Effectiveness of a Web 2.0 Intervention to Increase Physical Activity in Real-World Settings: Randomized Ecological Trial

Background The translation of Web-based physical activity intervention research into the real world is lacking and becoming increasingly important. Objective To compare usage and effectiveness, in real-world settings, of a traditional Web 1.0 Web-based physical activity intervention, providing limited interactivity, to a Web 2.0 Web-based physical activity intervention that includes interactive features, such as social networking (ie, status updates, online “friends,” and personalized profile pages), blogs, and Google Maps mash-ups. Methods Adults spontaneously signing up for the freely available 10,000 Steps website were randomized to the 10,000 Steps website (Web 1.0) or the newly developed WALK 2.0 website (Web 2.0). Physical activity (Active Australia Survey), quality of life (RAND 36), and body mass index (BMI) were assessed at baseline, 3 months, and 12 months. Website usage was measured continuously. Analyses of covariance were used to assess change over time in continuous outcome measures. Multiple imputation was used to deal with missing data. Results A total of 1328 participants completed baseline assessments. Only 3-month outcomes (224 completers) were analyzed due to high attrition at 12 months (77 completers). Web 2.0 group participants increased physical activity by 92.8 minutes per week more than those in the Web 1.0 group (95% CI 28.8-156.8; P=.005); their BMI values also decreased more (–1.03 kg/m2, 95% CI –1.65 to -0.41; P=.001). For quality of life, only the physical functioning domain score significantly improved more in the Web 2.0 group (3.6, 95% CI 1.7-5.5; P<.001). The time between the first and last visit to the website (3.57 vs 2.22 weeks; P<.001) and the mean number of days the website was visited (9.02 vs 5.71 days; P=.002) were significantly greater in the Web 2.0 group compared to the Web 1.0 group. The difference in time-to-nonusage attrition was not statistically significant between groups (Hazard Ratio=0.97, 95% CI 0.86-1.09; P=.59). Only 21.99% (292/1328) of participants (n=292 summed for both groups) were still using either website after 2 weeks and 6.55% (87/1328) were using either website after 10 weeks. Conclusions The website that provided more interactive and social features was more effective in improving physical activity in real-world conditions. While the Web 2.0 website was visited significantly more, both groups nevertheless displayed high nonusage attrition and low intervention engagement. More research is needed to examine the external validity and generalizability of Web-based physical activity interventions. Trial Registration Australian New Zealand Clinical Trials Registry: ACTRN12611000253909; https://anzctr.org.au /Trial/Registration/TrialReview.aspx?id=336588&isReview=true (Archived by WebCite at http://www.webcitation.org/6ufzw 2HxD)


2 3 4 5 subitem not at all important essential
Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study Not applicable, neither a condition nor a group were targeted. 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.

1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT
Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Keep in mind the needs of systematic reviewers and indexers by including important synonyms. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important essential

1b-ii) Level of human involvement in the METHODS section of the ABSTRACT
Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study

1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT
Mention how participants were recruited (online vs. ooine), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials). Note: In traditional ooine trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered. To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e. participants can self-enrol). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important essential https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…l=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full Does your paper address subitem 1b-iii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study 1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study '1,328 participants completed baseline assessments. Only 3-month outcomes (224 completers) were analyzed due to high attrition at 12months (77 completers). '

1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials
Conclusions/Discussions in abstract for negative trials: Discuss the primary outcome -if the trial is negative (primary outcome not changed), and the intervention was not used, discuss whether negative results are attributable to lack of uptake and discuss reasons. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem 1b-v?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study INTRODUCTION 2a) In INTRODUCTION: ScientiUc background and explanation of rationale

2a-i) Problem and the type of system/solution
Describe the problem and the type of system/solution that is object of the study: intended as standalone intervention vs. incorporated in broader health care program? Intended for a particular patient population? Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions? (Note: Details about the intervention are provided in "Methods" under 5) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 2a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study 'The translation and dissemination of web-based physical activity intervention research into the real world is lacking, and becoming increasingly important. Therefore, the main aim of this study was to compare the physical activity behaviour of individuals using a traditional Web 1.0 physical activity website to those using an innovative Web 2.0 physical activity website in real-world settings.' Does your paper address subitem 2a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study It has been asserted that the highly controlled nature of RCTs, which aim to minimise impact of selection bias, confounding factors and contamination, stifle the dynamic, spontaneous, and viral nature of Web 2.0 features [12]. While RCTs are an essential component of the research process, complementary approaches with high external validity and generalizability are also essential. For example, if one is not able to invite friends to join an online social network due to RCTrelated restrictions, the social network is unlikely to be as functional and effective as it would be in real-world circumstances [13]. As such, there is a need for alternative and ecologically valid research designs that evaluate web-based 2.0 interventions in real-life conditions in order to advance the science in this area [14]. '

2b) In INTRODUCTION: SpeciUc objectives or hypotheses
Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study 'Therefore, the main aim of this study was to compare the physical activity behaviour of individuals using a traditional Web 1.0 physical activity website to those using an innovative Web 2.0 physical activity website in real-world settings. The study also aimed to assess the effectiveness of Web 2.0 features to engage and retain individuals to a physical activity promotion website, as well as examine differences in quality of life and BMI between intervention groups. The primary hypothesis was that participants in the Web 2.0 condition would display higher levels of physical activity at 3 and 12 months, compared to those in the Web 1.0 condition. The secondary hypotheses were that, in the Web 2.0 condition, there would be higher website engagement and retention, as well as improvements in quality of life and BMI, when compared to the Web 1.0 condition at 3 and 12 months.' METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study More details in protocol paper (ref 13).
'Using a computer-generated algorithm, they were randomized to receive access to one of two intervention websites: a Web 1.0 intervention (which was the 10,000 Steps website they were originally signing up for) or a Web 2.0 intervention (which was the newly developed WALK 2.0 website).' https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…l=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study Not applicable, no changes made.

3b-i) Bug Uxes, Downtimes, Content Changes
Bug Uxes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug Uxes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have inpuenced study design such as staff changes, system failures/downtimes, etc. [2].
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study 4a) Eligibility criteria for participants Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 'Exclusion criteria were: being under 18 years of age; seeking to participate in a 10,000 Steps Workplace Challenge; have been a participant in the WALK 2.0 RCT; and have a medical condition that prevents them from increasing physical activity (assessed through the Physical Activity Readiness Questionnaire) [18]. '

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clariUed.

Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. ooine), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email conUrmation, phone calls) were used to detect/prevent these.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 'Adults (18 years of age or older) spontaneously signing up for the freely available and web-based 10,000 Steps program (www.10000steps.org.au), which attracts over a 1,000 new members per month [17], were asked during the registration process whether they wanted to participate in a research study from November 2012 to June 2014. ' 'All actions (from study invitation to completion) were fully automated, with no interaction from the research team at any point.'

4a-iii) Information giving during recruitment
Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.

Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study

See protocol paper (ref 13)
'If they agreed, they received more information about the study, were screened online for eligibility, provided informed consent, and completed a brief baseline survey.' 4b) Settings and locations where the data were collected Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study 'Using a computer-generated algorithm, they were randomized to receive access to one of two intervention websites: a Web 1.0 intervention (which was the 10,000 Steps website they were originally signing up for) or a Web 2.0 intervention (which was the newly developed WALK 2.0 website). For technical reasons, participants were randomized before completing the baseline measures, however they only gained access to intervention materials after completing the baseline assessment. Follow-up outcomes were assessed 3 and 12 months post-baseline, using online questionnaires; participants were invited by e-mail and received up to 3 reminders.' 'All actions (from study invitation to completion) were fully automated, with no interaction from the research team at any point.,
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study 'Using a computer-generated algorithm, they were randomized to receive access to one of two intervention websites: a Web 1.0 intervention (which was the 10,000 Steps website they were originally signing up for) or a Web 2.0 intervention (which was the newly developed WALK 2.0 website). For technical reasons, participants were randomized before completing the baseline measures, however they only gained access to intervention materials after completing the baseline assessment. Follow-up outcomes were assessed 3 and 12 months post-baseline, using online questionnaires; participants were invited by e-mail and received up to 3 reminders.'

4b-ii) Report how institutional a.liations are displayed
Report how institutional atliations are displayed to potential participants [on ehealth media], as atliations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results) 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study 5) The interventions for each group with sutcient details to allow replication, including how and when they were actually administered

5-i) Mention names, credential, a.liations of the developers, sponsors, and owners
Mention names, credential, atliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conpict of interest" section or mentioned elsewhere in the manuscript).

Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study

5-ii) Describe the history/development process
Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.

Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.

Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study

5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screencapture video, and/or providing ^owcharts of the algorithms used
Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing powcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientiUc reporting.

Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.

Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of speciUc group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).

2 3 4 5
subitem not at all important essential Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full (www.10000steps.org.au), which attracts over a 1,000 new members per month [17], were asked during the registration process whether they wanted to participate in a research study from November 2012 to June 2014. ' 'For technical reasons, participants were randomized before completing the baseline measures, however they only gained access to intervention materials after completing the baseline assessment' subitem not at all important essential Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study More info in protocol paper (ref 13) 'Interventions Web 1.0 Intervention: Participants allocated to the Web 1.0 group were given access to the existing 10,000 Steps website. This website was originally developed to promote the community-based 10,000

5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework
Steps Australia project [19,20], and includes features that support individual self-monitoring (e.g., step log), communication exchange (e.g., discussion forums) and provides access to a library with educational resources (e.g., benefits of activity). Participants were able to log steps and/or type and duration of other physical activities.
Participants also had the ability to share stories, ask questions, or make comments in the discussion forum.
Web 2.0 Intervention: Participants allocated to the Web 2.0 group were given access to a newly developed website (WALK 2.0) that provided content and functionality similar to the Web 1.0 condition (e.g., step log, library), however this website was supplemented with Web 2.0 features that included annotation, messaging and group publishing tools implemented in a social networking setting. Participants in the Web 2.0 group also had access to self-monitoring features and educational resources, however these had advanced functionalities that provided greater interactivity and participatory communication between users (e.g., status updates, internal emails, inviting 'friends', personalized profile pages). Participants could upload content to their own profile page, share this information with others, invite individuals who are not study participants to become their 'friend'and use the website. '

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.

Does your paper address subitem 5-ix?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).

Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study 'All actions (from study invitation to completion) were fully automated, with no interaction from the research team at any point. No pedometers were provided. '

5-xi) Report any prompts/reminders used
Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full None used. Reported in the protocol paper (ref 13).

5-xii) Describe any co-interventions (incl. training/support)
Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as standalone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study None used. Reported in the protocol paper (ref 13).
6a) Completely deUned pre-speciUed primary and secondary outcome measures, including how and when they were assessed Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study 'For technical reasons, participants were randomized before completing the baseline measures, however they only gained access to intervention materials after completing the baseline assessment. Follow-up outcomes were assessed 3 and 12 months post-baseline, using online questionnaires; participants were invited by e-mail and received up to 3 reminders. '

6a-ii) Describe whether and how "use" (including intensity of use/dosage) was deUned/measured/monitored
Describe whether and how "use" (including intensity of use/dosage) was deUned/measured/monitored (logins, logUle analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.

Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text 'Website engagement and retention: Website usage statistics for both websites were continuously measured using Google Analytics (e.g., time on site) and data were extracted directly from the website databases (e.g., step entry information). These measures were only examined from baseline to 3 months (first 12 weeks), due to the low survey completion rate at 12 months. The total and average number of website visits were assessed, as well as the time between the first and last visit. The total and average number of days with a step entry and step entry comments were assessed, including the time between first and last step entry. Non-usage attrition was defined as not having visited the website and/or logged steps for at least two consecutive weeks [11,17].'

6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained
Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups). Copy and paste relevant sections from manuscript text 6b) Any changes to trial outcomes after the trial commenced, with reasons Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study No applicable, no changes made.
7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed

7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size
Describe whether and how expected attrition was taken into account when calculating the sample size.

Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full Details in protocol paper (ref 13).

7b) When applicable, explanation of any interim analyses and stopping guidelines
Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study Not applicable.
8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study More details in the protocol paper (ref 13).
'Using a computer-generated algorithm, they were randomized to receive access to one of two intervention websites: a Web 1.0 intervention (which was the 10,000 Steps website they were originally signing up for) or a Web 2.0 intervention (which was the newly developed WALK 2.0 website). ' 8b) Type of randomisation; details of any restriction (such as blocking and block size) Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study More details in the protocol paper (ref 13).
'Using a computer-generated algorithm, they were randomized to receive access to one of two intervention websites: a Web 1.0 intervention (which was the 10,000 Steps website they were originally signing up for) or a Web 2.0 intervention (which was the newly developed WALK 2.0 website). ' 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study More details in the protocol paper (ref 13).
'Using a computer-generated algorithm, they were randomized to receive access to one of two intervention websites: a Web 1.0 intervention (which was the 10,000 Steps website they were originally signing up for) or a Web 2.0 intervention (which was the newly developed WALK 2.0 website). ' 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study More details in the protocol paper (ref 13).
'Using a computer-generated algorithm, they were randomized to receive access to one of two intervention websites: a Web 1.0 intervention (which was the 10,000 Steps website they were originally signing up for) or a Web 2.0 intervention (which was the newly developed WALK 2.0 website). ' https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment

11a-i) Specify who was blinded, and who wasn't
Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study Not applicable 'All actions (from study invitation to completion) were fully automated, with no interaction from the research team at any point.'

11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator"
Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".

Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 11b) If relevant, description of the similarity of interventions (this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention)

Does your paper address CONSORT subitem 11b? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study Not applicable 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study ' Differences between participants with complete and missing data were compared using t-tests or Pearson chi-squared tests. Analysis of covariance (ANCOVA) was used to test for differences between treatment groups at 3 months in physical activity, quality of life and BMI, whereby baseline physical activity, BMI and quality of life levels and confounding variables were included in the models as covariates. Logistic regression was used to estimate between-group differences in the proportion of participants who achieved sufficient physical activity. Results are presented both for those with complete data at baseline and 3 months (Completer analyses), as well as those with missing data (following intention-to-treat principles). Multiple imputation was applied to deal with missing data (under the missing at random assumption), using the chained equations method. Rubin's method was used to pool the treatment effects using 25 imputed datasets, as the fraction of missing data was high (30). To analyze between-group differences in website engagement and retention, ttests were used. A propositional hazards regression model was used to estimate between-group differences in time from randomization to non-usage; Kaplan-Meier estimates of the proportion remaining active (the "Survival distribution") are also presented [31]. '

12a-i) Imputation techniques to deal with attrition / missing values
Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]). Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study 'Results are presented both for those with complete data at baseline and 3 months (Completer analyses), as well as those with missing data (following intention-to-treat principles). Multiple imputation was applied to deal with missing data (under the missing at random assumption), using the chained equations method. Rubin's method was used to pool the treatment effects using 25 imputed datasets, as the fraction of missing data was high (30).'

12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses
Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study 'To analyze between-group differences in website engagement and retention, t-tests were used. A propositional hazards regression model was used to estimate between-group differences in time from randomization to non-usage; Kaplan-Meier estimates of the proportion remaining active (the "Survival distribution") are also presented [31]. '

X26-i) Comment on ethics committee approval
1 2 3 4 5 subitem not at all important essential

Does your paper address subitem X26-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained ooine or online (how? Checkbox, etc.?), and what information was provided (see 4a-ii). See [6] for some items to be included in informed consent documents.

Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full RESULTS 13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study Also see figure 1, flowchart.
'A participant flowchart is provided in Figure 1. After automatically screening out ineligible people, 10,673 people were invited and 3,480 indicated an interest in participating. After eligibility checks, providing informed consent and website registration, 1,328 people completed all baseline measures. A total of 224 (17%) participants completed the 3month assessment, and 77 (6%) completed the 12-month assessment. ' 13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT ^ow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study Also see figure 1, flowchart.
'A participant flowchart is provided in Figure 1. After automatically screening out ineligible people, 10,673 people were invited and 3,480 indicated an interest in participating. After eligibility checks, providing informed consent and website registration, 1,328 people completed all baseline measures. A total of 224 (17%) participants completed the 3month assessment, and 77 (6%) completed the 12-month assessment. '

13b-i) Attrition diagram
Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other Ugures or tables demonstrating usage/dose/engagement.
Copy and paste relevant sections from the manuscript or cite the Ugure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study logged steps for approximately 10 days. There were no significant between group differences with regard to time on site, entering steps without comments, and the System Usability Score. However, total (9.019.3 vs. 5.717.9, p=0.002) and average (0.71.6 vs. 0.41.4, p=0.002) number of visits were significantly higher in the Web 2.0 group, as well as the time between first and last visit (3.63.7 vs. 2.22.9, p<0.001). Total (0.75.9 vs. 0.21.5, p=0.03) and average (0.050.45 vs. 0.010.10, p=0.02) days with a step entry comment were also significantly higher in the Web 2.0 group. A Kaplan-Meier survival plot shows the proportion of participants that remain using the website for each week of the study (Figure 2). Only 22% of participants were still using either website after 2 weeks (n = 292 summed for both groups), 7% after 10 weeks (n=87). The between-group difference in time-to-non-usage attrition was not statistically significant (HR=0.97, 95%CI=0.86-1.09, p=0.586). ' 14a) Dates deUning the periods of recruitment and follow-up Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study 'Adults (18 years of age or older) spontaneously signing up for the freely available and web-based 10,000 Steps program (www.10000steps.org.au), which attracts over a 1,000 new members per month [17], were asked during the registration process whether they wanted to participate in a research study from November 2012 to June 2014. '

14a-i) Indicate if critical "secular events" fell into the study period
Indicate if critical "secular events" fell into the study period, e.g., signiUcant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 14b) Why the trial ended or was stopped (early) Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study Not applicable.

15) A table showing baseline demographic and clinical characteristics for each group
NPT: When applicable, a description of care providers (case volume, qualiUcation, expertise, etc.) and centers (volume) in each group Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study Also see table 1 ' Table 1 presents participant demographics. At baseline, the majority of participants were female (82%), under 44 years of age (62%), overweight or obese (66%), had a higher education (53%), full-time employed (58%), had a professional or white-collar job (67%) and participated in sufficient physical activity (57%). '

15-i) Report demographics associated with digital divide issues
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known. Not applicable for this 'real world' ecological trial. Our sample was also diverse.
16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups

16-i) Report multiple "denominators" and provide deUnitions
Report multiple "denominators" and provide deUnitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speciUc pre-deUned time points of interest (in absolute and relative numbers per group). Always clearly deUne "use" of the intervention.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study See flow chart and all tables.

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).

Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% conUdence interval) Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study See table 2 and 3.

17a-i) Presentation of process outcomes such as metrics of use and intensity of use
In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational deUnitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is deUned (e.g., timeout after idle time) [1] (report under item 6a).

Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study Not applicable.

18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-speciUed from exploratory
Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study Not applicable

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).

19-i) Include privacy breaches, technical problems
Include privacy breaches, technical problems. This does not only include physical "harm" to participants, but also incidents such as perceived or real privacy breaches [1], technical problems, and other unexpected/unintended incidents. "Unintended effects" also includes unintended positive effects [2].

Does your paper address subitem 19-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study

19-ii) Include qualitative feedback from participants or observations from staff/researchers
Include qualitative feedback from participants or observations from staff/researchers, if available, on https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full strengths and shortcomings of the application, especially if they point to unintended/unexpected effects or uses. This includes (if available) reasons for why people did or did not use the application as intended by the developers.

Does your paper address subitem 19-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study DISCUSSION 22) Interpretation consistent with results, balancing beneUts and harms, and considering other relevant evidence NPT: In addition, take into account the choice of the comparator, lack of or partial blinding, and unequal expertise of care providers or centers in each group

22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use)
Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full variable (i.e., physical functioning) in the Web 2.0 group compared to the Web 1.0 group at 3 months. However, there were no between group differences for several other engagement variables (e.g., logging steps, non-usage drop out) and most quality of life variables. This study the first to demonstrate the importance of using Web 2.0 features in web-based physical activity interventions in a real-life setting. These outcomes are strengthened by not finding between group differences in website usability, indicating that outcomes were not influenced by factors such as 'user-friendliness'. '

22-ii) Highlight unanswered new questions, suggest future research
Highlight unanswered new questions, suggest future research.

Does your paper address subitem 22-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study 20) Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events. Web 2.0 intervention features. The large non-usage and study attrition, however, was an important limitation, making it problematic to analyze 12-month outcomes. This limitation, though, could be considered as a finding that is of interest, as it is a reflection of how web-based interventions are being used in ecologically valid circumstances; it is not, per se, a reflection of poor study methodology. That said, several methodological limitations are inherent to ecological trials, such as the lack of a true control group, and having to resort to less intrusive (self-report) measures to assess outcomes. These methodological concerns can, however, be alleviated by comparing the study outcomes to those of a RCT that applied more rigorous methods [11]. Furthermore, all engagement and retention measures were assessed objectively through the use of website usage statistics. However, it was a limitation of this study that the interventions were only accessible via websites, as the technology landscape has rapidly changed since the study inception, and it is now very common to also use smartphone apps, which are more convenient to access than websites [17]. ' 21) Generalisability (external validity, applicability) of the trial Undings NPT: External validity of the trial Undings according to the intervention, comparators, patients, and care providers or centers involved in the trial

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study

21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting
Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.

Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study OTHER INFORMATION 23) Registration number and name of trial registry Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study Australian and New Zealand Clinical Trial Registry: ACTRN12611000253909 24) Where the full trial protocol can be accessed, if available Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study 25) Sources of funding and other support (such as supply of drugs), role of funders https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study This trial was funded by the National Health and Medical Research Council of Australia (Project grant number 589903). The funder did not have any role in the study other than to provide funding. CV (ID 100427) and MJD (ID 100029) are supported by a Future Leader Fellowship from the National Heart Foundation of Australia.

X27-i) State the relation of the study team towards the system being evaluated
In addition to the usual declaration of interests (Unancial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.

Does your paper address subitem X27-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study About the CONSORT EHEALTH checklist As a result of using this checklist, did you make changes in your manuscript? * yes, major changes yes, minor changes no What were the most important changes you made as a result of using this checklist? https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full How much time did you spend on going through the checklist INCLUDING making changes in your manuscript *

hours
As a result of using this checklist, do you think your manuscript has improved? * yes no Other:

Would you like to become involved in the CONSORT EHEALTH group?
This would involve for example becoming involved in participating in a workshop and writing an "Explanation and Elaboration" document yes no Other:

Any other comments or questions on CONSORT EHEALTH
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