Multicomponent mHealth Intervention for Large, Sustained Change in Multiple Diet and Activity Risk Behaviors: The Make Better Choices 2 Randomized Controlled Trial

Background Prevalent co-occurring poor diet and physical inactivity convey chronic disease risk to the population. Large magnitude behavior change can improve behaviors to recommended levels, but multiple behavior change interventions produce small, poorly maintained effects. Objective The Make Better Choices 2 trial tested whether a multicomponent intervention integrating mHealth, modest incentives, and remote coaching could sustainably improve diet and activity. Methods Between 2012 and 2014, the 9-month randomized controlled trial enrolled 212 Chicago area adults with low fruit and vegetable and high saturated fat intakes, low moderate to vigorous physical activity (MVPA) and high sedentary leisure screen time. Participants were recruited by advertisements to an open-access website, screened, and randomly assigned to either of two active interventions targeting MVPA simultaneously with, or sequentially after other diet and activity targets (N=84 per intervention) or a stress and sleep contact control intervention (N=44). They used a smartphone app and accelerometer to track targeted behaviors and received personalized remote coaching from trained paraprofessionals. Perfect behavioral adherence was rewarded with an incentive of US $5 per week for 12 weeks. Diet and activity behaviors were measured at baseline, 3, 6, and 9 months; primary outcome was 9-month diet and activity composite improvement. Results Both simultaneous and sequential interventions produced large, sustained improvements exceeding control (P<.001), and brought all diet and activity behaviors to guideline levels. At 9 months, the interventions increased fruits and vegetables by 6.5 servings per day (95% CI 6.1-6.8), increased MVPA by 24.7 minutes per day (95% CI 20.0-29.5), decreased sedentary leisure by 170.5 minutes per day (95% CI –183.5 to –157.5), and decreased saturated fat intake by 3.6% (95% CI –4.1 to –3.1). Retention through 9-month follow-up was 82.1%. Self-monitoring decreased from 96.3% of days at baseline to 72.3% at 3 months, 63.5% at 6 months, and 54.6% at 9 months (P<.001). Neither attrition nor decline in self-monitoring differed across intervention groups. Conclusions Multicomponent mHealth diet and activity intervention involving connected coaching and modest initial performance incentives holds potential to reduce chronic disease risk. Trial Registration ClinicalTrials.gov NCT01249989; https://clinicaltrials.gov/ct2/show/NCT01249989 (Archived by WebCite at https://clinicaltrials.gov/ct2/show/NCT01249989).

yes: all primary outcomes were signi cantly better in intervention group vs control partly: SOME primary outcomes were signi cantly better in intervention group vs control no statistically signi cant difference between control and intervention potentially harmful: control was signi cantly better than intervention in one or more outcomes inconclusive: more research is needed Other: Approx. Percentage of Users (starters) still using the app as recommended after 3 months * Overall, was the app/intervention effective? * TITLE AND ABSTRACT 1a) TITLE: Identi cation as a randomized trial in the title yes Other: subitem not at all important 1 2 3 4 5 essential Manuscript tracking number * If this is a JMIR submission, please provide the manuscript tracking number under "other" (The ms tracking number can be found in the submission acknowledgement email, or when you login as author in JMIR. If the paper is already published in JMIR, then the ms tracking number is the four-digit number at the end of the DOI, to be found at the bottom of each published article in JMIR) JMIR 10528 1a) Does your paper address CONSORT item 1a? * I.e does the title contain the phrase "Randomized Controlled Trial"? (if not, explain the reason under "other") 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.
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 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 "mHealth" 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 Yes: "Multicomponent" 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 Yes: target population are those with "multiple diet and activity risk behaviors" 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 brie y explain why the item is not applicable/relevant for your study "The Make Better Choices 2 (MBC2) trial tested whether a multicomponent intervention integrating mHealth, modest incentives, and remote coaching could sustainably improve diet and activity." "Participants were randomly assigned to either of two active interventions targeting MVPA Simultaneously with or Sequentially after other diet and activity targets or a stress and sleep contact control intervention." 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 "They used an app and accelerometer to track targeted behaviors and receive personalized remote coaching." 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). Note: In traditional o ine trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered. To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e. participants can self-enrol). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-iii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Participants were recruited by advertisements to an open-access website, screened, and randomly assigned to either of two active interventions targeting MVPA Simultaneously with or Sequentially after other diet and activity targets or a stress and sleep contact control intervention. They used an app and accelerometer to track targeted behaviors and receive personalized remote coaching from trained paraprofessionals." 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 "The 9-month RCT enrolled 212 Chicago area adults between 2012-2014 with low fruit and vegetable and high saturated fat intakes, low moderate vigorous physical activity (MVPA) and high sedentary leisure screen time. Participants were recruited by advertisements to an open-access website, screened, and randomly assigned to either of two active interventions targeting MVPA Simultaneously with (N=84) or Sequentially after (N=84) other diet and activity targets or a stress and sleep contact control intervention (N=44). They used an app and accelerometer to track targeted behaviors and receive personalized remote coaching from trained paraprofessionals. Perfect behavioral adherence was incentivized $5/week for 12 weeks. Diet and activity behaviors were measured at baseline, 3, 6, and 9 months; primary outcome was 9-month diet and activity composite improvement." "Both Simultaneous and Sequential interventions produced large, sustained improvements exceeding Control (p<.001), and bringing all diet and activity behaviors to guideline levels. At 9 months, the interventions increased fruit/vegetables by 6.5 servings/day, 95% CI [6. 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 "We hypothesized that community dwelling adults with multiple diet and activity risk behaviors could be activated to achieve and maintain guideline levels of these behaviors by a scalable, multicomponent intervention that integrates mHealth technology, modest incentives, and remote connected coaching." 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 "... a 3-arm prospective randomized controlled trial which compared two sequences of diet and activity intervention to a contact-control intervention. The active interventions targeted MVPA either simultaneously with (Simultaneous) or sequentially after (Sequential) other diet and activity risk behaviors (fruit/vegetables, sedentary leisure screen time). The control intervention addressed stress and sleep. Eligible participants were strati ed by gender and individually randomized to a condition using randomly permuted blocks with an allocation ratio of 2:2:1 (Simultaneous: Sequential: Control). " subitem not at all important 1 2 3 4 5 essential 4a) Eligibility criteria for participants 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 "Bankruptcy of the mobile phone service provider necessitated the return and provision of new mobile phones, creating a budget shortfall that required reducing enrollment from 250 to 212 participants. " 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 N/A 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 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 "Inclusion criteria were willingness to be randomized, age 18-65 years, and met all of the following: <5 servings of fruits and vegetables/day; ≥8% daily calories from saturated fat; <150 minutes/week MVPA; >120 minutes/week of leisure screen time (i.e., television, movies, videogames, recreational internet. These discretionary activities were targeted because they can be decreased without jeopardizing necessary work-related activities). Exclusion criteria were unstable medical condition (i.e. uncontrolled hypertension or diabetes), pregnancy or intent to become pregnant, anorexia, bulimia, or binge eating disorder."

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 Implicit: could be trained to use the app 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.
subitem not at all important 1 2 3 4 5 essential 4b) Settings and locations where the data were collected Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Participants were recruited by advertisements to an open-access website." 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

Consent document included as supplementary material
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 Participants recorded behavioral data via the smartphone app and accelerometer as they went about their daily activities, so study data was collected in each participant's individual natural life setting.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5) The interventions for each group with su cient details to allow replication, including how and when they were actually administered 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 Primary outcome data were reported via smartphone app and measured by accelerometer.

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) 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 Your answer Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study App was locally custom-designed by grant-funded support staff programmers 5-ii) Describe the history/development process Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.
Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study

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 App was frozen during the trial except for one update to the food database

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 brie y explain why the item is not applicable/relevant for your study N/A subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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 Screenshots of the MBC2 app appear in the TOC photo provided, and are also shown in the published design paper, attached as supplementary information

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.
Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Screenshots are published in the appended design paper.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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 Participants accessed the internet through study-provided smartphones via studycontracted telecommunications provider. A version of the app, personalized to their assigned study condition was downloaded from Google Play and then locally installed onto their phone. 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 brie y explain why the item is not applicable/relevant for your study "Inclusion of intervention components was guided by three principleseffectiveness, scalability, and synergy. Telephone coaching was used because it is more scalable than in-person counseling and has demonstrated effectiveness. [31,32] Since remote coaching produces smaller behavior changes than in-person treatment but larger magnitude changes are maintained better, [32,33] we used modest incentives to maximize initial behavior change. [34,35] A smartphone app and accelerometer were used to provide diet and physical activity feedback synchronously to participants and their coaches, enabling connected, maximally personalized, adaptive coaching."

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 "Those receiving Simultaneous treatment were asked to gradually modify all 3 target behaviors from the outset of the intervention. Those receiving Sequential treatment were asked to modify only sedentary leisure screen time and fruit/vegetables for the rst 6 weeks. Between weeks 7-12, they were asked to maintain goal levels for leisure screen time and fruit/vegetables, while progressively increasing MVPA. Control participants were coached to perform 3 relaxation exercises/day and achieve end goals of ≥7.5 hours of sleep/day and a 30% reduction in stress over the 12-week intervention." 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 brie y explain why the item is not applicable/relevant for your study "During treatment initiation (weeks 1-12), a trained paraprofessional telephoned each participant weekly for a 10-15 minute coaching session. Coaches delivered a sequence of online didactic lessons speci c to each condition[37] and used motivational interviewing to tailor counseling using data from the participant's app and accelerometer. Call frequency decreased to bi-weekly in weeks 13-24 and monthly in weeks 25-40." 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 None used 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/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 standalone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability. Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "After screening, eligible candidates attended an in-person session where they discussed the three treatment options' pros and cons, provided written informed consent, and were loaned a smartphone and accelerometer. They were trained to estimate portion sizes, use the assessment version of a custom-built smartphone app to record behaviors (dietary intake, leisure screen time, stress level, relaxation exercises, and sleep), and wear an accelerometer for a baseline week." "During treatment initiation (weeks 1-12), a trained paraprofessional telephoned each participant weekly for a 10-15 minute coaching session. Coaches delivered a sequence of online didactic lessons speci c to each condition[37] and used motivational interviewing to tailor counseling using data from the participant's app and accelerometer. Call frequency decreased to bi-weekly in weeks 13-24 and monthly in weeks 25-40." 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 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The primary trial outcome was the composite diet and activity improvement score measured during 1-week assessment periods at 3, 6, and 9 months when participants wore an accelerometer and used the assessment app to self-monitor their behaviors without receiving any feedback. Secondary outcomes were healthy change in fruits/vegetables, saturated fat, MVPA, and leisure screen time.
6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed If outcomes were obtained through online questionnaires, describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed [9].
Does your paper address subitem 6a-i?
Copy and paste relevant sections from manuscript text N/A 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.
subitem not at all important 1 2 3 4 5 essential 6b) Any changes to trial outcomes after the trial commenced, with reasons 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text "Treatment receipt was measured by the percent of scheduled coaching calls completed. Self-monitoring adherence was assessed by the proportion of days participant used the app and wore the accelerometer to track behaviors during 1week assessments at baseline, 3, 6, and 9 months." 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 Your answer Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No changes to outcomes after commencement of trial.
subitem not at all important 1 2 3 4 5 essential 7b) When applicable, explanation of any interim analyses and stopping guidelines 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size Describe whether and how expected attrition was taken into account when calculating the sample size.
Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The average effect size (mean difference in composite diet and activity improvement Z-score divided by common standard deviation) in our previous MBC1 trial equaled 0.46. Based on our power calculations, we aimed to recruit 50 control subjects and 100 subjects into each of the two intervention groups, assuming a correlation of 0.50 for the composite z scores across time and an attrition rate of 20% at the nal time point. We powered the study for an effect size in the range of 0.5 for the rst Helmert contrast (H1: Simultaneous + Sequential versus control) and 0.4 for the second Helmert contrast (H2: Simultaneous vs. Sequential). Bankruptcy of the mobile phone service provider necessitated the return and provision of new mobile phones, creating a budget shortfall that required reducing enrollment from 250 to 212 participants: 84 allocated to the Simultaneous intervention; 84 allocated to Sequential; and 44 to Control. However, because the observed correlation of the composite z scores over time was smaller (r=0.44) than the predicted 0.50, the study remained su ciently powered for the posited effect sizes. " 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 Not applicable, no interim analyses conducted or stopping guidelines speci ed. 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 The random allocation sequence was computer-generated in R, using randomly permuted blocks.
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 Randomly permuted blocks were of size 5 with 2 simultaneous, 2 sequential, and 1 control assignment in each block; these randomly permuted blocks were strati ed by gender.
10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Participants learned their treatment assignment by downloading one of three custom-built, intervention-speci c study apps.
[36] Each app prompted recording of only those behaviors the intervention targeted (i.e., dietary intake, sedentary leisure, and MVPA for the Simultaneous and Sequential conditions; stress, relaxation exercises, and sleep for Control). " 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 Study statisticians (DH, JS) generated the random allocation sequence. Coaches screened and enrolled participants. Coaches learned the participant's treatment assignment at the same time as participants did (i.e., when participant downloaded the intervention-speci c study app). Coaches were blinded to treatment allocation prior to the app download.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering 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 brie y explain why the item is not applicable/relevant for your study Once participants were allocated to treatment, study personnel were not blinded to treatment assignment.
11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".
Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study " After screening, eligible candidates attended an in-person session where they discussed the three treatment options' pros and cons." This "equipoise induction" prompted participants to think about the advantages and disadvantages of all three intervention conditions equally.
https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1 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 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 All 3 conditions involved equal treatment burden, by requiring self-monitoring of the same number of behaviors and receipt of the same number of coaching calls.
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 "Intent-to-treat analyses of primary and secondary endpoints used 3-level linear mixed-effects models that treated daily measurements (level 1) nested within oneweek assessment periods (level 2) nested within subjects (level 3). Thus, we analyzed at the daily level and considered the correlation of the daily measurements within weeks and subjects by including random subject intercept and time trends at level 3 (subjects), and a random intercept at level 2 (one-week assessment periods). For comparisons across assessment periods, we treated baseline as the reference, and estimated changes at 3-, 6-, and 9-month follow-up. For comparisons between the intervention groups we used Helmert contrasts, in which the rst contrast compared the combined Simultaneous and Sequential groups to Control, and the second contrast compared the Simultaneous to the Sequential group. We also included group by time interactions to assess the degree to which change from baseline varied for either of the Helmert contrasts at each follow-up. " 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 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 Our modeling approach was to use linear mixed models for longitudinal data. This class of models does not require that subjects are measured at all time points, and therefore can include subjects with missing data across time. All randomized participants were included in analyses of primary and secondary outcomes.

X26) REB/IRB Approval and Ethical Considerations [recommended as subheading under "Methods"] (not a CONSORT item)
Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No subgroup analyses were performed. Additional analyses of treatment delity and adherence were conducted as follows: "Three components of treatment implementation were assessed: delity, receipt, and adherence. Fidelity was considered present for sessions when the coach delivered all required treatment elements correctly (e.g., encouraging a Control participant to go to bed earlier) and absent if the coach delivered any incorrect treatment element (e.g., encouraging a Control participant to exercise in order to be tired at bedtime). Treatment receipt was measured by the percent of scheduled coaching calls completed. Self-monitoring adherence was assessed by the proportion of days participant used the app and wore the accelerometer to track behaviors during 1-week assessments at baseline, 3, 6, and 9 months. Goal attainment was assessed by the proportion of weeks during treatment initiation when the participant met behavioral goals." "Baseline characteristics were compared across groups using ANOVA for continuous variables and chi-squared tests for categorical variables. The percentage of coaching calls received and completed in the rst versus the second six weeks of treatment was analyzed using repeated measures ANOVA. The percentage of days participants adhered to self-monitoring was measured at baseline, 3-, 6-, and 9months and analyzed using repeated measures ANOVA. Goal attainment (yes/no), measured every two weeks during treatment initiation, was analyzed using mixedeffects logistic regression with time modeled as either the rst or the second 6weeks of initiation. All models of treatment receipt, adherence, and goal attainment included group by time interactions to assess differences between groups at each time point. " subitem not at all important 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 "After screening, eligible candidates attended an in-person session where they discussed the three treatment options' pros and cons, provided written informed consent, and were loaned a smartphone and accelerometer"

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 13b) For each group, losses and exclusions after randomisation, together with reasons 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 "During treatment initiation (weeks 1-12), a trained paraprofessional telephoned each participant weekly for a 10-15 minute coaching session. Coaches delivered a sequence of online didactic lessons speci c to each condition[37] and used motivational interviewing to tailor counseling using data from the participant's app and accelerometer. Call frequency decreased to bi-weekly in weeks 13-24 and monthly in weeks 25-40." 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 See Figure 1 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 brie y explain why the item is not applicable/relevant for your study See Figure 1 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1 subitem not at all important 1 2 3 4 5 essential 14a) Dates de ning the periods of recruitment and follow-up 13b-i) Attrition diagram Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other gures or tables demonstrating usage/dose/engagement. Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the gure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Loss to follow-up was 17.9% and not differential across treatments (Figure 1). In the composite z analysis, 84.0% of participants provided a composite z score at two or more time points; 68.4% provided 3 or more; and 50.0% provided all four time points.
Receipt of calls declined from 66.0% during the rst half of treatment initiation to 57.7% during the second half [F(1, 209)=12.05, p<.001], not differing among treatment groups (61.9%; 95% CI, 58.065.7; p = .12). Self-monitoring decreased from an average of 96.3% at baseline to 72.3% at 3 months, 63.5% at 6 months, and 54.6% at 9 months (F(3, 627)= 95.0, (p<.001), without differences across intervention groups (p=.406). Goal attainment was greater for the Active intervention groups (58.8%, 95% CI 52.2%, 65.0%) than Control (33.6%, 95% CI 23.1%, 46.0%) during the rst half of treatment initiation, (z=3.46, p< 0.001), but Active and Control groups did not differ during the last half of treatment (38.3%, 95% CI 32.6%, 44.2%) (z=0.13, p=0.894)." 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 study was conducted in Chicago between July 2012 and July 2014." subitem not at all important 1 2 3 4 5 essential 14b) Why the trial ended or was stopped (early) 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 "Bankruptcy of the mobile phone service provider necessitated the return and provision of new mobile phones, creating a budget shortfall that required reducing enrollment from 250 to 212 participants: 84 allocated to the Simultaneous intervention; 84 allocated to Sequential; and 44 to Control. However, because the observed correlation of the composite z scores over time was smaller (r=0.44) than the predicted 0.50, the study remained su ciently powered for the posited effect sizes." 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 "Bankruptcy of the mobile phone service provider necessitated the return and provision of new mobile phones, creating a budget shortfall that required reducing enrollment from 250 to 212 participants: 84 allocated to the Simultaneous intervention; 84 allocated to Sequential; and 44 to Control. However, because the observed correlation of the composite z scores over time was smaller (r=0.44) than the predicted 0.50, the study remained su ciently powered for the posited effect sizes." 15) A Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study See 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 See Table 1 subitem not at all important 1 2 3 4 5 essential 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-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 See Figure 1 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 "Intent-to-treat analyses of primary and secondary endpoints used 3-level linear mixed-effects models that treated daily measurements (level 1) nested within oneweek assessment periods (level 2) nested within subjects (level 3)." subitem not at all important 1 2 3 4 5 essential 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 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 See Table 2 17a-i) Presentation of process outcomes such as metrics of use and intensity of use In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational de nitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is de ned (e.g., timeout after idle time) [1] (report under item 6a).
Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 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 Not applicable 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 Pre-speci ed comparisons: "For comparisons across assessment periods, we treated baseline as the reference, and estimated changes at 3-, 6-, and 9-month follow-up. For comparisons between the intervention groups we used Helmert contrasts, in which the rst contrast compared the combined Simultaneous and Sequential groups to Control, and the second contrast compared the Simultaneous to the Sequential group. We also included group by time interactions to assess the degree to which change from baseline varied for either of the Helmert contrasts at each follow-up." "The combined Simultaneous and Sequential interventions produced sustained improvement, as compared to Control, on the composite diet and activity score at 3, 6, and 9 months (p<.001) (See Table 2 and Figure 2A). Sequential treatment produced a small, signi cantly greater composite diet and activity improvement than Simultaneous treatment at 6 months (p=.025); however, no differences were evident at 3 and 9 months (see Table 2 and Figure 2B). "

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 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 N/A 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 20) Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses 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 Primary="These ndings support the hypothesis that adults with multiple diet and activity risk behaviors can be activated to make and maintain large improvements in diet and activity behaviors by a scalable, multicomponent intervention that integrates mHealth technology, modest incentives, and remote connected coaching by trained paraprofessionals. Both active MBC2 interventions produced larger sustained improvements in fruit/vegetables, saturated fat, physical activity, and sedentary leisure screen time than those observed in most prior trials, including our MBC1 study, such that all four behaviors surpassed guideline recommended levels at the nal study follow-up. Also, unlike the prior MBC1 interventions, both active MBC2 interventions yielded a sustained increase in MVPA documented by accelerometry."

22-ii) Highlight unanswered new questions, suggest future research
Highlight unanswered new questions, suggest future research.
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 "Although intervention bene ts persisted through 9 months, longer duration followup remains needed. " subitem not at all important 1 2 3 4 5 essential 21) Generalisability (external validity, applicability) of the trial ndings NPT: External validity of the trial ndings according to the intervention, comparators, patients, and care providers or centers involved in the trial 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.
Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The study also had limitations. Three of four behavioral outcomes were assessed exclusively by self-report and could have been subject to demand characteristics. Fruit and vegetable consumption may have been overestimated and time spent in leisure sedentary screen time underestimated. However, although some risk of bias persists, the objective accelerometer derived measure of MVPA also showed large, sustained improvement following the active interventions. Although intervention bene ts persisted through 9 months, longer duration follow-up remains needed. A lack of sustained superiority of sequential over simultaneous treatment could have been caused by the fact that goal progression was time dependent, rather than mastery-based. The Sequential intervention added a physical activity goal at week 7, regardless of whether participants had achieved mastery of their fruit/vegetable or sedentary leisure screen time goals. It remains possible that Sequential treatment could have increased MVPA even more if the addition of this new target goal had been delayed until initial behavior targets were reached. " subitem not at all important 1 2 3 4 5 essential 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 Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "MBC2's $5/week incentive for participants to meet behavioral goals during treatment initiation apparently had the intended effect of motivating participants to make large improvements. Notably, MBC2 participants made somewhat larger diet and activity improvements than those in MBC1, even though the MBC2 incentive was 2/3 smaller. Moreover, no incentive to sustain healthful diet and activity changes was operative in either the MBC1 or MBC2 trial; nevertheless, behavioral improvements were maintained. Hence, these ndings contradict the worry that use of incentives followed by their discontinuation inevitably undermines behavioral maintenance. Results accord with a growing body of evidence showing sustained improvements after incentives cease. [34,35] Potential scalability of modest incentives is suggested by Centers for Medicare and Medicaid reimbursement of contingency contracting for some habit disorders, and by the growing number of individuals and employers that nd incentives for healthy lifestyle change cost effective.
[57] " "Including behavior change coaching as a service provided by trained paraprofessionals or arti cially intelligent agents could soon make technologysupported behavioral interventions a scalable part of the health care system. " 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 brie y explain why the item is not applicable/relevant for your study Increasing numbers of worksite wellness programs provide either local or distance coaching and deploy incentives for self-monitoring and behavior change. "Potential scalability of modest incentives is suggested by Centers for Medicare and Medicaid reimbursement of contingency contracting for some habit disorders, and by the growing number of individuals and employers that nd incentives for healthy lifestyle change cost effective.
[57] " 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 brie y explain why the item is not applicable/relevant for your study "Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique Identi er: NCT01249989 " subitem not at all important 1 2 3 4 5 essential About the CONSORT EHEALTH checklist yes, major changes yes, minor changes no X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests ( nancial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.
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 brie y explain why the item is not applicable/relevant for your study "Con ict of Interest Disclosures Authors report no con icts of interest." Funder is NIH; Developers have no commercial interest in the technologies As a result of using this checklist, did you make changes in your manuscript? * What were the most important changes you made as a result of using this checklist? STOP -Save this form as PDF before you click submit To generate a record that you lled in this form, we recommend to generate a PDF of this page (on a Mac, simply select "print" and then select "print as PDF") before you submit it.
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This would involve for example becoming involved in participating in a workshop and writing an "Explanation and Elaboration" document Any other comments or questions on CONSORT EHEALTH Your answer