A Web-Based Positive Psychological Intervention to Improve Blood Pressure Control in Spanish-Speaking Hispanic/Latino Adults With Uncontrolled Hypertension: Protocol and Design for the ¡Alégrate! Randomized Controlled Trial

Background Growing evidence links psychological well-being and resilience with superior cardiac health, but there remains a critical scientific gap about whether (or how) interventions that aim to cultivate psychological well-being reduce cardiac risk. Hispanic/Latino people in the United States have high cardiovascular disease risk and poorly controlled blood pressure (BP) compared with their peers of European ancestry, and they represent a population in need of new and innovative therapeutic approaches. As such, a focused intervention to boost psychological well-being holds promise as a novel therapeutic target for hypertension in Hispanic/Latino adults; to date, however, no research has explored whether a causal link is evident. Objective The aim of this paper is to detail the protocol for the ¡Alégrate! (Be Happy!) intervention, a Phase II randomized controlled trial testing initial efficacy in improving BP of a web-based positive psychological intervention designed to boost psychological well-being in Spanish-speaking Hispanic/Latino people with hypertension. Methods A total of 70 Hispanic/Latino people aged ≥18 years, fluent in Spanish, and with elevated BP (≥140/90 mm Hg) will be recruited in person from a single Federally Qualified Health Center in Chicago. Enrollees will be randomly assigned to 1 of 2 trial arms: (1) web-based positive psychological intervention or (2) an active control condition (eg, 3 times weekly emotion reporting). Our 5-week Spanish-language ¡Alégrate! intervention is web-based and delivers curricular content via didactic instruction, journaling, and assigned at-home practice—all accessed via our website using investigator-purchased tablet computers, with a unique username and password assigned to each enrollee. Targeted skills include noting daily positive events, positive reappraisal of stressful events, effective expression of gratitude, performing acts of kindness, and regular practice of mindfulness and meditation. The primary outcome is improvement in BP, both sitting values and 24-hour ambulatory readings, as measured at baseline and 5 and 12 weeks from baseline. Secondary outcomes include psychological well-being, engagement in healthy behaviors, and circulating levels of inflammatory markers. The outcomes of interest are collected by trained research staff through in-person interviews using the REDCap software. Results Activities of the ¡Alégrate! intervention were funded in August 2017, and data collection is ongoing. We expect to submit trial results for peer-reviewed publications in 2021, soon after recruitment has been concluded and statistical analyses are finalized. Conclusions Findings will provide evidence on whether interventions to boost psychological well-being and resilience have downstream effects on BP control and cardiovascular health, particularly as they are deployed in the Spanish language with cultural tailoring and via a web-based platform. If effective, we will have an easily disseminatable application that can positively impact well-being profiles and BP control in Hispanic/Latino people, with the possibility of addressing health disparities of this US racial/ethnic minority group. Trial Registration ClinicalTrials.gov NCT03892057; https://clinicaltrials.gov/ct2/show/NCT03892057 International Registered Report Identifier (IRRID) PRR1-10.2196/17721


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 ovine 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 briewy explain why the item is not applicable/relevant for your study "Web-based Positive Psychological Intervention" subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1a-ii) Non-web-based components or impo"ant 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 briewy explain why the item is not applicable/relevant for your study Your answer 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 briewy explain why the item is not applicable/relevant for your study "Spanish-speaking Hispanic/Latino Adults with Uncontrolled Hypertension" 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
subitem not at all important 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 briewy explain why the item is not applicable/relevant for your study "Enrollees will be randomly assigned to one of two trial arms: (1) Web-based positive psychological intervention, or (2) an active control condition (e.g., thrice weekly emotion reporting). Our 5-week Spanish-language ¡Alégrate! intervention is Web-based and delivers curricular content via didactic instruction (e.g., text, videos), journaling, and assigned athome practice-all accessed online using investigator-purchased tablet computers, with unique username and passwords assigned to each enrollee. Targeted skills of ¡Alégrate! include noting daily positive events, positive reappraisal of stressful events, effective expression of gratitude, performing acts of kindness, and regular practice of mindfulness and meditation, among others." subitem not at all important 1 2 3 4 5 essential 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) 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 briewy explain why the item is not applicable/relevant for your study "Our 5-week Spanish-language ¡Alégrate! intervention is Web-based and delivers curricular content via didactic instruction (e.g., text, videos), journaling, and assigned at-home practice -all accessed online using investigator-purchased tablet computers, with unique username and passwords assigned to each enrollee." "The outcomes of interest are collected by trained research staff through in-person interviews using REDCap software." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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. ovine), 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 ovine trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered. To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e. participants can self-enrol). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 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 briewy explain why the item is not applicable/relevant for your study "The outcomes of interest are collected by trained research staff through in-person interviews using REDCap software." 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)

INTRODUCTION 2a) In INTRODUCTION: Scienti!c background and explanation of rationale
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 briewy explain why the item is not applicable/relevant for your study "Activities of the ¡Alégrate! intervention were funded in 2017, and data collection is on-going. We expect to submit trial results for peer-reviewed publication in 2021, soon after recruitment has concluded and statistical analyses are Pnalized." 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 briewy explain why the item is not applicable/relevant for your study Not applicable; data collection is on-going.
subitem not at all important 1 2 3 4 5 essential 2a-i) Problem and the type of system/solution Describe the problem and the type of system/solution that is object of the study: intended as stand-alone intervention vs. incorporated in broader health care program? Intended for a particular patient population? Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions? (Note: Details about the intervention are provided in "Methods" under 5) Does your paper address subitem 2a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briewy explain why the item is not applicable/relevant for your study "Mounting evidence suggests that positive psychological well-being (hereafter, psychological well-being)-which includes positively valenced feelings or cognitive appraisals such as happiness, optimism, and purpose in life-is independently associated with favorable cardiac health, e.g., reduced risk for incident hypertension, better lipid proPles, reduced inwammatory markers, and reduced odds of incident heart disease and cardiac related mortality [5][6][7]. Nevertheless, while multiple studies link psychological wellbeing with better cardiac health [6][7][8] there is a need to investigate the most effective approaches to cultivate psychological well-being in an effort to reduce cardiac risk." "Additional research is needed, however, to explore strategies that boost psychological wellbeing speciPcally in Hispanic/Latino adults and whether this leads to better heart health and blood pressure management.

2b) In INTRODUCTION: Speci!c objectives or hypotheses
Does your paper address subitem 2a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briewy explain why the item is not applicable/relevant for your study "Observational evidence links psychological well-being with better overall health, more healthful coping tendencies, improved quality of life, and healthy longevity [8,21]. Psychological well-being focuses on positive thoughts and feelings at the individual-level, which may be key in promoting health behaviors in hypertension management [8]. Evidence suggests that psychological well-being is related to healthier blood pressure (BP) proPles and plays a protective role in disease incidence [22,23]. In over 1,000 healthy non-Hispanic adults, a large prospective study found that higher levels of psychological well-being were associated with decreased likelihood of incident hypertension at a one-year follow-up [24]. In 126 British civil servants, aggregate baseline levels of happiness were negatively associated with year 3 measures of systolic blood pressure, independent of known confounders." "The use of Web-based interventions in different clinical populations has grown signiPcantly [26]. Web-based interventions tend to be less costly than face-to-face designs, offering wexibility, and greater access [27]. Internet use has also grown substantially among Hispanic/Latino adults, with 80% reporting use of the internet [27]. A majority of Hispanic/Latinos report having a computer (78%), and report owning a smartphone (71%) [28]. Web-based interventions have the potential for broad dissemination and may help eliminate common barriers to participation (e.g. transportation, scheduling conwict, and lack of child care) [29]. Recent studies have used Web-based interventions to promote psychological well-being in different patient populations [26]. For example, Web-based delivery formats were found to be effective in the management of symptoms of depression, anxiety and stress [30][31][32][33][34] in healthy and clinical populations. However, most of these studies have been conducted in non-Hispanic white samples. There is a need for better representation of underserved, racial/ethnic minorities, in Web-based psychological wellbeing interventions." "Empirical evidence suggests that effect sizes for Web-based therapies are similar to those deployed using traditional face-to-face approaches, with high patient satisfaction reported across these hi-tech platforms. Few evidenced-based programs, however, are developed speciPcally for and deployed with Hispanic/Latino adults using Web-based platforms. 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 briewy explain why the item is not applicable/relevant for your study "The RCT intends to boost psychological well-being in Spanish-speaking Hispanic/Latino adults with hypertension by examining changes in BP, psychological well-being, health behavior adherence, and circulating serum inwammation. This Web-based intervention is built on activities that target psychological well-being by promoting optimism, gratitude, and positive affect directly though activities such as recalling positive life events, identifying and employing personal strengths, and engaging in acts of kindness, among others. We hypothesized that compared to participants in the control condition, those in the active intervention group will show greater improvements in BP, higher scores for psychological well-being, greater engagement in healthful behaviors, and lower levels of inwammatory makers at follow up." 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 briewy explain why the item is not applicable/relevant for your study "As such, the current Phase II pilot trial implements a parallel group design with a 1:1 allocation ratio-with two Pxed factors: a) sex [male, female] and b) antihypertensive medication use [yes, no]." subitem not at all important 1 2 3 4 5 essential 4a) Eligibility criteria for pa"icipants 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 briewy explain why the item is not applicable/relevant for your study Not applicable; no issues have arrived to require change in eligibility criteria.

3b-i) Bug %xes, Downtimes, Content Changes
Bug Pxes, 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 Pxes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have inwuenced 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 briewy explain why the item is not applicable/relevant for your study Not applicable; there has been no change to methods nor problems with the "¡Alégrate!" website that has required bug Pxes, downtimes, or changes to content.
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 briewy explain why the item is not applicable/relevant for your study "Spanish-speaking Hispanic/Latino adults are eligible to enroll in the ¡Alégrate! trial if they meet the following criteria: 1) Hispanic/Latino heritage based on self-report, 2) aged 18 years or older, 3) wuent in Spanish, i.e., ability to read, speak, and write Spanish, 4) elevated sitting BP (≥140/90), and 5) basic technological literacy with the ability to access internet at home or in a public setting."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clariPed.
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 briewy explain why the item is not applicable/relevant for your study "5) basic technological literacy with the ability to access internet at home or in a public setting." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. ovine), e.g., from an open access website or from a clinic, and clarify if this was a purely webbased trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email conPrmation, 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 briewy explain why the item is not applicable/relevant for your study "The attending physician and clinical staff (e.g., registered nurse, medical assistant) identify potentially eligible patients and subsequently refers them to ¡Alégrate! research staff who then follow-up via phone or in-person; participant information is stored in a secure on-line portal." "Research staff will also approach patients in the waiting area to provide information about the research study and offer an invitation to receive a no-cost blood pressure screening; research staff will collect contact information of those expressing interest to determine full eligibility."

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.

4b) Se$ings and locations where the data were collected
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 briewy explain why the item is not applicable/relevant for your study "The consent form and study materials outline the design of the study and inform participants of random assignment into one of two groups, either the group where "they learn skills to boost their mood and positive emotions" or the group where "they would report their emotions on a thrice-weekly basis." It is communicated that all curricular instruction occurs on-line by visiting our ¡Alégrate! website. Additionally, staff inform participants that three in-person clinical visits are required, each 2-3 hour in length, where staff collect survey and clinical data, including collection of anthropometric information, blood spots, and 24-hour blood pressure monitoring; home visits are also offered for data collection to increase rates of retention. Participants are informed that they keep the investigator-purchased tablet computer at the end of the study as compensation for their participation and time invested [37]." 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 briewy explain why the item is not applicable/relevant for your study "Additionally, staff inform participants that three in-person clinical visits are required, each 2-3 hour in length, where staff collect survey and clinical data, including collection of anthropometric information, blood spots, and 24-hour blood pressure monitoring; home visits are also offered for data collection to increase rates of retention." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 4b-i) Repo" if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise.
Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briewy explain why the item is not applicable/relevant for your study "Survey and clinical assessments are conducted in Spanish through in-person interviews by trained bilingual research staff in a one-to-one encounter at the participating FQHC."

4b-ii) Repo" how institutional a!liations are displayed
Report how institutional ayliations are displayed to potential participants [on ehealth media], as ayliations 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) 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 briewy explain why the item is not applicable/relevant for your study Your answer 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 5-i) Mention names, credential, a!liations of the developers, sponsors, and owners Mention names, credential, ayliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conwict of interest" section or mentioned elsewhere in the manuscript).

Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briewy explain why the item is not applicable/relevant for your study "Our Spanish-language Web-based ¡Alégrate! positive psychological intervention was adapted from previously published and empirically validated curricula of Moskowitz's MARIGOLD trial [38][39][40][41][42]." "The website was designed and managed by Michael Cohn, a co-investigator of ¡Alégrate!."

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.
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 briewy explain why the item is not applicable/relevant for your study "Our Spanish-language Web-based ¡Alégrate! positive psychological intervention was adapted from previously published and empirically validated curricula of Moskowitz's MARIGOLD trial [38][39][40][41][42]."

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 briewy explain why the item is not applicable/relevant for your study

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
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 briewy explain why the item is not applicable/relevant for your study Your answer 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing &owcha"s of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing wowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientiPc 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 briewy explain why the item is not applicable/relevant for your study

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

Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briewy explain why the item is not applicable/relevant for your study "enrollees accessed content using the following URL: [https://www.marigoldstudy.org/alegrate/login/index.php]."

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 speciPc group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briewy explain why the item is not applicable/relevant for your study "Each participant logs in to the ¡Alégrate! Web-site using a unique username and password assigned by research staff-and, the tablet interface is customized with shortcuts for ease of navigation." subitem not at all important 1 2 3 4 5 essential 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 briewy explain why the item is not applicable/relevant for your study "Our 5-week ¡Alégrate! intervention delivers curricular content via didactic instruction (e.g., text, videos), journaling, and assigned at-home practice-all accessed online using investigator-purchased tablet computers. The website was designed and managed by Michael Cohn, a co-investigator of ¡Alégrate!. This Pve-session, multi-component Web-based intervention, instructs on eight emotion regulation skills which have proven eycacious for increasing positive emotion and decreasing symptoms of depression and psychological distress in patients with varying chronic illness diagnoses, i.e., those with metastatic breast cancer, HIV, and type 2 diabetes [39,41,42]. Detailed description of the curricula is published elsewhere [43]. Briewy, eight empirically validated behavioral and cognitive skills are taught via our Web-based interface, and include the following: (1) identiPcation and use of personal strengths;

5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework
(2) noticing of positive events in daily life; (3) prolonged appreciation and relishing of positive events; (4) positive reappraisal of stressful events or situations; (5) gratitude; (6) regular practice of mindfulness and meditation; (7) setting and working toward pragmatic and achievable goals; and (8) planning and performing acts of kindness. We have previously tested in-person delivery of MARIGOLD in the Spanish language [19]." "Participants randomly assigned to the active control condition are asked to visit the study site where they report their emotions (e.g., grateful, happy, guilty, relieved, ashamed, etc.), thrice weekly, using the Differential Emotions Scale (DES), but-they are not granted access to curricular content of our ¡Alégrate! positive psychological intervention."

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.
subitem not at all important 1 2 3 4 5 essential 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 briewy explain why the item is not applicable/relevant for your study "As such, participants are instructed to login to the ¡Alégrate! Web-site for 30 minute sessions at least three time per week. New skills are sequentially taught every week (see Table 1 for sequencing and content); to ensure successive instruction, new content only becomes available after a 7-day period and once participants have completed the prior week's content and at-home practice." "It takes 5-10 minutes to complete the DES on-line."

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).

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 briewy explain why the item is not applicable/relevant for your study "In addition, staff hold in-person 15-20 minute tutorials at baseline to familiarize enrollees on tablet use, with assurance of continual availability via phone or in-person to assist with any issues and to troubleshoot diyculties encountered with the technology." subitem not at all important 1 2 3 4 5 essential 5-xi) Repo" 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 briewy explain why the item is not applicable/relevant for your study "In addition to accessing our Web-based positive psychological intervention, participants also receive weekly phone calls and text messages to reinforce lessons learned and as a strategy to maximize retention and continued visitation to our study site. Weekly phone calls are brief, 10-15 minutes in duration, in which study staff review highlights of skills taught that week-along with tech support on any issues in handling the tablet computer or in navigating the ¡Alégrate! site. Finally, participants with cell phone capability receive a weekly text message from research staff highlighting the skills taught that week with the reminder to put them into daily practice-these, sometimes take the form of a 'meme' containing both images and text." "Concerted efforts are undertaken to promote retention among participants in the control arm, including postcard notices and phone calls to remind participants to engage in on-line emotion reporting and to appear, in-person, for scheduled clinical assessments." subitem not at all important 1 2 3 4 5 essential 6a) Completely de!ned pre-speci!ed primary and secondary outcome measures, including how and when they were assessed

5-xii) Describe any co-interventions (incl. training/suppo")
Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability. Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briewy explain why the item is not applicable/relevant for your study Not applicable; the pilot trial does not include any co-interventions.
subitem not at all important 1 2 3 4 5 essential 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 briewy explain why the item is not applicable/relevant for your study "Survey and clinical exams occur in tandem at three time points, as follows: Time 1 (baseline) at study enrollment; Time 2, immediately post-intervention (5-weeks after baseline); and Time 3 (12-weeks after baseline)." "Measures of sitting and ambulatory blood pressure serve as the primary outcomes for the current ¡Alégrate! trial. An ambulatory BP monitoring (ABPM) method will be used to capture 24-hour daytime and nighttime BP readings in the natural environment (UltraliteTM 90217A ABPM from Spacelabs Healthcare); this device has shown adequate reliability and accuracy. We will consider 24-hour mean systolic and diastolic readings." "We will additionally use an automatic sphygmomanometer to evaluate sitting BP. This measurement device has been validated across multiple cohort studies including MESA, NHANES, and HCHS/SOL. Three systolic and diastolic blood pressure readings will be taken with participants in the seated position; mean values will be obtained by averaging the last two readings." "SpeciPcally, secondary outcomes include: a) psychological well-being [depressive symptoms, perceived stress, positive and negative affect, optimism, emotional vitality, life engagement and meaning, happiness inducing behavior, and social support], (2) health behaviors [physical activity, diet, sodium intake, smoking status, sleep quality and duration, and mediation use], and (3)  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 dePned/measured/monitored (logins, logPle analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.

Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text "Finally, we will also analyze data describing overall use of the Web-site by trial participants, including the number of website logins per participant, average length of screen time per site visit, and extent to which enrollees completed and recorded practicing of at-home exercises." 6a-iii) Describe whether, how, and when qualitative feedback from pa"icipants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).
6b) Any changes to trial outcomes a#er the trial commenced, with reasons 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text "Additionally, we will conduct qualitative exit interviews to capture facilitators and barriers in using the tablet computer to access ¡Alégrate! curricular content. Indeed, qualitative process evaluation techniques further inform metrics of acceptability and utility for modality of content distribution." 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 briewy explain why the item is not applicable/relevant for your study Not applicable; study is on-going and changes to trial outcomes have not been made.

7a-i) Describe whether and how expected a'rition was taken into account when calculating the sample size
Describe whether and how expected attrition was taken into account when calculating the sample size.
7b) When applicable, explanation of any interim analyses and stopping guidelines 8a) Method used to generate the random allocation sequence

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 briewy explain why the item is not applicable/relevant for your study "We estimated the sample size requirements of a two-arm randomized trial to evaluate whether our Web-based positive psychological intervention results in differential and clinically meaningful improvements in systolic BP of 6 mmHg compared to an attention control condition. A repeated-measures design with systolic blood pressure determination at baseline, 5-and 12-weeks was used. In addition, the following operating characteristics were assumed: 1) a between-subject standard deviation for blood pressure of ; 2) a withinsubject correlation, 3) a two-sided type I error probability of 0.05; 4) 80% statistical power. 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 briewy explain why the item is not applicable/relevant for your study "In a supplementary analysis, we will use ordinary or logistic regression (as appropriate, given variable distribution) to implement a dose-response analysis to test whether participation-related factors (e.g., number of sessions viewed, rate of homework completion) impact outcomes of interest." 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 briewy explain why the item is not applicable/relevant for your study "The principal investigator created a random allocation table using Sealed Envelope, after which it was uploaded to REDCap to dePne the randomization model of ¡Alégrate! to ensure proper blocking and stratiPcation by sex [male, female] and use of antihypertensive medication [yes, no]." 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 briewy explain why the item is not applicable/relevant for your study "After completing baseline assessments, participants are randomly assigned in a 1:1 ratio to the intervention or active control condition using block randomization alternating between varying block sizes of four, six, or eight." 10) Who generated the random allocation sequence, who enrolled pa"icipants, and who assigned pa"icipants to interventions 11a) If done, who was blinded a#er assignment to interventions (for example, pa"icipants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briewy explain why the item is not applicable/relevant for your study "A trained research staff generated allocation assignment through REDCap; note, REDCap conceals the allocation table and associated sequencing from research staff to prevent selection bias." 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 briewy explain why the item is not applicable/relevant for your study The principal investigator created a random allocation

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).

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 briewy explain why the item is not applicable/relevant for your study "Finally, given the pilot nature of a Phase II trial, blinding occurs only at the level of data analysis." 11a-ii) Discuss e.g., whether pa"icipants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".

11b) If relevant, description of the similarity of interventions
(this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briewy explain why the item is not applicable/relevant for your study "The consent form and study materials outline the design of the study and inform participants of random assignment into one of two groups, either the group where 'they learn skills to boost their mood and positive emotions' or the group where 'they would report their emotions on a thrice-weekly basis.'" 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 briewy explain why the item is not applicable/relevant for your study "Participants in the both the treatment and control arms receive detailed handouts on how to operate the Samsung Galaxy Tab A tablet computer, along with instructions on connecting to Wi-Fi and accessing the ¡Alégrate! web-site. Handouts display textual instructions along with detailed step-by-step visual screenshots, along with a listing of Wi-Fi locations in the local neighborhood, e.g., coffee shops and public libraries or bookstores." 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 briewy explain why the item is not applicable/relevant for your study "Descriptive statistics, at baseline, will summarize participant characteristics for the full sample and stratiPed by intervention arm. Bivariate tests will be conducted to compare the intervention and control conditions to ensure compatibility across key variables (e.g., demographic factors, well-being proPles, etc.) and to test success of the randomization protocol." "Independent samples t-tests will be performed using 5-week systolic BP and diastolic BP as the dependent variables with treatment condition serving as the grouping variable. Other model-based approaches to handle missing data, such as weighted estimating equations, will be implemented. We will also use mixed effects models to compare changes in BP between the control and intervention arms as measured at baseline, 5 weeks, and 12 weeks. The independent variables include a time variable t (t = 0, 5, 12), a dummy variable N (N=1 if PP intervention group; N=0 if attention control), and a cross-product term (t X N). For ambulatory data collected across a 24-hour period, sensitivity analyses will compare mean overall daytime versus nighttime values of BP. All data analysis will be conducted using SAS 9.4 software (SAS Institute, Cary, NC)." "Similar analytic techniques will be implemented for Aim 2 as used for Aim 1. The interaction of Group x Time will test if greater improvements are evident for psychological well-being and engagement in healthful behaviors (e.g., dietary intake and self-reported physical activity) at 5-weeks post-baseline for the treatment arm as compared to the active control group. RM-ANOVA will also be used to examine whether the '¡Alégrate!' intervention is associated with greater improvements in psychological well-being and engagement in healthful behavior. In addition to reporting nominal p-values, we will document the number of tests conducted and associated Bonferroni correction. Finally, we will conduct mediation analysis to test whether psychological well-being and health behaviors serve as intermediates (or mediators) through which ¡Alégrate! impacts blood pressure control. Tests of mediation will follow recommendations of Shrout and Bolder to bootstrap product terms using Mplus. Given dependency of indirect effects on the time interval, for multiwave models we will compute overall, rather than time-speciPc, indirect effects." "Similar analytic techniques as previously described will be used when testing intervention effects on chronic inwammation. SpeciPcally, the term capturing Group x Time interaction will test whether lower levels of inwammation are evident at 8-weeks post-baseline for the intervention group vs. the active control arm." subitem not at all important 1 2 3 4 5 essential 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses 12a-i) Imputation techniques to deal with a'rition / 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 briewy explain why the item is not applicable/relevant for your study "Additionally, we will document the number of missing observations over time to assess potential for bias resulting from signiPcant dropout and differential attrition by condition.
We will perform independent sample t-tests and/or Fisher's exact tests to compare baseline characteristics of enrollees who completed the trial versus those who prematurely dropped out, allowing us to test possible predictors of attrition." "Sensitivity analysis will use multiple imputation procedures across missing values to ensure inclusion of all observations, particularly those resulting from participants who withdraw, are lost to follow-up, or do not complete all assessments." "Independent samples t-tests will be performed using 5-week systolic BP and diastolic BP as the dependent variables with treatment condition serving as the grouping variable. Other model-based approaches to handle missing data, such as weighted estimating equations, will be implemented."

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 briewy explain why the item is not applicable/relevant for your study "In a supplementary analysis, we will use ordinary or logistic regression (as appropriate, given variable distribution) to implement a dose-response analysis to test whether participation-related factors (e.g., number of sessions viewed, rate of homework completion) impact outcomes of interest."

X26-i) Comment on ethics commi'ee 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 briewy explain why the item is not applicable/relevant for your study "The Institutional Review Board at the University of Illinois at Urbana-Champaign (UIUC) approved the ¡Alégrate! trial and all subjects gave written informed consent." subitem not at all important 1 2 3 4 5 essential

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

Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briewy explain why the item is not applicable/relevant for your study "The consent form and study materials outline the design of the study and inform participants of random assignment into one of two groups, either the group where "they learn skills to boost their mood and positive emotions" or the group where "they would report their emotions on a thrice-weekly basis." It is communicated that all curricular instruction occurs on-line by visiting our ¡Alégrate! website. Additionally, staff inform participants that three in-person clinical visits are required, each 2-3 hour in length, where staff collect survey and clinical data, including collection of anthropometric information, blood spots, and 24-hour blood pressure monitoring; home visits are also offered for data collection to increase rates of retention. Participants are informed that they keep the investigator-purchased tablet computer at the end of the study as compensation for their participation and time invested [37]." "Participants expressing interest in enrolling in the trial who are screened for full eligibility and ultimately qualify, undergo a face-to-face consent process and complete the survey and clinical exams prior to randomization." subitem not at all important 1 2 3 4 5 essential RESULTS 13a) For each group, the numbers of pa"icipants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline)

Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briewy explain why the item is not applicable/relevant for your study "Note, all data will be de-identiPed, stored in a password protected computer, and/or will be stored in a locked cabinet in the principal investigator's oyce." "Each participant logs in to the ¡Alégrate! Web-site using a unique username and password assigned by research staff-and, the tablet interface is customized with shortcuts for ease of navigation. Participants are also instructed to password protect their tablet to mitigate any data breaches from outside parties." 13b) For each group, losses and exclusions a#er 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 briewy explain why the item is not applicable/relevant for your study Not applicable; data collection is on-going.
Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT &ow 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 briewy explain why the item is not applicable/relevant for your study Not applicable; data collection is on-going.

13b-i) A'rition 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 Pgures or tables demonstrating usage/dose/engagement.

14a) Dates de!ning the periods of recruitment and follow-up
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the Pgure 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 briewy explain why the item is not applicable/relevant for your study Not applicable; data collection is on-going.
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 briewy explain why the item is not applicable/relevant for your study "Activities of the Spanish-language ¡Alégrate! intervention were funded in 2017, and data collection is on-going. We expect to submit trial results for peer-reviewed publication in 2021, soon after recruitment has concluded and statistical analysis are Pnalized." 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signiPcant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" 14b) Why the trial ended or was stopped (early) 15) A 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 briewy explain why the item is not applicable/relevant for your study Not applicable; recruitment is on-going and no need to change computer hardware or delivery resources has emerged.
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 briewy explain why the item is not applicable/relevant for your study Not applicable; data collection is on-going.
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 briewy explain why the item is not applicable/relevant for your study Not applicable; data collection is on-going.

15-i) Repo" 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 briewy explain why the item is not applicable/relevant for your study Not applicable; data collection is on-going.

16-i) Repo" multiple "denominators" and provide de%nitions
Report multiple "denominators" and provide dePnitions: 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 speciPc pre-dePned time points of interest (in absolute and relative numbers per group). Always clearly dePne "use" of the intervention.
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 e&ect size and its precision (such as 95% con!dence interval) 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 briewy explain why the item is not applicable/relevant for your study "The independent variables include a time variable t (t = 0, 5, 12), a dummy variable N (N=1 if PP intervention group; N=0 if attention control), and a cross-product term (t X N)."

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 briewy explain why the item is not applicable/relevant for your study "Given our design and main objective of treatment evaluation, an intent-to-treat analysis will be conducted where we will consider data of all participants randomized-with retention of their original intervention assignment." subitem not at all important 1 2 3 4 5 essential 17b) For binary outcomes, presentation of both absolute and relative e&ect sizes is recommended 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 briewy explain why the item is not applicable/relevant for your study Not applicable; data collection is on-going.

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 dePnitions 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 dePned (e.g., timeout after idle time) [1] (report under item 6a).

Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briewy explain why the item is not applicable/relevant for your study Not applicable; data is on-going.

18)
Results of any other analyses pe'ormed, including subgroup analyses and adjusted analyses, distinguishing pre-speci!ed from exploratory subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briewy explain why the item is not applicable/relevant for your study Not applicable; data collection is on-going.
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 briewy explain why the item is not applicable/relevant for your study Not applicable; data collection is on-going.

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

19) All impo"ant harms or unintended e&ects in each group
(for speciPc guidance see CONSORT for harms) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briewy explain why the item is not applicable/relevant for your study Not applicable; data collection is on-going.

Does your paper address CONSORT subitem 19? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briewy explain why the item is not applicable/relevant for your study "Note, all data will be de-identiPed, stored in a password protected computer, and/or will be stored in a locked cabinet in the principal investigator's oyce." "Each participant logs in to the ¡Alégrate! Web-site using a unique username and password assigned by research staff-and, the tablet interface is customized with shortcuts for ease of navigation. Participants are also instructed to password protect their tablet to mitigate any data breaches from outside parties."

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

DISCUSSION
Does your paper address subitem 19-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briewy explain why the item is not applicable/relevant for your study "Each participant logs in to the ¡Alégrate! Web-site using a unique username and password assigned by research staff-and, the tablet interface is customized with shortcuts for ease of navigation. Participants are also instructed to password protect their tablet to mitigate any data breaches from outside parties." 19-ii) Include qualitative feedback from pa"icipants or observations from sta$/researchers Include qualitative feedback from participants or observations from staff/researchers, if available, on strengths and shortcomings of the application, especially if they point to unintended/unexpected effects or uses. This includes (if available) reasons for why people did or did not use the application as intended by the developers.

Does your paper address subitem 19-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briewy explain why the item is not applicable/relevant for your study 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 subitem not at all important 1 2 3 4 5 essential 22-i) Restate study questions and summarize the answers suggested by the data, sta"ing with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).

Does your paper address subitem 22-i? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briewy explain why the item is not applicable/relevant for your study Not applicable; data collection is on-going. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briewy explain why the item is not applicable/relevant for your study "Future trials may want to explore more user-friendly modalities that require little to no coaching that may be more appealing to less technological savvy community members."

22-ii) Highlight unanswered new questions, suggest future research
"Future trials may want to deploy a more active control condition where participant's access Web-based content unrelated to the outcome of interest, e.g., money management skills." "How might technology be deployed within a more user-friendly interface for those with limited exposure to technology or those with little formal educational training who experience literacy challenges?"

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

21) Generalisability (external validity, applicability) of the trial !ndings
NPT: External validity of the trial Pndings according to the intervention, comparators, patients, and care providers or centers involved in the trial subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briewy explain why the item is not applicable/relevant for your study "Selective enrollment has the potential to introduce bias as Hispanics/Latinos with limited technological proPciency may decline to participate in the trial, or if enrolled, may have diyculty in connecting to Wi-Fi or in navigating the study site." "We are recruiting in a Chicago-based neighborhood with a large populace of Hispanics/Latino adults, the majority of which are of Mexican ancestry. Thus, Pndings of the trial may not generalize to the wider more heterogeneous Hispanic/Latino population across the U.S. with differences by country of origin, nativity status, and level of acculturation." "Finally, blinding occurs only at the level of data analysis and both trial participants and assessors (research staff collecting outcome data) are aware of randomization assignment, which can introduce unintended bias."

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations subitem not at all important 1 2 3 4 5 essential

OTHER INFORMATION
Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briewy explain why the item is not applicable/relevant for your study "We are recruiting in a Chicago-based neighborhood with a large populace of Hispanics/Latino adults, the majority of which are of Mexican ancestry. Thus, Pndings of the trial may not generalize to the wider more heterogeneous Hispanic/Latino population across the U.S. with differences by country of origin, nativity status, and level of acculturation."

21-ii) Discuss if there were elements in the RCT that would be di$erent in a routine application se'ing
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.

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 briewy explain why the item is not applicable/relevant for your study "Finally, we provided all enrollees with an investigator-purchased tablet computer and we developed detailed Spanish-language user guides (with screenshots) to assist participants in accessing our website-with, research staff available via phone for additional tech support."

OTHER INFORMATION
23) Registration number and name of trial registry 24) Where the full trial protocol can be accessed, if available 25) Sources of funding and other suppo" (such as supply of drugs), role of funders Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briewy explain why the item is not applicable/relevant for your study "This work was funded by the Rosenfeld Heart Foundation and is registered at clinicaltrials.gov under registration number NCT03892057." Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briewy explain why the item is not applicable/relevant for your study Description of the full trial protocol can be accessed at clinicaltrials.gov under registration number NCT03892057.

X27) Con(icts of Interest (not a CONSORT item)
subitem not at all important 1 2 3 4 5 essential About the CONSORT EHEALTH checklist Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briewy explain why the item is not applicable/relevant for your study "Additionally, research reported in this publication was supported, in part, by the National Heart, Lung, and Blood Institute under award number 1K01HL130712 and the National Institute on Minority Health and Health Disparities of the National Institutes of Health (NIH) under award number U54MD012523."

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

Does your paper address subitem X27-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 briewy explain why the item is not applicable/relevant for your study "The authors have no conwicts of interest in this work. None declared." About the CONSORT EHEALTH checklist yes, major changes yes, minor changes no yes no Other: As a result of using this checklist, did you make changes in your manuscript? * What were the most impo"ant changes you made as a result of using this checklist?

Your answer
How much time did you spend on going through the checklist INCLUDING making changes in your manuscript *

hours
As a result of using this checklist, do you think your manuscript has improved? * yes no Other: STOP -Save this form as PDF before you click submit To generate a record that you Plled 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.
When you submit your (revised) paper to JMIR, please upload the PDF as supplementary Ple.
Don't worry if some text in the textboxes is cut off, as we still have the complete information in our database. Thank you! Would you like to become involved in the CONSORT EHEALTH group?
This would involve for example becoming involved in participating in a workshop and writing an "Explanation and Elaboration" document