Effects of a Web-Based Lifestyle Intervention on Weight Loss and Cardiometabolic Risk Factors in Adults With Overweight and Obesity: Randomized Controlled Clinical Trial

Background The high proportion of people with overweight and obesity has become a worldwide problem in recent decades, mainly due to health consequences, such as cardiovascular diseases, neoplasia, and type 2 diabetes mellitus. Regarding effective countermeasures, the digitization of health services offers numerous potentials, which, however, have not yet been sufficiently evaluated. Web-based health programs are becoming increasingly interactive and can provide individuals with effective long-term weight management support. Objective The purpose of this randomized controlled clinical trial was to evaluate the effectiveness of an interactive web-based weight loss program on anthropometric, cardiometabolic, and behavioral variables and to compare it with a noninteractive web-based weight loss program. Methods The randomized controlled trial included people who were aged between 18 and 65 years (mean 48.92, SD 11.17 years) and had a BMI of 27.5 to 34.9 kg/m2 (mean 30.71, SD 2.13 kg/m2). Participants (n=153) were assigned to either (1) an interactive and fully automated web-based health program (intervention) or (2) a noninteractive web-based health program (control). The intervention program focused on dietary energy density and allowed for dietary documentation with appropriate feedback on energy density and nutrients. The control group only received information on weight loss and energy density, but the website did not contain interactive content. Examinations were performed at baseline (t0), at the end of the 12-week intervention (t1), and at 6 months (t2) and 12 months (t3) thereafter. The primary outcome was body weight. The secondary outcomes were cardiometabolic variables as well as dietary and physical activity behaviors. Robust linear mixed models were used to evaluate the primary and secondary outcomes. Results The intervention group showed significant improvements in anthropometric variables, such as body weight (P=.004), waist circumference (P=.002), and fat mass (P=.02), compared with the control group over the course of the study. The mean weight loss after the 12-month follow-up was 4.18 kg (4.7%) in the intervention group versus 1.29 kg (1.5%) in the control group compared with the initial weight. The results of the nutritional analysis showed that the energy density concept was significantly better implemented in the intervention group. Significant differences in cardiometabolic variables were not detected between the 2 groups. Conclusions The interactive web-based health program was effective in reducing body weight and improving body composition in adults with overweight and obesity. However, these improvements were not associated with relevant changes in cardiometabolic variables, although it should be noted that the study population was predominantly metabolically healthy. Trial Registration German Clinical Trials Register DRKS00020249; https://drks.de/search/en/trial/DRKS00020249 International Registered Report Identifier (IRRID) RR2-10.3390/ijerph19031393

Manuscript tracking number * If this is a JMIR submission, please provide the manuscript tracking number under "other" (The ms tracking number can be found in the submission acknowledgement email, or when you login as author in JMIR. If the paper is already published in JMIR, then the ms tracking number is the four-digit number at the end of the DOI, to be found at the bottom of each published article in JMIR) 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 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 telephone support").
subitem not at all important 1 2 3 4 5 essential 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
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 1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial 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 subitem not at all important Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Keep in mind the needs of systematic reviewers and indexers by including important synonyms. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 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 "Participants (n=153) were assigned to either (1) an interactive and fully automated webbased health program (intervention) or (2) a noninteractive web-based health program (control). The intervention program focused on dietary energy density and allowed for dietary documentation with appropriate feedback on energy density and nutrients. The control group only received information on weight loss and energy density, but the website did not contain interactive content."

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) subitem not at all important 1 2 3 4 5 essential 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 "Participants (n=153) were assigned to either (1) an interactive and fully automated webbased health program (intervention) or (2) a noninteractive web-based health program (control)." 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. 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 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) subitem not at all important 1 2 3 4 5 essential 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 (n=153) were assigned to either (1) an interactive and fully automated webbased health program (intervention) or (2) a noninteractive web-based health program (control)." "Examinations were performed at baseline (t0), at the end of the 12-week intervention (t1), and at 6 months (t2) and 12 months (t3) thereafter." 1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 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 A comprehensive analysis of usage data from this overall project (3 online RCTs: doi: 10.1186/s13063-021-05470-8. and 2 clinical RCTs: doi: 10.3390/ijerph19031393) will be submitted in a timely manner. In this clinical RCT, multiple use was consistently seen in the intervention group. 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 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 primary outcome changed significantly. "The interactive web-based health program was effective in reducing body weight and improving body composition in adults with overweight and obesity. However, these improvements were not associated with relevant changes in cardiometabolic variables, although it should be noted that the study population was predominantly metabolically healthy." 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 stand-alone intervention vs. incorporated in broader health care program? Intended for a particular patient population? Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions? (Note: Details about the intervention are provided in "Methods" under 5) Does your paper address subitem 2a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "Despite promising approaches, the effectiveness of web-based interventions is still under debate. In particular, longer-term effects and interactive web-based interventions require further investigation [21]. In addition, it should be noted that web-based interventions can be designed and structured very differently and that these differences can also influence the results to a large extent. In this context, it seems that interactive and tailored programs have greater effects on weight loss than informative websites [21,26,29].
Using interactive web-based interventions and addressing dietary energy density are considered 2 potential approaches for successful weight management, but to the best of our knowledge, they have not been studied in combination. The purpose of this randomized controlled ..." subitem not at all important

2b) In INTRODUCTION: Specific objectives or hypotheses
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 "Although there are specific and evidence-based dietary and physical activity recommendations to prevent and treat obesity and its associated comorbidities, these behaviors often cannot be implemented and established in the long term. Systemic and environmental drivers have a lasting effect on behavior and make long-term behavior change difficult [1]. For example, the food environment affects the control of food intake, whereby constantly available and energy-dense foods could lead to an increase in energy intake. These external signals influence the neural regulation of energy balance unconsciously, and a mere recommendation to reduce food intake is thus ineffective for long-term weight loss [11]. In this context, emerging evidence supports the relevance of dietary energy density in modifying energy intake and suggests it is a useful approach to weight loss [12][13][14][15][16].
In addition to potential solutions from nutrition or sports science, ways to improve preventive and therapeutic lifestyle interventions to counter the global trend of rising BMI and associated comorbidities are also being sought at the level of the delivery medium used. It is now well established that face-to-face lifestyle interventions can be effective in preventing and treating obesity and its associated diseases [17][18][19]. As digitization and technological capabilities continue to advance, web-based interventions to promote physical activity and healthy eating have increasingly come into focus to reduce body weight [20,21]. With potentially unlimited distribution, practically no waiting times, and low barriers, webbased interventions are intended to provide effective and low-cost care over the usual period of a face-to-face lifestyle intervention [22,23]. In terms of effectiveness and cost, there is preliminary evidence that web-based interventions can be used reasonably to treat overweight and obesity, as well as cardiovascular risk factors [24][25][26][27][28]..." METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio 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 "Using interactive web-based interventions and addressing dietary energy density are considered 2 potential approaches for successful weight management, but to the best of our knowledge, they have not been studied in combination. The purpose of this randomized controlled clinical trial was to investigate the effectiveness of an interactive and fully automated web-based weight loss program focusing on dietary energy density in adults with overweight and obesity. Therefore, the study compared interactive and noninteractive webbased interventions, as both interventions have an unlimited reach and availability due to the lack of human involvement. We hypothesized that the interactive program would result in statistically significant improvements with small to medium effect sizes. Moreover, we assumed that these improvements would be significantly more pronounced in the interactive program than in the noninteractive program. The interactive weight loss program is part of a multimodal health program developed by a German health insurance company. This multimodal health program addresses individual health goals, such as weight loss, physical fitness, healthy eating, and smoking cessation. The different modules provide an individually tailored health intervention depending on the health goal and status. Each of the modules enables interactive health intervention for the prevention of noncommunicable diseases via selectable activities and corresponding feedback. This clinical substudy is part of an evaluation of a German-language web-based lifestyle intervention coordinated by the Section for Health Services Research and Rehabilitation Research (SEVERA) at the University Medical Center Freiburg [30,31]. The web-based weight loss program was investigated both in an online questionnaire study [32] and regionally in southwest Germany with medical variables in this clinical substudy." 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons 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 "Study participants in the online questionnaire study "weight loss" who were living in southwest Germany (postcode area: 79) were additionally invited to the Department of Sport and Sport Science of the University of Freiburg for the clinical substudy [30,31]. While changes in body weight were also reported by the participants in the online questionnaire study, in this subgroup, in which participants appeared in person for examination, additional clinical parameters and laboratory variables were collected. Medical examinations took place at baseline (t0), after the 12-week intervention (t1), and after an additional 6 months (t2) and 12 months (t3) of follow-up. During these medical examinations, participants had the opportunity to provide qualitative feedback. Besides these medical examinations, the participants of the clinical trial received the same web-based intervention as the participants of the online questionnaire study.
The study included intervention and control groups with automated randomization after completing the questionnaire at t0. Permuted block randomization was performed to obtain an approximately equal distribution in both study groups. Variable block sizes of 4, 6, and 8 were used for this purpose. The allocation sequence was created by SEVERA using RITA software (Version 1.50; Universität zu Lübeck) [30,31]. Randomization was performed automatically after online registration of the study participants. Because study participants can recognize their allocated intervention, blinding was not possible. Outcome assessors were blinded until completion of the analysis [30]." 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, as no changes have been made. 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 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 "The web-based health program was frozen for the evaluation to create a consistent study version." Not applicable, as no changes have been made.
subitem not at all important 1 2 3 4 5 essential 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 aged 18 to 65 years in the online questionnaire study and residing in southwest Germany were additionally eligible to participate in the clinical substudy. The inclusion criteria for the clinical trial were a BMI of 27.5 to 34.9 kg/m2 and no pregnancy or breastfeeding. Furthermore, subjects were required to be in good health, especially without any illnesses where weight reduction could possibly lead to subsequent health problems. In the case of existing health problems and illnesses, a medical certificate had to be submitted confirming eligibility for participation in the study. Since the intervention was purely webbased, appropriate computer skills were required for online registration and participation."

4a-i) Computer / Internet literacy
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 "Since the intervention was purely web-based, appropriate computer skills were required for online registration and participation." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS...
subitem not at all important 1 2 3 4 5 essential 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 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.
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 "Participants aged 18 to 65 years in the online questionnaire study and residing in southwest Germany were additionally eligible to participate in the clinical substudy." "Recruitment of the participants took place online and offline through various media, such as local newspapers, flyers, and Google advertisements. Through the various recruitment media, interested individuals were directed to an open-access landing page. On the landing page, people were able to find out about the study and register. Written informed consent was obtained for registration. After registration, automatic randomization was performed immediately, and the clinical substudy staff contacted the prospective study participants. During the contact, information about the study was provided again, the inclusion and exclusion criteria were verified, and an appointment was made for the first medical examination. With the successful completion of the first medical examination, the study enrollment was completed. As an incentive, participants in the clinical trial received an activity tracker, which also served as a measurement tool to record physical activity. Specific information on sample calculation and recruitment can be found in the detailed study protocol [30]." subitem not at all important 1 2 3 4 5 essential 4b) Settings and locations where the data were collected 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 "Recruitment of the participants took place online and offline through various media, such as local newspapers, flyers, and Google advertisements. Through the various recruitment media, interested individuals were directed to an open-access landing page. On the landing page, people were able to find out about the study and register. Written informed consent was obtained for registration. After registration, automatic randomization was performed immediately, and the clinical substudy staff contacted the prospective study participants. During the contact, information about the study was provided again, the inclusion and exclusion criteria were verified, and an appointment was made for the first medical examination. With the successful completion of the first medical examination, the study enrollment was completed. As an incentive, participants in the clinical trial received an activity tracker, which also served as a measurement tool to record physical activity. Specific information on sample calculation and recruitment can be found in the detailed study protocol [30]." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS...
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 "Study participants in the online questionnaire study "weight loss" who were living in southwest Germany (postcode area: 79) were additionally invited to the Department of Sport and Sport Science of the University of Freiburg for the clinical substudy [30,31]. While changes in body weight were also reported by the participants in the online questionnaire study, in this subgroup, in which participants appeared in person for examination, additional clinical parameters and laboratory variables were collected. Medical examinations took place at baseline (t0), after the 12-week intervention (t1), and after an additional 6 months (t2) and 12 months (t3) of follow-up."

4b-i) Report if outcomes were (self-)assessed through online questionnaires
Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise.
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 "Study participants in the online questionnaire study "weight loss" who were living in southwest Germany (postcode area: 79) were additionally invited to the Department of Sport and Sport Science of the University of Freiburg for the clinical substudy [30,31]. While changes in body weight were also reported by the participants in the online questionnaire study, in this subgroup, in which participants appeared in person for examination, additional clinical parameters and laboratory variables were collected." subitem not at all important 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 Meine Antwort

5-i) Mention names, credential, affiliations 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).
subitem not at all important 1 2 3 4 5 essential 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 "The Department of Sport and Sport Science (JK, JB, RW, DK, and RF) and Section for Health Services Research and Rehabilitation Research (SEVERA) (MS, IT, EF, CA, UAF, and PM) were commissioned by Techniker Krankenkasse (German Health Insurance Company) for the scientific evaluation of the web-based health program." "The project was funded by Techniker Krankenkasse (German Health Insurance Company).
The project funder had no influence on the planning and implementation of the study, the analysis and interpretation of the data, or the publication of the results."

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.
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 main methodological points of this randomized controlled clinical trial with relevance to this paper are described below. A detailed description of the study methods can be found in the study protocol, which has already been published [30]. Additional information on the related online questionnaire study can be found elsewhere [31]." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).

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 "The web-based health program was frozen for the evaluation to create a consistent study version." "Further details about the intervention can be found in the study protocol [30,31]."

5-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 1 2 3 4 5 essential 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 Not applicable to this fully automated intervention.

5-v)
Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screencapture 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 subitem not at all important

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.

Does your paper address subitem 5-vi?
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 Screenshots can be found in the corresponding study protocol. doi: 10.3390/ijerph19031393 The current version of the intervention can be accessed. https://ecoach.tk.de/de/info/coaching

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 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 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS...
"Both interventions were fully automated and without human involvement. The intervention group received an interactive web-based health program. The multimodal web-based health program could provide personalized intervention depending on health goals. The web-based health program was frozen for the evaluation to create a consistent study version. For this study, all participants in the intervention group received the health program's weight loss module. This module of the health program runs for 12 weeks and aims to achieve longterm behavior change. The 12-week intervention was divided into 3 phases. In phase 1, users should try out and get to know the program (weeks 1-3). In phase 2, consolidation of the new behavior should occur (weeks 4-6). In the final phase 3, the new habits should be strengthened (weeks 7-12). Despite this division, the program was freely usable and did not follow a linear sequence. All information texts, videos, and activities could be accessed at any time, allowing the program to be used according to individual pace or need.
The focus of the interactive weight loss program was on reducing dietary energy density. For this, the program offered the possibility to log the diet and receive feedback accordingly in terms of energy density, energy intake, and macronutrients. The primary goal was not to have the participants lose as many kilograms as possible in terms of a crash diet. Rather, the goal was to achieve relatively slow weight loss, thereby primarily losing fat mass and maintaining the resting metabolic rate [33]. Therefore, the participants had the choice whether they wanted to lose 3 or 5 kg during the 12-week intervention. However, a higher weight loss was not prevented by the program. Moreover, the health program could be further individualized with numerous selectable activities. For the "weight loss" health goal, these included activities such as achieving 2 servings of fruit and 3 servings of vegetables, drinking at least 1.5 liters of water per day, or reaching 10,000 steps per day. The interactivity of the weight loss program was generated via the selectable activities and logging of the diet with corresponding visualized feedback.
In addition to this interactive content, there was an extensive knowledge area. This knowledge area included evidence-based articles on dietary energy density, healthy eating, and weight loss. Some of these articles were part of a weekly task and were staggered throughout the 12-week intervention. Besides the evidence-based information, the intervention offered a comprehensive collection of recipes to support users in practical application.
In contrast, the control group received noninteractive web-based information on how to lose weight by lowering dietary energy density while eating healthy. This noninteractive information was transmitted by short articles and was intended to serve the transfer of knowledge. This was a static intervention, meaning that no change in content occurred over the course of the 12 weeks.
Both groups were allowed to use or rerun their program following the 12-week intervention period. Thus, the corresponding program was freely available during the follow-up. Further details about the intervention can be found in the study protocol [30,31]." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.
Does your paper address subitem 5-ix?
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 No direct recommendations for use were given. The program recommends only indirect use (daily or weekly), in which logging of selected tasks and goals is necessary for fulfillment. Information on this can be found in the associated study protocol. doi: 10.3390/ijerph19031393

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
subitem not at all important 1 2 3 4 5 essential 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 "Both interventions were fully automated and without human involvement."

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 were reminded for participation in the medical examinations. No reminder to use the program was provided. Information on this can be found in the associated study protocol. doi: 10.3390/ijerph19031393 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS...
subitem not at all important 1 2 3 4 5 essential 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed 5-xii) Describe any co-interventions (incl. training/support) Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability. 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 Technical support was provided in case of problems. Information on this can be found in the study protocol of the online questionnaire studies: doi: 10.1186/s13063-021-05470-8.
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 "The primary outcome of the study was body weight. This was measured using the validated bioelectrical impedance scale Seca mBCA 515 (Seca GmbH & Co KG) [34-36]. The standardized measurement was performed in underwear, without accessories, such as glasses and jewelry, after 12 hours of fasting, and with an empty bladder.
In addition, behavioral and physiological variables were defined as secondary outcomes. In the behavioral domain, dietary and physical activity behaviors were recorded. Seven-day dietary records were generated at each of the 4 measurement time points using NutriGuide Plus software (Version 4.8; Nutri-Science GmbH). Energy intake, dietary energy density (excluding beverages), and macronutrients were evaluated using the dietary data. Physical activity was assessed using the activity tracker Fitbit Charge 3 (Fitbit, Inc) and the long version of the International Physical Activity Questionnaire (IPAQ-L; German) [37]. A minimum of 5 reliable days was required for each of the 1-week diet (dietary record) and physical activity (activity tracker) data collections to be included in the analysis.
In addition to the primary outcome of body weight, other anthropometric variables were measured or calculated. Does your paper address subitem 6a-i?

Copy and paste relevant sections from manuscript text
No use of online questionnaires occurred in this study.
6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was de�ned/measured/monitored (logins, log�le analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.
Does your paper address subitem 6a-ii?

Copy and paste relevant sections from manuscript text
A comprehensive analysis of usage data from this overall project (3 online RCTs: doi: 10.1186/s13063-021-05470-8. and 2 clinical RCTs: doi: 10.3390/ijerph19031393) will be submitted in a timely manner. In this clinical RCT, multiple use was consistently seen in the intervention group.
subitem not at all important 1 2 3 4 5 essential 6b) Any changes to trial outcomes after the trial commenced, with reasons 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).

Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text "During these medical examinations, participants had the opportunity to provide qualitative feedback." 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 No changes in trial outcomes were made.
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 "The sample size was calculated to be 150 based on the primary outcome of body weight [31]." 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 8b) Type of randomisation; details of any restriction (such as blocking and block size) 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "Permuted block randomization was performed to obtain an approximately equal distribution in both study groups. Variable block sizes of 4, 6, and 8 were used for this purpose. The allocation sequence was created by SEVERA using RITA software (Version 1.50; Universität zu Lübeck) [30,31]. Randomization was performed automatically after online registration of the study participants." 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 "Permuted block randomization was performed to obtain an approximately equal distribution in both study groups. Variable block sizes of 4, 6, and 8 were used for this purpose. The allocation sequence was created by SEVERA using RITA software (Version 1.50; Universität zu Lübeck) [30,31]. Randomization was performed automatically after online registration of the study participants." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS...

10)
Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Information on this can be found in the associated study protocol. doi: 10.3390/ijerph19031393 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 subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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 cointerventions (if any).

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 "Because study participants can recognize their allocated intervention, blinding was not possible. Outcome assessors were blinded until completion of the analysis [30]." 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".

11b) If relevant, description of the similarity of interventions
(this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "Because study participants can recognize their allocated intervention, blinding was not possible." 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 "Both interventions were fully automated and without human involvement. The intervention group received an interactive web-based health program. The multimodal web-based..." "In contrast, the control group received noninteractive web-based information on how to lose weight by lowering dietary energy density while eating healthy. This noninteractive information was transmitted by short articles and was intended to serve the transfer of knowledge. This was a static intervention, meaning that no change in content occurred over the course of the 12 weeks.
Both groups were allowed to use or rerun their program following the 12-week intervention period. Thus, the corresponding program was freely available during the follow-up. Further details about the intervention can be found in the study protocol [30,31]." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS...
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 "R (Version 4.1.3; R Core Team) and R Studio (Version 2021.09.1; Posit PBC) were used for statistical analysis and creation of the graphs. Statistical analysis of all variables was performed with robust linear mixed models using the R packages lme4 [38] and robustlmm [39]. The significance level was set at .05 for all comparisons. Graphs of descriptive results of anthropometric variables were created using the R package ggplot2 [40].
Per-protocol (PP) and intention-to-treat (ITT) analyses were performed. In the PP analysis, only subjects without missing values for the respective variable were included (complete cases). If missing data were available for individual outcomes, fewer study participants were considered accordingly. In the ITT analysis, all randomized cases were included. Missing values were imputed by multiple imputation (n=50) using the R package micemd [41]. PP and ITT analyses showed similar results across all variables. Owing to the large number of variables, only the ITT analysis has been presented here." 12a-i) Imputation techniques to deal with attrition / missing values Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]). Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "In the ITT analysis, all randomized cases were included. Missing values were imputed by multiple imputation (n=50) using the R package micemd [41]." 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 No additional analyses were performed.
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 "This study followed the principles of the Declaration of Helsinki. The study was approved by the Ethics Committee of the University of Freiburg on July 25, 2019 (vote number: 237/19). A clinical pilot study was conducted (vote number: 409/18, DRKS00016512), resulting in minor changes to the study protocol. These changes were positively assessed by the Ethics Committee (date of approval: October 22, 2019; protocol version: amendment 01). Written informed consent was provided by all participants prior to study inclusion."

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 subitem not at all important 1 2 3 4 5 essential RESULTS 13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) 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 Information on this can be found in the associated study protocol. doi: 10.3390/ijerph19031393 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 * 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 1. Flow chart depicting participant recruitment and dropout."

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 �gures or tables demonstrating usage/dose/engagement.

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 A comprehensive analysis of usage data from this overall project (3 online RCTs: doi: 10.1186/s13063-021-05470-8. and 2 clinical RCTs: doi: 10.3390/ijerph19031393) will be submitted in a timely manner. In this clinical RCT, multiple use was consistently seen in the intervention group.
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication 14b) Why the trial ended or was stopped (early) Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "Recruitment of participants took place from January 2020 to July 2020." "Medical examinations took place at baseline (t0), after the 12-week intervention (t1), and after an additional 6 months (t2) and 12 months (t3) of follow-up." 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 15) A 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 The study was not stopped or ended earlier.
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 " Table 1. Baseline (t0) characteristics of the study participants."

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.
16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups subitem not at all important 1 2 3 4 5 essential 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 Demographics are examined in the associated online questionnaire study. This was not examined in the clinical substudy.

16-i) Report multiple "denominators" and provide definitions
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-de�ned time points of interest (in absolute and relative numbers per group). Always clearly de�ne "use" of the intervention.
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 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% confidence interval)

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 "Owing to the large number of variables, only the ITT analysis has been presented here." 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 Effect sizes for each variable can be found in the Multimedia Appendix.
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 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 A comprehensive analysis of usage data from this overall project (3 online RCTs: doi: 10.1186/s13063-021-05470-8. and 2 clinical RCTs: doi: 10.3390/ijerph19031393) will be submitted in a timely manner. In this clinical RCT, multiple use was consistently seen in the intervention group.

18) Results of any other analyses performed, including subgroup analyses and
adjusted analyses, distinguishing pre-specified from exploratory subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study No binary outcomes are reported.
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 "Owing to the large number of variables, only the ITT analysis has been presented here."

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).

19) All important harms or unintended effects in each group
(for speci�c guidance see CONSORT for harms) subitem not at all important 1 2 3 4 5 essential 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 Not applicable, as such an analysis was not performed.
Does your paper address CONSORT subitem 19? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "None of the health reasons of the dropouts were associated with the intervention."

19-i) Include privacy breaches, technical problems
Include privacy breaches, technical problems. This does not only include physical "harm" to participants, but also incidents such as perceived or real privacy breaches [1], technical problems, and other unexpected/unintended incidents. "Unintended effects" also includes unintended positive effects [2].

DISCUSSION
Does your paper address subitem 19-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Not applicable, as this did not occur.

19-ii) Include qualitative feedback from participants or observations from staff/researchers
Include qualitative feedback from participants or observations from staff/researchers, if available, on strengths and shortcomings of the application, especially if they point to unintended/unexpected effects or uses. This includes (if available) reasons for why people did or did not use the application as intended by the developers.

Does your paper address subitem 19-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study 22) Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence NPT: In addition, take into account the choice of the comparator, lack of or partial blinding, and unequal expertise of care providers or centers in each group subitem not at all important 1 2 3 4 5 essential 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).

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 "The main finding of this study was that the interactive web-based health program focusing on dietary energy density showed positive effects on body weight, fat mass, and waist circumference. These effects were significantly more pronounced in the intervention group than in the control group with only web-based knowledge transfer and were also evident in the longer-term 12-month follow-up period. With regard to short-term weight loss from webbased interventions (3-4 months), comparable interventions reported short-term weight loss of 2.0 kg [42], 2.3 kg [43], and 4.2 kg [44], while the participants in the intervention group in this study lost 3.98 kg in the ITT analysis. At the 12-month follow-up, the weight loss of participants in the intervention group in this study was 4.18 kg in the ITT analysis, which is above the reported weight loss for comparable interventions of 0.9 kg [45] and 2.1 kg [46] after 12 months. In a recent meta-analysis, weight loss for web-based interventions ranged from 1.3 to 6.2 kg [25]. With 3.98 to 4.18 kg weight loss in the intervention group, depending on the time of measurement, the weight loss for the interactive web-based intervention..." subitem not at all important 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 "Future research should consider in more detail what and how much interactivity is necessary to make web-based weight loss interventions effective."

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events.

21) Generalisability (external validity, applicability) of the trial findings
NPT: External validity of the trial �ndings according to the intervention, comparators, patients, and care providers or centers involved in the trial subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "Several limitations must be considered in this study. First, complete blinding was not possible due to the recognition of the program by the participants. Therefore, the motivation of the participants might have been influenced based on the recognition of the program. Second, both study groups might have been additionally motivated to attain their health goals by interest in free medical examinations as well as activity trackers received as incentives. Conversely, the participants of the clinical substudy might have been more motivated than the participants of the online study already at the beginning, since participation in medical examinations required more commitment. Third, the effect of the COVID-19 pandemic on both groups was difficult to quantify. Qualitative..."

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 "Second, both study groups might have been additionally motivated to attain their health goals by interest in free medical examinations as well as activity trackers received as incentives. Conversely, the participants of the clinical substudy might have been more motivated than the participants of the online study already at the beginning, since participation in medical examinations required more commitment."

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 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.
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 See Limitations: "Second, both study groups might have been additionally motivated to attain their health goals by interest in free medical examinations as well as activity trackers received as incentives." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS...

X27) Conflicts of Interest (not a CONSORT item)
subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "The project was funded by Techniker Krankenkasse (German Health Insurance Company). The project funder had no influence on the planning and implementation of the study, the analysis and interpretation of the data, or the publication of the results."

X27-i) State the relation of the study team towards the system being evaluated
In addition to the usual declaration of interests (�nancial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention. How much time did you spend on going through the checklist INCLUDING making changes in your manuscript * It took me 2 hours.
As a result of using this checklist, do you think your manuscript has improved? *

Would you like to become involved in the CONSORT EHEALTH group?
This would involve for example becoming involved in participating in a workshop and writing an "Explanation and Elaboration" document

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