An Internet-Based Psychological Intervention With a Serious Game to Improve Vitality, Psychological and Physical Condition, and Immune Function in Healthy Male Adults: Randomized Controlled Trial

Background Recently, internet-based cognitive behavioral therapy (ICBT) and serious gaming interventions have been suggested to enhance accessibility to interventions and engagement in psychological interventions that aim to promote health outcomes. Few studies, however, have investigated their effectiveness in the context of simulated real-life challenges. Objective We aimed to examine the effectivity of a guided ICBT combined with a serious gaming intervention in improving self-reported psychophysiological and immunological health endpoints in response to psychophysiological and immune-related challenges. Methods Sixty-nine healthy men were randomly assigned to the intervention condition, receiving ICBT combined with serious gaming for 6 weeks, or the control condition, receiving no intervention. Self-reported vitality was the primary endpoint. Other self-reported psychophysiological and immunological endpoints were assessed following various challenges, including a bacillus Calmette-Guérin vaccination evoking pro-inflammatory responses, 1 and 4 weeks after the intervention period. Results Although the intervention did not affect vitality-associated parameters, self-reported sleep problems (P=.027) and bodily sensations (P=.042) were lower directly after the intervention compared with controls. Furthermore, wellbeing (P=.024) was higher in the intervention group after the psychophysiological challenges. Although no significant group differences were found for the psychophysiological and immunological endpoints, the data provided preliminary support for increased immunoglobulin antibody responses at the follow-up time points (P<.05). Differential chemokine endpoints between conditions were observed at the end of the test day. Conclusions The present study provides some support for improving health endpoints with an innovative ICBT intervention. Future research should replicate and further extend the present findings by consistently including challenges and a wide range of immune parameters into the study design. Trial Registration Nederlands Trial Register NTR5610; https://www.trialregister.nl/trial/5466

coNSoRT-EHEALTH (V 1.6. 1) Submission/Publ ication Form The CONSORT-EHEALTH checklist is intended for authors of randomized trials evaluating web-based and lnternet-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.9. all subitems under item 5description 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 lnternet 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 *. ln the textboxes, either copy & paste the relevant sections from your manuscript into this formplease 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. CONSORT-EHEALTH (V 1.6.1) -SubmissiorVPublication Form Overall, was the app/intervention effective? * o yes: all primary outcomes were significantly better in intervention group vs control o partly: SOME primary outcomes were significantly better in intervention group vs control Page 6 of 47 o no statistically significant difference between control and intervention potentially harmful: control was significantly better than intervention in one or more outcomes submitted to a journal and after receiving  Manuscript tracking number * lf 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. lf the paper is already published in JMIR, then the ms tracking number is the four-digit number at the end of the Dol, to be found at the bottom of each published article in JMIR) O no ms number (yet) / not (yet)  1a-i) ldentify the mode of delivery in the title ldentify 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 "lnternet-based" only if lntervention includes non-web-based lnternet components (e.9. 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. 1a-ii) Non-web-based components or ¡mportant co-interventions ir Mention non-web-based components or important co-interventions in title, if any (e.9., "with telephone support").
Does your paper address subitem 1 a-ii?
Copy and paste relevant sections from manuscript t¡tle (include quotes in quotation 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 1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.9., anrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. Does your paper address sub¡tem 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 nla aa) Eligibility criteria for participants Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study See study population section (page ) 4a-i) Computer / lnternet literacy Computer / lnternet literacy is often an implicit "de facto" eligibility criterionthis should be explicitly clarified.
subitem not at all important OOOOOessential Does your paper address subitem 4a-t?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "All participants had access to a compatible device to complete the e-health https://docs.google.comlformsldlellFAIpQLSflZBSUplbwOc_OimqcS64RdflAFvmrTS... 5-6-2019 aa-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. offline), e.9., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. ln online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.9., cookies, email confirmation, phone calls) were used to detect/prevent these.
Does your paper address subitem 4a-ä? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study See intervent¡on paragraph of the methods sect¡on (page 5) 4a-iii) lnformation giving during recru¡tment Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.9., 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.
subitem not at all important subitem not at all important OOOOOessential ocoo essential Does your paper address subitem 4a-äi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study See study population paragraph of the methods sect¡on (page a) 4b) Settings and locations where the data were co llected E o https://docs.google.comlforrnsldlellFAIpQLSZBSUplbwOc_OimqcS64RdflAFvmrTS... 5-6-2019 Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to ¡ndicate direct quotes from your manuscript), or elaborate on th¡s item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study See methods section (page -9) 4b-¡) Report if outcomes were (self)assessed through online ques Clearly report if outcomes were (self)assessed through online questionnaires (as common in web-based trials) or otherwise.
Does your paper address subitem b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not 5) The interventions for each group w¡th sufficient details to allow replication, including how and when they were actually administered 5-i) Mention names, credential, affiliations of the developers, spon Mention names, credential, affiliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conflict of interest" section or mentioned elsewhere in the manuscript).
Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation 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 authors acknowledge Chantal Eckhardt, Dion de Hoog, Sander van den Oever, Shirley de Wit and Rafael Bidarra of Delft University of 5-ii) Describe the history/development process Describe the history/development process of the application and previous formative evaluations (e.9., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpret¡ng results.
subitem not at all important subitem not at all important oooo essential oo C O essential Does your paper address subitem S-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We did not mention this in this study. lt is very important and we will take this into account for our future projects on digital interventions.

5-¡¡¡) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the tr¡al. 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 We did not mention this in this study. lt is very important and we will take this into account for our future projects on digital interventions.
S-iv) Quality assurance methods Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
subitem not at all important subitem not at all important OOOOOessential OOOOOessential Does your paper address subitem S-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We did not ment¡on this in this study. lt is very important and we will take this into account for our future projects on digital interventions, F https://docs.google.com/formsldlelLFAIpQLSfZBSUplbwOc_OimqcS64RdflAFvmrTS... 5-6-2019 5-v) Ensure repl¡cability by publishing the source code, and/or pror Ensure replicability by publishing the source code, and/or providing screenshots/screencapture video, and/or providing flowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientific reporting. essential Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study See intervention paragraph of the methods sect¡on (page 5)

S-vi) Digital preservat¡on
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (lnternet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.
subitem not at all important sub¡tem not at all important ooco OOOOOessential Does your paper address subitem S-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The intervent¡on was del¡vered on the internet platform and software, hosted by S-vii) Access Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of specific group. lf known, describe how participants obtained "access to the platform and lnternet" [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 S-ix) Describe use parameters Describe use parameters (e.9., intended "doses" and optimal t¡ming for use). Clarify what instructions or recommendations were given to the user, e.9., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.
Page22 of 47 essential Does your paper address subitem S-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 ¡n the ms, or briefly explain why the item is not applicable/relevant for your study See outcome measures paragraph of the methods section (page 6-8)

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as 'type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". lt 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).
subitem not at all important sub¡tem not at all important oooc OOOOOessent¡al Does your paper address subitem 5-x?
Copy and paste relevant sect¡ons from the manuscript (include quotes in quotation 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 intervention contained 6 modules (goal sett¡ng, healthy food and exercise, relaxat¡on, sleep, cognitions and worldview, and long-term goals) which were S-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. lt may be necessary to distingu¡sh 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 21generalizability).
Does your paper address subitem S-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item ¡s not Bb) Type of randomisation; details of any restriction (such as blocking and block size) Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate d¡rect 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 block randomization was performed by the first author with random.org (block size = 4) in order to control for seasonal influences 9) Mechan¡sm used to implement the random allocation sequence (such as sequentially numbered conta¡ners), describing any steps taken to conceal the sequence unt¡l interventions were ass¡gned Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "A block randomization was performed by the first author with random.org (block size = 4) in order to control for seasonal influences 10) Who generated the random allocation sequence, who enrolled part¡c¡pants, and who assigned participants to interventions F https://docs.google.com/forms/d/e/lFAIpQLSfZBSUplbwOc_OimqcS64RdflAFvmrTS... 5-6-2019 Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "A block random¡zation was performed by the first author with random.org (block size = 4) in order to control for seasonal influences 1 1a) lf done, who was blinded after ass¡gnment to interventions (for example, participants, care prov¡ders, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment 1 1a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials ¡t 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 cointerventions (if any).
subitem not at all important OOOCOessential Does your paper address subitem 1 1a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The test leader on the test day was blinded for group allocation." 1 1a-ii) Discuss e.9., whether participants knew which intervention lnformed consent procedures (4a-ii) can create biases and certain expectationsdiscuss e.9., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".
subitem not at all important OOOOOessential Does your paper address subitem 11a-ä?
Copy and paste relevant sections from the manuscript (include quotes in quotation 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 informed that the study was about the effectiveness ofa 1 1 b) lf relevant, description of the similarity of interventions (this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) Does your paper address CONSORT subitem 1 1 b? * Copy and paste relevant sections from the manuscript (include quotes in quotation 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 nla 12a) Statistical methods used to compare groups for pr¡mary 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 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate d¡rect 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 appl icable/relevant for your study nla 12a-i) lmputation techniques to deal w¡th attrition / missing values lmputation techniques to deal with attr¡tion / missing values: Not all participants will use the ¡ntervention/comparator as intended and attrition is typically high in ehealth trials.
Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4] Copy and paste relevant sections from the manuscript (include quotes in quotation 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 "After si gning i nformed consent, partici pants com pleted self-reported and https://docs.google.com/forms/d/e/lFAIpQLSZBSUplbwOc_OimqcS64RdflAFvmrTS... 5-6-2019 X26-¡¡¡) Safety and secur¡ty procedures Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likel¡hood or detection of harm (e.9., education and training, availability of a hotline) Page 32 of 47 sub¡tem not at all important oocoo essential Does your paper address subitem X26-aaa?
Copy and paste relevant sections from the manuscript (include quotes in quotation 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 nla RESULTS / 13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study nla 13b) For each group, losses and exclusions after random¡sation, together w¡th reasons Does your paper address CONSORT subitem 13b? (NOTE: Preferal Copy and paste relevant sections from the manuscript (include quotes in quotation 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 ¡s not applicable/relevant for your study See results section (page 9-10) 1 3b-¡) Attrition diagram Strongly recommended:An attrition diagram (e.9., 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.
subitem not at all important OOOOOessential Does your paper address subitem 1 3b-¡?
Copy and paste relevant sections from the manuscript or cite the figure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study See Figure 1 (page 10) 14a) Dates defining the periods of recru¡tment and follow-up Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants were recruited through digital and printed Xyers at various faculties / E https://docs.google.comlformsldlellFAIpQLSZBSUplbwOc_OimqcS64RdflAFvmrTS... 5-6-2019 1aa-i) lndicate if critical "secular events" fell into the study period lndicate if critical "secular events" fell into the study period, e.9., significant changes in lnternet resources available or "changes in computer hardware or lnternet delivery resources" subitem not at all important OOOOOessential Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to ¡nd¡cate 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 nla 14b) Why the trial ended or was stopped (early) Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotat¡on 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 through digital and printed Xyers at various faculties 1 5) A OCOOOessent¡al 16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups 16-¡) Report multiple "denominators" and provide definitions Report multiple "denominators" and provide definitions: Report N's (and effect sizes) "across a range of study participation land use] thresholds" [1], e.9., 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. Does your paper address sub¡tem 16-a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study See results section (page 9-16) 16-¡¡) Primary analys¡s 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-¡).
subitem not at all important OOOOOessent¡al Does your paper address subitem 16-ai?
Copy and paste relevant sections from the manuscript (include quotes in quotation 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 "Analyses were performed for available data." 17a) For each pr¡mary and secondary outcome, results for each group, and the estimated effect size and its prec¡s¡on (such as 95% confidence interval) Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study See results section (page 9-16) 17a-i) Presentation of process outcomes such as metr¡cs of use a ln addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operat¡onal 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.9., timeout after idle time) [ Does your paper address subitem 21-a?
Copy and paste relevant sections from the manuscript (include quotes in quotat¡on marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study See discussion section (page 16-19) 21-aa) Discuss if there were elements in the RCT that would be diffr Discuss if there were elements in the RCT that would be different in a routine application setting (e.9., prompts/reminders, more human involvement, training sessions or other cointerventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.
sub¡tem not at all important oo oo essential Does your paper address sub¡tem 21-ä?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study See discussion section (page 16-19) OTHER INFORMATION / 23) Registration number and name of trial registry / Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Trial regístration: Nederlands Trial Register (NTR5610); 4 January F a 2a) Where the full trial protocol can be accessed, ¡f available Does your paper address CONSORT subitem24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sect¡ons from the manuscript (include quotes in quotation 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 study protocol and design have been published 25) Sources of funding and other support (such as supply of drugs), role of funders Does your paper address CONSORT subitem25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to ¡ndicate 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 "Sources of funding To generate a record that you filled 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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