An Internet-Based Childhood Obesity Prevention Program (Time2bHealthy) for Parents of Preschool-Aged Children: Randomized Controlled Trial

Background Electronic health (eHealth) obesity programs offer benefits to traditionally delivered programs and have shown promise in improving obesity-related behaviors in children. Objective This study aimed to assess the efficacy of a parent-focused, internet-based healthy lifestyle program for preschool-aged children, who are overweight or at or above the fiftieth percentile for body mass index (BMI) for their age and sex, on child BMI, obesity-related behaviors, parent modeling, and parent self-efficacy. Methods The Time2bHealthy randomized controlled trial was conducted in Australia, during 2016 to 2017. Participants were recruited both online and through more traditional means within the community. Parent or carer, and child (aged 2-5 years) dyads were randomized into an intervention or comparison group. Intervention participants received an 11-week internet-based healthy lifestyle program, underpinned by social cognitive theory, followed by fortnightly emails for 3 months thereafter. Intervention participants set goals and received individual feedback from a dietitian. They were also encouraged to access and contribute to a closed Facebook group to communicate with other participants and the dietitian. Comparison participants received email communication only. Objectively measured child BMI was the primary outcome. Secondary outcomes included objectively measured physical activity, parent-measured and objectively measured sleep habits, and parent-reported dietary intake, screen time, child feeding, parent modeling, and parent self-efficacy. All data were collected at face-to-face appointments at baseline, 3 months, and 6 months by blinded data collectors. Randomization was conducted using a computerized random number generator post baseline data collection. Results A total of 86 dyads were recruited, with 42 randomized to the intervention group and 44 to the comparison group. Moreover, 78 dyads attended the 3- and 6-month follow-ups, with 7 lost to follow-up and 1 withdrawing. Mean child age was 3.46 years and 91% (78/86) were in the healthy weight range. Overall, 69% (29/42) of participants completed at least 5 of the 6 modules. Intention-to-treat analyses found no significant outcomes for change in BMI between groups. Compared with children in the comparison group, those in the intervention group showed a reduced frequency of discretionary food intake (estimate −1.36, 95% CI −2.27 to −0.45; P=.004), and parents showed improvement in child feeding pressure to eat practices (−0.30, 95% CI 0.06 to −0.00; P=.048) and nutrition self-efficacy (0.43, 95% CI 0.10 to 0.76; P=.01). No significant time by group interaction was found for other outcomes. Conclusions The trial demonstrated that a parent-focused eHealth childhood obesity prevention program can provide support to improve dietary-related practices and self-efficacy but was not successful in reducing BMI. The target sample size was not achieved, which would have affected statistical power. Trial Registration Australian New Zealand Clinical Trials Registry ANZCTR12616000119493; https://www.anzctr.org.au/ Trial/Registration/TrialReview.aspx?id=370030 (Archived by WebCite at http://www.webcitation.org/74Se4S7ZZ).

Recommended "Dose" * What do the instructions for users say on how often the app should be used?
Approx. Percentage of Users (starters) still using the app as recommended after 3 months * yes: all primary outcomes were signi cantly better in intervention group vs intervention control partly: SOME primary outcomes were signi cantly better in intervention intervention group vs control no statistically signi cant difference between control and intervention intervention potentially harmful: control was signi cantly better than intervention in one intervention or more outcomes inconclusive: more research is needed Other: not submitted yet -in early draft status not submitted yet -in late draft status, just before submission submitted to a journal but not reviewed yet submitted to a journal and after receiving initial reviewer comments submitted to a journal and accepted, but not published yet Is this a full powered effectiveness trial or a pilot/feasibility trial? * Manuscript tracking number * If this is a JMIR submission, please provide the manuscript tracking number under "other" (The ms tracking number can be found in the submission acknowledgement email, or when you login as author in JMIR. If the paper is already published in JMIR, then the ms tracking number is the fourdigit number at the end of the DOI, to be found at the bottom of each published article in JMIR) 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 Intervention "electronic" only if o ine products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.
Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study " 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 intervention telephone support").
Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study N subitem not at all important 1 2 3 4 5 essential 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 Intervention Diabetes: Randomized Controlled Trial Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Time2bHealthy -an internet-based childhood obesity prevention program for parents of preschool-aged children: outcomes of a randomized controlled trial" 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 intervention 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) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Intervention participants received an 11-week internet-based healthy lifestyle program, which was underpinned by Social Cognitive Theory, followed by fortnightly emails for 3-months thereafter. Comparison participants received email communication only" 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Intervention participants were encouraged to access and contribute to a closed (secret) Facebook group to communicate with other participants and a dietitian".
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-toface assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for intervention assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials). Note: In traditional o ine trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered. To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e. participants can self-enrol). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-iii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Participants were recruited both online and through more traditional means". "All data were collected at face-to-face appointments at baseline, 3-and 6-months by blinded data collectors". 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 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) INTRODUCTION 2a) In INTRODUCTION: Scienti c background and explanation of rationale Does your paper address subitem 1b-iv? Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Eighty-six dyads were recruited, with 42 randomized to the intervention group and 44 to the comparison group. 78 dyads attended the 3-and 6-month followups, with 7 lost to follow-up and one withdrawing". "Sixty-nine percent of participants completed at least 5 of the 6 modules". 1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials Conclusions/Discussions in abstract for negative trials: Discuss the primary outcome -if the trial is negative (primary outcome not changed), and the intervention was not used, discuss whether intervention negative results are attributable to lack of uptake and discuss reasons. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 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 brie y explain why the item is not applicable/relevant for your study "The target sample size was not achieved, which would have affected statistical power".
subitem not at all important 1 2 3 4 5 essential 2a-i) Problem and the type of system/solution Describe the problem and the type of system/solution that is object of the study: intended as standalone intervention vs. incorporated in broader health care program? Intended for a particular patient intervention population? Goals of the intervention, e.g., being more cost-effective to other interventions, replace intervention intervention or complement other solutions? (Note: Details about the intervention are provided in "Methods" intervention 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 brie y explain why the item is not applicable/relevant for your study "The World Health Organization (WHO) has described childhood obesity as one of the most signi cant public health issues. Around 23% of children and adolescents in developed countries and 13% in developing countries are overweight or obese. One of the main in uences on the development of childhood obesity is parental guidance and role-modelling around obesity-related behaviors, particularly in the early years of life up to 5 years of age. Health behaviors become more di cult to change with age and tend to track into adulthood, but are quite malleable in the early years. Therefore, early childhood is an opportune time to intervene and involving parents in interventions appears to be crucial". "Overweight and obesity interventions which use an eHealth delivery method offer many advantages compared to traditional delivery methods, particularly around convenience and accessibility". "In this review, no studies targeting children under the age of ve years were included and it was recommended that larger, higher quality parent-focussed eHealth studies be conducted, with a particular focus on younger age groups". "This paper reports the outcomes of a randomized controlled trial (RCT) evaluating the e cacy of a parent-focussed internet-based program in facilitating behavior change in preschool-aged children who are overweight or at-risk of becoming overweight". Does your paper address subitem 2a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Overweight and obesity interventions which use an eHealth delivery method offer many advantages compared to traditional delivery methods, particularly around convenience and accessibility". "In this review, no studies targeting children under the age of ve years were included and it was recommended that larger, higher quality parent-focussed eHealth studies be conducted, with a particular focus on younger age groups".
"This paper reports the outcomes of a randomized controlled trial (RCT) evaluating the e cacy of a parent-focussed internet-based program in facilitating behavior change in preschool-aged children who are overweight or at-risk of becoming overweight". "We hypothesized that children in the intervention group would achieve signi cantly greater reductions in BMI compared to the comparison group at 6month follow-up. It was also hypothesized that the intervention group would achieve signi cantly greater improvements in child dietary intake, physical activity, screen-time, sleep, child feeding and parent self-e cacy and role modelling".
https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dG… 14/52 METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "We hypothesized that children in the intervention group would achieve signi cantly greater reductions in BMI compared to the comparison group at 6month follow-up. It was also hypothesized that the intervention group would achieve signi cantly greater improvements in child dietary intake, physical activity, screen-time, sleep, child feeding and parent self-e cacy and role modelling".
Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The current study was a two-arm parallel RCT involving parent-child dyads, recruited into six cohorts".
"Randomization was performed in a 1:1 ratio using a concealed computerized random number generator".
Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable. There were no changes to the methods after trial commencement.
subitem not at all important 1 2 3 4 5 essential 4a) Eligibility criteria for participants 3b-i) Bug xes, Downtimes, Content Changes Bug xes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or intervention comparator during the trial (e.g., major bug xes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have in uenced study design such as staff changes, system failures/downtimes, etc. [2].
Does your paper address subitem 3b-i? Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable. There were no bug xes, down times or content changes. There was a previous feasibility trial which ensured that there were no issues such as these in this RCT.
Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Participants were eligible if their child was 2-5 years of age (and not yet attending school) and was at or above the WHO 50th percentile for body mass index (BMI) for their age and sex [24,25]. Parents also needed to have a Facebook account or agreed to create one.
Child participants were excluded if they were taking medications or had a medical condition with the potential to affect weight or restrict age-appropriate play. Children with conditions which required the restriction of certain foods (e.g. Coeliac Disease or food allergies) were deemed eligible to participate, but parents were informed that parts of the program would not be completely appropriate and that they would need to make some adaptations to the material provided in order to match their child's individual dietary/health needs". Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clari ed.
Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Participants were eligible if they had access to the internet.." Access to the internet was determined, rather than computer/internet literacy.
4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for intervention assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email con rmation, phone calls) were used to detect/prevent these.
subitem not at all important 1 2 3 4 5 essential 4b) Settings and locations where the data were collected Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Provisional eligibility was determined through contact with participants via phone or email and was con rmed at the face-to-face baseline data collection visit when the child's height and weight were measured to con rm if the child's BMI was at or above the WHO 50th percentile for age and sex".
"Participant measures were collected at the University of Wollongong, in the participant's home or in a community setting. Questionnaires were completed by the parents on an iPad during these sessions, which took approximately 30-45 minutes. Demographic information was also collected from parents at the baseline data collection point. Participants in the intervention group were asked to complete an evaluation questionnaire at the end of the online program, which assessed user acceptability of the program content, length, goal-setting, Facebook discussion group and the modality used".

4a-iii) Information giving during recruitment
Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.
Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 22 Hopewood Cres "Informed written consent was provided by the parents/guardians after reading a participant information sheet".
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Measurements were taken at baseline, 3-and 6-months post-baseline.
Participant measures were collected at the University of Wollongong, in the participant's home or in a community setting. Questionnaires were completed by the parents on an iPad during these sessions, which took approximately 30-45 minutes. Demographic information was also collected from parents at the baseline data collection point. Participants in the intervention group were asked to complete an evaluation questionnaire at the end of the online program, which assessed user acceptability of the program content, length, goal-setting, Facebook discussion group and the modality used".

4b-i) Report if outcomes were (self-)assessed through online questionnaires
Clearly report if outcomes were (self-)assessed through online questionnaires (as common in webbased trials) or otherwise.
Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Participants in the intervention group were asked to complete an evaluation questionnaire at the end of the online program, which assessed user acceptability of the program content, length, goal-setting, Facebook discussion group and the modality used".

4b-ii) Report how institutional a liations are displayed
Report how institutional a liations are displayed to potential participants [on ehealth media], as a liations 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) intervention 5) The interventions for each group with su cient details to intervention allow replication, including how and when they were actually administered subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 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 brie y explain why the item is not applicable/relevant for your study Not reported in manuscript. Details of all investigators and a liations were provided on the participant information sheet.

5-i) Mention names, credential, a liations of the developers, sponsors, and owners
Mention names, credential, a liations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Con ict of interest" section or mentioned elsewhere in the manuscript).
Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Con ict of Interest: "The University of Wollongong developed the Time2bHealthy Program".

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.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The protocol for this study has been published. Brie y, the Time2bHealthy study was based on formative research with parents of preschool-aged children and was piloted prior to this trial".

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 intervention underwent major changes during the evaluation process, or whether the development intervention 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 intervention events see item 3b).

Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Details regarding changes made to the intervention are provided in the previously published protocol paper. Hammersley ML, Jones RA, and Okely AD, Time2bHealthy -An online childhood obesity prevention program for preschoolaged children: A randomised controlled trial protocol. Contemp Clin Trials 2017; 61:73-80.
One module was added to the program after the feasibility trial. Amendments were made to ensure consistency with latest guidelines and enhancements made such as addition of videos.

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Content was consistent with evidence-based guidelines 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing owcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing owcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scienti c reporting.
Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Should the manuscript be accepted for publication, we will discuss provision of screen-shots of the program. We are currently planning to implement a translational research trial involving a few external stakeholders, so we will need to consider the level of information that can be published.

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or intervention disappear over the course of the years; also make sure the intervention is archived (Internet Archive, intervention 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.
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The current website for the program is https://time2bhealthy.uow.edu.au/ however the content does sit behind a login. As discussed in 5-v, should the manuscript be accepted for publication, we will discuss the provision of screenshots.

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of speci c group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Participants randomized to the intervention group were provided with an individual login to access the Time2bHealthy program" "The intervention targeted multiple behaviors and consisted of six modules including an introduction, nutrition (n=2), physical activity, screen-time and sleep which were completed by participants over an 11-week period. Each module comprised of reading material, videos, activities, quizzes and a goal-setting component. Participants received feedback on their goals at the end of each module by a dietitian and were provided with advice to improve their goals using the SMART goal framework. Participants also received weekly emails reminding them to log on to the website and participate in the activities. Participants in each of the cohorts were encouraged to access and contribute to a closed (secret) Facebook group to communicate with other members of the cohort and the dietitian. There was a separate group for each cohort and they were regularly monitored and moderated by the dietitian. Participants were asked to post photos, recipes and personal experiences and ideas that they had found helpful for behavior change which were relevant to each module".
"Participants continued to receive emails fortnightly at the end of the program until the 6-month follow-up. Infographics summarising the key points from each of the modules were provided in these emails and participants were also encouraged to log back into the website to revise the material and review their progress with their goals". 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 brie y explain why the item is not applicable/relevant for your study "The development, content and theoretical framework for this intervention has been previously published. Brie y, the intervention was guided by Bandura's Social Cognitive Theory and was designed using a backwards intervention mapping process. The intervention targeted multiple behaviors and consisted of six modules including an introduction, nutrition (n=2), physical activity, screentime and sleep which were completed by participants over an 11-week period.
Each module comprised of reading material, videos, activities, quizzes and a goal-setting component. Participants received feedback on their goals at the end of each module by a dietitian and were provided with advice to improve their goals using the SMART goal framework. Participants also received weekly emails reminding them to log on to the website and participate in the activities.
Participants in each of the cohorts were encouraged to access and contribute to a closed (secret) Facebook group to communicate with other members of the cohort and the dietitian" "Participants continued to receive emails fortnightly at the end of the program until the 6-month follow-up. Infographics summarising the key points from each of the modules were provided in these emails and participants were also encouraged to log back into the website to revise the material and review their progress with their goals".
Further details are also provided in the protocol paper: Hammersley

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. intervention subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-ix?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The intervention targeted multiple behaviors and consisted of six modules including an introduction, nutrition (n=2), physical activity, screen-time and sleep which were completed by participants over an 11-week period". Participants received weekly emails to remind them to log on and they were guided to complete one module per fortnight.
"Participants continued to receive emails fortnightly at the end of the program until the 6-month follow-up".

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 intervention intervention involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21generalizability).
Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Participants received feedback on their goals at the end of each module by a dietitian and were provided with advice to improve their goals using the SMART goal framework. Participants also received weekly emails reminding them to log on to the website and participate in the activities. Participants in each of the cohorts were encouraged to access and contribute to a closed (secret) Facebook group to communicate with other members of the cohort and the dietitian".
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 6a) Completely de ned pre-speci ed primary and secondary outcome measures, including how and when they were assessed 5-xi) Report any prompts/reminders used Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Participants also received weekly emails reminding them to log on to the website and participate in the activities".

5-xii) Describe any co-interventions (incl. training/support)
Describe any co-interventions (incl. training/support): Clearly state any interventions that are intervention intervention provided in addition to the targeted eHealth intervention, as ehealth intervention may not be intervention intervention designed as stand-alone intervention. This includes training sessions and support [1]. It may be intervention necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability. Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable. There were no co-interventions.
Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Child height and weight were measured using a standardized method [30] to calculate BMI. A stadiometer was used to measure height to the nearest 0.1mm.
Weight was measured (with no shoes and minimal clothing) to the nearest 0.1kg using a SECA scale. Both height and weight were measured twice. The mean of these two measurements was used to calculate BMI. A third measurement was taken when height measurements differed by more than 0.5cm and weight measurements differed by more than 0.5kg." "Dietary intake was assessed using both a parent-reported food questionnaire (modi ed from the Eating and Physical Activity Questionnaire (EPAQ) and a parent-reported 24-h recall of child dietary intake (using the 'Easy Diet Diary' app (Xyris Software (Australia) Pty Ltd)). The section of the food questionnaire which asked about frequency of intake of discretionary foods was expanded to include additional discretionary food categories, which used the same scale as the existing question. Cronbach's alpha=0.68 for these discretionary food questions.
Data from the 24-h recall was used to calculate kJ per kg of body weight, percentage of kJ from sugar and percentage of kJ from saturated fat. Data from the food questionnaire were used to assess daily fruit intake, daily vegetable intake and frequency of fruit juice and sugary drinks intake. A discretionary food score was calculated based on responses to questions on frequency of intake of takeaway or fast food; sugary cereals; potato chips or other salty snacks; sweets; cakes, doughnuts, and sweet cookies or mu ns". "Physical activity intensity and duration was measured using an ActiGraph GT3X+ accelerometer (ActiGraph Corporation, Pensacola, FL) which was worn on an elasticized belt around the child's waist for seven days. Accelerometer data were analysed in ActiLife version 6 (ActiGraph Corporation, Pensacola, FL). A sampling frequency of 30 Hz was used, with the les then reintegrated into 15 s epochs. Non-wear time was de ned as 20 minutes or more of 0 counts. Accelerometer data used for the physical activity analysis were considered valid based on wear time of at least 6 hours per day on 3 days, which has been found to be reliable in previous research. The following cut-points appropriate for preschool-aged children were used to categorize physical activity intensity; sedentary <100 counts/min, low light-intensity physical activity 101-800 counts/min, high lightintensity physical activity 801-1679 counts/min, moderate-intensity physical activity 1680-3367 count/min and vigorous-intensity physical activity ≥1680 count/min". 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed If outcomes were obtained through online questionnaires, describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed [9].
Does your paper address subitem 6a-i?
Copy and paste relevant sections from manuscript text Questionnaires used for outcome measures were not used online, they were completed by participants on an iPad in a face-to-face setting.
6a-ii) Describe whether and how "use" (including intensity of use/dosage) was de ned/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was de ned/measured/monitored (logins, log le 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 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text Use was measured by the number of modules completed. "Within the intervention group, 29 participants (69%) completed at least 5 of the 6 online modules". 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).

Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text "Participants in the intervention group were asked to complete a process evaluation questionnaire at the end of the online program, which assessed user acceptability of the program content, length, goal-setting, Facebook discussion group and the modality used".
Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable. There were no changed to trial outcomes after the trial commenced.
subitem not at all important 1 2 3 4 5 essential 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 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size Describe whether and how expected attrition was taken into account when calculating the sample size.
Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Based on the results of the pilot study, we expected a BMI effect size of approximately 0.4 for this trial. To detect a statistically signi cant difference between groups (α=0.05 and power=0.8), 136 participants were required (68 per group) and based on an estimated attrition rate of 15%, we aimed to recruit 160 participants (80 per group)".
Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable 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 intervention Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Participants were randomized into the intervention or comparison group following the collection of baseline measures. Randomization was performed in a 1:1 ratio using a concealed computerized random number generator. A data manager with no other involvement in the study conducted the randomization. The researcher responsible for implementing the intervention was the only person who was informed about group allocation. At the follow-up data collection time-points, height and weight measurements were taken by trained data collectors blinded to group allocation".
Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Randomization was performed in a 1:1 ratio using a concealed computerized random number generator". 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions intervention 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those intervention assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment intervention subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Randomization was performed in a 1:1 ratio using a concealed computerized random number generator".
"A data manager with no other involvement in the study conducted the randomization. The researcher responsible for implementing the intervention was the only person who was informed about group allocation. At the follow-up data collection time-points, height and weight measurements were taken by trained data collectors blinded to group allocation".
Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "A data manager with no other involvement in the study conducted the randomization. The researcher responsible for implementing the intervention was the only person who was informed about group allocation". The PhD researcher (dietitian) elded enquiries, assessed eligibility and enrolled participants into the study.
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). intervention subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Participants were not blinded and the PhD student researcher (dietitian) was not blinded. Baseline measured were collected by the PhD researcher prior to randomization and follow-up data collection was performed by trained, blinded data collectors.
"Participants were randomized into the intervention or comparison group following the collection of baseline measures. Randomization was performed in a 1:1 ratio using a concealed computerized random number generator. A data manager with no other involvement in the study conducted the randomization.
The researcher responsible for implementing the intervention was the only person who was informed about group allocation. At the follow-up data collection time-points, height and weight measurements were taken by trained data collectors blinded to group allocation".
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 intervention intervention the "comparator".

Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study In order to provide informed consent, the information sheet speci ed the names of the intervention (Time2bHealthy) and comparison (Raising Children) groups.
However, at the time of group allocation, participants were informed of the groups they were allocated to, but the names of the groups were referred to (rather than 'intervention' and 'control'). 11b) If relevant, description of the similarity of interventions intervention (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) intervention 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 CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Differences in changes over time between the intervention and comparison groups were assessed for each outcome. Linear mixed models were used to determine differences between groups over time (baseline, 3-months and 6months) with adjustment for potential covariates. Intention-to-treat (ITT) principles were used for parametric data, with all participants analysed in the group which they were randomized regardless of whether they attended all data collection time-points or completed the intervention. Covariates included baseline values, age and cohort. In addition to the ITT analysis, a completers analysis was conducted using linear mixed models, which included intervention participants who had completed at least 5 modules (>80% of online content) and comparison participants who attended all data collection time-points. Due to non-parametric distributions for some variables, Freidman's tests and Wilcoxon Signed Rank tests were used followed by Mann Whitney tests to analyse nonparametric data using completed cases. Generalized estimating equations were considered, however the analyses would not converge.
Posthoc ANCOVA analyses were used to detect changes between groups at individual time-points, which included the baseline value, age and cohort as covariates. Within group changes were analysed using repeated measures ANOVA, which included age and cohort as covariates. These were complete case analyses. Analyses were performed using IBM SPSS Statistics for Windows, version 25 (IBM Corp., Armonk, N.Y., USA)".
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 intervention participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4] Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Linear mixed models were used to conduct intention-to-treat analyses.
"Linear mixed models were used to determine differences between groups over time (baseline, 3-months and 6-months) with adjustment for potential covariates.
Intention-to-treat (ITT) principles were used for parametric data, with all participants analysed in the group which they were randomized regardless of whether they attended all data collection time-points or completed the intervention".
Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Analyses were adjusted for covariates. "Covariates included baseline values, age and cohort".

X26-i) Comment on ethics committee approval
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential Does your paper address subitem X26-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The study was registered with the Australian and New Zealand Clinical Trials Registry (12616000119493) and approved by the University of Wollongong Human Research Ethics Committee (HE15/354)".

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained o ine or online (how? Checkbox, etc.?), and what information was provided (see 4a-ii). See [6] for some items to be included in informed consent documents.
Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Informed written consent was provided by the parents/guardians after reading a participant information sheet". Information sheets were emailed or given to participants. Consent was not provided online. Hard copy consent forms were collected at the baseline data collection visit.

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Participants were informed that they could make contact via email or phone if they had questions or concerns at any time".

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 intervention the number of patients treated by each care provider in each center 13b) For each group, losses and exclusions after randomisation, together with reasons subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Of the 93 parent/child dyads who attended the initial visit, 86 were eligible and enrolled in the study. Forty-two participant dyads were randomized to the intervention group and 44 to the comparison group. Seventy-eight participants (91%) attended the 3-and 6-month follow-ups, with 7 (8%) lost to follow-up and one participant (1%) withdrawing from the intervention group due to problems accessing the internet". Also see Figure 1.
Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT ow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study See 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 intervention gures or tables demonstrating usage/dose/engagement. 14b) Why the trial ended or was stopped (early) Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the gure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study See Figure 2 Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Recruitment was conducted between January 2016 and June 2017". "Follow-up was conducted between July 2016 and December 2017".
14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signi cant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 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 brie y explain why the item is not applicable/relevant for your study Not applicable 15) A 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 brie y explain why the item is not applicable/relevant for your study Please refer to Table 1 15-i) Report demographics associated with digital divide issues In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known.
Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Please refer to Table 1 16-i) Report multiple "denominators" and provide de nitions Report multiple "denominators" and provide de nitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speci c pre-intervention de ned time points of interest (in absolute and relative numbers per group). Always clearly de ne "use" of the intervention. intervention subitem not at all important 1 2 3 4 5 essential 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% con dence interval) Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Refer to Figure 1 for number of participants included at each page. Refer to Tables for number of participants included in analyses. Note: main analysis used intention-to-treat principles.

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).
Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Intention-to-treat (ITT) principles were used for parametric data, with all participants analysed in the group which they were randomized regardless of whether they attended all data collection time-points or completed the intervention".
Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Main results for each group, precision and signi cance are provided in table 2.
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 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing prespeci ed from exploratory 17a-i) Presentation of process outcomes such as metrics of use and intensity of use In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational de nitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is de ned (e.g., timeout after idle time) [1] (report under item 6a).
Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study " Figure 2 shows the completion of each of the intervention program modules. At least 5 of 6 modules were completed by 29 participants (69%)".
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 brie y explain why the item is not applicable/relevant for your study Not applicable. There were no binary outcomes included in the analyses.
subitem not at all important 1 2 3 4 5 essential 19) All important harms or unintended effects in each group (for speci c guidance see CONSORT for harms) 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 brie y explain why the item is not applicable/relevant for your study There were no sub-group analyses, but ANCOVA analyses were conducted to determine differences between groups at each time-point and repeated measures ANOVA analyses were conducted to determine change within groups. "The ANCOVA analyses (shown in Table 3) also found no signi cant differences between groups at each time-point. When considering changes within groups, the repeated measures ANOVA found a signi cant change in BMI within the intervention group at both the 3-month (adjusted mean difference -0.262, 95% CI -0.506 to -0.017, p=0.032) and 6-month time-point (adjusted mean difference -0.216, 95% CI -0.401 to -0.031, p=0.017) and no signi cant changes within the comparison group (as displayed in Table 4)".

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).
Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "A completers analysis was conducted using linear mixed models, which included intervention participants who had completed at least 5 modules (>80% of online content) and comparison participants who attended all data collection time- Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study A process evaluation was completed, but this did not determine any unexpected or unexpected effects of uses. "Thirty-seven participants from the intervention group (88%) completed the process evaluation questionnaire". "Most participants agreed or strongly agreed that the program content was interesting (95%), easy to understand (100%) and relevant (97%). Most also agreed or strongly agreed that the length of the program was appropriate (87%), the goal-setting component was helpful (79%) and that the dietitian was helpful and knowledgeable (92%). Most participants discussed the program with extended family members (74%).
The internet-based delivery mode of the program was suitable for the majority of participants (97%), however six participants stated that they would have preferred a different mode of delivery such as a mobile-optimized website (2), smartphone app (2), face-to-face (2) or hard copy (2). Only 15 participants (41%) agreed or strongly agreed that the Facebook component was useful".
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).
subitem not at all important 1 2 3 4 5 essential 20) Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "In this RCT, we found no signi cant difference in BMI change between the two groups at 6-months post-baseline. There were no signi cant differences in physical activity, screen-time or sleep outcomes between groups. The intervention did, however, demonstrate some positive outcomes in relation to dietary intake, child feeding and nutrition parent self-e cacy. To the best of our knowledge, Time2bHealthy is the rst RCT to assess the e cacy of a parentfocussed healthy lifestyle intervention on BMI in preschool-aged children which is delivered entirely online".

22-ii) Highlight unanswered new questions, suggest future research
Highlight unanswered new questions, suggest future research.
Does your paper address subitem 22-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "A cost-effectiveness analysis was not within the scope of this study. While it is generally perceived that that eHealth interventions are more cost-effective than traditionally-delivered programs, more research is needed [63]. Studies with a longer follow-up period and those which translate programs into primary health care are required to demonstrate long-term effectiveness".
"Future studies with a larger sample size, longer follow-up period and those that translate effective eHealth childhood obesity prevention programs into primary health care are needed".
subitem not at all important 1 2 3 4 5 essential 21) Generalisability (external validity, applicability) of the trial ndings NPT: External validity of the trial ndings according to the intervention, comparators, intervention patients, and care providers or centers involved in the trial subitem not at all important 1 2 3 4 5 essential 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 nonuse of the intervention/usability issues, biases through informed consent procedures, unexpected intervention events.
Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "While it was intentional to include children of a healthy weight in this study, there were a higher than anticipated proportion of children (over 90%) in the healthy weight range. Therefore, the effect on BMI may have been diluted". "As there were multiple outcomes assessed, there is a risk that there may have been a Type 1 error". "Statistical power would have been affected by the fact that the target sample size was not achieved despite measures to enhance participant recruitment, including expanding the recruitment area and extending the recruitment period. It is also possible that a longer follow-up period may have been required to demonstrate differences in BMI change between groups".

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 subitem not at all important 1 2 3 4 5 essential OTHER INFORMATION Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The weight status range of children in this sample demonstrates that the intervention can be applied to both healthy weight and overweight/obese children. However, further work is required to explore optimal avenues to access at-risk and hard to reach populations. It has been reported that the majority of parents do not recognise that their child is overweight and obese children [64].
Education and monitoring initiatives may therefore be useful to enhance parent awareness".
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 intervention what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting. intervention 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 brie y explain why the item is not applicable/relevant for your study "As this intervention is solely internet-based, it could be easily translated to a realworld setting given that most developed countries have a high proportion of internet users. The program would also be easily transferable to other countries by adapting the content to comply with local guidelines. In a real-world setting, data could be collected online which could improve participant retention, but lack of objectively measured data may create bias issues. It is recommended that further studies with a longer follow-up period and those which translate programs into primary health care be conducted to demonstrate long-term effectiveness". STOP -Save this form as PDF before you click submit To generate a record that you lled in this form, we recommend to generate a PDF of this page (on a Mac, simply select "print" and then select "print as PDF") before you submit it.
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