Incorporating a Static Versus Supportive Mobile Phone App Into a Partial Meal Replacement Program With Face-to-Face Support: Randomized Controlled Trial

Background Mobile phone apps may be acceptable to users and could improve retention and adherence over more traditional methods, but there is mixed literature supporting their efficacy. In the weight management space, very little is known about how a mobile phone app integrating features beyond text messaging (short message service) can affect behavior, particularly when combined with face-to-face support. Objective The objective of this study was to examine the effectiveness of a mobile phone app when combined with a partial meal replacement program including face-to-face support. This paper compares a static versus supportive app over a 6-month randomized trial for effects on weight loss, weight-related biomarkers, and psychological outcomes. Methods Overweight and obese adults (71.2% female, 104/146; mean 48.11, SD 11.75 years) were recruited to participate in the weight loss study, and they were randomized on a 1:1 basis using a computer algorithm. The supportive app (n=75) provided information, food intake recording, rewards, prompts for regular interaction through reminders, and the opportunity to review personal compliance with the dietary program. The static app (n=71) included only recipes and weight loss information. Both groups recieved equal amounts of face-to-face support in addition to app. Results The overall reduction in app usage over 24 weeks was lower for the supportive app in comparison with the static app; approximately 39.0% (57/146) of the users were still using the app at week 24. Despite the promising results for app usage, there were no differences in weight loss between groups (F1,128.12=0.83, P=.36). However, it should be noted that almost 60% (49/84) of all participants lost 5% or more of body weight during the trial. No weight-related biomarkers were significantly different between groups. Both groups experienced an increase in positive mood, but this was significantly higher for those who received the static app (F1,118.12=4.93, P=.03). Conclusions Although the supportive app was well received by users, we found little evidence of the added benefit of this versus the static app in combination with face-to-face support in a community-delivered weight loss program. Future versions of the app may incorporate more unique behavioral techniques beyond those provided by the consultant to improve the potency of the app. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12613000547741; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364187 (Archived by WebCite http://www.webcitation.org/6yivwfMI9)

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? * You're editing your response. Sharing this URL allows others to also edit your response.

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Is this a full powered effectiveness trial or a pilot/feasibility trial? * You're editing your response. Sharing this URL allows others to also edit your response. 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) #7796 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.

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You're editing your response. Sharing this URL allows others to also edit your response. 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").

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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 "Incorporating a Static Versus Supportive Mobile Phone App Into a Partial Meal Replacement Program With Face-to-Face Support: Randomized Controlled Trial" 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 No, because this trial has no speci c target.
You're editing your response. Sharing this URL allows others to also edit your response.  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 supportive app provided information, food intake recording, rewards, prompts for regular interaction through reminders, and the opportunity to review personal compliance with the dietary program. The static app included only recipes and weight loss information."

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1b-ii) Level of human involvement in the METHODS section of the ABSTRACT 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 No, details in remainder of paper.
1b-iii) Open vs. closed, web-based (self-assessment) vs. face-toface assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials Does your paper address subitem 1b-iii? Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No, details in remainder of paper 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.  [9] observed that the effect of technology looked promising during the early stages but described this effect as "transient" with brief, regular personal contact ultimately more effective at assisting participants with sustained weight loss. Therefore, it is unclear whether apps can be a useful adjunct for weight loss interventions when combined with face-to-face or in-person support." 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 "It is hypothesized that for a group of dieters following a partial meal replacement program including face-to-face support, an interactive and supportive app will be more effective for weight loss than a static app. A" You're editing your response. Sharing this URL allows others to also edit your response. 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 detailed description of the method has been published elsewhere [12]. Brie y, participants were asked to follow a partial meal replacement program, and during the initial active period, they received personalized advice from a trained consultant about how to incorporate high-protein meal replacement shakes (manufactured by Probiotec Pty Ltd) and high-protein meals into their lifestyle. Meal replacements were provided for the rst 4 weeks, and then the participants were required to purchase them (Aus $1 per sachet) for the remainder of the study period to attempt to better simulate a pharmacy environment. Participants were randomized to one of the 2 groups that received mobile phone apps differing in the number of monitoring tools and supportive features they contained (described in detail below). Both groups received the same level of face-to-face support and the same weight control program. Apps were 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 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 "A screening questionnaire was reviewed against eligibility criteria, which included having a body mass index (BMI) greater than 25 kg/m2 (based on the self-reported height and weight), access to an iPhone, and willingness to have a pin-prick blood glucose and lipids assessment on 4 occasions at the purpose-built trial clinic. "

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clari ed.
You're editing your response. Sharing this URL allows others to also edit your response. Copy and paste relevant sections from the manuscript (include quotes in quotation 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 Internet literacy was not an eligibility criteria for the trial, but "access to an iphone"

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was. An assumption was made that those who had smart phones were internet literate.
4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email con rmation, phone calls) were used to detect/prevent these.
Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "were recruited via an established clinic database and local media in Adelaide, South Australia. The recruitment process has been published in detail elsewhere " "Both groups received the same level of face-to-face support and the same weight control program." 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.
You're editing your response. Sharing this URL allows others to also edit your response. Copy and paste relevant sections from the manuscript (include quotes in quotation 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
The recruitment process has been published in detail elsewhere [12].
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 "were recruited via an established clinic database and local media in Adelaide, South Australia, between March and August 2013. " 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.
You're editing your response. Sharing this URL allows others to also edit your response. 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 "Objective Outcomes The primary outcome measures were percentage weight loss from baseline and changes in blood pressure, fasting blood glucose, and fasting blood lipids (total cholesterol, low-density lipoprotein [LDL], high-density lipoprotein

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[HDL], and triglycerides). These were measured at baseline; week 2 (weight only); and weeks 4, 12, and 24 ( Figure 2 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 "Commonwealth Scienti c and Industrial Research Organisation (CSIRO) has an ongoing research partnership with Probiotec to develop the Impromy program.
Probiotec had no input into the nal version of this paper and only offered advice on the trial design regarding the plausibility of the program in a commercial setting. The app was developed by the authors and remains the property of CSIRO. Meal replacements were provided in kind by Probiotec. Probiotec also paid for the commercial development of the app."

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.
You're editing your response. Sharing this URL allows others to also edit your response. Does your paper address subitem 5-ii?

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Copy and paste relevant sections from the manuscript (include quotes in quotation 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 focus groups or formal usability testing were completed prior to this trial.

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

Yes
Only updates to address bugs occurred. The app was frozen as is described in the method.
"Two major technical errors occurred while the trial was underway. Database errors occurred during the rst weekend of the trial, which affected only those in the intervention group. Seven users reported problems relating to this. This issue was resolved within 5 days of the initial report. 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 Not Applicable 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 8 app screen shots provided You're editing your response. Sharing this URL allows others to also edit your response.

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 As the product is commercially available, the digital preservation process is not suitable for this project, at this time.

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 were provided with free and discounted price meal replacement products -"Meal replacements were provided for the rst 4 weeks, and then the participants were required to purchase them (Aus $1 per sachet) for the remainder of the study" You're editing your response. Sharing this URL allows others to also edit your response. Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The Weight Management Program (WMP) app was designed to support participants' behavior modi cation during the partial meal replacement program by providing information, simplifying food intake recording, rewarding positive behavior, and prompting regular interaction through reminders. The features included were selected based on both behavioral theory and successful behavior change techniques, as well as dietetic methods associated speci cally with weight loss programs (ie, dietary compliance feedback) and app design features known to improve engagement, such as gami cation, through the award of medals.

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For purposes of the trial, the prototype WMP was implemented as a native app for iPhones running iOS 6 or later. Upon download, users set up an account entering a username, their starting weight, a weight loss goal, and by when they wish to achieve the goal.
The WMP home screen included a dashboard access to the tools and services provided in the app (Figure 1). At log-in, each day the users were presented with a randomly selected motivational message or thought for the day on the home screen. Some of these messages were as follows: "Planning ahead will help you to stick to your goals," "Don't focus on your failures, learn from them," and "All great achievements take time. Hang in there." These messages were developed based on the health action process approach of behavior change and included messages to initiate behavior (action-planning) and manage setbacks (coping planning) [13].
The home screen showed a summary of progress, including weight loss and medals received. Dietary information speci c to the program was presented in the Information section of the app indicated by the "i" icon on the top left-hand side ( Figure 1).
The WMP app provided monitoring tools for weight and food, and it communicated weight loss progress and compliance visually and through virtual rewards. Selfmonitoring is considered one of the most effective strategies for behavior change Daily compliance is an essential part of any weight management program.
Compliance to the partial meal replacement program was communicated to users through the receipt of gold, silver, and bronze medals, which re ect how well the recorded food intake met the daily guidelines speci ed by the weight control diet ( Figure 1). Medals were also used to add an element of gami cation, which has been sho n to impro e ser engagement in other beha ioral domains indicated that the guidelines were met, a silver medal indicated that the intake was close to the guidelines, and a bronze medal indicated that some progress toward the guidelines was made. No medal was rewarded if a minimal amount of information was entered, or if a user was well short of the dietary prescriptions. A snapshot of daily intake was shown on the Calendar screen. Users' weight loss was summarized on the home screen for convenient re ection and presented graphically in a separate section (Figure 1). The app generated 3 daily task prompts (morning, afternoon, and evening) to encourage self-monitoring. Morning tasks required completion of the meal diary for the previous day and the recording of weight. The afternoon and evening tasks asked the users to update their food diary (Figure 1). Prompt times for tasks were customizable, and afternoon tasks could be disabled by the user. These prompts were all designed to promote closer self-monitoring of progress (weight) and compliance (food diary), and they appeared through push noti cations.

Control App
The control/static app did not include any recording tools (weight or food) or any tasks. It provided information about the program only, including the detailed recipes. It had the same visual appearance as the home screen on the intervention app with only the recipes button, the day number, and the information button."

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.
You're editing your response. Sharing this URL allows others to also edit your response. Copy and paste relevant sections from the manuscript (include quotes in quotation 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. See Figure 6 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).

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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 Yes Face to face visits occurred throughout the trial as indicated in Figure 2 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).
You're editing your response. Sharing this URL allows others to also edit your response. 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

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The app generated 3 daily task prompts (morning, afternoon, and evening) to encourage self-monitoring. Morning tasks required completion of the meal diary for the previous day and the recording of weight. The afternoon and evening tasks asked the users to update their food diary (Figure 1). Prompt times for tasks were customizable, and afternoon tasks could be disabled by the user. These prompts were all designed to promote closer self-monitoring of progress (weight) and compliance (food diary), and they appeared through push noti cations.

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 Yes Brie y, participants were asked to follow a partial meal replacement program, and during the initial active period, they received personalized advice from a trained consultant about how to incorporate high-protein meal replacement shakes (manufactured by Probiotec Pty Ltd) and high-protein meals into their lifestyle. Meal replacements were provided for the rst 4 weeks, and then the participants were required to purchase them (Aus $1 per sachet) for the remainder of the study period to attempt to better simulate a pharmacy environment.
You're editing your response. Sharing this URL allows others to also edit your response. Does your paper address subitem 7a-i?

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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 "Overweight and obese adults (aged 18 years and above) were recruited via an established clinic database and local media in Adelaide, South Australia, between March and August 2013. The recruitment process has been published in detail elsewhere [12]. Based on our previous pilot study [6], 61 completers were required to have 80% power to detect a 2.5% difference in weight loss between the two groups.
To account for participant withdrawals, more than 122 participants will be recruited and based on a drop-out of 20% [6], we aim to recruit 148 overweight/obese adults who own an iPhone. " 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
You're editing your response. Sharing this URL allows others to also edit your response.

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https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&edit2=2_ABaOnufjwjg4YxJxCGB5IGJEilYEK 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 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 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 "...and they were randomized using a computer algorithm" 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

No restrictions included
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 "Overweight and obese adults (71.2% female,104/146;48.11 [SD 11.75] years) were recruited to participate in the weight loss study, and they were randomized using a computer algorithm" You're editing your response. Sharing this URL allows others to also edit your response. 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 Computer generated 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).

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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 It was not possible to blind the patients to the treatment. Clinic based staff assisted in the upload of the technology onto participants phones, so those taking clinical measurements were also not blinded.
You're editing your response. Sharing this URL allows others to also edit your response. 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 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator"

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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 "It had the same visual appearance as the home screen on the intervention app with only the recipes button, the day number, and the information button." "Both groups received the same level of face-to-face support and the same weight control program. " 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

Not included in the paper
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12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses
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 "All analyses were performed in SPSS version 23 (IBM, Armonk, New York, US). Usage data were aggregated and analyzed using descriptive methods and then compared using general linear models, where appropriate. Mixed models were used to answer the primary hypothesis. These models were designed to assess differences between app condition (main effect) and the interaction between app condition and study week for outcomes, including percentage change from baseline weight, self-reported frequency of weighing, self-reported dietary compliance, and changes in psychological and blood measures (from baseline). ….." 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 "Due to errors in readings, 3 recordings of cholesterol and 1 for blood glucose were deleted from the nal analyses and entered as missing values." You're editing your response. Sharing this URL allows others to also edit your response.

RESULTS
13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center Does your paper address subitem X26-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 This study was a 24-week randomized controlled trial (RCT) (ACTRN12613000547741), including a 12-week active intervention period followed by a 12-week free-living period. The research was approved by the CSIRO Human Research Ethics Committee (Approval 12/14). All participants signed formal consent forms before their participation in this trial.

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study NA You're editing your response. Sharing this URL allows others to also edit your response. 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 All information pertaining to experimental groups presented in tabular form in paper 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 Dropout by the end of week 24 was 42.5% (58/146) (Figure 2). There were no differences in attrition between app groups at any week of the study. The greatest dropout occurred after cessation of the provision of free meal replacements. Most dropouts (42%, 24/58) were lost to contact and, therefore, provided no reason for stopping their participation. In total, 14 visits were skipped throughout the trial.

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.
You're editing your response. Sharing this URL allows others to also edit your response. 14b) Why the trial ended or was stopped (early)

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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 Attrition diagram included "During the free-living period, usage of the app continued to fall in both groups, with approximately 39% and 9% of the intervention and control groups, respectively, still using the app by the nal week of the study (Figure 3). " 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 "were recruited via an established clinic database and local media in Adelaide, South Australia, between March and August 2013" 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

Not applicable
You're editing your response. Sharing this URL allows others to also edit your response. included in each analysis and whether the analysis was by original assigned groups Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Table Included (Table 1) 15-i) Report demographics associated with digital divide issues

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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 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 "According to univariate analysis of variance, the percentage of days that people interacted with the app (days with interactions/total trial days) was signi cantly different between groups, with this number higher in the intervention group (43.1%) compared with the control group (11.1%; F1,144=83.30, P<.001)."

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 "Mixed models included all available data and, therefore, were considered an intention-to-treat method of analysis. " You're editing your response. Sharing this URL allows others to also edit your response. 17a-i) Presentation of process outcomes such as metrics of use and intensity of use

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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 "The number of active days (a day where a recipe-or information-viewing action occurred) was plotted against users' membership duration (the number of days between enrolment and last logged use of the app). " You're editing your response. Sharing this URL allows others to also edit your response. 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 NA

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).
Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study NA You're editing your response. Sharing this URL allows others to also edit your response. Copy and paste relevant sections from the manuscript (include quotes in quotation 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 "Reasons for withdrawal include stomach issues and health professional advice are reported in Figure 2" 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].

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Does your paper address subitem 19-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Two major technical errors occurred while the trial was underway. Database errors occurred during the rst weekend of the trial, which affected only those in the intervention group. Seven users reported problems relating to this. This issue was resolved within 5 days of the initial report. 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 Not included.
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).
You're editing your response. Sharing this URL allows others to also edit your response. Copy and paste relevant sections from the manuscript (include quotes in quotation 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 aim of this randomized controlled trial was to compare the effect of 2 apps included as part of a weight control program to assess whether a supportive app could improve participant outcomes, including weight, risk factor indicators (such as cholesterol), psychological outcomes (such as mood and motivation), and app engagement. Despite promising results for user engagement (higher usage of the supportive app relative to the static app), we found few differences in the other outcomes assessed between the 2 apps over the 6-month trial. "

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 "Future trials will need to assess the effect of combining multiple forms of support relative to usual care in a community-delivered weight management program. " "Weight monitoring may be most effective when combined with feedback [26]. We provided graphical weight summaries to users, but minimal other feedback relating to the weight entries. A future app could target additional behavioral techniques such as contingency planning and problem solving to improve outcomes [27]. Elements of user experience are also likely to improve engagement and, therefore, weight loss. Mining of large amounts of data from a health app also suggests that weight loss success is greater when users can customize features within an app [28]. However, only future controlled trials will reveal the e cacy of these techniques in combination with face-to-face support." You're editing your response. Sharing this URL allows others to also edit your response.

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 "It may be the case that participants in the static group relied more heavily on the inperson support. All the consultants were trained to provide standard care to each participant. Unfortunately, the amount of face-to-face support that participants received was not recorded or evaluated as part of this trial. The limitations of this study, such as the restriction to iPhone users, its focus on dietary intervention (more so than exercise) and the primarily female sample have been reported in other similar trials [6] and are unlikely to account for the null effects observed. Although additional features may improve the potency of the supportive app in the future, it remains possible that a supportive app alone is not enough to dramatically in uence weight-related outcomes when combined with the support provided in person. Future trials will need to assess the effect of combining multiple forms of support relative to usual care in a community-delivered weight management program. " You're editing your response. Sharing this URL allows others to also edit your response.

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 "The study retention below 60% and nonuse attrition (less than half still using the app by the end of the study) warrant discussion. We attempted to better replicate a pharmacy environment by including a small cost impediment after an initial weight loss period of 4 weeks. We witnessed a spike in attrition at this point, and this may have in ated our total dropout rate relative to other trials. Including a cost impediment for the meal replacements may have also reduced the weight loss observed as the provision of free products can improve weight outcomes [19].
Fortunately, dropout did not differ between the app groups. Furthermore, the use of intention-to-treat analysis method optimizes statistical power by accounting for missing data. Although nonuse attrition appears high for both of our apps, other studies have seen similar rates in more sophisticated Web-based programs [20]. " 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.
You're editing your response. Sharing this URL allows others to also edit your response. Copy and paste relevant sections from the manuscript (include quotes in quotation 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 attempted to better replicate a pharmacy environment by including a small cost impediment after an initial weight loss period of 4 weeks. We witnessed a spike in attrition at this point, and this may have in ated our total dropout rate relative to other trials. Including a cost impediment for the meal replacements may have also reduced the weight loss observed as the provision of free products can improve weight outcomes [19]. Fortunately, dropout did not differ between the app groups. "

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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 Australian New Zealand Clinical Trials Registry ACTRN12613000547741 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 brie y explain why the item is not applicable/relevant for your study NA You're editing your response. Sharing this URL allows others to also edit your response.

About the CONSORT EHEALTH checklist
Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study None 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 Commonwealth Scienti c and Industrial Research Organisation (CSIRO) has an ongoing research partnership with Probiotec to develop the Impromy program.
Probiotec had no input into the nal version of this paper and only offered advice on the trial design regarding the plausibility of the program in a commercial setting. The app was developed by the authors and remains the property of CSIRO. Meal replacements were provided in kind by Probiotec. Probiotec also paid for the commercial development of the app.
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