Effectiveness of an Ecological Momentary Intervention for Reducing Risky Alcohol Consumption Among Young Adults: Protocol for a Three-Arm Randomized Controlled Trial

Background Recent research has investigated the utility of mobile phone–delivered interventions for reducing risky single-occasion drinking, also known as binge drinking. In the past five years, focus has been placed on ecological momentary interventions (EMIs), which aim to deliver intervention content in correspondence to real-time assessments of behavior, also known as ecological momentary assessments (EMAs). Objective This study aims to assess the effect of a fully automated, tailored, mobile phone–delivered EMI termed Mobile Intervention for Drinking in Young people (MIDY) on young people's risky single-occasion drinking behavior. Methods We will use a three-armed randomized controlled trial design to determine the impact of MIDY on peak consumption of alcohol among young people. A list of mobile telephone numbers for random digit dialing will be generated, and researchers will telephone potential participants to screen for eligibility. Participants will be randomized into one of three intervention groups. For 6 weeks, EMI, EMA, and attention control groups will complete hourly EMA surveys on their mobile phones on Friday and Saturday nights. EMI participants will receive personalized feedback in the form of text messages corresponding to their EMA survey responses, which focus on alcohol consumption, spending, and mood. EMA participants will not receive feedback. A third group will also complete EMA and receive feedback text messages at the same time intervals, but these will be focused on sedentary behavior and technology use. All groups will also complete a short survey on Saturday and Sunday mornings, with the primary outcome measure taken on Sunday mornings. A more detailed survey will be sent on the final Sunday of the 6-week period, and then again 1 year after recruitment. Results The primary outcome measure will be an observed change (ie, reduction) in the mean peak number of drinks consumed in a single night over the 6-week intervention period between the EMI and attention control groups as measured in the weekly EMA. We expect to see a greater reduction in mean peak drinking in the EMI group compared to that in the attention control group. As a secondary aim, we will assess whether mean peak drinking is reduced in the EMA group compared to the attention control group. We will use a random-effects mixed-modeling approach using maximum-likelihood estimation to provide estimates of differences in peak drinking across time periods between those receiving the intervention (EMI) and attention control participants. An intention-to-treat approach will be taken for the analysis. Individuals and study groups will be modeled as random and fixed factors, respectively. Conclusions This study extends our previous work investigating the efficacy of a mobile EMI (MIDY) for reducing risky drinking among young adults in Australia, and will add to the expanding literature on the use of mobile interventions for reducing risky alcohol consumption. Trial Registration Australian New Zealand Clinical Trials Registration (ANZCTR): ACTRN12617001509358p; http://www.anzctr.org.au/ACTRN12617001509358p.aspx International Registered Report Identifier (IRRID) DERR1-10.2196/14190

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.
Does your paper address subitem 1a-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 Basically all Ecological Momentary Interventions are mobile phone delivered and the title is already long with the other requirements that JMIR has. The delivery is explained early (and repeatedly) in the abstract 1a-ii) Non-web-based components or important co-interventions in title Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support"). subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1a-ii?
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 Not relevant. 1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial 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 briefly explain why the item is not applicable/relevant for your study "Effectiveness of the MIDY ecological momentary intervention for reducing risky alcohol consumption among young adults"

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) https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dG… 10/52 subitem not at all important 1 2 3 4 5 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 "For 6 weeks, EMI, EMA and Attention Control groups will complete hourly EMA surveys on their mobile phone on Friday and Saturday nights. EMI participants will receive personalised feedback SMS messages corresponding to their EMA survey responses, which focus on alcohol consumption, spending and mood.
EMI participants will not receive feedback SMS. A third group will also complete EMAs and receive feedback messages at the same time intervals, but focused on sedentary behaviour and technology use." 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) 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 "This study aims to assess the effect of a fully-automated, tailored, mobile 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-toface 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) 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 "A list of mobile telephone numbers for random digit dialling will be generated and researchers will telephone potential participants and screen for eligibility." 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) 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 including allocation ratio adults with risky drinking behaviour. We conducted a three-armed randomised controlled trial (RCT), comparing the full MIDY intervention to an assessmentonly control and a no-contact control groups. Participants were asked to complete the intervention or assessments on six nights over a 12 week study period. Our analyses showed a small and nonsignificant increase between baseline and follow-up in the mean number of standard drinks consumed at the most recent heavy drinking occasion in the EMI group (Mbaseline=12.5 vs Mfollow-up= 12.7). The EMA and control groups showed a nonsignificant decrease (EMA: Mbaseline=13.8 vs ). There were no significant differences in these changes between the groups and effect sizes were small. However, this study was challenged by a small sample size relating to difficulties with recruitment, which affected our ability to detect significant effects. We therefore recommended further research into the efficacy of the MIDY intervention to clarify any effect on alcohol consumption." 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 "Based on the two previous studies [15,18] 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 "We will use a three-armed randomised controlled trial design to determine the impact of MIDY on peak consumption of alcohol among young people. " 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 Protocol paper 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 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 We required people to already own and use a mobile phone with internet access to participate, however we did not assess 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.
subitem not at all important 1 2 3 4 5 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 "Participants will be recruited using random digit dialling by trained researchers employed by TKW Research Group, a Computer Assisted Telephone Interview (CATI) service provider. A list of mobile telephone numbers for random digit dialling will be generated and researchers will telephone potential participants and screen for eligibility." "If eligible to enrol in the study, researchers will invite them to participate using a standard script to describe the study (i.e. all three groups will receive the same information about completing mobile phone surveys on Friday and Saturday nights for the next 6 weeks). If they provide verbal consent, the researcher will administer the baseline questionnaire over the phone on the spot. " 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. 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 "If eligible to enrol in the study, researchers will invite them to participate using a standard script to describe the study (i.e. all three groups will receive the same information about completing mobile phone surveys on Friday and Saturday nights for the next 6 weeks). If they provide verbal consent, the researcher will administer the baseline questionnaire over the phone on the spot. " "Follow completion of the interview, TKW Research Group will forward the details of new participants to the Burnet Institute, and we will send a welcome SMS with a link to detailed study information relevant to the participants' assigned arm; this will include a plain language summary of the procedures relating to their trial arm, additional information as per the usual requirements of an 'explanatory statement' required by an ethics committee, as well as some frequently asked questions. Participants will be blinded to the purpose of the study. The nature of the intervention means it will not be possible to blind participants to their allocated arm; however, they will remain unaware of the detailed procedures of the other arms." 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 "Eligible participants will be: • Australian residents" 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.
subitem not at all important 1 2 3 4 5 essential 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered subitem not at all important 1 2 3 4 5 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 "Each participant from the EMA/EMI groups will fill out the same self-reported mobile-phone delivered surveys on Friday and Saturday nights for six weeks." 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) 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 Your answer 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).
subitem not at all important 1 2 3 4 5 essential 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 ". Our SMS system was developed by company Questmetrics which is linked with SurveyGizmo (which hosts our EMA surveys) using webhooks, so that data from the surveys is immediately passed in to the Questmetrics database and used to retrieve a relevant tailored message. "

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 "The current study extends our previous work in developing and testing a mobile phone-delivered EMI for reducing risky drinking in the event. Our 2016 study [15] outlined the co-design process taken to develop the Mobile Intervention for Drinking in Young people (MIDY), during which 42 young people participated in workshops to inform the delivery platform, timing and frequency of assessment and intervention, questionnaires, tailoring process and intervention content. The subsequent design included SMS-prompted mobile web-based EMAs (i.e. being sent an SMS with a link to a survey that opens in your mobile phone webbrowser), with SMS feedback sent after each EMA was completed. Our feedback was informed by participant's preferences, in addition to motivational interviewing and brief intervention theory [17]. Hourly EMA were preferred by most, between 6pm and 2am on intervention nights. Participants requested feedback messages that were short, practical and non-judgmental. The same young people then tested the intervention on one night and completed follow-up interviews. The design was reported to be feasible and acceptable by almost all participants, with a response rate of over 90% for EMAs. " 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 There is no specific version number. This is a protocol.

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 briefly explain why the item is not applicable/relevant for your study Not relevant 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used 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.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 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 Not possible due to IP.

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 Not possible -we can't pay to have a functioning system preserved and be accessible.

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 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).
subitem not at all important 1 2 3 4 5 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 "Follow completion of the interview, TKW Research Group will forward the details of new participants to the Burnet Institute, and we will send a welcome SMS with a link to detailed study information relevant to the participants' assigned arm" "As with our previous study which tested an earlier version of this intervention [18], at 6pm on study nights, participants will receive a short text message (SMS) asking them to complete a survey, containing a link to an online questionnaire. "......
"All participants will receive reimbursements varied based on the level of participation in the study, with the baseline, 6-week follow up and 12-month follow up incentivised in addition to the next-day surveys (11am Saturday, following Friday night event, and 11am Sunday, following Saturday night event).
Each survey is worth AUS$5, with a bonus AUS$10 for completing the final Sunday survey at the end of the 6 weeks, and AUS$10 for the 12 month follow up. Total possible reimbursement is therefore AUS$80." 5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework 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 briefly explain why the item is not applicable/relevant for your study "The EMI intervention, including questionnaires, message framing and content were developed in a participatory study with a group of 42 young adults in 2014 [20,21]. This three-part study involved half-day workshops to inform the design, individual testing of the intervention on a single night of drinking, and evaluation involving both in-depth interviews and a structured online survey. Further refinements were made following the implementation and evaluation of a pilot randomised controlled trial [18,22]  essential that they make an alternative plan such as "It's probably not safe for you to ride home tonight. What's your back up plan?". A participant who reports in their presurvey that they would like to avoid having a hangover the next day and that they have not eaten dinner yet and plan to have more than 2 drinks that night, may receive a message such as "Don't want to spend tomorrow in bed? Dinner now is a great idea"."

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 "Each participant from the EMA/EMI groups will fill out the same self-reported mobile-phone delivered surveys on Friday and Saturday nights for six weeks."...
"In line with Ecological Momentary Intervention principles [13], the EMI group will additionally receive repeated SMS intervention messages each time they fill in a survey on intervention nights. "

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 21generalizability).
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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 This will be described in the results paper.

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).
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 N/A -once enrolled in the study participants received messages scheduled on Friday and Saturdays for 6 weeks.

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 stand-alone 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. 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 N/A -no co-interventions 6a) Completely defined pre-specified 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 briefly explain why the item is not applicable/relevant for your study "Primary outcome measure All measures were defined a priori. The primary outcome measure will be an observed change (i.e. reduction) in the mean peak number of drinks consumed in a single night, over the six-week intervention period between those receiving the intervention (EMI) and attention control participants (AC), as measured in the weekly EMAs. The method improves on our previous study, which only collected this primary outcome measure at baseline and a follow-up 12 weeks later. The primary outcome measure is collected in the 11am (next-day) survey on Sunday mornings each week during the 6-week study period (total of 6 measurements). The question asks participants to report on the highest number of alcoholic drinks consumed in a single occasion in the past week, and the night of the week it was consumed. This measure will also be collected in a survey 12 months after the commencement of the intervention period.
We expect to see a greater reduction in mean peak drinking in the EMI group, compared to the attention control group. We also expect that the EMA group will show a reduction in mean peak drinking, compared to the attention control group. The latter hypothesis is based on findings from our 2018 study which showed a large but non-significant reduction in the EMA group, compared to the control [25]. It should be noted that this outcome is based on reducing peak consumption on a single occasion, rather than the general frequency or quantity of alcohol consumption over a period of time. This outcome is recognised as the most accurate measure of the key aim of binge drinking interventions, namely to reduce the level of consumption (and harm) in an acute event. This single item numerical measure has been shown to be reliable when compared to detailed time and location specific questioning across the drinking occasion [26]. Secondary outcome measures The following secondary outcomes of interest will be measured at the baseline, 6-week follow up (final Sunday 11am survey) and the 12-month follow up. Secondary alcohol consumption measures include annual consumption of >730 standard drinks per year (which equates to >2 standard drinks per day, in line with the Australian National Health and Medical Research Council guidelines for alcohol consumption) and, as two additional outcomes, monthly consumption of ≥ 5 and ≥ 11 drinks in a single session. These three measures will be derived from the graduated frequency measures [34] which includes the following questions: "In the past 12 months, how often have you had 20 or more standard drinks in a day?" with response options including "Every day," "5 to 6 days a week," "3 to 4 days a week," "1 to 2 days a week," "1 day a week," "2 to 3 days a subitem not at all important 1 2 3 4 5 essential month," "About 1 day a month," and "Less often than 1 day a month." The question is then repeated inquiring about frequency of consumption: 11-19 standard drinks, 7-10 standard drinks, 5-6 standard drinks, 3-4 standard drinks, and 1-2 standard drinks. We will also examine changes in hazardous alcohol consumption, using the Alcohol Use Disorders Identification Test (AUDIT).
We will measure experience of alcohol-related harms with yes/no/don't know responses whether they have experienced different types of harm on their heaviest drinking occasion in the past 3 months including: "Did you get into any verbal arguments or verbal fights on that occasion?," "Did you fail to do what you intended to do the day after the session?" and "Did you have any trouble getting home on that occasion?". These items were derived from the GenACIS [27] and VYADS questionnaires [28].
Usability and acceptability will be assessed in the follow-up survey among all groups using 5 point Likert scales asking participants to rate a series of individual statements pertaining to their experience of undertaking the intervention (e.g. 'the assessments were easy to complete'). Additional process evaluation measures, such as participant levels of response, refusal, and timeliness of response, will also be explored to assess feasibility and acceptability.
" 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed 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 NA 8b) Type of randomisation; details of any restriction (such as blocking and block size) 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 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 "We will use the Stata statistical software package version 15 to conduct block randomisation in order to ensure balanced randomisation to each of the three study arms [29]. Randomisation will be undertaken by a researcher external to the study team." 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 "We will use the Stata statistical software package version 15 to conduct block randomisation in order to ensure balanced randomisation to each of the three study arms [29]. Randomisation will be undertaken by a researcher external to the study team." 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 "We will use the Stata statistical software package version 15 to conduct block randomisation in order to ensure balanced randomisation to each of the three study arms [29]. Randomisation will be undertaken by a researcher external to the study team." 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 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 subitem not at all important 1 2 3 4 5 essential 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 "We will use the Stata statistical software package version 15 to conduct block randomisation in order to ensure balanced randomisation to each of the three study arms [29]. Randomisation will be undertaken by a researcher external to the study team." 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).
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 "Participants will be blinded to the purpose of the study. The nature of the intervention means it will not be possible to blind participants to their allocated arm; however, they will remain unaware of the detailed procedures of the other arms" subitem not at all important 1 2 3 4 5 essential 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) 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 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 will be blinded to the purpose of the study. The nature of the intervention means it will not be possible to blind participants to their allocated arm; however, they will remain unaware of the detailed procedures of the other arms" 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 NA mHealth subitem not at all important 1 2 3 4 5 essential 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 "We will use a random effects mixed modelling approach using maximum likelihood estimation to provide estimates of differences in peak drinking across time between those receiving the intervention EMI and attention control participants. An intention-to-treat approach will be taken to analysis. Initially, individuals and study group will be modelled as random and fixed factors respectively in these mixed model analyses. Appropriate fixed terms for the functional form of the association between study time and peak drinking will also be estimated in modelling. Additional analyses will explore the model fit of estimation of study group and time factors as random effects. The interaction between group allocation and study time is our primary focus. These analyses will be repeated, as secondary analyses, to determine the impact of the assessments alone (i.e. comparison of EMA and attention control) using participant observations from the EMA group. Simple main effects for both treatment and time will also be estimated in the models. Distributional assumptions of models will be tested in the data and appropriate transformations applied where these are not reasonably met. All statistical analyses will be performed using the Stata statistical software package version 15 [29]. " 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]).
12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses X26) REB/IRB Approval and Ethical Considerations [recommended as subheading under "Methods"] (not a CONSORT item) 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 "We will use a random effects mixed modelling approach using maximum likelihood estimation to provide estimates of differences in peak drinking across time between those receiving the intervention EMI and attention control participants. An intention-to-treat approach will be taken to analysis. Initially, individuals and study group will be modelled as random and fixed factors respectively in these mixed model analyses. Appropriate fixed terms for the functional form of the association between study time and peak drinking will also be estimated in modelling. Additional analyses will explore the model fit of estimation of study group and time factors as random effects. The interaction between group allocation and study time is our primary focus. These analyses will be repeated, as secondary analyses, to determine the impact of the assessments alone (i.e. comparison of EMA and attention control) using participant observations from the EMA group. Simple main effects for both treatment and time will also be estimated in the models. Distributional assumptions of models will be tested in the data and appropriate transformations applied where these are not reasonably met. All statistical analyses will be performed using the Stata statistical software package version 15 [29]. " 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 NA subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential X26-i) Comment on ethics committee approval 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 Ethics approval for the RCT has been obtained from the Alfred Hospital Ethics Committee (project 18/18).

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 "If they provide verbal consent, the researcher will administer the baseline questionnaire over the phone on the spot. Reasons for refusal will be documented. Follow completion of the interview, TKW Research Group will forward the details of new participants to the Burnet Institute, and we will send a welcome SMS with a link to detailed study information relevant to the participants' assigned arm; this will include a plain language summary of the procedures relating to their trial arm, additional information as per the usual requirements of an 'explanatory statement' required by an ethics committee, as well as some frequently asked questions. " subitem not at all important 1 2 3 4 5 essential 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 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) 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 "There is a small risk that participants will experience discomfort when answering questions about their alcohol consumption and its impacts, and reflecting on their previous weekend night. Participants do not have to answer any question if they feel uncomfortable about doing so.
There is also a small risk of participants feeling inconvenienced at having to answer hourly surveys on weekend nights. The impact is minimal given the surveys will take only 1-2 minutes each. Participants are also given the option at each hourly survey to opt out of completing subsequent assessments for that night.
Small payment will also be provided, as above, to compensate participants for their time.

"
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 NA -protocol  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" 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 NA -protocol 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 NA -protocol 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 NA -protocol subitem not at all important 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 NA -protocol 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 pre-defined time points of interest (in absolute and relative numbers per group). Always clearly define "use" of the intervention.
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 briefly explain why the item is not applicable/relevant for your study NA -protocol subitem not at all important 1 2 3 4 5 essential 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) subitem not at all important 1 2 3 4 5 essential 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 briefly explain why the item is not applicable/relevant for your study "An intention-to-treat approach will be taken to analysis. Individuals and study group will be modelled as random and fixed factors respectively." 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 briefly explain why the item is not applicable/relevant for your study NA -protocol 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).
17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing prespecified from exploratory subitem not at all important 1 2 3 4 5 essential 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 NA -protocol 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 NA -protocol 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 NA -protocol

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 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 NA -protocol 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).
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 NA -protocol 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 NA -protocol

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.
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 NA -protocol 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 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 NA -protocol 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 NA -protocol 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 "Australian New Zealand Clinical Trials Registration (ANZCTR) number: ACTRN12617001509358p" 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 This is the protocol.
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 briefly explain why the item is not applicable/relevant for your study "This study is funded by the Australian National Health and Medical Research Council and the Victorian Health Promotion Foundation, who did not have any input into the research design, implementation, or analysis. " 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. yes no Other: STOP -Save this form as PDF before you click submit To generate a record that you filled in this form, we recommend to generate a PDF of this page (on a Mac, simply select "print" and then select "print as PDF") before you submit it.
When you submit your (revised) paper to JMIR, please upload the PDF as supplementary file.
Don't worry if some text in the textboxes is cut off, as we still have the complete information in our database. Thank you!