The Empowering Role of Mobile Apps in Behavior Change Interventions: The Gray Matters Randomized Controlled Trial

Background Health education and behavior change programs targeting specific risk factors have demonstrated their effectiveness in reducing the development of future diseases. Alzheimer disease (AD) shares many of the same risk factors, most of which can be addressed via behavior change. It is therefore theorized that a behavior change intervention targeting these risk factors would likely result in favorable rates of AD prevention. Objective The objective of this study was to reduce the future risk of developing AD, while in the short term promoting vascular health, through behavior change. Methods The study was an interventional randomized controlled trial consisting of subjects who were randomly assigned into either treatment (n=102) or control group (n=42). Outcome measures included various blood-based biomarkers, anthropometric measures, and behaviors related to AD risk. The treatment group was provided with a bespoke “Gray Matters” mobile phone app designed to encourage and facilitate behavior change. The app presented evidence-based educational material relating to AD risk and prevention strategies, facilitated self-reporting of behaviors across 6 behavioral domains, and presented feedback on the user’s performance, calculated from reported behaviors against recommended guidelines. Results This paper explores the rationale for a mobile phone–led intervention and details the app’s effect on behavior change and subsequent clinical outcomes. Via the app, the average participant submitted 7.3 (SD 3.2) behavioral logs/day (n=122,719). Analysis of these logs against primary outcome measures revealed that participants who improved their high-density lipoprotein cholesterol levels during the study duration answered a statistically significant higher number of questions per day (mean 8.30, SD 2.29) than those with no improvement (mean 6.52, SD 3.612), t97.74=−3.051, P=.003. Participants who decreased their body mass index (BMI) performed significantly better in attaining their recommended daily goals (mean 56.21 SD 30.4%) than those who increased their BMI (mean 40.12 SD 29.1%), t80 = −2.449, P=.017. In total, 69.2% (n=18) of those who achieved a mean performance percentage of 60% or higher, across all domains, reduced their BMI during the study, whereas 60.7% (n=34) who did not, increased their BMI. One-way analysis of variance of systolic blood pressure category changes showed a significant correlation between reported efforts to reduce stress and category change as a whole, P=.035. An exit survey highlighted that respondents (n=83) reported that the app motivated them to perform physical activity (85.4%) and make healthier food choices (87.5%). Conclusions In this study, the ubiquitous nature of the mobile phone excelled as a delivery platform for the intervention, enabling the dissemination of educational intervention material while simultaneously monitoring and encouraging positive behavior change, resulting in desirable clinical effects. Sustained effort to maintain the achieved behaviors is expected to mitigate future AD risk. Trial Registration ClinicalTrails.gov NCT02290912; https://clinicaltrials.gov/ct2/show/NCT02290912 (Archived by WebCite at http://www.webcitation.org/6ictUEwnm)


1a-i) Identify the mode of delivery in the title
Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if offline products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms. This paper targeted those in mid-life, aged 40-64 and did not have a condition or health status focus.
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 Does your paper address subitem 1b-i? * 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 briefly explain why the item is not applicable/relevant for your study "The study was a randomised control trial pilot; consisting of subjects who were randomly assigned into either treatment (n=102) or control groups (n=42). Primary outcome measures included a set of anthropometric measures, blood-based biomarkers, objective cognitive testing, and behaviour in targeted domains. Secondary outcome measures included metacognition, motivation, readiness-forchange, sleep quality, social engagement, depression, and couple satisfaction. The treatment group were provided with a bespoke 'Gray Matters' smartphone app. The app presented evidence-based educational material relating to AD risk and prevention strategies, facilitated self-reporting of behaviours across 6 behavioural domains, and presented feedback on their performance; calculated from reported behaviours against recommended guidelines."

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) https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJwH…full&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&hl=en_US 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 briefly explain why the item is not applicable/relevant for your study The methods section states that "The treatment group were provided with a bespoke 'Gray Matters' smartphone app" and that this app "facilitated self-reporting of behaviours across 6 behavioural domains, and presented feedback on their performance".

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. offline), 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 offline 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

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 briefly explain why the item is not applicable/relevant for your study Recruitment of participants was achieved by emailing announcements to faculty, alumni and staff of Utah State University and distributing flyers at health fairs and other venues, assisted by the local health department and their community liaisons. This was not included in the abstract.
The abstract does detail however the assessment measures as so: "Primary outcome measures included a set of anthropometric measures, blood-based biomarkers, objective cognitive testing, and behaviour in targeted domains. Secondary outcome measures included metacognition, motivation, readiness-for-change, sleep quality, social engagement, depression, and couple satisfaction." In addition to this, users also self reported various behaviours, in terms of effort level and quantifiable targets: "facilitated self-reporting of behaviours across 6 behavioural domains, and presented feedback on their performance; calculated from reported behaviours against recommended guidelines." 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 briefly explain why the item is not applicable/relevant for your study Number of participants: "The study was a randomised control trial pilot; consisting of subjects who were randomly assigned into either treatment (n=102) or control groups (n=42)." Outcomes: "Via the app, the average participant submitted 7.3 +-3.2 behavioural logs/day (n=122,719). Analysis of these logs against primary outcome measures revealed that participants who improved their HDL Cholesterol levels during the study duration answered a statistically significant higher number of questions per day (8.30 ± 2.29) than those with no improvement (6.52±3.612), t(97.74)=-3.051, p=.003. Participants who decreased their BMI performed significantly better..."

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 briefly explain why the item is not applicable/relevant for your study The conclusion section of the abstract summarises the positive results from the treatment group. "In this pilot study, the smartphone, offered the opportunity for clinical effects to occur through behaviour change. The app excelled as a method to deliver intervention material, and simultaneously encourage and monitor behaviour change, both for the participant and health investigators."

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) "At the G8 dementia summit held on December 2013, clinical AD experts called upon the governments of G8 countries to make the prevention of AD a major health aim, whilst highlighting the suggestion to study the risk factors associated with the disease [11]." Stakeholder motivations: "The health education interventions that individually targeted such factors for other conditions exhibited positive results, suggesting that a similar effort targeting AD would be likely to result in the desirable adoption of healthy behaviours [14]."

2b) In INTRODUCTION: Specific 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 briefly explain why the item is not applicable/relevant for your study Objective: "The objective of this study was to reduce the future risk of developing Alzheimer's disease, whilst in the short term promoting vascular health through behaviour change." "It is therefore further hypothesized that an intervention targeted at those in mid-life, holds the greatest potential for reducing future risk of developing AD." 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 briefly explain why the item is not applicable/relevant for your study "The study was a randomised control trial (RCT); consisting of subjects who were randomly assigned into either treatment or control groups. The treatment group were not given a strict regimen and therefore a wide range of engagement levels were anticipated. A uniform random number generator (0,1) within SPSS v21 was used to randomize participants into treatment and control groups, with the aim of allocating 1/3 to control, and 2/3 to treatment." Power: "To achieve 80% statistical power to detect a medium effect size (Cohen's d=.50) when comparing the difference between two independent means at a 2:1 (treatment:control) ratio, 96 treatment and 48 control (144 total) participants were needed, calculated using G*Power [54]. Upon randomisation, 104 participants were assigned to treatment and 42 to control. To avoid intra-couple contamination of intervention material, married couples were assigned to the same randomised group (n=12). " 3b) Important changes to methods after trial https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJw…full&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&hl=en_US 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 briefly explain why the item is not applicable/relevant for your study There were no changes to methods are commencement, including eligibility criteria.

3b-i) Bug fixes, Downtimes, Content Changes
Bug fixes, 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 fixes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have influenced study design such as staff changes, system failures/downtimes, etc. [2].

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 briefly explain why the item is not applicable/relevant for your study The app did receive updates throughout the intervention, including feature requests from participants. Content did not change, however various visual elements did.
"Initially the app was developed for iOS 7.x devices, including iPhone and iPad, as the analysis showed a favouring for these devices in the area. As technology screening during the recruitment phase progressed, additional demand appeared for an Android version, which was subsequently developed. The functionality and visual layout of both versions are virtually indistinguishable" 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 briefly explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJw…full&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&hl=en_US "Eligibility criteria included: (a) Age between 40 and 64 years (b) BMI no higher than 41 (c) Possession of a smartphone or tablet (iOS or Android) (d) Fluency in the English language (e) Residence in Cache County (f) Not having any of the following medical conditions: pregnancy, dementia, unmanaged diabetes, or untreated major depression."

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

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 briefly explain why the item is not applicable/relevant for your study Possession of a smartphone or tablet was an criteria of recruitment. This inferred computer literacy.

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. offline), 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 confirmation, 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 briefly explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJw…full&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&hl=en_US Participants were invited to an official study launch day, where they were instructed how to download and install the app onto their personal smartphone. In addition to the app participants also had access to a face-to-face coach, however this was under-utilised as many did not know this was available to them: "Participants also had access to a personal coach whom they could contact if they required assistance with any aspect of the behavioural domains. A team of 28 student interns with majors in the six behavioural domains volunteered to be personal coaches."

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 briefly explain why the item is not applicable/relevant for your study 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 briefly explain why the item is not applicable/relevant for your study Data from the app was uploaded directly to a database: "Answers are uploaded to a remote server via HTTP protocols, using the openstandard JSON format to package the data." https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJw…full&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&hl=en_US

4b-i) Report if outcomes were (self-)assessed through online questionnaires
Clearly report if outcomes were (self-)assessed through online questionnaires (as common in webbased trials) or otherwise.
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 briefly explain why the item is not applicable/relevant for your study Primary outcome measures including anthropometric measures, blood-based biomarkers, objective cognitive testing were performed in a clinical setting pre and post study.
Parts of the outcomes were assessed through self-reporting, although not an online questionnaire: The methods section states that "The treatment group were provided with a bespoke 'Gray Matters' smartphone app" and that this app "facilitated self-reporting of behaviours across 6 behavioural domains, and presented feedback on their performance". Further, "This tab facilitates the collection of behavioural data via self-reporting. As seen in Table 1, 12 questions were designed to collect all relevant behavioural data for the study." "By answering each question, the user can longitudinally track their behaviours across all 6 domains, including their wearable device metrics."

4b-ii) Report how institutional affiliations are displayed
Report how institutional affiliations are displayed to potential participants [on ehealth media], as affiliations 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 briefly explain why the item is not applicable/relevant for your study 5) The interventions for each group with sufficient details to allow replication, including how and when https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJw…full&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&hl=en_US they were actually administered

5-i) Mention names, credential, affiliations of the developers, sponsors, and owners
Mention names, credential, affiliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conflict 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 briefly explain why the item is not applicable/relevant for your study The work has been supported by "the Vice President for Research seed grant, Utah State University and the Department for Employment and Learning, Northern Ireland" Conflicts of Interest: "None declared."

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 briefly explain why the item is not applicable/relevant for your study This did not take place. The app was created and launched under very tight deadlines and was not evaluated before hand. https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJw…full&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&hl=en_US

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).

Does your paper address subitem 5-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 briefly explain why the item is not applicable/relevant for your study Content was frozen under the trial, although not explicitly stated in the body of text.

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
1 2 3 4 5 subitem not at all important essential 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 briefly 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 flowcharts of the algorithms used https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJw…full&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&hl=en_US Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientific reporting.
1 2 3 4 5 subitem not at all important essential 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 briefly explain why the item is not applicable/relevant for your study There are screenshots available within the article, including the questions asked, their scale variables and an equation to calculate performances. Source code is intended to be released in near future.

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 briefly 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 https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJw…full&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&hl=en_US pay (or were paid) or not, whether they had to be a member of specific 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).
1 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 briefly explain why the item is not applicable/relevant for your study Participants downloaded the application from the Google Play store on Android devices, and via the TestFlight platform on iOS devices.
"This was performed through a launch event, in which attending participants were instructed how to signup and download the application through the TestFlight platform. TestFlight is a platform by which developers can distribute applications to internal or external testers. This platform allowed the investigators to control visibility in the app marketplace; ensuring only enrolled participants could see and install the app. " Content Generation: "To enable the dissemination of evidence-based educational material relating to AD risk and prevention strategies, over 130 peer-reviewed journals and papers relating to AD risk were analysed."

5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework
Feedback provided: "The performance tab is designed to present various summaries of the data collected from the log tab, whilst encouraging continual participation via rewards."

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 briefly explain why the item is not applicable/relevant for your study Users were simply asked to use the app as they wished, and where not instructed on number of times per day to use.

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 briefly explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJw…full&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&hl=en_US The app was supported from a technical standpoint, if user had forgotten a password, or had trouble installing onto their device etc. This did not extend beyond technical support, which was needed approx. 5 times during the study.

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 briefly explain why the item is not applicable/relevant for your study "The app was distributed with 2 default notification times. The first notification was issued in the morning at 8 am by default, which reminded the user to check their daily fact pair. The second notification was issued at 6pm by default, which reminded the user to complete the questions in the app's log tab." The user could however turn these notifications off.

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 briefly explain why the item is not applicable/relevant for your study "Intervention Components -In addition to the aforementioned smartphone app, participants in the treatment group had access to a number of components to encourage behaviour change. These included a wrist-worn activity monitor, booster-events, a personal coach and a study website..." 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored (logins, logfile 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 "Use" in the context of the app relates to launching of the app, and interaction with its components. This was monitored using bespoke tracking code. "In addition to monitoring self-reported behaviours, the app also monitors in-app actions using proprietary and open-source analytical tools. This analytical data enables the investigators to examine the profile of the average user and provide insight into how the app is actually being used. Examination of the analytical tracking data also highlights features that fulfil their purpose, whilst also identifying problematic areas of the app, flagging them to be addressed in future updates. Components of the app that contain analytic tracking code include: app launching, tab navigation, updating log values, changing notification times, question detail expansion and performance analysis. "

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).

2 3 4 5
subitem not at all important essential

Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text "An exit survey was designed to capture opinions of participants in the treatment group. The survey asked questions about app usage, motivations, their perceived behaviour change and social network usage. At the end of the study 102 of the 104 participants completed this survey." 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 https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJw…full&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&hl=en_US indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study None.
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 briefly explain why the item is not applicable/relevant for your study "The treatment group were not given a strict regimen and therefore a wide range of engagement levels were anticipated. A uniform random number generator (0,1) within SPSS v21 was used to randomize participants into treatment and control groups, with the aim of allocating 1/3 to control, and 2/3 to treatment. The intervention was delivered over a 6-month period, commencing in April 2014, with post-test collection performed at the close. " Also, "To achieve 80% statistical power to detect a medium effect size (Cohen's d=.50) when comparing the difference between two independent means at a 2:1 (treatment:control) ratio, 96 treatment and 48 control (144 total) participants were needed, calculated using G*Power [54]. Upon randomisation, 104 participants were assigned to treatment and 42 to control. To avoid intra-couple contamination of intervention material, married couples were assigned to the same randomised group (n=12). "

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 briefly explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJw…full&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&hl=en_US 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 briefly explain why the item is not applicable/relevant for your study "The treatment group were not given a strict regimen and therefore a wide range of engagement levels were anticipated. A uniform random number generator (0,1) within SPSS v21 was used to randomize participants into treatment and control groups, with the aim of allocating 1/3 to control, and 2/3 to treatment." 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 indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "A uniform random number generator (0,1) within SPSS v21 was used to randomize participants into treatment and control groups, with the aim of allocating 1/3 to control, and 2/3 to treatment." 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJw…full&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&hl=en_US 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 briefly explain why the item is not applicable/relevant for your study "A uniform random number generator (0,1) within SPSS v21 was used to randomize participants into treatment and control groups, with the aim of allocating 1/3 to control, and 2/3 to treatment." 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 briefly explain why the item is not applicable/relevant for your study item is not applicable/relevant for your study 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 briefly explain why the item is not applicable/relevant for your study Was not performed.

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 briefly explain why the item is not applicable/relevant for your study Participants either received app, or did not.

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) https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJw…full&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&hl=en_US 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 briefly explain why the item is not applicable/relevant for your study Was not performed.
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 briefly explain why the item is not applicable/relevant for your study Independent samples t-Tests.

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]).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 12a-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 briefly explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJw…full&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&hl=en_US If a participant had missing values for a particular test their data was excluded from that test. For behaviour data, recorded from the app, averages were calculated, in some cases on a weekly basis, which handled missing values.

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 briefly explain why the item is not applicable/relevant for your study N/A.

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 briefly explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJw…full&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&hl=en_US The Institutional Review Board at USU approved this research however was not included in paper. Link to other journal paper containing this information is referenced.

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained offline 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 briefly explain why the item is not applicable/relevant for your study The Institutional Review Board at USU approved this research, and written informed consent was collected from all participants

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 briefly explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJw…full&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&hl=en_US No identified risk with use of the smartphone app, however co-ordinators were available to be contacted via email which was provided to all participants.

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 briefly explain why the item is not applicable/relevant for your study "The study was a randomised control trial pilot; consisting of subjects who were randomly assigned into either treatment (n=102) or control groups (n=42). " "Of the 104 users using the app, at the end of the study, 75.97% of all Gray Matters app sessions were on iOS devices (iPhone: 54.7%; iPad: 21.27%) and the remainder on Android devices (24.03%).
Regarding self-reporting of behaviours, the average user answered 7.3 ± 3.16 questions per day during their participation in the study. " All where analysed.
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 flow 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 briefly explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJw…full&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&hl=en_US " To avoid intra-couple contamination of intervention material, married couples were assigned to the same randomised group (n=12). "

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 figures or tables demonstrating usage/dose/engagement. 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the figure 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 briefly explain why the item is not applicable/relevant for your study Apps are now no longer available on the Play Store or App Store. Users who still have apps installed can continue to use however, they are technically unsupported. Statistics of usage attrition are included but diagram of adoption removed due to space.

14a) Dates defining 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 briefly explain why the item is not applicable/relevant for your study "The intervention was delivered over a 6-month period, commencing in April 2014, with post-test collection performed at the close. " https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJw…full&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&hl=en_US

14a-i) Indicate if critical "secular events" fell into the study period
Indicate if critical "secular events" fell into the study period, e.g., significant 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 briefly explain why the item is not applicable/relevant for your study No significant changes or secular events.
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 briefly 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, qualification, 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 briefly explain why the item is not applicable/relevant for your study

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.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 15-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 briefly explain why the item is not applicable/relevant for your study N/A 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 definitions
Report multiple "denominators" and provide definitions: 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 specific predefined time points of interest (in absolute and relative numbers per group). Always clearly define "use" of the intervention.
e.g. from manuscript "Significant correlation, at the 95% confidence interval, was found in pre-post total cholesterol (r=.217, p=.03). The null hypothesis is accepted for all but this case."

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 definitions 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 defined (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 briefly explain why the item is not applicable/relevant for your study Various metrics are included, including session times: "Of the 104 users using the app, at the end of the study, 75.97% of all Gray Matters app sessions were on iOS devices (iPhone: 54.7%; iPad: 21.27%) and the remainder on Android devices (24.03%).
Regarding self-reporting of behaviours, the average user answered 7.3 +-3.16 questions per day during their participation in the study. The average duration of each session with the app, across all devices, is 1 minute 55 seconds. This time is under the originally specified goal of 2 minutes for a user's session duration. Additional analytical tracking code was added to the app in Week 18, to analyse the specific behaviours when answering questions in the log screen. The tracking code recorded the number of times the user alters their behavioural values ( Figure 5). Across all users in the study, Question 12 was altered a statistically significant amount more than the rest (z=3.054, p=.0023). " 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 briefly explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJw…full&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&hl=en_US N/A 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified 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 briefly explain why the item is not applicable/relevant for your study To reduce the certain effects on the data, various quintiles and percentiles were used when applicable.
Example: "Since there were a number of highly active and healthy living individuals within the treatment group, to reduce the ceiling effect on the data, the first quintile (n=20) of participants were removed from the analysis. Using the dichotomous groupings of Improvement and No-Improvement, significant correlations were found between daily goal percentage achieved and BMI reduction (r=.264, p=.017). "

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).

Does your paper address subitem 18-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 briefly explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJw…full&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&hl=en_US "Logically, it is hypothesized that increased exposure to the app and its material would result in favourable outcomes, both in behaviour change and in clinical markers. Firstly, the number of times that the app was launched per week was calculated and categorised into groups (<1, 1-3, 3-5, 5-7, 7+ per week). These groups were then evaluated with various clinical and biometric measurements taken from the participants at the start and end of the study, along with the control group."

19) All important harms or unintended effects in each group
(for specific guidance see CONSORT for harms) Does your paper address CONSORT subitem 19? * 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 briefly explain why the item is not applicable/relevant for your study

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 briefly explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJw…full&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&hl=en_US No privacy breaches or unintended effects occurred.

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 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 briefly explain why the item is not applicable/relevant for your study Section of future improvements contains information gathered from investigators and users.
Examples: "Wearable device integration -The Nike Fuelband's proprietary and non-disclosed metric of fuel points is rather ambiguous for the purpose of a scientific study. Many users reported that the device did not accurately award them with points during activity..." "There is a huge opportunity for personalisation in all aspects of the app. Users of the Gray Matters app have suggested that they wish to set their own targets and behaviour change goals..."

22) Interpretation consistent with results, balancing benefits 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). https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJw…full&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&hl=en_US 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 briefly explain why the item is not applicable/relevant for your study "In this trial, the recommended values for each behaviour played a key role in the uniform assessment of participants' performance. Analysis of pre-post measurements from the treatment group showed clear physiological changes in those who achieved the highest in their attempts to meet recommended values. This was especially apparent in those who were previously underachievers in certain behavioural domains, prior to the study (based on first week of observed behaviour logs). Effects observed included a desirable lowering of BMI, improvements in HDL and LDL cholesterols, improvements in systolic blood pressure, lowering of resting heart rate and improvements in perceived stress levels. "

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 briefly explain why the item is not applicable/relevant for your study "Half of users wished that their educational material was focused on a specific domain of interest, rather than evenly spread throughout all behavioural domains. Such a focus may be beneficial if the user requires extensive change in one particular domain, but for the purpose of a multi-domain intervention the investigators decided it was of great importance to educate across all domains" Other limitations: "The findings of the study may be bias to the study cohort's locale and ethnic group. The study cohort were predominantly white (96.6%) and resided in an county that is classified as 96.23% rural [57]. Whilst desirable changes in behaviour were observed within this cohort, additional research is required to examine the efficacy of the approach within other countries, in various settings, spanning numerous ethnic groups. Within this larger study, additional work would be required to accommodate and account for the cultural, regional and religious differences across groups, e.g. adjusting dietary recommendations based on religious practice." 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 https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJw…full&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&hl=en_US the intervention/usability issues, biases through informed consent procedures, unexpected events.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 20-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 briefly explain why the item is not applicable/relevant for your study "The findings of the study may be bias to the study cohort's locale and ethnic group. The study cohort were predominantly white (96.6%) and resided in an county that is classified as 96.23% rural [57]. Whilst desirable changes in behaviour were observed within this cohort, additional research is required to examine the efficacy of the approach within other countries, in various settings, spanning numerous ethnic groups. Within this larger study, additional work would be required to accommodate and account for the cultural, regional and religious differences across groups, e.g. adjusting dietary recommendations based on religious practice." 21) Generalisability (external validity, applicability) of the trial findings NPT: External validity of the trial findings 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 briefly explain why the item is not applicable/relevant for your study "The findings of the study may be bias to the study cohort's locale and ethnic group. The study cohort were predominantly white (96.6%) and resided in an county that is classified as 96.23% rural [57]. Whilst desirable changes in behaviour were observed within this cohort, additional research is required to examine the efficacy of the approach within other countries, in various settings, spanning numerous ethnic groups. Within this larger study, additional work would be required to accommodate and account for the cultural, regional and religious differences across groups, e.g. adjusting dietary recommendations based on religious practice." https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJw…full&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&hl=en_US

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 indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Improvements to Distribution, education material and also inclusion of smoking cessation discussed: "Improvement of Daily fact and Question Database On an on-going basis, we will strengthen and expand the daily fact database, adding new facts and suggestions, with each vetted using a modification of the rating system developed by the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) workgroup [60]..." "Distribution A number of suggestions were provided by users of the app informally via email during the duration of the study. A familiar complaint included improving the distribution method of the application."

"Additional Behavioural Domains (Smoking Cessation)
Smoking cessation was not included in the original pilot study, as there is an extremely low rate of smokers in the Cache County area [59]."

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 briefly explain why the item is not applicable/relevant for your study 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 briefly explain why the item is not applicable/relevant for your study

X27-i) State the relation of the study team towards the system being evaluated
In addition to the usual declaration of interests (financial 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 briefly explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJw…full&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&hl=en_US There are no conflicts of interest.

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?
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: