RCT) have examined the effectiveness of web-based physical activity interventions, and overall, these intervention studies have found to increase participants’ physical activity levels.3 Few studies, however, have examined how well these interventions work in ‘real world’ or ecologically valid settings, where there are no repeated contacts with research staff, comprehensive assessments or incentives.4 A recent systematic review examined mobile health (mHealth) clinical trial study methodology for trials conducted in 2014 and 2015 and did not identify a single ecological trial, yet RCTs were dominant (80%, 51/71).5
To address this, we conducted two studies using the same web-based physical activity interventions: a RCT and a randomised ecological trial (RET).6 7 For the RCT, 504 inactive participants were randomised into either a control group or intervention group using the existing Australian 10000 Steps website or a new website with social network features that included annotation, messaging and group-publishing, as well as ‘status updates’, inviting ‘friends’ and personalised profile pages (WALK 2.0).7 Outcomes (accelerometer-based activity monitoring, Active Australia Survey questionnaire,8 website usage) were assessed at 0, 3, 12 and 18 months. For the RET, 1328 adults spontaneously signing up for the free 10000 Steps website were randomised into either the 10000 Steps website or the WALK 2.0 website. …
Contributors In terms of preparing the commentary, CV drafted the initial version, SJA conducted additional statistical analyses to produce table 1 and all other authors provided constructive feedback/edits for improvement. All authors read, edited and approved the commentary. In terms of the studies on which the commentary is based: CV, MJD, GSK, CMC, AJM and WKM conceived the project and procured the project funding. GSK led the coordination of the trial. CV, MJD, GSK, CMC, AJM, RRR and WKM assisted with the protocol design. TNS managed the trial including data collection with data management from AVI. RT developed the WALK 2.0 website. MJD performed the sample size calculations. CO conducted the analyses for both studies. MJD, GSK, CO and RRR interpreted the data.
Funding The trials were funded by the National Health and Medical Research Council of Australia (Project grant number 589903).
Competing interests CV (ID 100427) and MJD (ID 100029) are supported by a Future Leader Fellowship from the National Heart Foundation of Australia.
Patient consent Not required.
Ethics approval Western Sydney University Human Research Ethics Committee.
Provenance and peer review Not commissioned; externally peer reviewed.