Pediatric Weight Management Through mHealth Compared to Face-to-Face Care: Cost Analysis of a Randomized Control Trial

Background Mobile health (mHealth) may improve pediatric weight management capacity and the geographical reach of services, and overcome barriers to attending physical appointments using ubiquitous devices such as smartphones and tablets. This field remains an emerging research area with some evidence of its effectiveness; however, there is a scarcity of literature describing economic evaluations of mHealth interventions. Objective We aimed to assess the economic viability of using an mHealth approach as an alternative to standard multidisciplinary care by evaluating the direct costs incurred within treatment arms during a noninferiority randomized controlled trial (RCT). Methods A digitally delivered (via a smartphone app) maintenance phase of a pediatric weight management program was developed iteratively with patients and families using evidence-based approaches. We undertook a microcosting exercise and budget impact analysis to assess the costs of delivery from the perspective of the publicly funded health care system. Resource use was analyzed alongside the RCT, and we estimated the costs associated with the staff time and resources for service delivery per participant. Results In total, 109 adolescents participated in the trial, and 84 participants completed the trial (25 withdrew from the trial). We estimated the mean direct cost per adolescent attending usual care at €142 (SD 23.7), whereas the cost per adolescent in the mHealth group was €722 (SD 221.1), with variations depending on the number of weeks of treatment completion. The conversion rate for the reference year 2013 was $1=€0.7525. The costs incurred for those who withdrew from the study ranged from €35 to €681, depending on the point of dropout and study arm. The main driver of the costs in the mHealth arm was the need for health professional monitoring and support for patients on a weekly basis. The budget impact for offering the mHealth intervention to all newly referred patients in a 1-year period was estimated at €59,046 using the assessed approach. Conclusions This mHealth approach was substantially more expensive than usual care, although modifications to the intervention may offer opportunities to reduce the mHealth costs. The need for monitoring and support from health care professionals (HCPs) was not eliminated using this delivery model. Further research is needed to explore the cost-effectiveness and economic impact on families and from a wider societal perspective. Trial Registration ClinicalTrials.gov NCT01804855; https://clinicaltrials.gov/ct2/show/NCT01804855


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.

Clear selection
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 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").

Clear selection
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 No. As the mobile arm of the trial predominantly involved use of the app at home, this was not included in the title descriptor.

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

Clear selection
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 Yes: "Pediatric Weight Management" is the term used in the title, which is aimed at conveying that the population is children with obesity. This is clarified in the text.

Clear selection
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 "A digitally delivered (via a smartphone app) maintenance phase of a pediatric weight management program was developed iteratively with patients and families using evidencebased approaches." We do not elaborate on the details of the intervention because there is a published protocol (referenced in the main text) and additionally a manuscript reporting the primary outcomes in preparation. 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)

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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 is not addressed in the abstract, due to this manuscript being focused on the cost analysis only, we instead avoided duplication of detailed descriptions of the intervention reported elsewhere.
1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials). Note: In traditional offline trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered. To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e. participants can self-enrol). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 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 Yes: "A digitally delivered (via a smartphone app) maintenance phase of a pediatric weight management program" -this sentence conveys that this trial was undertaken within an existing clinical service. "We undertook a microcosting exercise and budget impact analysis to assess the costs of delivery from the perspective of the publicly funded health care system. Resource use was analyzed alongside the RCT, and we estimated the costs associated with the staff time and resources for service delivery per participant." No details of outcome measures are provided other than costs as they are the only outcome assessed in this manuscript.
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)

Clear selection
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 Yes: "In total, 109 adolescents participated in the trial, and 84 participants completed the trial (25 withdrew from the trial). We estimated the mean direct cost per adolescent attending usual care at €142 (SD 23.7), whereas the cost per adolescent in the mHealth group was €722 (SD 221.

Clear selection
Does your paper address subitem 1b-v?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This paper does not report the primary outcome of the trial, but the secondary outcome of cost. This is discussed in the abstract: "This mHealth approach was substantially more expensive than usual care, although modifications to the intervention may offer opportunities to reduce the mHealth costs"

2a-i) Problem and the type of system/solution
Describe the problem and the type of system/solution that is object of the study: intended as stand-alone intervention vs. incorporated in broader health care program? Intended for a particular patient population? Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions? (Note: Details about the intervention are provided in "Methods" under 5) Clear selection 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 Yes: "There is evidence that telemedicine interventions can support self-management of nutrition and physical activity in children and adolescents [5]; however, there is a scarcity of studies focusing on the economic evaluations of such interventions, particularly for mHealth interventions developed to incorporate evidence-based approaches [1,5,6]." 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 Yes: "We aimed to assess the direct costs of delivering the mHealth intervention to participants in the trial relative to usual care participants to inform future designs of mHealth trials to assess effectiveness and cost-effectiveness within this population as well as contribute to the evidence base for the economic viability of integrating mHealth into pediatric weight management services in future." Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The pilot noninferiority RCT"

4a) Eligibility criteria for participants
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 This was not addressed as there were no relevant changes to report.

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].

Clear selection
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 No this is aspect is not addressed in this paper as it was not a major issue during the trial, but such issues will be reported with the primary outcome findings. Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study These are not provided as this paper focuses on cost, however reference to the published protocol which details the eligibility criteria is provided in the main text. (reference 13)

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

Clear selection
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 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. offline), e.g., from an open access website or from a clinic, and clarify if this was a purely webbased 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. 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 "Eligible trial participants were recruited from the W82GO Child and Adolescent Weight Management Service, which is the only dedicated Tier 3 service for children and adolescents with obesity in the Republic of Ireland. All new adolescent referrals made to the service by a pediatrician were screened against the inclusion/exclusion criteria. Those eligible were invited to participate in the study following the consideration of the study by their parents and upon receipt of parental consent and adolescent assent forms."

Clear selection
"In total, 109 adolescent participants with clinical obesity (40 boys, 69 girls) were recruited through the W82GO service and received phase 1 of the treatment face to face before being randomized to receive the maintenance phase (phase 2) of treatment either through usual care (three additional face-to-face booster sessions with the multidisciplinary team either through one-to-one sessions or group sessions) or remotely via the mHealth app (Reactivate) [13]." "The sensitivity analysis showed that the main driver of costs for the mHealth group was the HCP time spent managing the mHealth service arm of the trial (platform administration, individualized care plans, providing feedback, troubleshooting, checking in). This was estimated to be approximately 12 hours per adolescent over 46 weeks (approximately 15 minutes per adolescent per week)"

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.
Clear selection 9/9/21, 1:48 PM 4b) Settings and locations where the data were collected Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study These details will be reported separately with the primary outcomes for the study once the analyses are completed.
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 Yes, details of the data collection relevant to the cost analysis only are provided: "Participant data including trial group data, whether they commenced one-to-one or group treatment, the number of sessions attended, and records of treatment completion or withdrawal stages, were collected during the trial and used for this analysis to ascertain variations in costs per patient. Cost data were obtained from multiple sources. For face-toface maintenance sessions, we used a time-driven activity-based microcosting method [18] to capture the direct costs associated with the face-to-face time of health care professionals (HCPs) with patients. We also included administrative time associated with appointment preparation. We interviewed personnel to map workflow processes associated with usual care to accurately assess the unit costs of program appointments and dropout/nonattendance costs. A record of the trial costs was maintained by the principal investigator, and it included invoices received for contracted mHealth service delivery, the related expenses, and the time allocated for checking in, monitoring, and processing participants. During baseline data collection, parents/carers were asked to provide details of their annual income, current occupation, the make and model of their car (if any), mode of transport, and distance traveled to attend hospital appointments." 4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise.

Clear selection
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 As the outcomes reported in this paper are related to cost only, this is explained in the data collection section.

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)

Clear selection
Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered subitem not at all important 1 2 3 4 5 essential

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).

Clear selection
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 "Acknowledgments This study was funded by the RCSI University of Medicine and Health Sciences -StAR program (grant 2151) and carried out as part of the Health Research Board (HRB) SPHeRE training program (SPHeRE/2013/1). The randomized controlled trial on which this study was based was funded by the HRB (HFP/2011/54) and the Children's Fund for Health & National Children's Research Centre of Ireland (PAC11-58). The funders had no role in the design of this study, including the collection, analyses, or interpretation of data, or in the preparation of the manuscript." Conflict of interest: we have declared that the senior author was responsible for the design and owns the Reactivate system.

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.

Clear selection
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 platform was designed using a participatory approach with the intended end users (adolescents with obesity and their parents) [14,15]. The findings of the RCT suggested that substituting face-to-face maintenance care with the mHealth intervention did not adversely affect the change in the primary outcome (BMI-SDS) of the overall treatment. Although study attrition was substantial and was similar to other pediatric trials [16], there was insufficient power to statistically confirm noninferiority [17]."

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

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

Clear selection
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 We used a bottom-up costing approach (microcosting), as well as financial records from the trial, and conducted sensitivity analyses, to ensure our cost analysis was as pragmatic as possible. The also declared our economic perspective to be that of the publicly funded healthcare system only. -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.

Clear selection
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 This is not described within the manuscript.

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.

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

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to 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).

Clear selection
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 This is not described within this manuscript, but will be reported with the primary outcome for the study. 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 These are described in detail within the published protocol that we reference within the text.

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.

Clear selection
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 This is not described within the manuscript.

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
Clear selection 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 "...the HCP time spent managing the mHealth service arm of the trial (platform administration, individualized care plans, providing feedback, troubleshooting, checking in). This was estimated to be approximately 12 hours per adolescent over 46 weeks (approximately 15 minutes per adolescent per week) during the trial."

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).

Clear selection
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 These are described in detail within the published protocol that we reference within the text.

Clear selection
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 "In total, 109 adolescent participants with clinical obesity (40 boys, 69 girls) were recruited through the W82GO service and received phase 1 of the treatment face to face before being randomized to receive the maintenance phase (phase 2) of treatment either through usual care (three additional face-to-face booster sessions with the multidisciplinary team either through one-to-one sessions or group sessions) or remotely via the mHealth app (Reactivate)" The interventions are described in further detail within the published protocol that we reference within the text.
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 These are described in detail within the published protocol that we reference within the text, however are not detailed in this manuscript as it assessed costs only. We acknowledge in the limitations that this analysis was exploratory.

Clear selection
Does your paper address subitem 6a-i?
Copy and paste relevant sections from manuscript text These are described within the published protocol that we reference within the text, and will also be reported with the primary outcome.
6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored (logins, logfile analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial. subitem not at all important 1 2 3 4 5 essential 6b) Any changes to trial outcomes after the trial commenced, with reasons Does your paper address subitem 6a-ii?

Clear selection
Copy and paste relevant sections from manuscript text Stage of dropout was recorded (or, if applicable, the stage at which the participant became unavailable for contact). This was accounted for in the cost analysis: "Withdrawal from or partial completion of the mHealth intervention was estimated to cost €310 to €680, depending on when the participant dropped out (see Multimedia Appendix 1). Accounting for partial completion and attrition costs, the mean cost incurred for those in the usual care arm was €142 (SD 23.7) (group participants: mean €133, SD 12.2; one-to-one participants: mean €177, SD 22.4). The mean cost for those randomized to use mHealth was estimated to be €722 (SD 221)." 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).

Clear selection
Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text Participant feedback was not addressed in the analysis presented in this paper. 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 briefly explain why the item is not applicable/relevant for your study This is not addressed in the manuscript as there were no relevant changes to report. We do however explain why a direct cost analysis was completed as opposed to a costeffectiveness analysis: Yes: "Although study attrition was substantial and was similar to other pediatric trials [16], there was insufficient power to statistically confirm noninferiority [17]. As a result of this, and in addition to high levels of missing secondary outcome data including health-related quality-of-life data, a full cost-effectiveness analysis was not possible despite conducting a clinical trial."

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.

Clear selection
Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "The null hypothesis in the trial protocol was that the mHealth intervention would have a positive effect on change in the BMI-SDS but that this change will be inferior to that observed in usual care. Based on a reduction of 0.21 in the BMI-SDS at 12 months, an SD of 0.24 in the usual care group, and a noninferiority limit of 0.12, the sample size at 80% power was calculated to be 50 per group or 100 in total. To allow for expected attrition, the target recruitment sample size was 134 [13]." 7b) When applicable, explanation of any interim analyses and stopping guidelines 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 8b) Type of randomisation; details of any restriction (such as blocking and block size) 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 This was not addressed in the manuscript.
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 do not report this, but rather reference the published protocol which states: "Adolescents who are eligible will be randomised to either a W82GO (usual care) group or a smartphone experimental group by the research team using a secure online randomisation system with full allocation concealment. They will be stratified by gender and parental obesity, and 134 adolescents will be randomised in total using a 1:1 randomisation ratio. After randomisation, adolescents will receive a study code, which will be used to analyse all the data related to that child." 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 This was not addressed in the manuscript as not applicable. 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 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 do not report this, but rather reference the published protocol which states: "Adolescents who are eligible will be randomised to either a W82GO (usual care) group or a smartphone experimental group by the research team using a secure online randomisation system with full allocation concealment. They will be stratified by gender and parental obesity, and 134 adolescents will be randomised in total using a 1:1 randomisation ratio. After randomisation, adolescents will receive a study code, which will be used to analyse all the data related to that child." 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 This will be reported with the primary outcome 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).

Clear selection
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 This will be reported with the primary outcome, and is also detailed in the published protocol which we reference in the text: "After randomisation and assignment to the study group, participants will be given a study identification number. The assessor of the primary outcome will not know the allocated intervention for the participant, to reduce the risk of bias. Given the nature of the intervention, it is not possible to blind the participants or the care providers. An independent data analyst will be blinded during the trial by the use of a fully anonymised dataset." 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".
Clear selection 9/9/21, 1:48 PM 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-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

This was not addressed in this manuscript
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 This was not addressed in detail in this manuscript, though a description of the format of interventions is described.
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 This was not addressed in this manuscript as not applicable to the cost. 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]).

Clear selection
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 describe how the cost analysis accounted for attrition by calculating the actual costs incurred by those who withdrew.
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 This was not addressed in this manuscript as not applicable. 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 "The pilot noninferiority RCT was approved by the ethics committee of Children's Health Ireland at Temple Street (reference number 11-033)"

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.

Clear selection
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 "Those eligible were invited to participate in the study following the consideration of the study by their parents and upon receipt of parental consent and adolescent assent forms."

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)

Clear selection
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 Whilst this is not reported in this manuscript, the published protocol describes the procedures: "At each visit, participants and their parents will complete an adverse events form in order to capture any unintended effects of the trial. Spontaneous reporting of adverse events will be possible by calling the study phone line." 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 These details as relevant to the cost analysis are shown in Figure 1. 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 These details as relevant to the cost analysis are shown in Figure 1. "In total, 109 adolescents and their families provided consent for participation in the trial; only 84 participants completed the trial as 25 adolescents withdrew from the study (13 from the usual care group and 12 from the mHealth group) after allocation, as shown in Figure 1."

13b-i) Attrition diagram
Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other figures or tables demonstrating usage/dose/engagement.

Clear selection
Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the figure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes this is presented in Figure 1. 14b) Why the trial ended or was stopped (early) Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Specific dates are not provided however the study year is given. "The conversion rate for the reference year 2013..." 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"

Clear selection
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 This is not reported in the manuscript.
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 This is not reported in the manuscript. 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 not provided for this cost analysis but will be reported with the primary outcome.

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.

Clear selection
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 This is not provided for this cost analysis but will be reported with the primary outcome. 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.

Clear selection
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 This is not provided for this cost analysis but will be reported with the primary outcome.

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).

Clear selection
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 That is not reported within this manuscript as it is not relevant to the cost analysis. 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 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 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 That is not reported within this manuscript as it is not relevant to the cost analysis.

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).

Clear selection
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 That is not reported within this manuscript as it is not relevant to the cost analysis.
18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory subitem not at all important 1 2 3 4 5 essential 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 That is not reported within this manuscript as it is not relevant to the cost analysis.
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 Yes, the limitations state that "Cost was not prespecified outcome for this trial and this study was undertaken as an exploratory analysis after completion of the trial."

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).

Clear selection
Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study That is not reported within this manuscript as it is not relevant to the cost analysis, which accounted for the costs incurred by all participants including those who withdrew.

19) All important harms or unintended effects in each group
(for specific guidance see CONSORT for harms) subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 19? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study That is not reported within this manuscript as it is not relevant to the cost analysis, but will be reported with the primary outcome.

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].

Clear selection
Does your paper address subitem 19-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study There were none to report. That is not reported within this manuscript as it is not relevant to the cost analysis, but will be reported with the primary outcome.

Clear selection
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 That is not reported within this manuscript.

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). where dropouts are common owing to the intensive nature of these interventions. The results show that this mHealth intervention, developed using evidence-based approaches, is associated with higher health care costs than face-to-face pediatric weight management."

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

Clear selection
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 "This highlights the need for further cost studies incorporating a wider perspective that is not limited to the health care provider." "Our results highlight the importance of conducting further research to explore the costeffectiveness of evidence-informed mHealth interventions in treating chronic diseases such as obesity across multiple centers."

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.

Clear selection
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 Yes, a detailed limitations section is provided: "This study had several strengths and limitations...the study did not meet the target recruitment number within the available time period, and coupled with the attrition rate, this led to insufficient power for demonstrating statistically significant noninferiority. In addition, low response rates for health-related quality-of-life measures used contributed to the decision of undertaking only a direct cost comparison. As a result, our cost analysis does not provide a full economic evaluation. Further, although it was the only treatment center available nationwide, we acknowledge the limited external validity of our findings given the recruitment through a single center for obesity management. Cost was also not prespecified outcome for this trial and this study was undertaken as an exploratory analysis after completion of the trial."

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations

Clear selection
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 "Further, although it was the only treatment center available nationwide, we acknowledge the limited external validity of our findings given the recruitment through a single center for obesity management" 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.
Clear selection 9/9/21, 1:48 PM CONSORT-EHEALTH (V 1.6.1) - 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 undertook the cost analysis under pragmatic "real-world" conditions and their cost implications (ie, estimates of implementing the intervention outside of a research trial) [19], as the trial costs included additional expenses that would not represent the cost of telemedicine if provided as part of usual care (eg, provision of smartphones and mobile data packages to trial 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 briefly explain why the item is not applicable/relevant for your study "The pilot noninferiority RCT was approved by the ethics committee of Children's Health Ireland at Temple Street (reference number 11-033; ClinicalTrials.gov trial registration: NCT01804855)." 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 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 was funded by the RCSI University of Medicine and Health Sciences -StAR program (grant 2151) and carried out as part of the Health Research Board (HRB) SPHeRE training program (SPHeRE/2013/1). The randomized controlled trial on which this study was based was funded by the HRB (HFP/2011/54) and the Children's Fund for Health & National Children's Research Centre of Ireland (PAC11-58). The funders had no role in the design of this study, including the collection, analyses, or interpretation of data, or in the preparation of the manuscript." 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.

Clear selection
Does your paper address subitem X27-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, we have reported the potential conflict of interest arising from the senior authors role in designing and retaining ownership of the app.