Mobile Technology for Vegetable Consumption: A Randomized Controlled Pilot Study in Overweight Adults

Background Mobile apps present a potentially cost-effective tool for delivering behavior change interventions at scale, but no known studies have tested the efficacy of apps as a tool to specifically increase vegetable consumption among overweight adults. Objective The purpose of this pilot study was to assess the initial efficacy and user acceptability of a theory-driven mobile app to increase vegetable consumption. Methods A total of 17 overweight adults aged 42.0 (SD 7.3) years with a body mass index (BMI) of 32.0 (SD 3.5) kg/m2 were randomized to the use of Vegethon (a fully automated theory-driven mobile app enabling self-monitoring of vegetable consumption, goal setting, feedback, and social comparison) or a wait-listed control condition. All participants were recruited from an ongoing 12-month weight loss trial (parent trial). Researchers who performed data analysis were blinded to condition assignment. The primary outcome measure was daily vegetable consumption, assessed using an adapted version of the validated Harvard Food Frequency Questionnaire administered at baseline and 12 weeks after randomization. An analysis of covariance was used to assess differences in 12-week vegetable consumption between intervention and control conditions, controlling for baseline. App usability and satisfaction were measured via a 21-item post-intervention questionnaire. Results Using intention-to-treat analyses, all enrolled participants (intervention: 8; control: 9) were analyzed. Of the 8 participants randomized to the intervention, 5 downloaded the app and logged their vegetable consumption a mean of 0.7 (SD 0.9) times per day, 2 downloaded the app but did not use it, and 1 never downloaded it. Consumption of vegetables was significantly greater among the intervention versus control condition at the end of the 12-week pilot study (adjusted mean difference: 7.4 servings; 95% CI 1.4-13.5; P=.02). Among secondary outcomes defined a priori, there was significantly greater consumption of green leafy vegetables, cruciferous vegetables, and dark yellow vegetables (adjusted mean difference: 2.6, 1.6, and 0.8 servings; 95% CI 0.1-5.0, 0.1-3.2, and 0.3-1.4; P=.04, P=.04, and P=.004, respectively). Participants reported positive experiences with the app, including strong agreement with the statements “I have found Vegethon easy to use” and “I would recommend Vegethon to a friend” (mean 4.6 (SD 0.6) and 4.2 (SD 0.8), respectively, (on a 5-point scale). Conclusions Vegethon demonstrated initial efficacy and user acceptability. A mobile app intervention may be useful for increasing vegetable consumption among overweight adults. The small sample size prevented precise estimates of effect sizes. Given the improved health outcomes associated with increases in vegetable consumption, these findings indicate the need for larger, longer-term evaluations of Vegethon and similar technologies among overweight adults and other suitable target groups. Trial Registration ClinicalTrials.gov NCT01826591; https://clinicaltrials.gov/ct2/show/NCT01826591 (Archived by WebCite at http://www.webcitation.org/6hYDw2AOB)

1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.

1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT
Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Keep in mind the needs of systematic reviewers and indexers by including important synonyms. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "[Participants were] randomized to the use of Vegethon (a fully automated theorydriven mobile app enabling selfmonitoring of vegetable consumption, goal setting, feedback, and social comparison) or a waitlisted control condition." 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "fully automated" 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials). Note: In traditional offline trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered. To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e. participants can self-enrol). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important essential 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 briefly explain why the item is not applicable/relevant for your study "All participants were recruited from an ongoing 12month weight loss trial (parent trial). Participants and researchers who performed data analysis were blinded to condition assignment. The primary outcome measure was daily vegetable consumption, assessed using an adapted version of the validated Harvard Food Frequency Questionnaire (FFQ) administered at baseline and 12 weeks postrandomization." 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) 1 2 3 4 5 subitem not at all important essential 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 briefly explain why the item is not applicable/relevant for your study "Using intentiontotreat analyses, all enrolled participants (intervention: 8; control: 9) were analyzed. Of the 8 participants randomized to the intervention, 5 downloaded the app and logged their vegetable consumption a mean of 0.7 (SD=0.9) times per day, 2 downloaded the app but did not use it, and 1 never downloaded it." "Consumption of vegetables was significantly greater among the intervention vs. control condition at the end of the 12week pilot study (adjusted mean difference: 7.4 servings; 95% CI: 1.4, 13.5; p=0.02). Among secondary outcomes defined a priori, there was significantly greater consumption of green leafy vegetables, dark yellow vegetables, and cruciferous vegetables (adjusted mean difference: 2.6; 1.6; and 0.8 servings; 95% CI: 0.1, 5.0; 0.1, 3.2; and 0.3, 1.4; p=0.04; 0.04; and 0.004; respectively). "

2a-i) Problem and the type of system/solution
Describe the problem and the type of system/solution that is object of the study: intended as standalone intervention vs. incorporated in broader health care program? Intended for a particular patient population? Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions? (Note: Details about the intervention are provided in "Methods" under 5) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 2a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Most mobile health apps are yet to undergo evaluation in randomized trials or incorporate theorybased strategies known to drive changes in health behaviors." "This pilot study (Trial Registration: ClinicalTrials.gov NCT01826591) aimed to assess the initial efficacy and user acceptability of Vegethon, a standalone mobile app designed to increase vegetable consumption through the creative application of behavior change theory and techniques. It is among the first apps specifically targeting only vegetable consumption to undergo evaluation in a randomized study of adults attempting to lose weight." 2a-ii) Scientific background, rationale: What is known about the (type of) system

2b) In INTRODUCTION: Specific objectives or hypotheses
Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "This pilot study (Trial Registration: ClinicalTrials.gov NCT01826591) aimed to assess the initial efficacy and user acceptability of Vegethon, a standalone mobile app designed to increase vegetable consumption through the creative application of behavior change theory and techniques. It is among the first apps specifically targeting only vegetable consumption to undergo evaluation in a randomized study of adults attempting to lose weight." METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "A randomized controlled study design was used, with a 1:1 allocation ratio of intervention to waitlisted control (12week delay)." 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No changes were made after the study commenced. Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The study was short in duration, and the app did not undergo changes during this time.

4a) Eligibility criteria for participants
Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants were overweight adults motivated to lose weight and eat healthier. Individuals were recruited from an ongoing 12month weight loss trial (n=609) based at Stanford University (parent trial), in which individuals were 1850 years of age, had initial BMI=2740, were non diabetic and nonhypertensive, had no cancer or heart, renal, or liver disease, and lived in the geographical area surrounding Stanford. The added eligibility criterion for the current pilot study was ownership of an iPhone."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The added eligibility criterion for the current pilot study was ownership of an iPhone." Beyond ownership of an iPhone, no further computer/internet literacy eligibility criterion was used.
4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email confirmation, phone calls) were used to detect/prevent these.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Individuals were recruited from an ongoing 12month weightloss trial (n=609) based at Stanford University (parent trial)." "During a prerandomization orientation session taking place faceto face, participants were instructed that the mobile app was intended to support them in increasing their vegetable consumption, and that it was ideally to be used for 12 minutes on a daily basis." "Participants providing written consent were requested to complete a baseline questionnaire selfadministered online." "Participants randomized to the pilot study intervention condition completed a short online tutorial that described the mobile app and its use."

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 briefly explain why the item is not applicable/relevant for your study "During a prerandomization orientation session taking place faceto face, participants were instructed that the mobile app was intended to support them in increasing their vegetable consumption, and that it was ideally to be used for 12 minutes on a daily basis. They were instructed to avoid using any other apps focused on vegetable consumption for the duration of the study. Participants providing written consent were requested to complete a baseline questionnaire selfadministered online. All participants who completed the questionnaire were randomized." 4b) Settings and locations where the data were collected Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Individuals were recruited from an ongoing 12month weightloss trial (n=609) based at Stanford University (parent trial). ...The study was implemented during months 710 of the parent trial (in which participants were randomized to either a lowfat or a lowcarbohydrate diet for 12 months and attended 22 evening classes with a health educator)." 4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in webbased trials) or otherwise.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Outcome data were collected from both conditions using a questionnaire selfadministered online 12 weeks postrandomization. ...To assess the primary outcome of daily vegetable consumption at baseline and 12 weeks postrandomization, an adapted version of the validated semiquantitative Harvard Food Frequency Questionnaire (FFQ) was used." 4b-ii) Report how institutional affiliations are displayed Report how institutional affiliations are displayed to potential participants [on ehealth media], as affiliations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered 5-i) Mention names, credential, affiliations of the developers, sponsors, and owners Mention names, credential, affiliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conflict of interest" section or mentioned elsewhere in the manuscript).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Dustin Yoder and his team at Vendus Product Labs for their technical development of Vegethon."

5-ii) Describe the history/development process
Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Formative research indicated that this target population desired a simple and efficient means of selfmonitoring. ...To facilitate weight loss and weight maintenance in the context of the parent trial, the app focused on nonstarchy vegetables with lower energy density and excluded starchy vegetables such as potatoes, corn, etc."

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).

2 3 4 5 subitem not at all important essential
Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJwHv4lE5IPjlPdqyWTzJ5o/viewform?hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1a… 15/44 "The tutorial guided them through the process of downloading the app onto their iPhones from the iTunes App Store on December 4, 2014."

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable.

5-v)
Ensure replicability by publishing the source code, and/or providing screenshots/screencapture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientific reporting.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Intervention screenshot are included in the archived version cited on webcitation.org: "Vegethon iPhone App.

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, the intervention URL is cited, along with the archived version on webcitation.org: "Vegethon iPhone App. Archived at: http://www.webcitation.org/6bejO73Gm2015; Available from: https://itunes.apple.com/us/app/vegethon/id920899262?mt=8."

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of specific group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants randomized to the pilot study intervention condition completed a short online tutorial that described the mobile app and its use. The tutorial guided them through the process of downloading the app onto their iPhones from the iTunes App Store on December 4, 2014, creating a user account with their individual registration code, and setting their initial goals for quantity and variety of vegetables consumed." was facilitated through a leaderboard in which users competed against "other Vegethoners" who were "most similar" to them. Feedback on the fulfillment of goals and challenges was reinforced through inapp notifications. Justintime prompts to log vegetables were delivered most evenings at 9pm through push notifications."

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. information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants were instructed that the mobile app was intended to support them in increasing their vegetable consumption, and that it was ideally to be used for 12 minutes on a daily basis. ...Participants in the intervention condition were instructed to use the app for a minimum of 6 weeks."

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

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). "Feedback on the fulfillment of goals and challenges was reinforced through inapp notifications. Justintime prompts to log vegetables were delivered most evenings at 9pm through push notifications."

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.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The study was implemented during months 710 of the parent trial (in which participants were randomized to either a lowfat or a low carbohydrate diet for 12 months and attended 22 evening classes with a health educator)." 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Though the survey's were not validated for online use, they have been used in online studies many times without problems being reported.
6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored (logins, logfile analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial. Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "A convenience sample drawn from the parent trial was used for this pilot study."

7b) When applicable, explanation of any interim analyses and stopping guidelines
Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "...a random, computergenerated allocation sequence to assign participants to each condition" 8b) Type of randomisation; details of any restriction (such as blocking and block size) Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJwHv4lE5IPjlPdqyWTzJ5o/viewform?hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1a… 25/44 "Participants were randomized and assigned prospectively via a balanced assignment approach designed to ensure balance across mobile intervention assignment, parent trial diet group (lowcarbohydrate or lowfat), and parent trial health educator (of four possible health educators). Because this pilot study was conducted within an existing randomized parent trial, diet group and health educator could not be manipulated and were instead treated as nested strata. Pilot study participants were randomly assigned within these strata via a randomized, balanced block of size 4; subsequent participant assignments were selected via an a priori, deterministic procedure. This randomization assignment procedure was preferable to other randomization approaches because it ensured balance in all three variables at any given sample size of this pilot trial. Additionally, it was preferable to sequentially adjusted randomization procedures such as Efron's biased coin [39] because it allowed all assignments to be created prospectively." 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 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants and researchers who performed data analysis were blinded to condition assignment. Randomization was performed by a researcher who had no contact with participants and used a random, computer generated allocation sequence to assign participants to each condition." 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJwHv4lE5IPjlPdqyWTzJ5o/viewform?hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1a… 26/44 "Randomization was performed by a researcher who had no contact with participants and used a random, computergenerated allocation sequence to assign participants to each condition. Enrollment and post randomization communication with participants was subsequently performed by a research assistant who did not play a role in the data analysis." 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 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).

2 3 4 5 subitem not at all important essential
Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants and researchers who performed data analysis were blinded to condition assignment. ...All parent trial staff members, including the dietitians leading the health education classes, were blinded to condition assignment, and participants were instructed not to discuss the app with their health educator or with other participants." 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". information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants...were blinded to condition assignment. " 11b) If relevant, description of the similarity of interventions (this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not relevant.
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 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJwHv4lE5IPjlPdqyWTzJ5o/viewform?hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1a… 28/44 "An analysis of covariance (ANCOVA) was used to assess differences between intervention and control conditions, with vegetable consumption as the dependent variable, condition assignment as the fixed factor, and baseline value of the dependent variable as a covariate. An intentiontotreat analysis was used such that baseline observations were carried forward when participants were lost to follow up. A sensitivity analysis with multiple imputations to account for missing data was also used. Five imputed datasets were created using the chained equations method and pooled estimates using BarnardRubin adjusted degrees of freedom [50,51]. Descriptive statistics were used to analyze participant baseline characteristics and user acceptability of the mobile app. SPSS Statistics software (v22, IBM, New York) was used."

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]).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "An intentiontotreat analysis was used such that baseline observations were carried forward when participants were lost to follow up."

12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses
Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Does your paper address subitem X26-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "All participants provided written informed consent, and this research was approved by the Stanford University Human Subjects Committee."

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

2 3 4 5 subitem not at all important essential
Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "During a prerandomization orientation session taking place faceto face, participants were instructed that the mobile app was intended to support them in increasing their vegetable consumption, and that it was ideally to be used for 12 minutes on a daily basis. They were instructed to avoid using any other apps focused on vegetable consumption for the duration of the study. Participants providing written consent..."

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable.

RESULTS
13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJwHv4lE5IPjlPdqyWTzJ5o/viewform?hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1a… 31/44 "17 completed a baseline questionnaire and were randomized and analyzed (intervention: 8; control: 9)" 13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Among the 17 enrolled participants, 75% of the intervention condition and 78% of the control condition completed the post questionnaire administered 12 weeks postrandomization. As noted earlier, an intent totreat approach was applied in analyzing the study data."

13b-i) Attrition diagram
Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other figures or tables demonstrating usage/dose/engagement. 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the figure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, this is included. " Figure 5. Frequency of vegetable logging among intervention condition, during 6week intervention period" 14a) Dates defining the periods of recruitment and https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJwHv4lE5IPjlPdqyWTzJ5o/viewform?hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1a… 32/44

follow-up
Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Enrollment began in October 2014, and the study ended in February 2015." 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., significant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable.
14b) Why the trial ended or was stopped (early) Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable.

) and centers (volume) in each group
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 briefly explain why the item is not applicable/relevant for your study Yes, this is included. " Table 1. Participant baseline characteristics (mean ± SD)"

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.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Demographics for gender, age, BMI, and race/ethnicity are presented in Table 1. " Table 1. Participant baseline characteristics (mean ± SD)" 16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups 16-i) Report multiple "denominators" and provide definitions Report multiple "denominators" and provide definitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at specific pre-defined time points of interest (in absolute and relative numbers per group). Always clearly define "use" of the subitem not at all important essential Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, N values were reported throughout the results section, in the tables, and in the CONSORT flowchart.

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, primary analysis was intentiontotreat. "Using intenttotreat analyses, daily vegetable consumption (primary outcome) was significantly greater in the mobile app intervention compared to control condition at the end of the 12week pilot study (adjusted mean difference: 7.4 servings; 95% CI: 1.4, 13.5; p=0.02). A multiple imputation sensitivity analysis (MI) was performed and did not significantly alter these results (p=0.03)." 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, effect sizes and confidence intervals are included for primary and all secondary outcomes. "Using intenttotreat analyses, daily vegetable consumption (primary outcome) was significantly greater in the mobile app intervention compared to control condition at the end of the 12week pilot study (

17a-i) Presentation of process outcomes such as metrics of use and intensity of use
In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational definitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is defined (e.g., timeout after idle time) [1] (report under item 6a).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Among those in the intervention condition who used the app (5 of 8 participants), participants logged their vegetable consumption a mean of 0.7 (SD=0.9) times per day. ...There was a downward trend in frequency of logging behavior over time, from 0.8 ± 1.2 times per day during week one to 0.3 ± 0.6 times per day during week six (mean ± SD). There was wide variation in logging frequency between individuals, ranging from 1.2 ± 1.1 to 0.3 ± 0.6 times per day (mean ± SD)." 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable.
18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable.

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).
1 2 3 4 5 subitem not at all important 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 briefly explain why the item is not applicable/relevant for your study This type of analysis was not undertaken.

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].
1 2 3 4 5 subitem not at all important essential 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 briefly explain why the item is not applicable/relevant for your study Not applicable. No privacy breaches or technical problems were reported to the investigators.

19-ii) Include qualitative feedback from participants or observations from staff/researchers
Include qualitative feedback from participants or observations from staff/researchers, if available, on strengths and shortcomings of the application, especially if they point to unintended/unexpected effects or uses. This includes (if available) reasons for why people did or did not use the application as intended by the developers.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 19-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable.

22)
Interpretation consistent with results, balancing benefits 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 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).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "This pilot study aimed to determine the initial efficacy and user acceptability of a mobile app intervention designed to increase vegetable consumption through the creative application of behavior change theory and techniques. Twelveweek testing indicated that it significantly increased consumption of vegetables, including green leafy vegetables, cruciferous vegetables, and dark yellow vegetables in the small sample being studied. The mobile app intervention achieved reasonably high rates of engagement and was found to be easy and enjoyable to use by the sample of participants. Vegetable logging increases observed at 9pm support the use of push notifications for increasing user engagement. High usage of serving increments "0.5" and "1.0" suggests that the availability of halfserving (vs. fullserving) increments is appropriate for the logging of individual vegetable types. Given the improved health outcomes associated with increases in vegetable consumption, this pilot study suggests the need for larger, longerterm studies of Vegethon and similar technologies among overweight adults and other suitable target groups."

22-ii) Highlight unanswered new questions, suggest future research
Highlight unanswered new questions, suggest future research.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 22-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The small sample size of this study offers only an imprecise estimate of the effect size for vegetable consumption and prevented analysis of potential mediators and moderators. A larger study is indicated to more precisely estimate differences in vegetable consumption and to assess mediators and moderators of observed changes in dietary behaviors. The 12week duration of this pilot study provides an assessment only of shortterm effects, and a longer trial is warranted to determine whether the observed effects are sustained over a longer period of time

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.

2 3 4 5 subitem not at all important 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 briefly explain why the item is not applicable/relevant for your study "There were several methodological limitations to this pilot study. The participants were concurrently enrolled in a weight loss trial and were interested in helping shape the development of mobile technology. Generalizability of these findings to other samples that are not enrolled in a weight loss trial and that may not be as highly motivated is unknown. The loss of 4 participants to followup in this short study may have resulted from the high volume of timeintensive requirements (e.g., classes, blood draws, questionnaires, etc.) simultaneously required of participants by the parent trial. There were inherent limitations to the adapted Harvard Food Frequency Questionnaire measurement tool used, including reliance on selfreport (as with most dietary studies of freeliving participants). Despite the high testretest reliability of the FFQ over time in the control condition and in measures not targeted by the intervention (e.g., bean intake), the observed effect size for the primary outcome was notably large. Although the hypothesis was supported, it is possible that a portion of the observed differences were due to the use of Vegethon causing participants to become more attuned to their vegetable consumption, more accurate reporters of their vegetable consumption, and/or more aware of the vegetables they consumed in other foods. The small sample size of this study offers only an imprecise estimate of the effect size for vegetable consumption and prevented analysis of potential mediators and moderators. A larger study is indicated to more precisely estimate differences in vegetable consumption and to assess mediators and moderators of observed changes in dietary behaviors. The 12week duration of this pilot study provides an assessment only of shortterm effects, and a longer trial is warranted to determine whether the observed effects are sustained over a longer period of time." 21) Generalisability (external validity, applicability) of the trial findings NPT: External validity of the trial findings according to the intervention, comparators, patients, and care providers or centers involved in the trial

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study subitem not at all important essential Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "These effects were observed among participants who already had a relatively high baseline vegetable consumption compared to the U.S. national average. ...Further studies are indicated to evaluate the effect of the app among participants outside of the context of a weight loss intervention who may respond to different types of motivation. ...Generalizability of these findings to other samples that are not enrolled in a weight loss trial and that may not be as highly motivated is unknown."

21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting
Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "...Further studies are indicated to evaluate the effect of the app among participants outside of the context of a weight loss intervention who may respond to different types of motivation. ...Generalizability of these findings to other samples that are not enrolled in a weight loss trial and that may not be as highly motivated is unknown."

OTHER INFORMATION
23) Registration number and name of trial registry Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Clinical Trial Registry: ClinicalTrials.gov Registration Number: NCT01826591" 24) Where the full trial protocol can be accessed, if available Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable.

25)
Sources of funding and other support (such as supply of drugs), role of funders Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests (financial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.
1 2 3 4 5 subitem not at all important essential 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 briefly explain why the item is not applicable/relevant for your study "CONFLICTS OF INTEREST None declared."

About the CONSORT EHEALTH checklist
As a result of using this checklist, did you make changes in your manuscript? * yes, major changes yes, minor changes no What were the most important changes you made as a result of using this checklist?
Including app usage data in the abstract results section.
How much time did you spend on going through the checklist INCLUDING making changes in your manuscript *

1-2 hours
As a result of using this checklist, do you think your manuscript has improved? * yes no Other: