Efficacy of the Aim2Be Intervention in Changing Lifestyle Behaviors Among Adolescents With Overweight and Obesity: Randomized Controlled Trial

Background Aim2Be is a gamified lifestyle app designed to promote lifestyle behavior changes among Canadian adolescents and their families. Objective The primary aim was to test the efficacy of the Aim2Be app with support from a live coach to reduce weight outcomes (BMI Z score [zBMI]) and improve lifestyle behaviors among adolescents with overweight and obesity and their parents versus a waitlist control group over 3 months. The secondary aim was to compare health trajectories among waitlist control participants over 6 months (before and after receiving access to the app), assess whether support from a live coach enhanced intervention impact, and evaluate whether the app use influenced changes among intervention participants. Methods A 2-arm parallel randomized controlled trial was conducted from November 2018 to June 2020. Adolescents aged 10 to 17 years with overweight or obesity and their parents were randomized into an intervention group (Aim2Be with a live coach for 6 months) or a waitlist control group (Aim2Be with no live coach; accessed after 3 months). Adolescents’ assessments at baseline and at 3 and 6 months included measured height and weight, 24-hour dietary recalls, and daily step counts measured with a Fitbit. Data on self-reported physical activity, screen time, fruit and vegetable intake, and sugary beverage intake of adolescents and parents were also collected. Results A total of 214 parent-child participants were randomized. In our primary analyses, there were no significant differences in zBMI or any of the health behaviors between the intervention and control groups at 3 months. In our secondary analyses, among waitlist control participants, zBMI (P=.02), discretionary calories (P=.03), and physical activity outside of school (P=.001) declined, whereas daily screen time increased (P<.001) after receiving access to the app compared with before receiving app access. Adolescents randomized to Aim2Be with live coaching reported more time being active outside of school compared with adolescents who used Aim2Be with no coaching over 3 months (P=.001). App use did not modify any changes in outcomes among adolescents in the intervention group. Conclusions The Aim2Be intervention did not improve zBMI and lifestyle behaviors in adolescents with overweight and obesity compared with the waitlist control group over 3 months. Future studies should explore the potential mediators of changes in zBMI and lifestyle behaviors as well as predictors of engagement. Trial Registration ClinicalTrials.gov NCT03651284; https://clinicaltrials.gov/ct2/show/study/NCT03651284 International Registered Report Identifier (IRRID) RR2-10.1186/s13063-020-4080-2

The CONSORT-EHEALTH checklist is intended for authors of randomized trials evaluating web-based and Internet-based applications/interventions, including mobile interventions, electronic games (incl multiplayer games), social media, certain telehealth applications, and other interactive and/or networked electronic applications. Some of the items (e.g. all subitems under item 5 -description of the intervention) may also be applicable for other study designs.
The goal of the CONSORT EHEALTH checklist and guideline is to be a) a guide for reporting for authors of RCTs, b) to form a basis for appraisal of an ehealth trial (in terms of validity) CONSORT-EHEALTH items/subitems are MANDATORY reporting items for studies published in the Journal of Medical Internet Research and other journals / scientific societies endorsing the checklist.
As the CONSORT-EHEALTH checklist is still considered in a formative stage, we would ask that you also RATE ON A SCALE OF 1-5 how important/useful you feel each item is FOR THE PURPOSE OF THE CHECKLIST and reporting guideline (optional).
Mandatory reporting items are marked with a red *. In the textboxes, either copy & paste the relevant sections from your manuscript into this form -please include any quotes from your manuscript in QUOTATION MARKS, or answer directly by providing additional information not in the manuscript, or elaborating on why the item was not relevant for this study. yes: all primary outcomes were significantly better in intervention group vs control partly: SOME primary outcomes were significantly better in intervention group vs control no statistically significant difference between control and intervention potentially harmful: control was significantly better than intervention in one 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   T  I  T  L  E  A  N  D  A  B  S  T  R  A  C  T   1  a  )  T  I  T  L  E  :  I  d  e  n  t  i  f  i  c  a  t  i  o  n  a  s  a  r  a  n  d  o  m  i  z  e  d  t  r  i  a  l  i  n  t  h  e  t  i  t  l  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. 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 This paper addresses subitem 1a-ii but only in secondary analyses.
Your response is too large. Try shortening some answers.
subitem not at all important T  R  A  C  T  :  S  t  r  u  c  t  u  r  e  d  s  u  m  m  a  r  y  o  f  t  r  i  a  l  d  e  s  i  g  n  ,  m  e  t  h  o  d  s  ,  r  e  s  u  l  t  s  ,  a  n  d  c  o  n  c  l  u  s  i  o  n  s   N  P  T  e  x  t  e  n  s  i  o  n  :  D  e  s  c  r  i  p  t  i  o  n  o  f  e  x  p  e  r  i  m  e  n  t  a  l  t  r  e  a  t  m  e  n  t  ,  c  o  m  p  a  r  a  t  o  r  ,  c  a  r  e  p  r  o  v  i  d  e  r  s  ,  c  e  n  t  e  r  s  ,  a  n  d  b  l  i  n  d  i  n  g  s  t  a  t  u e  a  t  u  r  e  s  /  f  u  n  c  t  i  o  n  a  l  i  t  i  e  s  /  c  o  m  p  o  n  e  n  t  s  o  f  t  h  e  i  n  t  e  r  v  e  n  t  i  o  n  a  n  d  c  o  m  p  a  r  a  t  o  r  i  n  t  h  e  M  E  T  H  O  D  S  s  e  c  t  i  o  n  o  f  t  h  e  A  B  S  T  R  A  C  T 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. Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "A 2-arm parallel randomized control trial was conducted from November 2018 to June 2020. Children age 10-17 years with overweight or obesity and their parents were randomized into an intervention group (Aim2Be with live coach for 6 months) or a waitlist control group (Aim2Be with no live coach; accessed after 3 months)." 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). 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 We do not report directly app use data but explain how app use did not change our findings: "App utilization did not modify any changes in outcomes among children in the intervention group."  Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, we explicitly report this in the abstract: "The Aim2Be app did not improve zBMI and lifestyle behaviours in children with overweight and obesity vs. a waitlist control group over 3 months. " Copy and paste relevant sections from the manuscript (include quotes in quotation 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 this paper, we report findings related to the efficacy of the Aim2Be app in altering health outcomes and lifestyle behaviours in children with overweight or obesity and their parents. We hypothesized that participants (child-parent dyads) randomized to the intervention group (access to the Aim2Be app) would improve their weight and health behaviors compared to participants who were randomized to a waitlist control group. The secondary aims of this study were to evaluate changes in health behaviour trajectories among participants assigned to the waitlist before and after receiving access to the app, assess whether additional support from a live coach enhanced intervention effects, and investigate whether app utilization influenced 6-month changes among children and parents in the intervention group." Copy and paste relevant sections from the manuscript (include quotes in quotation 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 "Interested participants were directed to provide their contact information through an electronic form and were then screened by telephone. Families were eligible for inclusion if children participants were between 10 and 17 years old, and had overweight or obesity (as defined by the age and sex specific World Health Organization (WHO) cut-offs 27), if the parent was capable of reading at the grade 5 level or above, was the caregiver with whom the child primarily lived with, and if families had a computer or mobile device and internet access at home. Families were ineligible if the child had a diagnosis of type 1 diabetes, anorexia nervosa or bulimia nervosa, any health condition that restricted the amount or type of PA they could do or the types of food they could eat, or a history of psychiatric problems or substance abuse which could interfere with adherence to the study protocol, if child was pregnant, or if the child was using other methods of weight management (e.g. participation in other programs or use of medication, nutritional supplements or herbal preparations to lose weight Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This is explicit in the inclusion criteria: "Families were eligible for inclusion if children participants were between 10 and 17 years old, and had overweight or obesity (as defined by the age and sex specific World Health Organization (WHO) cut-offs 27), if the parent was capable of reading at the grade 5 level or above, was the caregiver with whom the child primarily lived with, and if families had a computer or mobile device and internet access at home." a c e a s s e s s m e n t s : 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. Copy and paste relevant sections from the manuscript (include quotes in quotation 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 were recruited from November 2018 to July 2019, and the 6-month follow up finished in June 2020. Families were recruited from 6 pediatric weight management programs across 3 Canadian provinces that typically provide in-person health services for managing childhood obesity: British Columbia Children's Hospital (Vancouver, British Columbia), Alberta Children's Hospital (Calgary, Alberta), Stollery Children's Hospital (Edmonton, Alberta), McMaster Children's Hospital (Hamilton, Ontario), the Hospital for Sick Children (Toronto, Ontario), and the Children's Hospital of Eastern Ontario (Ottawa, Ontario). Clinical sites used a combination of clinic handouts, mail, email and telephone to recruit families. Families who were waitlisted for in-person weight management programs and those who declined participation in face-to-face programs were offered participation in the Aim2Be trial as an alternative. Families were provided with an invitational package that described the study and included copies of the consent and assent forms as well as a link to the study website. Families were also recruited using clinic waitlists for in-person weight management programs and advertisements on Facebook." Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Families were provided with an invitational package that described the study and included copies of the consent and assent forms as well as a link to the study website. Families were also recruited using clinic waitlists for in-person weight management programs and advertisements on Facebook." Copy and paste relevant sections from the manuscript (include quotes in quotation 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 were recruited from November 2018 to July 2019, and the 6-month follow up finished in June 2020. Families were recruited from 6 pediatric weight management programs across 3 Canadian provinces that typically provide in-person health services for managing childhood obesity: British Columbia Children's Hospital (Vancouver, British Columbia), Alberta Children's Hospital (Calgary, Alberta), Stollery Children's Hospital (Edmonton, Alberta), McMaster Children's Hospital (Hamilton, Ontario), the Hospital for Sick Children (Toronto, Ontario), and the Children's Hospital of Eastern Ontario (Ottawa, Ontario). Clinical sites used a combination of clinic handouts, mail, email and telephone to recruit families. Families who were waitlisted for in-person weight management programs and those who declined participation in face-to-face programs were offered participation in the Aim2Be trial as an alternative. Families were provided with an invitational package that described the study and included copies of the consent and assent forms as well as a link to the study website. Families were also recruited using clinic waitlists for in-person weight management programs and advertisements on Facebook." Your response is too large. Try shortening some answers.   Copy and paste relevant sections from the manuscript (include quotes in quotation 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/relevant for this study. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, this is declared in the "Funding" section of the manuscript.

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Your response is too large. Try shortening some answers. Copy and paste relevant sections from the manuscript (include quotes in quotation 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 "Details on the Aim2Be evaluation protocol and theoretical framework guiding the development of the app were published previously 19. Aim2Be was built on the foundational knowledge learned in the first generation of the program called LiGHT (Living Green Healthy and Thrifty) 25. LiGHT was an 11-module online program that integrated lifestyle behavior modification principles with environmental and financial concerns to address childhood obesity among 10-to 17-year-old children and their families 25. The second generation of the intervention transitioned from a web-based intervention to a mobile app (iOs and Android) and was renamed Aim2Be version 1 (v1)." Your response is too large. Try shortening some answers.
subitem not at all important 1 2 3 4 5 essential subitem not at all important Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial.
Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study this is not applicable/relevant for our study as there were no unexpected events that occurred. Copy and paste relevant sections from the manuscript (include quotes in quotation 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 "Height and weight were measured by parents using the Centers for Disease Control and Prevention home protocol 29, a valid and reliable method to assess BMI in children 30. "

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Self-report data was also manually checked for outliers in all of the health behaviours examined. Copy and paste relevant sections from the manuscript (include quotes in quotation 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 "Three versions of the app were used in this RCT: a preteen version (for children age 10-13 years), a teen version (14-17 years), and a companion parent app, with some variations in app features depending on the age of the user. Once they enrolled in the app, all preteen and teen users were asked to select a personalized animal avatar as part of the onboarding process to personalize their profile. After enrolling in the app, users were offered a selection of aims to address (e.g., "Drop sugary drinks", "Be a healthy family") and then provided with tasks to help them set incremental goals, plan, and self-monitor their behaviors. Users then progressed along their journey by completing quick wins and quizzes. In the preteen and teen versions of the app, users received a currency which they could draw on to unlock items (collectibles) and purchase "choose your own adventure" stories. All users (preteens, teens and parents) were provided with tools within the app to further support their journey including Check-Ins and Articles. In the teen and parent versions of the app, users were able to interact with one another through a moderated Social Wall where they could post, comment and/or react to each others' posts." Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer Your response is too large. Try shortening some answers. 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). Copy and paste relevant sections from manuscript text "Intervention Utilisation: Intervention use and retention/adherence was assessed using webanalytic data that was internally collected within the Aim2Be app for parents and children.

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Intervention use was evaluated using the following indicators: 1) proportion of participants who downloaded and used the app, 2) total time (in min) spent in the app over 3 months, 3) proportion of participants who used the app and time spent in the app, by week, over 3 months; and finally, 4) proportion of participants who used an app feature at least once over 3 months. These analyses included the whole sample, combining parents and children from both the Aim2Be (intervention) and waitlist control group (who accessed the app from 3-to 6-months). These measures were computed separately for parents, preteens (10-13 years) and teens (14-17 years) since a slightly different app version was developed for preteens 19." Your response is too large. Try shortening some answers. 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 "Power and Sample Size: A sample size of at least 60 people was estimated to provide an 80% power at an alpha of .05 to detect a 0.5 decrease in zBMI in the intervention group. The zBMI was used to calculate sample size because this is the most difficult variable to change and requires the largest sample size of all primary outcomes. However, to be able to detect a 20% difference in adherence (e.g., secondary aims outcome) between the two groups (odds ratio of 2.33) at an alpha of .05 with 80% power using a one-sided t-test, 77 families were needed in each group. Additionally, to account for both missing data and attrition, we projected needing at least 80 families in each group. As the waitlist control group received the intervention at 3 months and further attrition was expected, we required 100 participants enrolled in each group (therefore accounting for 15% attrition from baseline to 3-month and a small proportion of families who would not download the Aim2Be app). Power calculations were conducted in nQuery (Statsols, USA). Based on these computations, we enrolled >200 participants in the RCT."  Copy and paste relevant sections from the manuscript (include quotes in quotation 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 "Once eligibility was confirmed, parents and children completed baseline measures and all participants received a package containing a scale, measuring tape, activity tracker (Fitbit), and a brochure with current health recommendations. Once baseline measures were completed, participants were randomized and provided with a $60 incentive over e-transfer. A computer-generated (www.sealedenvelope.com) randomization schedule was used to allocate participants in blocks of four, six, or eight participants with a randomization ratio of 1:1".
Your response is too large. Try shortening some answers. Copy and paste relevant sections from the manuscript (include quotes in quotation 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 "Once eligibility was confirmed, parents and children completed baseline measures and all participants received a package containing a scale, measuring tape, activity tracker (Fitbit), and a brochure with current health recommendations. Once baseline measures were completed, participants were randomized and provided with a $60 incentive over e-transfer. A computer-generated (www.sealedenvelope.com) randomization schedule was used to allocate participants in blocks of four, six, or eight participants with a randomization ratio of 1:1 28. The allocation schedule was concealed in the randomization module of REDCap and only assigned after informed consent and baseline assessments were obtained. Research team members did not enter or modify the allocation schedule; it was computer generated exclusively. Participants were not blinded to their allocation conditions, although allocation assignment was concealed to researchers at the analysis stage." 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". Copy and paste relevant sections from the manuscript (include quotes in quotation 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 were not blinded to their allocation conditions, although allocation assignment was concealed to researchers at the analysis stage." Copy and paste relevant sections from the manuscript (include quotes in quotation 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 "Sensitivity analyses were conducted to evaluate differences in outcomes between the control group and the intervention group to examine the stability of the results when the sample included only those who used the app for at least 30 minutes in total (from baseline to 3-months). Based on dose-response analyses from previous formative evaluation phases of the app 19, we used an a priori cut-off of 30 min to categorize participants as 'lower' and 'higher' app users." Your response is too large. Try shortening some answers. Copy and paste relevant sections from the manuscript (include quotes in quotation 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 "Families were provided with an invitational package that described the study and included copies of the consent and assent forms as well as a link to the study website. Families were also recruited using clinic waitlists for in-person weight management programs and advertisements on Facebook."  y  a  s  s  i  g  n  e  d  ,  r  e  c  e  i  v  e  d  i  n  t  e  n  d  e  d  t  r  e  a  t  m  e  n  t  ,  a  n  d  w  e  r  e  a  n  a  l  y  s  e  d  f  o  r  t  h  e  p  r  i  m  a  r  y  o  u  t  c  o  m  e   N  P  T  :  T  h  e  n  u  m  b  e  r  o  f  c  a  r  e  p  r  o  v  i  d  e  r  s  o  r  c  e  n  t  e  r  s  p  e  r  f  o  r  m  i  n  g  t  h  e  i  n  t  e  r  v  e  n  t  i  o  n  i  n  e  a  c  h  g  r  o  u  p  a  n  d  t  h  e  n  u  m  b  e  r  o  f  p  a  t  i  e  n  t  s  t  r  e  a  t  e  d  b  y  e  a  c  h  c  a  r  e  p  r  o  v  i  d  e  r  i  n  e  a  c  h  c  e  n  t  e  Copy and paste relevant sections from the manuscript (include quotes in quotation 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 2 shows the study flow of participants. A total of 329 families contacted the research team and of the 278 families screened for eligibility, 218 agreed to participate, completed all baseline measurements, and were randomized into the study. After randomization, 4 parent-child dyads were eliminated because of paired families (within these two paired families, 1 child was randomized to the control group whereas the child was randomized to the intervention group). Therefore, the final analytical sample was comprised of 214 parent-child dyads. "   D  o  e  s  y  o  u  r  p  a  p  e  r  a  d  d  r  e  s  s  C  O  N  S  O  R  T  s  u  b  i  t  e  m  1  3  b  ?  (  N  O  T  E  :  P  r  e  f  e  r  a  b  l  y  ,  t  h Copy and paste relevant sections from the manuscript (include quotes in quotation 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 2 shows the study flow of participants. A total of 329 families contacted the research team and of the 278 families screened for eligibility, 218 agreed to participate, completed all baseline measurements, and were randomized into the study. After randomization, 4 parent-child dyads were eliminated because of paired families (within these two paired families, 1 child was randomized to the control group whereas the child was randomized to the intervention group). Therefore, the final analytical sample was comprised of 214 parent-child dyads." Your response is too large. Try shortening some answers.
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. Copy and paste relevant sections from the manuscript (include quotes in quotation 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 protocol for this study has been published elsewhere 19. The study was a 2-arm parallel design randomized control trial (RCT) which took place from November 2018 to June 2020. " Your response is too large. Try shortening some answers. Copy and paste relevant sections from the manuscript (include quotes in quotation 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 COVID-19 pandemic started towards the end of the trial. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This is not relevant for this trial.
Your response is too large. Try shortening some answers. Copy and paste relevant sections from the manuscript (include quotes in quotation 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 "Baseline characteristics of the participants by intervention arm are shown in Table 1. In total, 44.9% were recruited from clinical sites and 55.1% were recruited from social media (i.e., Facebook). Randomization was successful in that participants' sociodemographic characteristics at baseline did not differ between the intervention and the waitlisted control group. Table 2 displays the mean values for health outcomes among the intervention group (n=107 participants) and the waitlist control group at baseline (n=107 participants). There were no significant differences between the intervention and the waitlist control participants at baseline except for unsaturated fats among children (43 g./day vs. 40 g./day in the intervention and control groups, respectively, P=0.039) and sugary beverages intakes among parents (0.62 vs. 0.40 times/day in the intervention and control groups, respectively, P=0.032). " 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.  Copy and paste relevant sections from the manuscript (include quotes in quotation 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 "Baseline characteristics of the participants by intervention arm are shown in Table 1. In total, 44.9% were recruited from clinical sites and 55.1% were recruited from social media (i.e., Facebook). Randomization was successful in that participants' sociodemographic characteristics at baseline did not differ between the intervention and the waitlisted control group." 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. 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 "Sensitivity analyses were run to compare changes in outcomes between participants who used the app for at least 30 min over the 0-3-month period (a reduced sample, n=73) and participants enrolled in the control group (n=105 at 3-months) (Multimedia Appendix 2). No significant differences in any outcomes emerged between the control group and the reduced sample of intervention participants at 3 months." Pre-specified secondary analyses are shown in the second part of the result section (pages 21-26). Copy and paste relevant sections from the manuscript (include quotes in quotation 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 "Sensitivity analyses were run to compare changes in outcomes between participants who used the app for at least 30 min over the 0-3-month period (a reduced sample, n=73) and participants enrolled in the control group (n=105 at 3-months) (Multimedia Appendix 2). No significant differences in any outcomes emerged between the control group and the reduced sample of intervention participants at 3 months. " Copy and paste relevant sections from the manuscript (include quotes in quotation 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

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Your response is too large. Try shortening some answers.  c  o  n  s  i  d  e  r  i  n  g  o  t  h  e  r  r  e  l  e  v  a  n  t  e  v  i  d  e  n  c  e   N  P  T  :  I  n  a  d  d  i  t  i  o  n  ,  t  a  k  e  i  n  t  o  a  c  c  o  u  n  t  t  h  e  c  h  o  i  c  e  o  f  t  h  e  c  o  m  p  a  r  a  t  o  r  ,  l  a  c  k  o  f  o  r  p  a  r  t  i  a  l  b  l  i  n  d  i  n  g  ,  a  n  d  u  n  e  q  u  a  l  e  x  p  e  r  t  i  s  e  o  f  c  a  r  e  p  r  o  v  i  d  e  r  s  o  r  c  e  n  t  e  r  s  i  n  e  a  c  h  g  r  o  u  Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Our study is the first RCT to assess the efficacy of a virtual lifestyle intervention on zBMI and lifestyle behaviours among Canadian youth with overweight and obesity that was entirely smartphone-based. In line with the findings from a systematic review examining weight outcomes for children 16, this study found no evidence of an intervention effect on zBMI or any co-primary outcomes (PA, diet and sedentary behaviours). While our primary analyses revealed no significant differences in zBMI or any of the health behaviours between the intervention and control groups at 3 months, secondary exploratory analyses revealed that among waitlist control participants, zBMI and discretionary calories declined after receiving app access compared to before receiving app access." Your response is too large. Try shortening some answers. Copy and paste relevant sections from the manuscript (include quotes in quotation 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 "Limitations: This study had several limitations, the first and likely most relevant being the generalizability of the findings given who was eligible to participate in this study (participants with either overweight or obesity). Second, the overall low engagement of participants with the app meant we could have also lacked variability to detect any doseresponse relationship between engagement levels and health behaviour change among participants. We found that preteens and teens predominantly spent time in the gamified components of the app instead of using the active ingredients of the app (such as setting Aims and completing Tasks). There was an effort to strengthen the access to the gamified or 'fun' elements of the revised version of the app for this trial and this might explain why there was no association in the evaluation phase as compared to an earlier formative evaluation phase. Third, we could not control for seasonality effects as the recruitment of participants for this trial could not occur over a year due to limited funds. Fourth, participants in both conditions were provided with their Fitbit at baseline (shortly after randomization), which could have resulted in an early PA intervention effect among waitlisted control participants. Finally, this study presented only the findings related to intervention's efficacy and there is growing consensus on the need to explore metrics beyond efficacy such as such as cost-effectiveness, reach and engagement which could allow for a broader examination of the impact of such interventions 51." Copy and paste relevant sections from the manuscript (include quotes in quotation 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 ""Limitations: This study had several limitations, the first and likely most relevant being the generalizability of the findings given who was eligible to participate in this study (participants with either overweight or obesity Copy and paste relevant sections from the manuscript (include quotes in quotation 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

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