Effectiveness of Pediatric Teleconsultation to Prevent Skin Conditions in Infants and Reduce Parenting Stress in Mothers: Randomized Controlled Trial

Background In Japan, eHealth for infants and mothers is currently an important aspect, but its effectiveness has rarely been examined. For infants, skin problems, including atopic dermatitis (AD), which is known to lead to other allergic diseases, are one of the most common conditions. Mothers of infants are prone to experiencing parenting stress, which adversely affects mothers’ and children’s well-being. Additionally, studies have reported that AD among offspring enhances parenting stress, and postnatal maternal psychological problems can increase the risk of AD in children. Objective This study evaluated the effectiveness of pediatric teleconsultation for preventing AD in infants and reducing parenting stress in mothers in Japan. Methods The study was an open-label, randomized, parallel-armed controlled trial. In total, 318 pairs of infants and mothers in the Yokohama City Sakae Ward were recruited when they submitted birth cards to the ward, received the explanation about the trial, and provided informed consent on the website for this trial. Eligible pairs of infants and mothers were randomly assigned to the intervention group (n=140) or the control group (n=138). Participants in the intervention and control groups received routine postnatal care from local government services. In addition, participants in the intervention group had the option to combine routine pediatric services with teleconsultation and email newsletters without charge from the date of registration until the infant turned 4 months. Primary outcomes were (1) the prevalence of AD in infants diagnosed based on the United Kingdom Working Party criteria and (2) parenting stress and mental status of mothers assessed using the Parenting Stress Index-Short Form (PSI-SF) and General Health Questionnaire-12 (GHQ-12). Data were collected by the ward office staff and researcher during the 4-month checkup. Results The prevalence of AD in infants was significantly lower in the intervention group than in the control group during the 4-month checkup (20% vs 33%, P=.02; relative risk ratio, 0.709 [95% CI 0.519-0.969]). No significant differences were observed in the PSI-SF and GHQ-12 scores between the 2 groups. There was a significant difference in the prevalence of AD between participants who used teleconsultation services and email newsletters, participants who did not use teleconsultation services but received email newsletters, and participants who neither received nor used either service (18% vs 22% vs 33%, P=.048). Conclusions This is the first randomized controlled trial demonstrating that routine pediatric care combined with teleconsultation and email newsletters was effective in reducing the prevalence of AD in infants. The findings highlight the potential of pediatric eHealth to become a useful new strategy for preventing AD. Trial Registration University Hospital Medical Information Network Clinical Trials Registry UMIN000029774; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034022

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 four-digit number at the end of the DOI, to be found at the bottom of each published article in JMIR) TITLE AND ABSTRACT 1a) TITLE: Identification as a randomized trial in the title

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 "Effectiveness of Pediatric Teleconsultation to Improve Skin Conditions in Infants and to Reduce Parenting Stress in Mothers: Randomized Controlled Trial" subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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 "Effectiveness of Pediatric Teleconsultation to Improve Skin Conditions in Infants and to Reduce Parenting Stress in Mothers: Randomized Controlled Trial" 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 "Effectiveness of Pediatric Teleconsultation to Improve Skin Conditions in Infants and to Reduce Parenting Stress in Mothers: Randomized Controlled Trial" 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
subitem not at all important 1 2 3 4 5 essential 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)

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 "Participants in both the intervention and control groups received routine postnatal care from the local government services. In addition, participants in the intervention group had the option to use combined pediatric services with teleconsultation and email newsletters without any charge from the date of registration until the infant was 4 months of age." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q1lNS… 11/57 subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it)

Clear selection
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 "In addition, participants in the intervention group had the option to use combined pediatric services with teleconsultation and email newsletters" without any charge from the date of registration until the infant was 4 months of age." 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 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 "In total, 318 pairs of infants and mothers in Yokohama City Sakae Ward in Japan were recruited when they submitted birth cards to the ward, received an explanation about the study, and completed online informed consent on the website for this trial." 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 "Eligible pairs of infant and mother were randomly assigned to the intervention group (n=140) or the control group (n=138

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 "No significant differences were observed in the PSI-SF and GHQ-12 scores between the two groups."

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) Does your paper address subitem 2a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "From the point of view of newborns and young infants, skin problems are one of the most common conditions to be addressed, because more than 50% of newborns and young infants have skin problems; such conditions include infantile eczema, diaper dermatitis, intertrigo, and seborrheic dermatitis [8]. In particular, atopic dermatitis/skin inflammation should be prevented because it may increase the risk of other allergic diseases [9]. Although some RCTs on eHealth for AD have been reported, they focused only on patients with AD [10,11], the feasibility of web-based consultations [12], or equivalence to ordinary in-person care [13], and no study has been performed to examine whether eHealth can prevent infants from developing AD.
However, parenting stress is one of the biggest problems in women's mental health and affects parents' and children's well-being [14]. Mothers with parenting stress experience depression and provide little cognitive stimulation for their children [15]. Some studies reported the effectiveness or feasibility of eHealth on parenting problems in other countries [16][17][18][19], and it also might be effective in Japan, where reports from the Sukoyaka (meaning "healthy and happy" in Japanese) Family 21, a national campaign for maternal and child health, suggested an ineffectiveness in improving women's mental health, the insufficiency of child care and development consultation services, and the necessity of support by pediatricians in addition to obstetricians, midwives, and public nurses [20,21]." 2a-ii) Scientific background, rationale: What is known about the (type of) system 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 "This study aimed to evaluate the effectiveness of pediatric teleconsultation for improving skin conditions in infants, especially in terms of the prevention of AD and reducing parenting stress in mothers in Japan.
Compared with the control group receiving routine postnatal care of local government services, we hypothesized that the additional service of teleconsultation and email newsletters by pediatricians would be an effective strategy for preventing AD in infants and reducing parenting stress in mothers at 4 months postpartum." 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons subitem not at all important 1 2 3 4 5 essential 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 "This study was an open-label, randomized, parallel-armed, controlled trial." "A simple randomization method was used, and participants were randomly assigned to the intervention or control group in a ratio of 1:1, in order of registration on the SIMPLE Study website, just after the time of enrollment." 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 Not applicable: no changes were made to the methods after trial commencement.

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

4a) Eligibility criteria for participants
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 Not applicable: there were no changes.
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 "The participants of this study were pairs of infants and mothers in Yokohama City Sakae Ward, Japan. The pairs were recruited when they submitted the birth card, which mothers submitted to the local governments when their babies were born, to Yokohama City Sakae Ward Office. The recruitment took place between November 1, 2017, and May 31, 2018. There were no other specific inclusion criteria for the trial.
The exclusion criteria were: an unwillingness or inability to comply with the study requirements and procedures; a determination by study staff that either the mother or the infant may be adversely affected by participating in this trial; a mothers' inability to understand Japanese (although communication through a Japanese interpreter could be performed in exceptional circumstances); infants born before 37 weeks of gestation; infants born after 42 weeks of gestation; twins or multiple births; and infants needing neonatal intensive care. These criteria were available for review at the Sakae Infants and Mothers with the Pediatric Teleconsultation (SIMPLE) study website exclusively for this study. We did not exclude any infant-mother pairs following the development of maternal mental health problems or infant skin problems."

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 "The exclusion criteria were: an unwillingness or inability to comply with the study requirements and procedures; a determination by study staff that either the mother or the infant may be adversely affected by participating in this trial; a mothers' inability to understand Japanese (although communication through a Japanese interpreter could be performed in exceptional circumstances); infants born before 37 weeks of gestation; infants born after 42 weeks of gestation; twins or multiple births; and infants needing neonatal intensive care." 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 "The participants of this study were pairs of infants and mothers in Yokohama City Sakae Ward, Japan. The pairs were recruited when they submitted the birth card, which mothers submitted to the local governments when their babies were born, to Yokohama City Sakae Ward Office. The recruitment took place between November 1, 2017, and May 31, 2018. " "A simple randomization method was used, and participants were randomly assigned to the intervention or control group in a ratio of 1:1, in order of registration on the SIMPLE Study website, just after the time of enrollment."

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
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 "The participants of this study were pairs of infants and mothers in Yokohama City Sakae Ward, Japan. The pairs were recruited when they submitted the birth card, which mothers submitted to the local governments when their babies were born, to Yokohama City Sakae Ward Office, received the explanation, and completed online informed consent on the Sakae Infants and Mothers with the Pediatric Teleconsultation (SIMPLE) Study website exclusively for this study." "We obtained online informed consent from the mothers of the participants at the time of enrollment. The protocol for this study was available on the SIMPLE Study website." 4b) Settings and locations where the data were collected subitem not at all important 1 2 3 4 5 essential 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 "All measures were completed via the ward office staff and the researcher at the community health center in Yokohama City Sakae Ward when participants visited there for the 4-month checkup."

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 Not applicable: outcomes were not assessed through online questionnaires.

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 Not applicable.

5-i) Mention names, credential, affiliations of the developers, sponsors, and owners
Mention names, credential, affiliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conflict of interest" section or mentioned elsewhere in the manuscript). Does your paper address subitem 5-i?

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 "The Syounika Online Service was launched by Kids Public Inc. in 2016."

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 Not applicable.

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).

Clear selection
Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable: there were no changes.

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 Not applicable. -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.

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 " Figure 1. The website of Syounika Online (translated to English from Japanese)"

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?

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 Not applicable.

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). 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 "In addition to routine postnatal care of local government services, such as home visits by public nurses and breastfeeding consultation services by midwives, participants in the intervention group had an option to use the pediatric teleconsultation named "Syounika (meaning "pediatric" in Japanese) Online" and received email newsletters without any charge from the time of registration to 4 months of age. The email newsletters from Syounika Online were delivered once every three days (30 times in total) during the intervention period.

Clear selection
The Syounika Online Service was launched by Kids Public Inc. in 2016. The core service is teleconsultation through video calls, voice calls, or text messages by smartphones, with which the users can consult with pediatricians about any matters regarding their children's health and parenting for 10 minutes on weekdays from 6 P.M. to 10 P.M. (see Figure 1). Syounika Online also engages in delivering email newsletters, which include useful information about children's health and parenting, such as infant skincare, breastfeeding, and maternal self-care." 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 "In addition to routine postnatal care of local government services, such as home visits by public nurses and breastfeeding consultation services by midwives, participants in the intervention group had an option to use the pediatric teleconsultation named "Syounika (meaning "pediatric" in Japanese) Online" and received email newsletters without any charge from the time of registration to 4 months of age. The email newsletters from Syounika Online were delivered once every three days (30 times in total) during the intervention period.

5-viii
The Syounika Online Service was launched by Kids Public Inc. in 2016. The core service is teleconsultation through video calls, voice calls, or text messages by smartphones, with which the users can consult with pediatricians about any matters regarding their children's health and parenting for 10 minutes on weekdays from 6 P.M. to 10 P.M. (see Figure 1). Syounika Online also engages in delivering email newsletters, which include useful information about children's health and parenting, such as infant skincare, breastfeeding, and maternal self-care."

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

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 "In addition to routine postnatal care of local government services, such as home visits by public nurses and breastfeeding consultation services by midwives, participants in the intervention group had an option to use the pediatric teleconsultation named "Syounika (meaning "pediatric" in Japanese) Online" and received email newsletters without any charge from the time of registration to 4 months of age. The email newsletters from Syounika Online were delivered once every three days (30 times in total) during the intervention period."

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 "In addition to routine postnatal care of local government services, such as home visits by public nurses and breastfeeding consultation services by midwives, participants in the intervention group had an option to use the pediatric teleconsultation named "Syounika (meaning "pediatric" in Japanese) Online" and received email newsletters without any charge from the time of registration to 4 months of age."

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 "The email newsletters from Syounika Online were delivered once every three days (30 times in total) during the intervention period."

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. Clear selection 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed 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 addition to routine postnatal care of local government services, such as home visits by public nurses and breastfeeding consultation services by midwives, participants in the intervention group had an option to use the pediatric teleconsultation named "Syounika (meaning "pediatric" in Japanese) Online" and received email newsletters without any charge from the time of registration to 4 months of age." 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 "All measures were completed via the ward office staff and the researcher at the community health center in Yokohama City Sakae Ward when participants visited there for the 4-month checkup." "The primary outcomes were the prevalence of AD in infants, parenting stress, and mental status in mothers at the 4-month checkup." "Secondary outcomes were breastfeeding rates and the developmental quotient (DQ) of infants, which were examined by a pediatrician through questionnaires at the 4-month checkup." 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.

Clear selection
Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text Not applicable. subitem not at all important 1 2 3 4 5 essential 6b) Any changes to trial outcomes after the trial commenced, with reasons 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed 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 Not applicable.
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 Not applicable: no changes to trial outcomes were made after the trial commenced.

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 "Overall, we expected a drop of approximately 10% and set the target number of pairs of participants to 300. This was estimated as follows: there were an estimated 132 infants per group, thus 264. Assuming a 10% non-response rate, 264 corresponded to 90% of study participants, and to factor in the non-responses, the sample size was inflated by a factor of 0.9, that is, (264/0.9) =293, which was rounded up to 300." 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 Not applicable.
https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q1lNS… 34/57 8b) Type of randomisation; details of any restriction (such as blocking and block size) 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "A simple randomization method was used, and participants were randomly assigned to the intervention or control group in a ratio of 1:1, in order of registration on the SIMPLE Study website, just after the time of enrollment." Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "A simple randomization method was used, and participants were randomly assigned to the intervention or control group in a ratio of 1:1, in order of registration on the SIMPLE Study website, just after the time of enrollment." Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "A simple randomization method was used, and participants were randomly assigned to the intervention or control group in a ratio of 1:1, in order of registration on the SIMPLE Study website, just after the time of enrollment." 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "A simple randomization method was used, and participants were randomly assigned to the intervention or control group in a ratio of 1:1, in order of registration on the SIMPLE Study website, just after the time of enrollment." 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 "The data collection was blinded to the intervention assignment of the participants." 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".

Clear selection
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 No participants were blinded after assignment to interventions.
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 Not applicable. 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 "Data were analyzed by intention-to-treat using the Statistical Package for the Social Sciences (SPSS, version 25.0; IBM Corp., Armonk, NY, USA). For categorical/count characteristic variables, we used Pearson chi-squared or Fisher's exact test to detect statistical differences in distributions between intervention and control groups. For continuous characteristic variables, we tested for the differences between the two groups using the t-test (for normally distributed variables) and Mann-Whitney U test (for nonnormally distributed variables). In presenting the differences between the groups, we calculated the differences as follows. For the categorical variables, the difference refers to the difference in percentages; for continuous variables, the difference refers to the difference in the means. We set the level of statistical significance for the primary outcome at 0.05."

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 briefly explain why the item is not applicable/relevant for your study We did not mention this in the "METHODS" section, but mentioned it in the "DISCUSSION" section: "If we consider that fewer participants in the intervention group dropped out than in the control group, assuming that 2 dropouts in the intervention developed AD and 11 dropouts in the control group did not, as the intervention was the most ineffective, the prevalence of AD would be 21% in the intervention group and 30% in the control group. This does not seem inconsistent with the original result, although the difference in the dropout rates is a limitation of this study." 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 We did not mention this in the "METHODS" section, but mentioned it in the "RESULTS" section: "The results of the outcomes assessed at the 4-month checkups were analyzed using a perprotocol analysis to examine the individual effectiveness of the teleconsultation and email newsletters received. This was achieved by comparing three groups: participants who used teleconsultation services and received email newsletters, participants who did not use them but received them, and participants who neither received nor used them. " 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 "This study received ethics approval from the institutional review board of the National Center for Child Health and Development (NCCHD) before recruitment of participants commenced (approval number: 1570)."

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 "We obtained online informed consent from the mothers of the participants at the time of enrollment."

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 Not applicable.
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 See Figure 2: Flow chart of participants.
"We allocated 140 pairs to the intervention group and 138 pairs to the control group." "Finally, we analyzed the data of 265 infant-mother pairs (95.3%)." 13b) For each group, losses and exclusions after randomisation, together with reasons subitem not at all important 1 2 3 4 5 essential 14a) Dates defining the periods of recruitment and follow-up Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study See Figure 2: Flow chart of participants.
"Thirteen pairs were excluded from this analysis because 6 moved out of the city, 5 withdrew participation voluntarily, and 2 postponed their 4-month checkups."

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 See Figure 2: Flow chart of participants. 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 "Between November 1, 2017, and May 31, 2018, all 440 pairs of infants and mothers who submitted the birth cards to Yokohama City Sakae Ward Office were recruited by the office staff." 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 Not applicable.
Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable: the trial ended because all data were collected.

15) A table showing baseline demographic and clinical characteristics for each group
NPT: When applicable, a description of care providers (case volume, qualification, expertise, etc.) and centers (volume) in each group subitem not at all important 1 2 3 4 5 essential 16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study See Table 1: Characteristics of infants and mothers by intervention and control groups.

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 See 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 "Fifty-nine (42.4%) participants used the teleconsultation service (intervention group) 116 times. The main reason for using the teleconsultation service is as follows. Skin problems in infants (n=32, 28%) were the most common reason for consultations, followed by gastrointestinal problems in infants (n=26, 22%), and breastfeeding problems (n=15, 13%). One participant in the control group used the teleconsultation service 17 times at her own expense. The email newsletters from Syounika Online were delivered 30 times and contained 28 pieces of advice on skin care in infants and 25 pieces of advice on breastfeeding. Overall, 138 participants in the intervention group and one participant in the control group received them, and their opening rates were 30%-58%."

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). Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Data were analyzed by intention-to-treat using the Statistical Package for the Social Sciences (SPSS, version 25.0; IBM Corp., Armonk, NY, USA)." in the "METHODS" section of the manuscript.

Clear selection
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 See Table 2: Primary and secondary outcomes assessed at the 4-month checkups.

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). Copy and paste relevant sections from the manuscript (include quotes in quotation 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 "Fifty-nine (42.4%) participants used the teleconsultation service (intervention group) 116 times. The main reason for using the teleconsultation service is as follows. Skin problems in infants (n=32, 28%) were the most common reason for consultations, followed by gastrointestinal problems in infants (n=26, 22%), and breastfeeding problems (n=15, 13%). One participant in the control group used the teleconsultation service 17 times at her own expense. The email newsletters from Syounika Online were delivered 30 times and contained 28 pieces of advice on skin care in infants and 25 pieces of advice on breastfeeding. Overall, 138 participants in the intervention group and one participant in the control group received them, and their opening rates were 30%-58%."

Clear selection
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 "Analysis of the primary outcome revealed that the prevalence of AD based on the UKWP criteria was significantly lower in the intervention group than in the control group ( 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 "The results of the outcomes assessed at the 4-month checkups were analyzed using a perprotocol analysis to examine the individual effectiveness of the teleconsultation and email newsletters received. This was achieved by comparing three groups: participants who used teleconsultation services and received email newsletters, participants who did not use them but received them, and participants who neither received nor used them. These data are summarized in Table 3. There was a significant difference in the prevalence of AD among the three groups (18% vs 22% vs 33%, P=.048), but no significant difference in the other outcomes." "We compared participants with a family history of AD and without a family history of AD because the participants with a family history of AD, a well-known risk factor for the development of AD, were less common in the intervention group than in the control group, although the difference was not statistically significant. The subgroup analysis showed that there was no significant difference in the prevalence of AD (data not shown)." in the "DISCUSSION" section of the manuscript.

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 Not applicable.

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 "There were no adverse events in this trial." in the "DISCUSSION" section of the manuscript.

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 Not applicable. 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).

Clear selection
Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The intention-to-treat analysis showed that the prevalence of AD based on the UKWP criteria was significantly lower in the intervention group than in the control group at the 4month checkup. This suggests that combined pediatric service with teleconsultation and email newsletters is effective in preventing AD in infants." "When infants were aged 4 months, maternal scores of parenting stress and mental status did not differ across the intervention and control groups. This suggests that the combined pediatric service with teleconsultation and email newsletters is ineffective for reducing parenting stress but also does not burden mothers with information delivered via the service." Copy and paste relevant sections from the manuscript (include quotes in quotation 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 "Future research should have a different perspective on parenting stress in this study and use appropriate measurements such as the PES, PIBQ, PSSP, WPBL, EPDS, or STAI, to assess postpartum mental status in mothers." "Future research should incorporate larger studies to address this topic." "Future studies are required over a longer duration at multiple sites to provide evidence for long-term effectiveness and more detailed information."

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 21) Generalisability (external validity, applicability) of the trial findings NPT: External validity of the trial findings according to the intervention, comparators, patients, and care providers or centers involved in the trial 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 briefly explain why the item is not applicable/relevant for your study "There were several limitations to this study. First, more participants in the intervention group than in the control group dropped out, although this would not have a profound impact on the results according to the imputation. Second, the participants with a family history of AD were less common in the intervention group; however, the subgroup analysis showed that there was no significant difference in the prevalence of AD. Third, as we adopted a combined service with teleconsultation and email newsletters as the intervention, it is not possible to deduce the individual effectiveness of the interventions. Fourth, due to the limited duration of this study for cooperation with the local government, we collected the outcome data only once and could not follow up on the participants for a long time. Fifth, we could not collect the skin treatment history of the infants and baseline data of the maternal mental condition."

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

23) Registration number and name of trial registry
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 "As we recruited pairs of infants and mothers in a whole ward and 60% of the recruited pairs were analyzed, our findings should be generalizable to many other areas in Japan whose surroundings are similar." 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
Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable: there were no different elements.
https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q1lNS… 54/57 24) Where the full trial protocol can be accessed, if available 25) Sources of funding and other support (such as supply of drugs), role of funders 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 "We registered this trial design, including the hypotheses and outcome measures, at UMIN-CTR (UMIN000029774), although we did not publish the protocol paper of this study." Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not available.
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 "The Yokohama City Sakae Ward Office covered the costs related to recruitment and assistance at the four-month checkup. Kids Public Inc. covered the costs related to teleconsultations and email newsletter services, including the development of the trial website. The Department of Health Policy, National Center for Child Health and Development Department of Pediatrics at The University of Tokyo covered the cost related to the planning and overall conduct of the trial."

X27) Conflicts of Interest (not a CONSORT item)
subitem not at all important 1 2 3 4 5 essential About the CONSORT EHEALTH checklist yes, major changes yes, minor changes no 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 Tomohisa Ando received payment for writing from Kids Public Inc.
As a result of using this checklist, did you make changes in your manuscript? *