Feasibility of an Electronic Health Tool to Promote Physical Activity in Primary Care: Pilot Cluster Randomized Controlled Trial

Background Physical inactivity is associated with increased health risks. Primary care providers (PCPs) are well positioned to support increased physical activity (PA) levels through screening and provision of PA prescriptions. However, PCP counseling on PA is not common. Objective This study aimed to assess the feasibility of implementing an electronic health (eHealth) tool to support PA counseling by PCPs and estimate intervention effectiveness on patients’ PA levels. Methods A pragmatic pilot study was conducted using a stepped wedge cluster randomized trial design. The study was conducted at a single primary care clinic, with 4 pre-existing PCP teams. Adult patients who had a periodic health review (PHR) scheduled during the study period were invited to participate. The eHealth tool involved an electronic survey sent to participants before their PHR via an email or a tablet; data were used to automatically produce tailored resources and a PA prescription in the electronic medical record of participants in the intervention arm. Participants assigned to the control arm received usual care from their PCP. Feasibility was assessed by the proportion of completed surveys and patient-reported acceptability and fidelity measures. The primary effectiveness outcome was patient-reported PA at 4 months post-PHR, measured as metabolic equivalent of task (MET) minutes per week. Secondary outcomes assessed determinants of PA, including self-efficacy and intention to change based on the Health Action Process Approach behavior change theory. Results A total of 1028 patients receiving care from 34 PCPs were invited to participate and 530 (51.55%) consented (intervention [n=296] and control [n=234]). Of the participants who completed a process evaluation, almost half (88/178, 49.4%) stated they received a PA prescription, with only 42 receiving the full intervention including tailored resources from their PCP. A cluster-level linear regression analysis yielded a non–statistically significant positive difference in MET-minutes reported per week at follow-up between intervention and control conditions (mean difference 1027; 95% CI −155 to 2209; P=.09). No statistically significant differences were observed for secondary outcomes. Conclusions Our results suggest that it is feasible to build an eHealth tool that screens and provides tailored resources for PA in a primary care setting but suboptimal intervention fidelity suggests greater work must be done to address PCP barriers to resource distribution. Participant responses to the primary effectiveness outcome (MET-minutes) were highly variable, reflecting a need for more robust measures of PA in future trials to address limitations in patient-reported data. Trial Registration ClinicalTrials.gov NCT03181295; https://clinicaltrials.gov/ct2/show/NCT03181295

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 o ine products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.
Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study We have not included the mode of delivery in the title as the surveys were administered via email or tablet, and the tool was embedded in the electronic medical record (EMR). These modes of delivery could not be appropriately summarized in the title. 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 brie y explain why the item is not applicable/relevant for your study Non-web-based components were not included in the title (same rationale as above).
1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "physical activity in primary care" subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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) Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The eHealth tool involved an electronic survey sent to the patients prior to their PHR via email or tablet; data were used to automatically produce tailored resources and a PA prescription in the electronic medical record of participants assigned to the intervention arm. Participants assigned to the control arm received usual care. Intervention feasibility was assessed by the proportion of completed surveys and patient-reported acceptability and delity measures. The primary effectiveness outcome was patient-reported PA at four months post-PHR, measured as Metabolic Equivalent of Task (MET) minutes. Secondary outcomes assessed determinants of PA, including selfe cacy and intention to change based on Health Action Process Approach (HAPA) behaviour change theory." 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Electronic surveys automatically produced resources, which could then be accessed by the patient's primary care provider during their annual periodic health review (PHR): "The eHealth tool involved an electronic survey sent to the patients prior to their PHR via email or tablet; data were used to automatically produce tailored resources and a PA prescription in the electronic medical record of participants assigned to the intervention arm." 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-toface assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials Does your paper address subitem 1b-iii? Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The eHealth tool involved an electronic survey sent to the patients prior to their PHR via email or tablet" 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) Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "1028 patients belonging to 34 physicians were invited to participate and 530 (51.6%) consented (intervention n=296, control n=234)." 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 text, consider adding it) Does your paper address subitem 1b-v?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Our results suggest that it is feasible to build an eHealth tool that screens and provides tailored resources for PA in a primary care setting but suboptimal intervention delity suggests greater work must be done to address physician barriers to resource distribution. Participant responses to the primary effectiveness outcome (MET-minutes) were highly variable, re ecting a need for more robust measures of PA in future trials to address limitations in patient-reported data." Does your paper address subitem 2a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Electronic screening of health behaviours can save time for PCPs and has been highly accepted by patients as a method to share information with their care team [22][23][24]. Furthermore, using computers to deliver tailored messaging and resources to patients can have a positive impact on behaviour change, including PA, relative to more traditional methods of health counselling [25][26][27][28][29][30]. Integrating screening and tailored information provision into one intervention may help change PA levels by addressing the complex needs of both providers and patients [24,25]." Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Our aim was to optimize the intervention, evaluate recruitment and retention of participants, and assess suitability of the primary outcome for a subsequent, larger de nitive trial [31,32]." 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 subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Stepped Wedge Cluster Randomized Controlled Trial Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "We conducted a pilot study using a pragmatic SW-CRT design to identify potential issues with implementation or analysis that might challenge the feasibility of future trials involving more clusters [35]." 3b-i) Bug xes, Downtimes, Content Changes Bug xes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug xes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have in uenced study design such as staff changes, system failures/downtimes, etc. [2].
Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study There were no bug xes or downtimes to report during the study period.

4a) Eligibility criteria for participants
This is a required question subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Your answer 4a-i) Computer / Internet literacy Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clari ed.
Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Patients rostered to a participating physician were eligible if they attended a periodic health review (PHR) during the study period and were aged 18 to 79 at the time of the PHR. PHRs were considered appropriate opportunities to deliver the intervention, as they focus on preventative care counselling [39]. Patients deemed unable to safely or effectively complete the intervention at the time of their PHR were excluded. This included those with dementia or cognitive impairment, major active illness, and/or those who were pregnant. Non-English speakers were also excluded due to a lack of resources to appropriately accommodate other languages." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 4b) Settings and locations where the data were collected 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email con rmation, phone calls) were used to detect/prevent these.
Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "All patients deemed eligible for the study received an email two weeks prior to their visit with a link to a secure electronic survey (e-survey). Those who did not complete the survey prior to their appointment were approached in clinic and the e-survey was completed using a digital tablet." 4a-iii) Information giving during recruitment Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.
Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The e-survey collected informed consent, assessed baseline PA, and assessed perceived barriers and motivators for PA." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Patients completed the survey in their own location (if by email) or in clinic on the day of their periodic health review.
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.
Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "After exposure to the intervention, patients received a paper survey immediately after their appointment or e-survey one day after to collect process measures" "The primary effectiveness outcome was patient-reported PA at four months post-PHR, measured as Metabolic Equivalent of Task (MET) minutes per week using the International Physical Activity Questionnaire -Short Form (IPAQ-SF) [48]. " "An e-survey collected responses for both primary and secondary outcomes, and data was securely transferred and collated into a single, study-speci c database (see Appendix 4 for survey)." 4b-ii) Report how institutional a liations are displayed Report how institutional a liations are displayed to potential participants [on ehealth media], as a liations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results) 5) The interventions for each group with su cient details to allow replication, including how and when they were actually administered subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 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 brie y explain why the item is not applicable/relevant for your study No institutional a liations were displayed on intervention materials. 5-i) Mention names, credential, a liations of the developers, sponsors, and owners 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The intervention was re ned using principles of user-centered design. This approach emphasizes the use of iterative product design with ongoing feedback from the end user to drive improvements and optimize acceptance and use of the tool [41][42][43]. This involved multiple interviews with potential end-users, as described in another paper [44]."

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).
Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study There were no changes made to the intervention during the study period.

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study We conducted a weekly quality assurance process where two research assistants would check the data from the database and compare it to the information populated in the intervention patient's chart. We also ensured that the participant was seen by the consenting PCP.

5-v)
Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing owcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing owcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scienti c reporting.
Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study We have not included the entire algorithm and toolkit possibilities as there are several. We are happy to provide these upon request.

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.
subitem not at all important 1 2 3 4 5 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 brie y explain why the item is not applicable/relevant for your study This tool is not publicly available. It is only available within the Women's College Hospital Family Practice Health Centre EMR, and will not disappear from this platform in the foreseeable future.

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of speci c group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Providers printed and handed the resources to intervention participants during their appointment.
subitem not at all important 1 2 3 4 5 essential 5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The intervention included three key components that were automatically generated based on the baseline survey. First, responses were summarized in the patient's EMR along with a statement comparing the results to current PA guidelines of 150 minutes of moderate to vigorous PA per week [12,45,46]. Second, the EMR was populated with a link to one of ve toolkits which included online and community-based resources tailored to the patient's current PA levels and perceived barriers. Third, a customized PA prescription was generated based on current PA levels and patient identi ed motivators to increase PA. During the PHR, the prescription could be edited by the PCP based on discussions with the patient and then printed along with the toolkit for the patient to take home. Each patient's toolkit was also sent to them two weeks after the PHR via mail or email.

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.
Does your paper address subitem 5-ix?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Second, the EMR was populated with a link to one of ve toolkits which included online and community-based resources tailored to the patient's current PA levels and perceived barriers. Third, a customized PA prescription was generated based on current PA levels and patient identi ed motivators to increase PA. During the PHR, the prescription could be edited by the PCP based on discussions with the patient and then printed along with the toolkit for the patient to take home. Each patient's toolkit was also sent to them two weeks after the PHR via mail or email. A full description and examples of the prescription and toolkit can be found in Appendix 1 [47]."

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).
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "During the PHR, the prescription could be edited by the PCP based on discussions with the patient and then printed along with the toolkit for the patient to take home. Each patient's toolkit was also sent to them two weeks after the PHR via mail or email." 5-xi) Report any prompts/reminders used Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Prompts and reminders were used to encourage participant survey completion. Email reminders and phone calls for a period of up to 6 weeks at 4 months post periodic health review (PHR), took place to decrease loss to follow-up.

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. 6a) Completely de ned pre-speci ed primary and secondary outcome measures, including how and when they were assessed Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "To encourage intervention delity, one of the principal investigators (PA or NI) spoke with each of their PCP colleagues for 5 to 15 minutes prior to their cluster switching to the intervention arm. The intervention, including EMR outputs, were demonstrated using a 'test' patient chart in the EMR, and then a handout was reviewed that addressed both work ow integration and evidence for PA counselling (see Appendix 2 for handout)." Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "After exposure to the intervention, patients received a paper survey immediately after their appointment or e-survey one day after to collect process measures (see Appendix 3). Acceptability was measured using a 5point Likert scale ranging from 'very dissatis ed' to 'very satis ed'.
Participants were also asked about the number of minutes of PA counselling they received (no discussion, less than 2 minutes, 2-5 minutes, 5-10 minutes, or more than 10 minutes), and if they received a PA prescription (yes/no). Feasibility was also assessed in part by number of eligible patients who completed a baseline survey and the frequency of missing or inaccurate data [35].
The primary effectiveness outcome was patient-reported PA at four months post-PHR, measured as Metabolic Equivalent of Task (MET) minutes per week using the International Physical Activity Questionnaire -Short Form (IPAQ-SF) [48]. The IPAQ-SF was selected for its short length, ease of administration, good test-retest reliability and low cost [48].
Secondary outcomes, also collected four months post-PHR, assessed attitudes towards PA using the HAPA constructs to guide assessment of proximal changes. Speci cally, three sub-dimensions of self-e cacy (action, recovery, maintenance) were assessed, each measured via two questions (using a 4-point Likert scale ranging from 'strongly disagree' to 'strongly agree') [Roni to provide references]. A score for each sub-dimension of selfe cacy was calculated by summing the two questions, dividing by the maximum possible score and multiplying by 100 (for self-e cacy scores ranging from 0 to 100). The total self-e cacy score was the average of all sub-dimension scores.
Participants' intention regarding PA was measured in a two-step process. Those meeting recommended PA guidelines of 150 minutes of moderate to vigorous activity a week were de ned as 'actors' [2]. Participants not meeting the recommended guidelines were de ned as 'non-actors'. This group was further subdivided to 'intenders' and 'pre-intenders'. Those who agreed with the statement "I have made the decision to take part in a new kind of physical activity or increase my amount or intensity of physical activity soon" were deemed to be 'intenders', while those who disagreed were labelled 'preintenders'. An e-survey collected responses for both primary and secondary outcomes, and data was securely transferred and collated into a single, study- 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was de ned/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was de ned/measured/monitored (logins, log le analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial. 1 2 3 4 5 essential 6b) Any changes to trial outcomes after the trial commenced, with reasons Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text "After exposure to the intervention, patients received a paper survey immediately after their appointment or e-survey one day after to collect process measures (see Appendix 3). Acceptability was measured using a 5point Likert scale ranging from 'very dissatis ed' to 'very satis ed'.
Participants were also asked about the number of minutes of PA counselling they received (no discussion, less than 2 minutes, 2-5 minutes, 5-10 minutes, or more than 10 minutes), and if they received a PA prescription (yes/no). Feasibility was also assessed in part by number of eligible patients who completed a baseline survey and the frequency of missing or inaccurate data [35]." 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).
Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text "After exposure to the intervention, patients received a paper survey immediately after their appointment or e-survey one day after to collect process measures (see Appendix 3). Acceptability was measured using a 5point Likert scale ranging from 'very dissatis ed' to 'very satis ed'. Participants were also asked about the number of minutes of PA counselling they received (no discussion, less than 2 minutes, 2-5 minutes, 5-10 minutes, or more than 10 minutes), and if they received a PA prescription (yes/no). Intervention feasibility was also assessed in part by number of eligible patients who completed a baseline survey and the frequency of missing or inaccurate data [35]." 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed subitem not at all important 1 2 3 4 5 essential 7b) When applicable, explanation of any interim analyses and stopping guidelines Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study N/A 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size Describe whether and how expected attrition was taken into account when calculating the sample size.
Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Your answer Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study N/A 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) 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Randomization occurred using computer-generated random numbers produced by an independent statistician [38]." Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "PCP teams functioning as naturally occurring clusters of clinicians and patients were randomized to allow gradual implementation of the tool and prevent intervention contamination across clusters [36][37][38]. The study was divided into ve periods, each six weeks in length. Initially, no teams were exposed to the intervention [37], then one team was randomly assigned to begin the intervention at the start of each period [36]." 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study ""Participants and researchers could not be blinded due to the nature of the intervention." Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "an independent statistician" produced the random allocation sequence, and research assistants enrolled participants in the intervention and control arms.
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). 1 2 3 4 5 essential 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) Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Participants and researchers could not be blinded due to the nature of the intervention." 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" 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 brie y explain why the item is not applicable/relevant for your study N/A Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Analysis of the pilot data was mainly descriptive [35]. The distribution of patient-and physician-level baseline characteristics were summarized by team via means and standard deviations (median and interquartile range when skewed) and frequencies and proportions, respectively [37,38]." "The presence of few clusters in our study limits options for estimating the preliminary effectiveness of the intervention. Speci cally, it precludes the use of conventional analytic approaches for stepped wedge trials [33,36,37] that model patient-level responses while accounting for clustering via random effects, which require observations on many clusters to yield unbiased estimates and accurate standard errors [49,50]. Correspondingly, patient-level responses to the primary outcome to the cluster-period level were aggregated, which removes the need to adjust for patient-or physician-level characteristics or clustering of patient responses within teams [51]. To obtain a preliminary estimate of intervention effectiveness on the primary outcome, the cluster-period mean response was then regressed as the outcome using linear regression with intervention exposure as the primary independent variable and the following xed effects included for as covariates: team (cluster); period; and mean baseline (or pretest) value [51]. To assess the robustness of our ndings to statistical outliers, a sensitivity analysis was conducted involving regression analysis as speci ed for the primary outcome; however, prior to aggregating patient-level responses to the cluster-period level, those patient responses in the top 5% by primary outcome value were excluded.
Secondary outcomes were analyzed similarly. Preliminary treatment effect estimates on each self-e cacy measure (action, recovery, maintenance, and overall) at the cluster-period level via multivariable linear regression with adjustment for team, period, and baseline response as covariates were obtained. With respect to intention to change PA levels, the proportion of participants meeting criteria as an 'actor' or 'intender' at follow-up per clusterperiod were calculated and expressed as a percentage. This value was then regressed as the outcome in a negative binomial regression model with intervention exposure as the primary independent variable, adjusting for period, team, and for the proportion meeting the outcome at baseline. A similar model focused only on the proportion of participants meeting criteria as an 'actor'.
subitem not at all important 1 2 3 4 5 essential 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses For each primary and secondary outcome, analysis was limited to patients who were randomized, attended their PHR, and provided baseline and followup data for that outcome. Statistical signi cance was assessed, where applicable, using a two-sided P-value of 0.05. SAS 9.4 (SAS Institute) was 12a-i) Imputation techniques to deal with attrition / missing values Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).
Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "To assess the robustness of our ndings to statistical outliers, a sensitivity analysis was conducted involving regression analysis as speci ed for the primary outcome; however, prior to aggregating patient-level responses to the cluster-period level, those patient responses in the top 5% by primary outcome value were excluded."

X26) REB/IRB Approval and Ethical Considerations [recommended as subheading under "Methods"] (not a CONSORT item)
subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The presence of few clusters in our study limits options for estimating the preliminary effectiveness of the intervention. Speci cally, it precludes the use of conventional analytic approaches for stepped wedge trials [33,36,37] that model patient-level responses while accounting for clustering via random effects, which require observations on many clusters to yield unbiased estimates and accurate standard errors [49,50]. Correspondingly, patient-level responses to the primary outcome to the cluster-period level were aggregated, which removes the need to adjust for patient-or physician-level characteristics or clustering of patient responses within teams [51]."

X26-i) Comment on ethics committee approval
Does your paper address subitem X26-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The e-survey collected informed consent, assessed baseline PA, and assessed perceived barriers and motivators for PA." Informed consent was the rst section of the electronic survey. If participants did not read and con rm their consent to the study, the survey automatically concluded.

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) 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 subitem X26-iii? Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Community resources were a key component of the toolkits, and PCPs were encouraged to offer these resources to their patients. We also developed additional documents for those with comorbidities such as cardiovascular disease or cancer, to account for the unique challenges posed by other conditions on the ability to be physically active. "Second, the EMR was populated with a link to one of ve toolkits which included online and community-based resources tailored to the patient's current PA levels and perceived barriers, as well as an additional conditionspeci c PA toolkit if the patient reported any other condition (e.g. cardiovascular disease)." 13b) For each group, losses and exclusions after randomisation, together with reasons subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "In total, 34 out of 39 eligible PCPs participated across the four teams in the clinic. Of 1,277 eligible patients, 1,028 were invited to participate and 948 consented. Randomization proceeded based on cluster allocation (see Figure  1). In total, 296/640 (46.3%) and 234/388 (60.3%) individuals randomized to the intervention and control groups respectively, completed the baseline survey and received their allocated treatment. Most participants (307/530 or 57.9%) completed the baseline survey via email prior to their PHR; 80/530 (15.1%) participants completed the survey via tablet (due to no email address in their EMR), and 143/530 (27.0%) completed the survey via tablet (after being sent the survey via email)." Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT ow diagram) * 14a) Dates de ning the periods of recruitment and follow-up subitem not at all important 1 2 3 4 5 essential 14b) Why the trial ended or was stopped (early) Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the gure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This can be found in Figure 1: CONSORT ow diagram.
Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The recruitment periods can be found in gure 2. Follow-up occurred up to 6 weeks after the four month follow-up date.
14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signi cant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study included in each analysis and whether the analysis was by original assigned groups Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study N/A Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Participant-level characteristics can be found in Table 1.

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.
Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study We reported the gender of our participants in Table 1.
subitem not at all important 1 2 3 4 5 essential 16-i) Report multiple "denominators" and provide de nitions Report multiple "denominators" and provide de nitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speci c pre-de ned time points of interest (in absolute and relative numbers per group). Always clearly de ne "use" of the intervention.
Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "In total, 183/296 (61.8%) of patients exposed to the intervention handed in a process evaluation survey following their PHR. Only 112 completed the survey fully, which represents 61.2% of those who handed in a survey and only 37.8% of the intervention group. Overall, fewer than half of respondents (88/178 or 49.4%) stated they received at least a PA prescription from their PCP. A chisquare test of independence indicated no signi cant difference in the proportion of patients who received at least a PA prescription versus no materials between teams (χ2(3)=3.03; P-value=0.39). Among the 88 patients who received a PA prescription, just under half (42/88 or 47.7%) also received tailored resources to take home. The proportion of intervention patients who completed the process evaluation receiving both a PA prescription and resources ranged from a low of 9.4% (6/64 patients) for team 1 to a high of 45.5% (15/33 patients) for team 3.
Only 12/183 (6.6%) patients completing a process evaluation indicated that no PA discussion occurred during their appointment. Nearly half (86/176 or 48.9%) of participants who estimated the length of their PA discussion reported a length of 2-5 minutes, with patients in team 4 were more likely to report a talk of <2 minutes. Most patients reported being satis ed with their PA discussion irrespective of team, with no patients indicating they were dissatis ed. Of the process evaluation questions, patient satisfaction with their PA counselling (if applicable) was most prone to missing responses, with only 114/183 (62.3%) providing a response. See Appendix 5 for a full f l ti lt " subitem not at all important 1 2 3 4 5 essential 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% con dence interval) 16-ii) Primary analysis should be intent-to-treat Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).
Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Primary analysis was intent-to-treat.
subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "After adjusting for time (period) and mean number of MET minutes at baseline, cluster-level linear regression yielded a non-statistically signi cant difference in the grand mean number of MET minutes reported per week at follow-up between intervention and control conditions (MD 1027, 95% CI -155 to 2209; p=.09)." "Outliers were, on average, more likely to self-report a signi cantly greater number of MET minutes at baseline versus non-outliers (MD 5650, 95% CI 4082 to 7218); otherwise, the distribution of all other baseline characteristics was statistically equivalent between outliers and non-outliers. After excluding outliers, the subsequent linear regression yielded a non-statistically signi cant, and less positive (closer to the null), difference in the grand mean number of MET minutes reported per week between intervention and control conditions (MD 487, 95% CI -298 to 1273; p=.22). "There were no signi cant treatment effects on action self-e cacy (n=392; MD (intervention-control) -1.73, 95% CI -5.56 to 2.11; p=.38), maintenance selfe cacy (n=361; MD (intervention-control) -1.92, 95% CI -5.68 to 1.85; p=.32), recovery self-e cacy (n=420; MD (intervention-control) 2.28, 95% CI -1.39 to 5.94; p=.22), and overall self-e cacy (n=413; MD (intervention-control) 1.13, 95% CI -1.73 to 4.00; p=.44). There were also no signi cant differences in the mean proportion of subjects who were in the volitional phase at 4 months (PR(intervention/control) 0.95, 95% CI 0.14 to 6.66; p=.96), or those who were classi ed as 'actors' at 4 months (PR(intervention/control) 0.88, 95% CI 0.11 t 7 12 91) " 17a-i) Presentation of process outcomes such as metrics of use and intensity of use In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational de nitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is de ned (e.g., timeout after idle time) [1] (report under item 6a).
17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing prespeci ed from exploratory Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study These can be found in Appendix 5.
Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study N/A Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "After adjusting for time (period) and mean number of MET minutes at baseline, cluster-level linear regression yielded a non-statistically signi cant difference in the grand mean number of MET minutes reported per week at follow-up between intervention and control conditions (MD 1027, 95% CI -155 to 2209; p=.09)." subitem not at all important 1 2 3 4 5 essential 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?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "In total, 183/296 (61.8%) of patients exposed to the intervention handed in a process evaluation survey following their PHR. Only 112 completed the survey fully, which represents 61.2% of those who handed in a survey and only 37.8% of the intervention group. Overall, fewer than half of respondents (88/178 or 49.4%) stated they received at least a PA prescription from their PCP. A chisquare test of independence indicated no signi cant difference in the proportion of patients who received at least a PA prescription versus no materials between teams (χ2(3)=3.03; P-value=0.39). Among the 88 patients who received a PA prescription, just under half (42/88 or 47.7%) also received tailored resources to take home. The proportion of intervention patients who completed the process evaluation receiving both a PA prescription and resources ranged from a low of 9.4% (6/64 patients) for team 1 to a high of 45.5% (15/33 patients) for team 3.
Only 12/183 (6.6%) patients completing a process evaluation indicated that no PA discussion occurred during their appointment. Nearly half (86/176 or 48.9%) of participants who estimated the length of their PA discussion reported a length of 2-5 minutes, with patients in team 4 were more likely to report a talk of <2 minutes. Most patients reported being satis ed with their PA discussion irrespective of team, with no patients indicating they were dissatis ed. Of the process evaluation questions, patient satisfaction with their PA counselling (if applicable) was most prone to missing responses, with only 114/183 (62.3%) providing a response. See Appendix 5 for a full f l ti lt " Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No harms/unintended effects to report.

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-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No privacy breaches or technical problems to report.

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

DISCUSSION
22) Interpretation consistent with results, balancing bene ts and harms, and considering other relevant evidence NPT: In addition, take into account the choice of the comparator, lack of or partial blinding, and unequal expertise of care providers or centers in each group subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 19-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Qualitative feedback was not retrieved from participants or staff, other than the completion of the process evaluation by patient participants.
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).
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "This study assessed the feasibility of implementing a primary care-based eHealth tool to screen for PA levels and provide tailored, evidence-based resources for both providers and patients. Over the course of 6 months, 530 patients were enrolled, with limited investment in personnel. Results show a trend towards improvement in PA levels for those who received the intervention, although the unexpectedly high variability limited statistical power." "The process evaluation indicates that almost all patients in the intervention arm received counselling about PA, almost half received a PA prescription and most were highly satis ed with counselling they received."

22-ii) Highlight unanswered new questions, suggest future research
Highlight unanswered new questions, suggest future research. 20) Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses Does your paper address subitem 22-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "It is possible that sending tailored information directly to patients prior to an appointment may facilitate shared decision-making on PA during the clinical encounter [58,59]." "In addition to careful consideration of outcome measures, appropriate patient selection is an important consideration for future work in this area. It is possible that patients who attend clinic for a PHR may be systematically different (i.e., biased toward an interest or willingness to engage in healthy lifestyle behaviours) from the general population. PHR visits were used as they present a highly feasible time to incorporate structured counselling on PA." "As a SW-CRT design is suitable to test the effect of an intervention on PA, future studies must recruit a large number of clusters to minimize the aforementioned issues. This would enable use of more conventional, mixed-effects regression that accounts for clustering via random effects and involves a greater number of observations (via avoiding aggregation) that can result in more power to detect treatment effects, if truly present [65], and adjust for baseline imbalances with reduced concern of over tting. Further, our process evaluation had a high level of missing data, particularly on the overall satisfaction question, increasing the risk of bias in the reported results. It is possible that those who were not satis ed with the intervention were less likely to respond. Steps to increase response rates to process measure surveys, including electronic delivery, should be considered for future work."