The Effect of Tailored Web-Based Feedback and Optional Telephone Coaching on Health Improvements: A Randomized Intervention Among Employees in the Transport Service Industry

Background Lifestyle-related health problems are an important health concern in the transport service industry. Web- and telephone-based interventions could be suitable for this target group requiring tailored approaches. Objective To evaluate the effect of tailored Web-based health feedback and optional telephone coaching to improve lifestyle factors (body mass index—BMI, dietary intake, physical activity, stress, sleep, tobacco and alcohol consumption, disease history, self-perceived health, and motivation to change health habits), in comparison to no health feedback or telephone coaching. Methods Overall, 3,876 employees in the Swedish transport services were emailed a Web-based questionnaire. They were randomized into: control group (group A, 498 of 1238 answered, 40.23%), or intervention Web (group B, 482 of 1305 answered, 36.93%), or intervention Web + telephone (group C, 493 of 1333 answered, 36.98%). All groups received an identical questionnaire, only the interventions differed. Group B received tailored Web-based health feedback, and group C received tailored Web-based health feedback + optional telephone coaching if the participants’ reported health habits did not meet the national guidelines, or if they expressed motivation to change health habits. The Web-based feedback was fully automated. Telephone coaching was performed by trained health counselors. Nine months later, all participants received a follow-up questionnaire and intervention Web + telephone. Descriptive statistics, the chi-square test, analysis of variance, and generalized estimating equation (GEE) models were used. Results Overall, 981 of 1473 (66.60%) employees participated at baseline (men: 66.7%, mean age: 44 years, mean BMI: 26.4 kg/m2) and follow-up. No significant differences were found in reported health habits between the 3 groups over time. However, significant changes were found in motivation to change. The intervention groups reported higher motivation to improve dietary habits (144 of 301 participants, 47.8%, and 165 of 324 participants, 50.9%, for groups B and C, respectively) and physical activity habits (181 of 301 participants, 60.1%, and 207 of 324 participants, 63.9%, for B and C, respectively) compared with the control group A (122 of 356 participants, 34.3%, for diet and 177 of 356 participants, 49.7%, for physical activity). At follow-up, the intervention groups had significantly decreased motivation (group B: P<.001 for change in diet; P<.001 for change in physical activity; group C: P=.007 for change in diet; P<.001 for change in physical activity), whereas the control group reported significantly increased motivation to change diet and physical activity (P<.001 for change in diet; P<.001 for change in physical activity). Conclusion Tailored Web-based health feedback and the offering of optional telephone coaching did not have a positive health effect on employees in the transport services. However, our findings suggest an increased short-term motivation to change health behaviors related to diet and physical activity among those receiving tailored Web-based health feedback.

file:///H:/Forskning/BV%20manuscript/BV%20manuscript%20summer%202015/to%20be%20submitted/Final/FINAL%20SUBMISSION%2020151116/CO… 3/38 TITLE AND ABSTRACT 1a) TITLE: Identification as a randomized trial in the title 1a) Does your paper address CONSORT item 1a? * I.e does the title contain the phrase "Randomized Controlled Trial"?(if not, explain the reason under "other") yes Övrigt: 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.1 2 3 4 5 subitem not at all important essential 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 "The effects of tailored webbased feedback with or without telephone coaching..."

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").
1 2 3 4 5 subitem not at all important essential 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 subitem not at all important essential 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 "among railway employees" "The effects of..." 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT Mention key features/functionalities/components of the intervention and comparator in the 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) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 1b-i?* Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study assessing nine selfreported health areas (Body Mass Index [BMI], dietary intake, physical activity, stress, sleep, tobacco and alcohol consumption, history of disease, selfperceived health) as well as motivation to change some health habits!They were randomly assigned either a: A) questionnaire (498 answered, 40%), or B) questionnaire + tailored webbased health feedback (482 answered, 37%), or C) questionnaire + tailored web based health feedback + telephone coaching (493 answered, 37%) 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) 1 2 3 4 5 subitem not at all important 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 "The questionnaire with tailored webbased feedback was fully automated"."The telephone coaching was assisted by trained health counsellors ..." 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."Tailored webbased health feedback and telephone coaching did not have a positive effect on railway employees' overall health in our lifestyle intervention study.However, our findings suggest an increased motivation to change health behaviors related to diet and physical activity among those who received tailored web based health feedback".
Note: We further discuss the negative results in the discussion section.

INTRODUCTION 2a)
In INTRODUCTION: Scientific background and explanation of rationale 2a-i) Problem and the type of system/solution Describe the problem and the type of system/solution that is object of the study: intended as standalone intervention vs. incorporated in broader health care program?Intended for a particular patient 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) 1 2 3 4 5 subitem not at all important essential 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 allcause mortality and disease".
"A needs assessment conducted by our research team indicated that more than 60% of the track technicians were overweight, 70% had an unhealthy diet, and almost 50% had high cholesterol levels.Thus, there is a strong need for health improvement among this target group, particularly as unhealthy lifestyles may put the employee, crew, and passengers at risk due to unsafe working conditions".
2a-ii) Scientific background, rationale: What is known about the (type of) system Scientific background, rationale: What is known about the (type of) system that is the object of the study (be sure to discuss the use of similar 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 no deviators to methods after trial commencement.
3b-i) Bug fixes, Downtimes, Content Changes Bug fixes, 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 fixes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have influenced study design such as staff changes, system failures/downtimes, etc. [2].
1 2 3 4 5 subitem not at all important essential 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 There were no updates to the website (content) during the intervention.

4a) Eligibility criteria for participants
Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Computers and mobilephones were accessible at the worksite(s) and were tools included in the employees' ordinary operation to carry out their work".
"The research group collected lists of potential participants (employees) from the company manager at the four companies.
All employees with an email address were eligible for the study.
The participant lists was given to the web company, which was responsible for distributing the questionnaires.Randomization lists were automatically created by the web company prior to 4a-i) Computer / Internet literacy Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified.
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 operation to carry out their work".
"....The method of using the web to deliver health interventions seems however appropriate for our study population.About 90% of the Swedish population has access to the web and 85% has broadband at home.Further, it is expected that more than 96% of all Internet users will be connected to social networks in the nearest future [33].A high computer literacy and experience of use among our study population is therefore likely".
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 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 confirmation, phone calls) were used to detect/prevent these.
1 2 3 4 5 subitem not at all important essential 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 "3,876 railway employees in Sweden were emailed an URL to a webbased lifestyle questionnaire ..." "The questionnaire with tailored webbased feedback was fully automated.The telephone coaching was assisted by trained health counsellors (using traditional behavioral change theories i.e. the Transtheoretical model and Motivational Interviewing technique).Nine months later, a followup questionnaire (version C) was emailed to the participants".

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.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" file:///H:/Forskning/BV%20manuscript/BV%20manuscript%20summer%202015/to%20be%20submitted/Final/FINAL%20SUBMISSION%2020151116/C… 11/38 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 "Participant information and informed consent documentation were given online by the participants' as part of the welcome and information letter provided in the starting procedure of the questionnaire".
4b) Settings and locations where the data were collected 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 "The interventions, the tailored webbased health feedback (saved on the website) and the telephone coaching services were available during nine months.Data was collected by the web company [18] and sent to the researchers after the intervention had ended".

4b-i) Report if outcomes were (self-)assessed through online questionnaires
Clearly report if outcomes were (self-)assessed through online questionnaires (as common in webbased trials) or otherwise.
1 2 3 4 5 subitem not at all important essential 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 "Both the baseline and the followup questionnaire assessed the following nine health areas divided into sections: Body Mass Index (BMI), dietary intake, physical activity, stress, sleep, tobacco and alcohol consumption, history of disease and selfperceived health.Each section comprised a number of items.All outcomes were self assessed through the webbased questionnaire".

4b-ii) Report how institutional affiliations are displayed
Report how institutional affiliations are displayed to potential participants [on ehealth media], as affiliations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Nota required item -describe only if this may bias results) 1 2 3 4 5 file:///H:/Forskning/BV%20manuscript/BV%20manuscript%20summer%202015/to%20be%20submitted/Final/FINAL%20SUBMISSION%2020151116/C… 12/38 subitem not at all important essential Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The university logotype (Karolinska Institutet) was available on the starting page of the website enlosing the webbased questionnaire.This page also had names and affiliations of the research group (main researchers) part of the participant information sheet and instructions.
5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered 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).
1 2 3 4 5 subitem not at all important 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 briefly explain why the item is not applicable/relevant for your study Helpline, 2) The AlcoholHelpline, and 3) The Diet and Exercise Helpline.The helplines for smoking and alcohol are well established public helplines in Sweden [21].The Diet and Exercise Helpline was developed for this study".
"The interventions, the tailored webbased health feedback (saved on the website) and the telephone coaching services were available during nine months.Data was collected by the web company [18] and sent to the researchers after the intervention had ended".

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.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-ii?
file:///H:/Forskning/BV%20manuscript/BV%20manuscript%20summer%202015/to%20be%20submitted/Final/FINAL%20SUBMISSION%2020151116/C… 13/38 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 researchers developed the questionnaire and the content of the feedback and were involved in the development of content of the telephone coaching.Nationally leading experts in respective health area of the questionnaire quality assured the content (questions and feedback).The questionnaire was pilot tested by the target group and by the research unit at Karolinska Institutet.Most questionnaire sections used validated items from previous research.We used a questionnaire to assess food frequency including the intake of carbohydrates/fibers; sugar; saturated

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).
1 2 3 4 5 subitem not at all important essential 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 briefly explain why the item is not applicable/relevant for your study No updates have been made since the start of the intervention when the questionnaire first was emailed.

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
1 2 3 4 5 subitem not at all important 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 briefly explain why the item is not applicable/relevant for your study 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 Flow charts and screen shots have been provided as figures in the manuscript.

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.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The website is not available.It was only available/active during study.

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).
1 2 3 4 5 subitem not at all important 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 briefly explain why the item is not applicable/relevant for your study "The employees were emailed a questionnaire (URL) with personal login details (username and password) and instructions on how to proceed to the questionnaire".
"which the participants could visit at any time using their personal login details".Does your paper address subitem 5-ix?

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 "The interventions, the tailored webbased health feedback (saved on the website) and the telephone coaching services were available during nine months".
The participants could login at any time during this time period.

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 21generalizability).
1 2 3 4 5 subitem not at all important 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 briefly explain why the item is not applicable/relevant for your study "The questionnaire with tailored webbased feedback was fully automated.The telephone coaching was assisted by trained health counsellors"..

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).
1 2 3 4 5 subitem not at all important essential 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 "Reminders were sent to all nonparticipants to encourage study participation at baseline and followup, which has previously been described [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 "When the questionnaire URL was emailed, the participants were randomly assigned one of three conditions: A) questionnaire, or B) questionnaire + tailored webbased health feedback, or C) questionnaire + tailored webbased health feedback + telephone health coaching".

5-xii
"A helpdesk was administered by the research group and the web company if participants needed any help to access or use the website, or had any questions regarding the content of the 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed 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 Outcomes were measured at baseline and followup.See flowchart.
All outcomes were selfassessed through the webbased questionnaire.
In details, our primary outcome was BMI (kg/m2), computed by dividing the body weight (in kilograms) by the height (in meters) squared.Secondary outcomes were: eating breakfast 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed If outcomes were obtained through online questionnaires, describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed [9].
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 6a-i?
Copy and paste relevant sections from manuscript text interactive virtual food plate developed by the research team to assess lunch intake, by allowing the participants to complete a typical lunch meal by dragging pictures of food items to a virtual food plate.This interactive food plate has been validated and described previously [14].Alcohol consumption was studied using the Alcohol Use Disorders Identification Test, AUDITC [23] and tobacco use was assessed using validated questionnaires provided by the QuitSmokingHelpline (see below).We also inquired about the average numbers of hours per week devoted to house hold activities, as well as leisure time physical activities 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 defined/measured/monitored (logins, logfile analysis, etc.).Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text "We did not track the participants' log ins to the tailored website enclosing the personal health feedback, which would have allowed us to study the participants' use of the website".
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).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text file:///H:/Forskning/BV%20manuscript/BV%20manuscript%20summer%202015/to%20be%20submitted/Final/FINAL%20SUBMISSION%2020151116/C… 19/38 The telephone coaching was assisted by trained health counsellors".. "The participants in group C received telephone coaching in addition to webbased tailored health feedback, if their reported health habits did not meet the national guidelines, or if they reported a motivation or willingness to change health habits (same conditions as for webbased health feedback).If the participants were referred to telephone coaching, they could either leave their phone number to be dialed (reactive help) by the telephone 6b) Any changes to trial outcomes after the trial commenced, with reasons 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 were made after the trial commenced.
7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed 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.
1 2 3 4 5 subitem not at all important essential 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 Sample size was computed in order to detect a prespecified effect size delta (computed as [largest_mean smallest_mean]/sigma) equal to 0.3 on the main outcome, BMI, in our main analysis (ANOVA), with a power higher than 80%, and assuming that 80% of the subjects involved would have withdrawn from the study.We have verified that the chosen sample size ensures adequate power (>80%) also in the secondary outcomes in the main analyses.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".
1 2 3 4 5 subitem not at all important essential 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 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 Ethics Committee of the Karolinska Institutet, Stockholm, Sweden, approved the study".

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.
1 2 3 4 5 subitem not at all important essential 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 "Participant information and informed consent documentation were given online by the participants' as part of the welcome and information letter provided in the starting procedure of the questionnaire".

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) 1 2 3 4 5 subitem not at all important essential 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 briefly explain why the item is not applicable/relevant for your study "The employees were emailed a questionnaire (URL) with personal login details (username and password)" "A helpdesk was administered by the research group and the web company if participants needed any help to access or use the website, or had any questions regarding the content of the feedback".

RESULTS
13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study They were randomly assigned either a: A) questionnaire (498 answered, 40%), or B) questionnaire + tailored webbased health feedback (482 answered, 37%), or C) questionnaire + tailored web based health feedback + telephone coaching (493 answered, 37%).
13b) For each group, losses and exclusions after randomisation, together with reasons 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 N/A "Only those who participated at both baseline and followup were considered for analyses".

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 figures or tables demonstrating usage/dose/engagement.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the figure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study considered for analyses".
"We have previously presented results on response rate in the present study, suggesting that the overall response rate may be vulnerable to specific occupational groups with less screen time, season of study, and the possibility to participate during work hours [19]".
See: Svensson et al.The effect of reminders in a webbased intervention study.
14a) Dates defining the periods of recruitment and follow-up Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Between September and December 2008, we asked 3,876 employees (1865 years) at four transportation companies in the Swedish railway industry to complete a webbased lifestyle questionnaire".
"The interventions, the tailored webbased health feedback (saved on the website) and the telephone coaching services were available during nine months".
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" 1 2 3 4 5 subitem not at all important essential 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 14b) Why the trial ended or was stopped (early) 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).
1 2 3 4 5 subitem not at all important essential 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 "Only those who participated at both baseline and followup were considered for analyses".
"We have previously presented results on response rate in the present study, suggesting that the overall response rate may be vulnerable to specific occupational groups with less screen time, season of study, and the possibility to participate during work hours [19]".
17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) 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).
1 2 3 4 5 subitem not at all important essential 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 See 17a 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 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 feeling wellrested after sleeping, ("never", "seldom", "sometimes", "do not know" VS "often", "mostly" ,"always") V = 0.0575 number of occasions of alcohol consumption ("never","1 time/m or less", "23 times/month", "23 times/week", "≥46 times/week" ) V = 0.0653 number of glasses during a typical alcohol occasion ("12 glasses","34 glasses" VS "≥ 5 glasses") V = 0.0604 smoke ("daily", "sometimes" VS "no") V = 0.0378 snus ("daily", "sometimes" VS "no") V = 0.0200 Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "... our findings point towards an impact of automatic tailored health feedback on increased motivation to change behaviors.More specifically, the intervention groups at baseline reported higher motivation to improve dietary and physical activity habits compared to group A, receiving no health feedback.At followup, all groups received health feedback including group A, but only group A reported an increased motivation to change dietary and physical activity habits.It may thus be proposed that tailored health feedback positively alters participants' willingness to engage in healthier lifestyle habits".
22-ii) Highlight unanswered new questions, suggest future research Highlight unanswered new questions, suggest future research.
1 2 3 4 5 subitem not at all important essential 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 briefly explain why the item is not applicable/relevant for your study "Future research is recommended to further study the effects on motivation with respect to short term and long term effects".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 file:///H:/Forskning/BV%20manuscript/BV%20manuscript%20summer%202015/to%20be%20submitted/Final/FINAL%20SUBMISSION%2020151116/C… 34/38 "The limited advertisement of the telephone helplines in the present study should also be highlighted".
"We did not track the participants' log ins to the tailored website enclosing the personal health feedback, which would have allowed us to study the participants' use of the website".
"The method of using the web to deliver health interventions seems however appropriate for our study population".
21) Generalisability (external validity, applicability) of the trial findings NPT: External validity of the trial findings according to the intervention, comparators, patients, and care providers or centers involved in the trial

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 1 2 3 4 5 subitem not at all important essential 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 "It must be acknowledged, however, that our participants represented mostly middleaged men working in the railway industry.Extending our findings to other populations is therefore difficult".
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.
1 2 3 4 5 subitem not at all important essential 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 briefly explain why the item is not applicable/relevant for your study To generate a record that you filled in this form, we recommend to generate a PDF of this page (on a Mac, simply select "print" and then select "print as PDF") before you submit it.
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Anmäl otillåten användning Användarvillkor Ytterligare villkor Skicka Skicka aldrig lösenord med Google Formulär It says "Randomized workplace intervention" file:///H:/Forskning/BV%20manuscript/BV%20manuscript%20summer%202015/to%20be%20submitted/Final/FINAL%20SUBMISSION%2020151116/CO… 4/38 with or without telephone coaching..." 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 ) 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. 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-xii?*

20)
Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses20-i) Typical limitations in ehealth trialsTypical 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, your paper address subitem 20-i?* 3,876 railway employees in Sweden were emailed an URL to a web based lifestyle questionnaire assessing nine selfreported health areas (Body Mass Index [BMI], dietary intake, physical activity, stress, sleep, tobacco and alcohol consumption, history of disease, selfperceived health) as well as motivation to change some health habits".
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:Copyandpaste 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 file:///H:/Forskning/BV%20manuscript/BV%20manuscript%20summer%202015/to%20be%20submitted/Final/FINAL%20SUBMISSION%2020151116/CO… 6/38 "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 "They were randomly assigned either a: A) questionnaire (498 answered, 40%), or B) questionnaire + tailored webbased health feedback (482 answered, 37%), or C) questionnaire + tailored web based health feedback + telephone coaching (493 answered, 37%)".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.(Note: Only report in the abstract what the main paper is reporting.If this information is missing from the main body of file:///H:/Forskning/BV%20manuscript/BV%20manuscript%20summer%202015/to%20be%20submitted/Final/FINAL%20SUBMISSION%2020151116/CO… 7/38 The questionnaire was pilot tested by the target group and by the research unit at Karolinska Institutet"...
file:///H:/Forskning/BV%20manuscript/BV%20manuscript%20summer%202015/to%20be%20submitted/Final/FINAL%20SUBMISSION%2020151116/C… 14/38 " 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 recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.
) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework Describe mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework [6] used to design them (instructional strategy [1], behaviour change techniques, persuasive features, etc., see e.g.,[7, 8]for terminology).This includes an in-depth description of the content (including where it is coming from and who developed it) [1]," whether [and how] it is tailored to individual circumstances and allows users to track their progress and receive feedback"[6].This also includes a description of communication delivery channels and -if computer-mediated communication is a component -whether communication was synchronous or asynchronous[6].It also includes information on presentation strategies [1], including page design principles, average amount of text on pages, presence of hyperlinks to other resources, etc. [1].Exercise Helpline was developed for this study.All helplines used counselors that were specifically trained to work effectively with behaviour changes using traditional counseling approaches such as the Motivational Interviewing technique [22] and TTM [16]"..5-ix) Describe use parametersDescribe use parameters (e.g., intended "doses" and optimal timing for use).Clarify what instructions 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 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 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 After assignment to the interventions, the participants were blinded to the interventions (A, B, C).
file:///H:/Forskning/BV%20manuscript/BV%20manuscript%20summer%202015/to%20be%20submitted/Final/FINAL%20SUBMISSION%2020151116/C… 20/38 NPT: When applicable, how care providers were allocated to each trial group 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 "All employees with an email address were eligible for the study.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 "Randomization lists were automatically created by the web company prior to distributing the questionnaire URL" "The company Netsurvey AB was responsible for randomization".See: http://www.netsurvey.se/en/ for company information.file:///H:/Forskning/BV%20manuscript/BV%20manuscript%20summer%202015/to%20be%20submitted/Final/FINAL%20SUBMISSION%2020151116/C…22/38 The particpants did not know about the different interventions when they started the study.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 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 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]).
file:///H:/Forskning/BV%20manuscript/BV%20manuscript%20summer%202015/to%20be%20submitted/Final/FINAL%20SUBMISSION%2020151116/C… 23/38 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 "Only those who participated at both baseline and followup were considered for analyses".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 BV%20manuscript/BV%20manuscript%20summer%202015/to%20be%20submitted/Final/FINAL%20SUBMISSION%2020151116/C… 28/38 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 Table1provides demographic and basic characteristics.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.Table1provides demographic and basic characteristics related to this subitem.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 to be dialed by, or to dial themselves to the Diet and Exercise Helpline, the QuitSmokingHelpline, and the AlcoholHelpline, respectively.Out of these, 77 (45%) participants left their phone numbers to the Diet and Exercise Helpline, 9 *Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" file:///H:/Forskning/ 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 Subgroup analysis of comparing only usersA 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).The questionnaire did not possess any potential harm to the participants."Ahelpdeskwas administered by the research group and the web company if participants needed any help to access or use the website, or had any questions regarding the content of the feedback"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 file:///H:/Forskning/BV%20manuscript/BV%20manuscript%20summer%202015/to%20be%20submitted/Final/FINAL%20SUBMISSION%2020151116/C… 31/38 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 briefly explain why the item is not applicable/relevant for your study file:///H:/Forskning/BV%20manuscript/BV%20manuscript%20summer%202015/to%20be%20submitted/Final/FINAL%20SUBMISSION%2020151116/C… 32/38 Does your paper address subitem 22-i?* file:///H:/Forskning/BV%20manuscript/BV%20manuscript%20summer%202015/to%20be%20submitted/Final/FINAL%20SUBMISSION%2020151116/C… 33/38 As a result of using this checklist, do you think your manuscript has improved?* file:///H:/Forskning/BV%20manuscript/BV%20manuscript%20summer%202015/to%20be%20submitted/Final/FINAL%20SUBMISSION%2020151116/C… 37/38 STOP -Save this form as PDF before you click submit