Combining Technology and Research to Prevent Scald Injuries (the Cool Runnings Intervention): Randomized Controlled Trial

Background New technologies, internet accessibility, social media, and increased smartphone ownership provide new opportunities for health researchers to communicate and engage target audiences. An innovative burn prevention intervention was developed using these channels. Objective The aim of this study was to evaluate the efficacy of Cool Runnings, an app-based intervention to increase knowledge of childhood burn risk (specifically hot beverage scalds) and correct burn first aid among mothers of young children. Methods This was a 2-group, parallel, single-blinded randomized controlled trial (RCT). Participants were women aged 18 years and above, living in Queensland, Australia, with at least 1 child aged 5-12 months at time of enrollment. The primary outcome measures were change in knowledge about risk of burns and correct burn first aid assessed via 2 methods: (1) overall score and (2) categorized as adequate (score=4) versus inadequate (score<4). Efficacy of gamification techniques was also assessed. Results In total, 498 participants were recruited via social media and enrolled. At the 6-month follow-up, 244 participants completed the posttest questionnaire. Attrition rates in both groups were similar. Participants who remained in the study did not differ from those lost to follow-up on any characteristics except education level. Although similar at baseline, intervention group participants achieved significantly greater improvement in overall knowledge posttest than control group participants on both primary outcome measures (overall knowledge intervention: mean [SD] of overall knowledge 2.68 [SD 1.00] for intervention vs 2.13 [SD 1.03] for control; 20.7% [25/121] adequate in intervention vs 7.3% [2/123] in control). Consequently, the number needed to treat was 7.46. Logistic regression showed participants exposed to the highest level of disadvantage had 7.3 times higher odds of improved overall knowledge scores than participants in other levels of disadvantage. There were also significant correlations between gamification techniques and knowledge change (P<.001). In addition, odds of knowledge improvement between baseline and 6-month follow-up was higher in participants with low-moderate app activity compared with no app activity (odds ratio [OR] 8.59, 95% CI 2.9-25.02) and much higher in participants with high app activity (OR 18.26, 95% CI 7.1-46.8). Conclusions Despite substantial loss to follow-up, this RCT demonstrates the Cool Runnings app was an effective intervention for improving knowledge about risks of hot beverage scalds and burn first aid in mothers of young children. The benefits of combining gamification elements in the intervention were also highlighted. Given the low cost and large reach of smartphone apps to deliver content to and engage with targeted populations, the results from this RCT provide important information on how smartphone apps can be used for widespread injury prevention campaigns and public health campaigns generally. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12616000019404; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=369745&showOriginal=true&isReview=true (Archived by WebCite at http://www.webcitation.org/72b1E8gTW)

Is this a full powered effectiveness trial or a pilot/feasibility trial? * Manuscript tracking number * If this is a JMIR submission, please provide the manuscript tracking number under "other" (The ms tracking number can be found in the submission acknowledgement email, or when you login as author in JMIR. If the paper is already published in JMIR, then the ms tracking number is the fourdigit number at the end of the DOI, to be found at the bottom of each published article in JMIR) https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q1l… 5/33 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 o ine 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 brie y explain why the item is not applicable/relevant for your study "Cool Runnings'

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").
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 brie y explain why the item is not applicable/relevant for your study Your answer 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 brie y explain why the item is not applicable/relevant for your study "Prevent Scald Injuries" 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions

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) 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 brie y explain why the item is not applicable/relevant for your study "Objective: The aim of this study was to evaluate the e cacy of Cool Runnings, an app-based intervention to increase knowledge of childhood burn risk (speci cally hot beverage scalds) and correct burn rst aid among mothers of young children.
Methods: This was a 2-group, parallel, single-blinded randomized controlled trial (RCT). Participants were women aged 18 years and above, living in Queensland, Australia, with at least 1 child aged 5-12 months at time of enrollment. The primary outcome measures were change in knowledge about risk of burns and correct burn rst aid assessed via 2 methods: (1) overall score and (2) categorized as adequate (score=4) versus inadequate (score less than 4). E cacy of gami cation techniques was also assessed." Theories used include the Health Belief Model.
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 brie y explain why the item is not applicable/relevant for your study "Participants were women aged 18 years and above, living in Queensland, 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. o ine), 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 o ine 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 brie y explain why the item is not applicable/relevant for your study Participants were recruited via social media channels. "In total, 498 participants were recruited via social media and enrolled" 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 brie y explain why the item is not applicable/relevant for your study "In total, 498 participants were recruited via social media and enrolled. At 6month follow-up, 244 participants completed the posttest questionnaire. Attrition rates in both groups were similar." 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. Does your paper address subitem 2a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Advances in technology, expansion of internet access, and increased mobile phone ownership globally have led to a new channel for disseminating health information and engaging with large or speci c populations. With the popularity of smartphones, there has been a proliferation of smartphone apps-6 million in the 2 leading app stores ( has not yet been studied is the use of this technology in injury prevention." 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 brie y explain why the item is not applicable/relevant for your study "On the basis of the Health Belief Model [18], the aim of the Cool Runnings randomized controlled trial (RCT) was to assess the impact of a contemporary app-based public health campaign using gami cation on knowledge about child burns. Speci cally, the aim of the intervention was to increase knowledge of the primary carer about the severity and frequency of hot drink scalds, provide them with developmental-stage messages on how to protect their child and intervene, and nally the correct burn rst-aid treatment to apply should a burn occur. The 2 aims of this study were therefore to (1) assess change in knowledge from baseline to follow-up in the intervention group compared with the control group and (2) investigate the impact of level of app engagement on change in knowledge from baseline to follow-up." 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 brie y explain why the item is not applicable/relevant for your study "This study was a 2-group, parallel, single-blinded RCT of an app-based prevention and rst-aid education intervention for burns." 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 brie y explain why the item is not applicable/relevant for your study No changes were made to the methods after trial commencement. Bug xes, 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 xes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have in uenced 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 brie y explain why the item is not applicable/relevant for your study There were no bug issues, downtime or content changes made after trial commencement.
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 brie y explain why the item is not applicable/relevant for your study "Eligibility criteria were females aged 18 years and above; who resided in Queensland, Australia; and had at least 1 child aged 5 to 12 months at enrollment. Ownership of a smartphone was required for intervention delivery. "

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clari ed.
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 brie y explain why the item is not applicable/relevant for your study Your answer 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. o ine), 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 con rmation, phone calls) were used to detect/prevent these.
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 brie y explain why the item is not applicable/relevant for your study 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 brie y explain why the item is not applicable/relevant for your study Participants were invited to download the Cool Runnings app via social media. Once the app was downloaded, individuals were provided with additional information about the study and given the opportunity to consent to participate. Participants completed a 19-item questionnaire detailing demographic factors (such as education level, age of youngest child, number of children, marital status, and smoking status) and level of child burn risk knowledge and burn rst aid knowledge.
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 brie y explain why the item is not applicable/relevant for your study Participants were from Queensland, Australia. Targeted social media adds were directed only to women in this geographic location (as per their social media status) 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.
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 brie y explain why the item is not applicable/relevant for your study Participants completed a 19-item questionnaire that took 5-8min to complete. 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 brie y explain why the item is not applicable/relevant for your study The university of Queensland logo is on the rst page of the app, and participants were told the study was developed by the university and speci cally the Centre for Children's Burns and Trauma Research.

5-i) Mention names, credential, a liations of the developers, sponsors, and owners
Mention names, credential, a liations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Con ict 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 brie y explain why the item is not applicable/relevant for your study The intervention was developed by the authors, and the app was developed through a technology partnership with iPug Pty Ltd.

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 brie y explain why the item is not applicable/relevant for your study Your answer

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

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Your answer 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing owcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing owcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scienti c reporting.
Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Your answer

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 brie y explain why the item is not applicable/relevant for your study Screenshots from the App have been saved.

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 speci c 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 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 brie y explain why the item is not applicable/relevant for your study Participants were informed about the Cool Runnings app through social media advertisements; speci cally Facebook and Instagram. Those interventions with demonstrated effectiveness mostly involve passive approaches such as legislation, engineering, technical and manufacturing strategies that require minimal input on the part of individuals (or their caregivers). These strategies are not applicable to HBS prevention; therefore, prevention campaigns must rely on raising awareness and changing knowledge and behaviour in individuals in order to reduce the incidence rate.
Fortunately, there are innovative new channels for delivering education messages to the public. Smartphone apps and gami cation techniques are increasingly being used for health behaviour change. While many researchers were initially sceptical, recent studies have shown signi cant success in using these methods, particularly if they have been developed with the inclusion of behaviour theory and scienti c evidence underpinning them. The success of these new methods, combined with their low-cost and scalability make them an ideal channel for injury prevention initiatives.

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.
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-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 brie y explain why the item is not applicable/relevant for your study "During the 6-month intervention, participants allocated to the intervention group received 9 intervention messages via the app related to risks of hot beverage scalds, risks of developmental stage-based burns, and burn rst-aid treatment (illustrated in Figure 1). These messages were provided in a variety of mediums (infographics, 30-second videos, and motion graphics) at 3-week intervals. In between these messages, participants were given opportunities to engage with the app through activities such as answering pop quizzes and completing missions (such as photo uploads) that reinforced each of the intervention message themes. Gami cation techniques were used to keep participants engaged and active on the app. Each time participants viewed a message, correctly answered a quiz question, or uploaded a photo, they were rewarded with points. Accrued points were displayed on weekly leaderboards in the app, and once a certain number of points were reached, they could be redeemed for rewards, such as shopping and movie vouchers. "

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).
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 brie y explain why the item is not applicable/relevant for your study Your answer 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 brie y explain why the item is not applicable/relevant for your study Emails were sent to prompt participants to complete the exit survey at the end of the 6-month intervention. Apart from that, Participants were only communicated to through the app.
subitem not at all important 1 2 3 4 5 essential 6a) Completely de ned pre-speci ed primary and secondary outcome measures, including how and when they were assessed subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study There were no co-intervention s in the study.
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 brie y explain why the item is not applicable/relevant for your study "Baseline and 6-month follow-up questionnaires were completed by participants in the intervention and control groups. The baseline questionnaire included demographic factors (such as education level, age of youngest child, number of children, marital status, and smoking status). Place of residence postcodes were also collected and later recoded using the Accessibility/Remoteness Index of Australia (ARIA) 2011 data [22], and the Socio-Economic Indexes for Areas (SEIFA) [23] as measures to broadly assess socioeconomic status (SES). The SEIFA data were based on aggregate area-level SES disadvantage indicators and were categorized into quintiles (1=most disadvantaged and 5=least disadvantaged). The ARIA is a measure of geographical remoteness, categorized as urban, periurban, and remote.
The questionnaires also included the extent of hot beverage scald risk awareness (2 questions) and burn rst aid knowledge (2 questions). Full baseline data from this study are described elsewhere [24]. The 6-month follow-up questionnaire repeated the questions relating to risks of hot beverage scalds and burn rst aid knowledge. Participant engagement with the app, including number of app opens, content views, and gami cation activities by participants in the intervention group were recorded by the app.

Primary Outcome Measures
The primary outcome for this study was change in knowledge based on a 4-point knowledge score measured by 3 components: Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No 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 brie y explain why the item is not applicable/relevant for your study

This information was provided in the published study protocol. A cross-sectional study of knowledge and attitudes toward burns rst aid in
Queensland by Cuttle et al, showed that 29% of mothers of children aged 0-4 years in Brisbane correctly identi ed appropriate burns rst aid (cool running water for 20 minutes). Assuming 90% power and alpha = .05, in order to detect a 20% increase in the proportion of mothers who can correctly identify the appropriate burns rst aid (type and length) in the intervention group relative to the control group, 240 participants in total are required (120 each in intervention group and control group), with 95% con dence. This will allow detection of improvement in the intervention group from 29-49%, with no improvement in the control group.
In order to determine the proportion of participants who correctly identify the main cause of burns/scalds in children under 4 years, and/or the main age group at risk for burns/scalds, a sample size of 96 is required. This will allow detection of the true proportion in this population with 95%CI and 10% precision (assuming 50% prevalence, the most conservative estimate possible). Further, in order to detect a subsequent increase in knowledge of 20% on both these dimensions for intervention group relative to control group, a total sample size of 240 is required (120 in each group). Assuming 50% loss to follow up in each group, a total sample of 480 is required (240 intervention; 240 control).
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 brie y explain why the item is not applicable/relevant for your study Your answer 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 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 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 brie y explain why the item is not applicable/relevant for your study "Computerized sequence generation was used to randomize participants. Randomization was strati ed by maternal age (18-28 years and 29+ years) based on the mean national maternal age" 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 brie y explain why the item is not applicable/relevant for your study Your answer 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 brie y explain why the item is not applicable/relevant for your study "Computerized sequence generation" 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 brie y explain why the item is not applicable/relevant for your study "Computerized sequence generation" 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).
https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q… 20/33 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 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 brie y explain why the item is not applicable/relevant for your study "Participants were blinded to their allocation group (the terms blue group and green group were used). Study investigators assessed the outcome data collected in pre-and postquestionnaires in a blinded format. However, blinding was not possible for analyzing the results of gami cation techniques, as they only applied to the intervention group." 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 brie y explain why the item is not applicable/relevant for your study Your answer 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 brie y explain why the item is not applicable/relevant for your study No 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 brie y explain why the item is not applicable/relevant for your study "All statistical analyses were conducted using SPSS version 24 (IBM Corporation, Armonk, NY, USA). Descriptive analyses were completed to determine whether there were any between-group differences (intervention vs control) at baseline on demographic characteristics and the primary outcome measure. Chi-square tests were used for categorical variables, and independent sample t tests were used for numerical variables [26]. Speci cally, an independent sample t test was used to assess between-group differences on change in overall knowledge score at 6-month follow-up as a function of the intervention. A chi-square test was performed to determine whether the proportion of participants with improved knowledge differed between intervention and control groups. Event rate of improved overall knowledge (all 4 responses correct) was also calculated for the intervention and control groups. Subsequently, the number needed to treat (NNT) was calculated. Correlations were performed to determine whether the 4 separate elements of app engagement were related to each other. Alpha of .05 was used in the interpretation of all descriptive analyses. Univariate logistic regression analyses were conducted to determine whether there were any signi cant independent predictors of knowledge improvement (no improvement vs improvement).
Potential predictor variables were intervention status (intervention vs control) and demographic variables (education level, age of youngest child, age of respondent, number of children, marital status, smoking status, ARIA category, SES as measured through SEIFA, and rst-time mother).
Any variables where P<.20 was obtained in univariate logistic regression analyses were then entered into 1 adjusted model. If a variable was not signi cantly associated with the outcome in the multivariate model, it was removed and the impact on all remaining variables was assessed. If the odds ratio (OR) for any other variables in the model changed more than 10%, the variable was retained in the model as a potential confounder. If not, it was removed. This process was repeated until there were no variables with P>.05 in the model or removing the nonsigni cant variables from the model did not create changes of greater than 10% to the ORs of variables remaining in the model.
To investigate the impact of level of app engagement on change in knowledge from baseline to follow-up, univariate analyses were rst completed using the 4 numerical measures of engagement for the intervention group only (frequency of app views, frequency of content views, number of pop quiz completions, and number of times participated in photo-sharing activities). Afterward, for all participants (intervention and control), univariate analyses were completed on the nal composite measure (no engagement, moderate engagement, and high engagement). Subsequently, an additional multivariate analysis was completed using this composite measure of app engagement as one of the predictor variables, instead of intervention status-the same demographic variables described above were used-and the same process followed. Analyses completed on any follow-up data were conducted on a per protocol basis " 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] 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 brie y explain why the item is not applicable/relevant for your study "The trial experienced 51% attrition overall. Attrition rates in both groups were similar: (intervention: 141/262, 53.8%; control: 113/236, 47.8%). Participants who remained in the study did not differ from those who were lost to follow-up on any baseline characteristics except for education level. A higher proportion of participants who remained in the study had a university degree (28.7%; n=70) than those who were lost to follow-up (16.5%; n=42) (χ24=15.8; P=.003). Mean overall knowledge was higher at baseline in participants (mean 2.06 [SD 0.87]) than in those who were lost to follow-up (mean 1.93 [SD 0.87]), but this difference was not signi cant (t490=1.72; P=.09). Within-group analyses were also conducted to see whether there were differences in participants who completed the study and those who were lost to follow-up. There was no difference between participants who completed the study and those who were lost to follow-up in relation to proportion with adequate overall knowledge (score of 4) versus inadequate (score<4) in the intervention group (P=.62) or in the control group (P=.99). However, among the participants allocated to the intervention group, overall knowledge at baseline was signi cantly higher in those who remained in the study (mean 2.12 [SD 0.84]) than in those who did not complete the study (mean 1.84 [SD 0.87]; t258=2.64; P=.009).
The remainder of the analyses were completed by compliance only." 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 brie y explain why the item is not applicable/relevant for your study See answer above.

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 brie y explain why the item is not applicable/relevant for your study "This study is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12616000019404)" and approved by the University of Queensland

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 13b) For each group, losses and exclusions after randomisation, together with reasons x26-ii) Outline informed consent procedures Outline informed consent procedures e.g., if consent was obtained o ine 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 brie y explain why the item is not applicable/relevant for your study Consent was obtained online, and participants were required to click on a checkerbox once they had read the study information to show their willingness to participate.

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 brie y explain why the item is not applicable/relevant for your study All collected data was kept on secure encrypted servers.
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 brie y explain why the item is not applicable/relevant for your study "A total of 498 participants were enrolled in the Cool Runnings study: 262 in the intervention group and 236 in the control group. After the 6-month intervention, 14b) Why the trial ended or was stopped (early) Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT ow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study A owchart diagram of participants through each stage of RCT is shown in this manuscript.

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 gures or tables demonstrating usage/dose/engagement.
Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the gure 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 brie y explain why the item is not applicable/relevant for your study Your answer 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 brie y explain why the item is not applicable/relevant for your study "Participants were recruited via online social media advertisements, speci cally through Facebook and Instagram, between January 2016 and February 2016. A detailed description of the recruitment process for this study has been published previously" 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signi cant 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 brie y explain why the item is not applicable/relevant for your study Your answer 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 brie y explain why the item is not applicable/relevant for your study The trial was a 6-month intervention, and after this intervention period the trial is closed.

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.
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 brie y explain why the item is not applicable/relevant for your study These data are included in the manuscript.
16-i) Report multiple "denominators" and provide de nitions Report multiple "denominators" and provide de nitions: 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 speci c pre-de ned time points of interest (in absolute and relative numbers per group). Always clearly de ne "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 brie y explain why the item is not applicable/relevant for your study These data are included in the manuscript. Analysis was by the original assic=gned groups of intervention and control.

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).
17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% con dence interval) subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study Number Needed to Treat analysis was completed. "Although similar at baseline, intervention group participants achieved signi cantly greater improvement in overall knowledge posttest than control group participants (t240=3.37; P<.001) (Figure 3). Event rate of improved overall knowledge (change from inadequate at baseline to adequate at 6-month follow-up) was signi cantly higher in the intervention group (25/121, 20.7%) than in the control group (9/123, 7.3%) (χ21=9.1; P=.003). Consequently, the NNT was 7.46. That is, 8 people needed to be exposed to this intervention to improve inadequate overall knowledge to adequate knowledge (ie, score of <4 to a score of 4) in 1 additional person. A sensitivity analysis was completed with respect to the event rate and NNT. First, the event rate was recalculated assuming that all participants who were lost to follow-up did not improve their score (ie, demonstrated inadequate knowledge at baseline and at follow-up). The event rate of improved overall knowledge was 9.5% in the intervention group and 3.8% in the control group. The NNT was 17.5.
Next, the event rate was recalculated assuming that all participants who were lost to follow-up did improve their score from inadequate at baseline to adequate at follow-up (intervention: 63.35%; control: 51.69%). The NNT was 8.57." 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 brie y explain why the item is not applicable/relevant for your study "Univariate logistic regressions indicated that the following variables were related to improvement in overall knowledge (from inadequate to adequate) between baseline and follow-up: being in the intervention group, age of respondent, SES as measured through SEIFA quintile, and remoteness (as measured by ARIA category). These variables were entered into 1 multivariate model ,and nonsigni cant variables were removed one at a time, assessing the impact on remaining variables. In the nal model, the only variables that were signi cantly associated with the improvement in overall knowledge were being allocated to the intervention (OR 3.3, 95% CI 1.4-7.7) and SES as measured through SEIFA. Speci cally, odds of improving overall knowledge scores were higher in participants whose postcode indicated they were exposed to the highest level of disadvantage (OR 7.30, 95% CI 1.2-42.9) compared with participants exposed to the lowest levels of disadvantage (ie, highest advantage). Age and remoteness (as measured by ARIA category) were not signi cantly associated with improved knowledge; however, they were retained in the model because there was evidence of confounding (ie, removing these variables from the model changed the ORs of other variables in the model more than 10%). " 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 de nitions 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 de ned (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 prespeci ed 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 brie y explain why the item is not applicable/relevant for your study Univariate logistic regression analyses (intervention group only) showed that each of the 4 (numerical) measures of engagement were signi cantly associated with improvement in overall knowledge from inadequate at baseline to adequate at 6-month follow-up (quiz total: OR 1.34, 95% CI 1. 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 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 brie y explain why the item is not applicable/relevant for your study Your answer 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 brie y explain why the item is not applicable/relevant for your study No harms or unintended effects were applicable to this 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 brie y explain why the item is not applicable/relevant for your study No privacy or technical issues were observed in this study.
19-ii) Include qualitative feedback from participants or observations from staff/researchers Include qualitative feedback from participants or observations from staff/researchers, if available, on 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 brie y explain why the item is not applicable/relevant for your study 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 brie y explain why the item is not applicable/relevant for your study "This RCT has demonstrated the Cool Runnings app to be an effective intervention for improving knowledge about risks of hot beverage scalds and burn rst aid in mothers of young children. Only 8 people needed to be exposed to this intervention to improve inadequate overall knowledge to adequate knowledge in 1 additional person. Hot beverage scalds present a major pediatric public health issue that requires attention and prevention efforts, and this RCT details the implementation and evaluation of innovative methods and techniques to address this injury."

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 brie y explain why the item is not applicable/relevant for your study "Additional studies are needed to determine the optimal follow-up time for this type of intervention to offset the high attrition rate noted in this intervention."

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. 21) Generalisability (external validity, applicability) of the trial ndings NPT: External validity of the trial ndings according to the intervention, comparators, patients, and care providers or centers involved in the trial 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 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 brie y explain why the item is not applicable/relevant for your study "This study has several limitations. In both the control and intervention groups, there was a large loss to follow-up (48.9%). This loss to follow-up raises the potential for attrition bias. However, the attrition rate in both groups was similar (54% vs 48%), and participants did not differ signi cantly from those who were lost to follow-up on most of the measured characteristics. The exception was education (participants who remained in the study demonstrated a higher level of education). In addition, participants originally allocated to the intervention group who completed the study demonstrated a signi cantly higher baseline overall knowledge score than those who were lost to follow-up. This did not occur in the control group. Interestingly, there was no difference in the proportion of participants versus dropouts who demonstrated adequate versus inadequate knowledge. It is also acknowledged that there may have been differences between participants who remained in the study and those who were lost to follow-up that were not measured in the survey. Given the novelty of this intervention, and in particular within this context, we intentionally conducted a per protocol analyses to demonstrate e cacy of the app, and this may be considered a limitation of the analyses, although sensitivity analyses were conducted to further understand the potential impact of the loss to follow-up.
The relatively small numbers involved in this study mean that the multivariate analyses on demographic variables associated with change in knowledge (especially when app engagement is considered) and the analyses on predictors of app engagement should be interpreted with caution."

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 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 brie y explain why the item is not applicable/relevant for your study This study shows the effective use of social media recruitment, and an app based intervention for this population -mothers with young children. Therefore it could equally be useful for other interventions aimed at this populationparticularly childhood injury interventions.
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. 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 brie y explain why the item is not applicable/relevant for your study The high loss to follow-up may have been different if there had been face-to-face contact with participants.
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 brie y explain why the item is not applicable/relevant for your study 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 brie y explain why the item is not applicable/relevant for your study No sources of funding to declare.
X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests ( nancial 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.