Indicated Web-Based Prevention for Women With Anorexia Nervosa Symptoms: Randomized Controlled Efficacy Trial

Background Although preventive interventions for eating disorders in general have shown promise, interventions specifically targeting individuals at risk for anorexia nervosa (AN) are lacking. Objective The aim of this study was to determine the efficacy of a guided, indicated web-based prevention program for women at risk for AN. Methods We conducted a randomized controlled efficacy trial for women at risk for AN. Assessments were carried out at baseline (before the intervention), after the intervention (10 weeks after baseline), and at 6- and 12-month follow-ups (FUs). A total of 168 women with low body weight (17.5 kg/m2≤BMI≤19 kg/m2) and high weight concerns or with normal body weight (19 kg/m2<BMI≤25 kg/m2), high weight concerns, and high restrained eating were recruited from 3 German universities as well as on the web and randomized to Student Bodies-AN (SB-AN; intervention group [IG]) or a wait-list control group (CG). The exclusion criteria were current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition–based full-syndrome eating disorders and serious medical or mental problems. The interventions were a cognitive-behavioral guided web-based prevention program (SB-AN) over 10 weeks (IG) and a wait-list CG. The primary outcomes were clinically significant changes in disordered eating attitudes and behaviors and change in BMI at 12-month FU in the group of participants who were underweight. The secondary outcomes were new onset of eating disorders, symptoms of disordered eating, and associated psychopathology. Results Data were available for 81.5% (137/168) of the women after the intervention and for 69% (116/168) of the women at 12-month FU. At 12-month FU, the IG participants showed larger decreases in Eating Disorder Examination total scores (38/48, 79% vs 33/58, 57%) than the CG participants and the IG participants who were underweight also showed larger clinically relevant increases in BMI (15/31, 49% vs 10/32, 32%) than the CG participants, but these differences were not significant. In addition, after the intervention and at 12-month FU, we found a significant increase in continuously measured BMI for the participants who were underweight and significant improvements in disordered eating attitudes and behaviors (eg, restrained eating as well as weight and shape concerns). At all time points, the rates of new-onset eating disorder cases were (nonsignificantly) lower in the IG than in the CG and the reductions in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition–based eating disorder syndromes were (nonsignificantly) higher in the IG than in the CG. Conclusions SB-AN is the first preventive intervention shown to significantly reduce specific risk factors for, and symptoms of, AN and shows promise for reducing full-syndrome AN onset. Trial Registration ISRCTN Registry ISRCTN70380261; https://www.isrctn.com/ISRCTN70380261

subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1a-i) Identify the mode of delivery in the title Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if offline products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.

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Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We designed the intervention Student Bodies-AN (SB-AN) upon existing targeted, webbased, cognitive-behavioural versions of the intervention "Student Bodies" (Jacobi, Volker, Trockel, & Taylor, 2012;Taylor et al., 2006;Völker et al., 2014) but expanded it from 8 to 10 weekly sessions.

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"). Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The program is supplemented by an online, asynchronous, moderated discussion group. Other elements include a personal journal and body image journal.

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

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Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Women With Anorexia Nervosa Symptoms 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)

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Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 1. Cognitive-behavioural, guided, Internet-based prevention program (SB-AN) over 10 weeks (IG); 2. Waiting list control condition (CG).

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) 05.01.22, 10:46 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form Seite 13 von 64 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full#gid=0 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 briefly explain why the item is not applicable/relevant for your study Cognitive-behavioural, guided, Internet-based prevention program (SB-AN) over 10 weeks (IG).
1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials). Note: In traditional offline 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)
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 168 women with low body weight (17.5≤BMI≤19) and high weight concerns, or with normal body weight 19<BMI≤25, high weight concerns and high restrained eating were recruited from three German universities as well as online, subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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)
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Data were available at post-intervention for N=137 women, and for N=116 women at 12month FU.

1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials
Conclusions/Discussions in abstract for negative trials: Discuss the primary outcome -if the trial is negative (primary outcome not changed), and the intervention was not used, discuss whether negative results are attributable to lack of uptake and discuss reasons. Does your paper address subitem 1b-v?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study At 12-month FU, IGs participants showed larger decreases in EDE Total scores (79% vs. 57%) compared to the CG, and underweight IG participants also showed larger clinically relevant increases in BMI (49% vs. 32%) compared with underweight CG participants, but these differences were not significant. In addition, at post-intervention and 12-month followup, we found a significant increase in continuously measured BMI for underweight participants and significant improvements in attitudes and behaviours of disordered eating (e.g., restrained eating, weight and shape concerns). At all time points, rates of newly emerging ED onset cases were (non-significantly) lower in the IG compared with the CG and reductions in DSM-5-based ED syndromes were (non-significantly) higher in the IG compared with the CG.

2a-i) Problem and the type of system/solution
Describe the problem and the type of system/solution that is object of the study: intended as stand-alone intervention vs. incorporated in broader health care program? Intended for a particular patient population? Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions? (Note: Details about the intervention are provided in "Methods" under 5) Does your paper address subitem 2a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Several previous reviews and meta-analyses have examined the efficacy of universal, targeted, and indicated prevention programs for ED delivered face-to-face (Harrer et al., 2020;Le, Barendregt, Hay, & Mihalopoulos, 2017;Pratt & Woolfenden, 2002;Stice, Shaw, & Marti, 2007;Watson et al., 2016) or over the Internet (Beintner, Jacobi, & Taylor, 2012;Harrer et al., 2020;Loucas et al., 2014;Melioli et al., 2016). .... However, based on (21 out of 26) prevention trials included in two meta-analyses, the mean BMI of young adult participants was 23.3 (SD 2.8;range 21.6-24.8;(Stice et al., 2007) and 23.5 (range 21.6-25.4;(Harrer et al., 2020) none of the studies had included low(er) body weight to determine risk status as selection criterion. Consequently, adult participants with a lower BMI (i.e., < 21) who may be specifically at risk for AN were not included in these programs. .... The major objective of the current study is to determine the efficacy of this intervention for women at risk for AN in reducing core risk factors, early symptoms and/or syndrome progression of pre-existing or onset of newly emerging subclinical syndromes of AN compared with a waiting list control group. We hypothesized that participants of the intervention group would show greater improvements in attitudes and symptoms that are more specific for AN, i.e., low BMI, in general ED risk factors such as weight and shape concerns. In addition, we expected that participating women would show significantly fewer subclinical ED syndromes at 12-month follow-up. 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 above but also:

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As part of a pilot study, we therefore specifically designed an indicated preventive intervention ("Student Bodies-AN") for this risk group and assessed its feasibility, acceptance and effectiveness in a pilot study with 36 women including women with low BMI (<19) and higher restrained eating. Overall, the pilot study showed that recruitment of at-risk participants for AN with low body weight and/or high restrained eating is feasible and shows promise. We found significant pre-post reductions of common risk factors for ED (e.g., weight concerns) with medium to large effects, but also specific effects for the underweight subgroup in terms of reductions of restrained eating and an increase in BMI (Ohlmer, Jacobi, & Taylor, 2013).
Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study See 2a-i and: We hypothesized that participants of the intervention group would show greater improvements in attitudes and symptoms that are more specific for AN, i.e., low BMI, in general ED risk factors such as weight and shape concerns. In addition, we expected that participating women would show significantly fewer subclinical ED syndromes at 12-month follow-up.
3a) Description of trial design (such as parallel, factorial) including allocation ratio 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We conducted a randomized, controlled efficacy trial in women at risk for anorexia nervosa.
Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study There were not relevant changes after trial commencement.

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Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study After the study had begun, DSM-5 (American Psychiatric Association (APA), 2013) was published which included slight changes to some of the diagnostic criteria. The new classification system loosens the criteria for some EDs, resulting in individuals who were not diagnosed as being a case with DSM-IV, now becoming cases with DSM-5. We decided to adopt DSM-5 criteria for all baseline and follow-up assessments. This resulted in 9 individuals becoming full-syndrome AN cases at baseline which also allowed us to determine the treatment effects of the intervention in reducing symptoms in this group. To determine the preventive effect of the intervention, we excluded all DSM-5 cases at baseline, and only examined individuals who became cases according to the new criteria. 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 We included women above age 18 years with high weight concerns (WCS >42) and lower body weight (17.5≤BMI≤21), or with normal body weight 21<BMI≤25, high weight concerns and high restrained eating (EDE-Q Restraint ≥2.6; =more than 1 SD above the mean of healthy controls; [23]). Exclusion criteria were a current DSM-IV-based full-syndrome AN, bulimia nervosa and binge eating disorder, serious medical or mental problems, such as current substance abuse, acute or chronic organic or schizophrenic psychosis, severe suicidal ideation or behaviour, and no Internet access.

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified.

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Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We included women above age 18 years with high weight concerns (WCS >42) and lower body weight (17.5≤BMI≤21), or with normal body weight 21<BMI≤25, high weight concerns and high restrained eating (EDE-Q Restraint ≥2.6; =more than 1 SD above the mean of healthy controls; [23]). Exclusion criteria were a current DSM-IV-based full-syndrome AN, bulimia nervosa and binge eating disorder, serious medical or mental problems, such as current substance abuse, acute or chronic organic or schizophrenic psychosis, severe suicidal ideation or behaviour, and no Internet access. 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. offline), e.g., from an open access website or from a clinic, and clarify if this was a purely webbased trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email confirmation, phone calls) were used to detect/prevent these.

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Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Participants were screened, recruited and assessed between 09/2013 and 11/2015 through different faculties at three German universities (Dresden, Leipzig, Halle) and other educational institutions in Dresden, through announcements in local media, health insurance membership magazines and social media (e.g., Facebook) as well as through flyer distribution. To ensure a high enough rate of women with subclinical AN, the study was also announced to women seeking information or help in a secondary advisory centre for eating disorders (ANAD e. V., Munich). .... All female students were invited to participate in a study to improve body image and asked to fill out a short screening questionnaire either as paper-pencil or online version. In addition, the online-version of the screening questionnaire was advertised via posters, university mailing lists, flyers, websites of eating disorder associations, local and nationwide media (e.g., Facebook), and health insurance companies. Women who screened positive were subsequently invited to a face-to-face or telephone interview where the study was described in detail and informed consent was obtained. Thereafter, the Eating Disorder Examination (EDE) interview (Fairburn & Cooper, 1993;Hilbert & Tuschen-Caffier, 2006) was administered to assess a current or past ED, and participants received login data to access the password protected online platform to fill out baseline self-report questionnaires. 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.
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 Women who screened positive were subsequently invited to a face-to-face or telephone interview where the study was described in detail and informed consent was obtained.
Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Participants were screened, recruited and assessed between 09/2013 and 11/2015 through different faculties at three German universities (Dresden, Leipzig, Halle) and other educational institutions in Dresden, through announcements in local media, health insurance membership magazines and social media (e.g., Facebook) as well as through flyer distribution. To ensure a high enough rate of women with subclinical AN, the study was also announced to women seeking information or help in a secondary advisory centre for eating disorders (ANAD e. V., Munich). 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.

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Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Women who screened positive were subsequently invited to a face-to-face or telephone interview where the study was described in detail and informed consent was obtained. Thereafter, the Eating Disorder Examination (EDE) interview (Fairburn & Cooper, 1993;Hilbert & Tuschen-Caffier, 2006) was administered to assess a current or past ED, and participants received login data to access the password protected online platform to fill out baseline self-report questionnaires. 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 4b-ii?

4b-ii) Report how institutional affiliations are displayed
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 Meine Antwort

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

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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

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.

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Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study As part of a pilot study, we therefore specifically designed an indicated preventive intervention ("Student Bodies-AN") for this risk group and assessed its feasibility, acceptance and effectiveness in a pilot study with 36 women including women with low BMI (<19) and higher restrained eating.

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?

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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 However, participant feedback on the intervention included in the pilot study lead to some content-related and technical revisions of the intervention (e.g., improvement of the dashboard function and the technical usability of the platform, revision of instructions for the symptom checklist and self-monitoring diary, inclusion of a booster-session two months after the end of the intervention).

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
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 interviews were conducted by assessors not involved in intervention moderation and data analyses. They completed a two-day workshop during which they were trained on the EDE interview assessments, on the use of the database for the assessments, and on providing feedback regarding ED psychopathology to participants. Feedback to participants was recorded and assessors were supervised by graduate students regarding the quality of the feedback provided. Over the course of the trial, interviewer trainings were repeated for new interviewers. -v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientific reporting.

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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 Meine Antwort

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?

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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 Meine Antwort

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of specific group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).

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Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Participants were provided individual feedback on current ED risk factors (EDE scores, BMI and ED symptoms) at baseline and on change in risk factors at post-and follow-up assessments. For completion of each interview participants received €20. Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We designed the intervention Student Bodies-AN (SB-AN) upon existing targeted, webbased, cognitive-behavioural versions of the intervention "Student Bodies" (Jacobi, Volker, Trockel, & Taylor, 2012;Taylor et al., 2006;Völker et al., 2014) but expanded it from 8 to 10 weekly sessions. The core goals of these programs are to reduce weight and shape concerns, enhance body image, promote healthy weight regulation, increase knowledge about the risks associated with EDs, and specific symptoms of ED, s. a. binge eating and compensatory behaviours. The program is supplemented by an online, asynchronous, moderated discussion group. Other elements include a personal journal and body image journal. For the current study, we made contextual adaptations according to the special needs of the groups with higher restrained and/or lower weight. In anticipation of the noted ambivalence to change in this population, we added elements of motivational interviewing (Miller & Rollnick, 2009) to the first sessions (e.g. pros and cons of low weight and restrained eating). We also expanded the psychoeducational content on EDs to increase participants' awareness of their current eating, exercise behaviour and body image compared to patients with other EDs. Furthermore, compared to programs addressing non-AN EDs, the program focused more specifically on restrictive eating. Other topics addressed were media literacy, coping with negative emotions, improving social skills, and healthy eating and exercise. The symptom checklist which was integrated into the online program was expanded to include frequencies of core ED symptoms (body weight, restraint eating, meals per day, missed meals, reduced meals, avoided foods, objective and subjective episodes of binge eating, episodes of vomiting, laxative abuse, abuse of diuretics or appetite suppressants to control weight, and driven exercise). To normalize their eating behaviour and reduce symptoms of ED (s. a. restraint eating, binge eating and purging), participants were prompted weekly to fill out the symptom checklist and were given individual weekly feedback by the program moderators on their entries in the symptom checklist and other interactive program modules (i.e., personal and self-monitoring logs, contributions to the online discussion group). The program was moderated by psychology (Master or Diploma-level) graduate students in training for behaviour therapy who were supervised by a licensed clinical psychologist. The feedback intended to foster reflection on and change of dysfunctional eating and weightrelated thoughts and behaviours. Each session of the program took between 45 and 90 min to complete. The program's home page also provided short CVs of the program moderators once participants had logged in to facilitate the credibility of the intervention.

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.
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

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).

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Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Addressed above -see 5-ix

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). 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 Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

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To normalize their eating behaviour and reduce symptoms of ED (s. a. restraint eating, binge eating and purging), participants were prompted weekly to fill out the symptom checklist and were given individual weekly feedback by the program moderators on their entries in the symptom checklist and other interactive program modules (i.e., personal and selfmonitoring logs, contributions to the online discussion group).

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.

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Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable, no co-interventions. Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, see also study registration and: Primary outcomes were rates (%) of participants with a decrease in EDE interview total score (Hilbert, Tuschen-Caffier, & Ohms, 2004) below a score of 1.87 between preintervention and 12-month FU (reflecting a clinically significant change), and rates (%) of underweight participants with a BMI increase of at least 0.8 kg/m2 between screening and 12-month FU. Secondary outcomes were BMI of underweight participants, attitudes and behaviours of disordered eating, numbers of subjective and objective binge eating episodes (for the binge eating subgroup), and rates of participants fulfilling criteria for onset of a full-syndrome and subclinical ED.
Copy and paste relevant sections from manuscript text

Meine Antwort
Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No changes after trial commencement. The only changes that were made happened between the pilot study and the current trial.

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Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We based sample size calculations on the assumption that 50% of the intervention group and 20% of the control group would show a decrease in EDE-total score below the critical value of 1.87. Applying Fisher's Exact test (two-sided, α= 0.05) and demanding a power of at least 80%, the required sample size would result in N= 44 per group or a total of N= 88 participants to be analysed.
For the group of underweight participants, we assumed that a rate of 50% of participants in the intervention group succeeding in increasing their BMI between pre-intervention and 12month FU by at least 0.8kg/m2 compared with 5% of control group participants represents a clinically significant difference. To detect this difference, N= 34 (17/17) participants would be required in the underweight BMI-group (17.5 -19; based on Fisher's Exact test with α= 0.05 and a power of 80%). Assuming similar rates of returned screens (74%), screen positive (13.9% of screened women) and eligible women (31.9% of screened positives) as in the pilot study, we would have to hand out 8273 screening questionnaires to get 6122 returned screens resulting in 851 (and 448 needed) screen-positive and 143 eligible women. Conservatively estimating an attrition rate of 45% until 12-month FU (15% of subjects at post-intervention and another 15% at each of the follow-up assessments), a total of 88 participants would provide sufficient data for analyses.
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 8b) Type of randomisation; details of any restriction (such as blocking and block size) Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable -no interim analyses.
Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Concealed randomization was carried out centrally by an independent clinical trials centre (Koordinierungszentrum für Klinische Studien (KKS), TU Dresden, Germany) after participants had been enrolled in the study and had given informed consent in a ratio 1:1. 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 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 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 Concealed randomization was carried out centrally by an independent clinical trials centre (Koordinierungszentrum für Klinische Studien (KKS), TU Dresden, Germany) after participants had been enrolled in the study and had given informed consent in a ratio 1:1.
11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Concealed randomization was carried out centrally by an independent clinical trials centre (Koordinierungszentrum für Klinische Studien (KKS), TU Dresden, Germany) after participants had been enrolled in the study and had given informed consent in a ratio 1:1.

11a-i) Specify who was blinded, and who wasn't
Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any).

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Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Assessors who carried out post-intervention and follow-up assessments were blind to intervention allocation and neither involved in the moderation of the intervention nor in final data analyses.

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) 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".

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Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Given the waiting-list control group, it was not possible to blind the participants regarding the group assignment.
See also: Given that SB-AN is the first prevention program specifically targeting women at risk of AN, no alternative interventions ("treatment as usual") exist. A waiting-list control group therefore seemed to be the first-choice control condition and ethically justifiable to determine the efficacy of the intervention. Participants assigned to the control group were assessed at all interview assessment points and offered to participate in the program after completion of the 12-month FU.
12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable -waiting list control group.
Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Primary Outcomes Originally, we planned to use Fisher's exact test to compare the 12-month FU rates of participants in the IG and CG fulfilling primary outcome variables (% of underweight participants with BMI increase of at least 0.8 kg/m2, % of participants with EDE Total score of no more than 1.87 with baseline scores above 1.87) at a significance level of 5% for the primary analysis. In this analysis, missing data were imputed using the last observation carried forward (LOCF) method. Because LOCF makes assumptions that can yield biased results and is no longer considered the best method to impute missing data, we also used the more robust method of generalized linear mixed models (GLMM; Wu, 2009). Here, the full available data from each participant at all assessments (post and follow-ups) are considered in the analyses using the maximum likelihood method. We entered fixed effects for randomized group, time, and the group*time interaction. Random intercepts, allowing to model repeated measurements and to account for heterogeneity in outcomes across individuals, were fitted. To model longitudinal data appropriately, we used a covariance matrix with a first-order autoregressive structure. The primary outcome variables were modelled with a binomial distribution and a logit link. To test differences on binary outcomes between the intervention and control group, Wald-Test p-values were calculated.

Secondary Outcomes
To analyse continuous secondary outcomes, GLMM were used as well. Data from each participant at all assessments [baseline, mid-intervention (except EDE-Scales, BMI and binge eating episodes) post and follow-ups] are considered in the analyses. We entered fixed effects for randomized group, time, and the group*time interaction and calculated suitable contrasts to test the changes from baseline to all subsequent time points between groups. Random intercepts were fitted and we used a covariance matrix with a first-order autoregressive structure. For skewed outcome variables we used the best fitting distribution (e.g., gamma) for the model. The canonical link function was chosen for all models, respectively. Changes in dichotomous secondary outcomes (diagnoses) between groups were analysed using Fisher`s exact tests for each assessment point separately.
We also analysed the onset of a new DSM-5-based diagnosis by means of a time-to-event analysis. Observation times were determined as days between baseline and date of onset or last observation. Participants without an onset were censored in the analysis at their last observation date. Cumulative incidence curves were calculated as 1 minus the Kaplan-Meier estimate. Numbers at risk are given along with the incidence curves. Groups were compared using Log-Rank test. 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]).

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Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes -see above (item 12a).
Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes -see above (item 12a). Does your paper address subitem X26-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The study was approved by the local ethics committee of TU Dresden (EK264082012). Written informed consent was obtained from all participants. The study was conducted according to the Declaration of Helsinki and Good Clinical Practice principles.

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained offline or online (how? Checkbox, etc.?), and what information was provided (see 4a-ii). See [6] for some items to be included in informed consent documents.

RESULTS
Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Written informed consent was obtained from all participants.

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)
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 Partly, before study start: If participants met criteria for a current full-syndrome ED, the research team provided treatment recommendations. 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 13b) For each group, losses and exclusions after randomisation, together with reasons 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 Yes, addressed in the Consort Flow of Participants.
Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, see above, item 13a. 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., significant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

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Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable. The trial was not stopped prematurely.

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.

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Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes -see above and Table 1. 16-i) Report multiple "denominators" and provide definitions Report multiple "denominators" and provide definitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at specific pre-defined time points of interest (in absolute and relative numbers per group). Always clearly define "use" of the intervention.

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Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Due to the length of the manuscript, a moderator analysis based on intervention use was not included (although intervention use was monitored).

16-ii) Primary analysis should be intent-to-treat
17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) 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 briefly explain why the item is not applicable/relevant for your study See study registration and Statistical Analysis section. We followed the outline of the study registration but also included intent-to-treat analyses.
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 Yes. See Table 2 and text: The analysis of the primary outcomes in the ITT-sample using Fisher's exact test and the LOCF method revealed no significant differences between the IC and the CG at 12-month FU (EDE-criterion p=1.00; weight gain criterion p=1.00). Based on the mixed models analyses of the primary outcomes, 79% (N=38/48) of intervention group participants and 57% (N=33/58) of control group participants with baseline EDE Total scores above 1.87 showed a decrease in EDE Total below a score of 1.87 at 12-month follow-up but this difference was again not significant (p=.185). In addition, 49% (N=15/31) of underweight intervention group participants and 32% (N=10/32) of underweight control group participants showed a BMI increase of at least 0.8 points. This difference was also not significant (p=.592; Table 2). subitem not at all important 1 2 3 4 5 essential 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 17a-i) Presentation of process outcomes such as metrics of use and intensity of use In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational definitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is defined (e.g., timeout after idle time) [1] (report under item 6a).

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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 briefly explain why the item is not applicable/relevant for your study Yes.
Program Adherence Eleven out of 84 (13.1%) intervention participants never logged on to the program. Of the remaining 73 women, 53 women (72%) opened at least half of the sessions and 47 women (64%) accessed at least half of the intervention content. On average, all intervention participants -including those who never logged on to the program -opened 55.4% of the program pages (median: 62.4%) and accessed 6.6 of the 10 sessions (median: 9). Active participants who logged on to the program at least once, on average opened 63.8% of the program pages (median: 83.3%) and accessed 7.6 of the 10 sessions (median: 10).
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 briefly explain why the item is not applicable/relevant for your study Yes. Included as additional outcomes that were not mentioned in the study registration outline.
Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Secondary outcomes were considered exploratory.

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii). Does your paper address subitem 18-i?

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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 Important, but due to the current length of the manuscript, no moderator analyses were included but are planned to be published in a second paper.
Does your paper address CONSORT subitem 19? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No harms were observed (no patient population!).

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]. 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 briefly 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 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).

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Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, summarized under "Principal Results". Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, summarized under "Implications" and "Conclusions".

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.

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Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, summarized under "Strengths and Weaknesses of the Study".

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

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Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, addressed under "Comparison With Other Studies".

21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting
Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting. 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

Meine Antwort
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 Yes (Abstract): Trial Registration: ISRCTN70380261.
Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Trial Registration: ISRCTN70380261. 25) Sources of funding and other support (such as supply of drugs), role of funders

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 briefly explain why the item is not applicable/relevant for your study Funding: This study was funded by the Else Kröner-Fresenius-Stiftung (2012_A01). The sponsor of the study had no role in the study design, data collection, data analysis, data interpretation, or writing of the report.

X27-i) State the relation of the study team towards the system being evaluated
In addition to the usual declaration of interests (financial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.