Long-term Weight Loss in a Primary Care–Anchored eHealth Lifestyle Coaching Program: Randomized Controlled Trial

Background Long-term weight loss in people living with obesity can reduce the risk and progression of noncommunicable diseases. Observational studies suggest that digital coaching can lead to long-term weight loss. Objective We investigated whether an eHealth lifestyle coaching program for people living with obesity with or without type 2 diabetes led to significant, long-term (12-month) weight loss compared to usual care. Methods In a randomized controlled trial that took place in 50 municipalities in Denmark, 340 people living with obesity with or without type 2 diabetes were enrolled from April 16, 2018, to April 1, 2019, and randomized via an automated computer algorithm to an intervention (n=200) or a control (n=140) group. Patients were recruited via their general practitioners, the Danish diabetes organization, and social media. The digital coaching intervention consisted of an initial 1-hour face-to-face motivational interview followed by digital coaching using behavioral change techniques enabled by individual live monitoring. The primary outcome was change in body weight from baseline to 12 months. Results Data were assessed for 200 participants, including 127 from the intervention group and 73 from the control group, who completed 12 months of follow-up. After 12 months, mean body weight and BMI were significantly reduced in both groups but significantly more so in the intervention group than the control group (–4.5 kg, 95% CI –5.6 to –3.4 vs –1.5 kg, 95% CI –2.7 to –0.2, respectively; P<.001; and –1.5 kg/m2, 95% CI –1.9 to –1.2 vs –0.5 kg/m2, 95% CI –0.9 to –0.1, respectively; P<.001). Hemoglobin A1c was significantly reduced in both the intervention (–6.0 mmol/mol, 95% CI –7.7 to –4.3) and control (–4.9 mmol/mol, 95% CI –7.4 to –2.4) groups, without a significant group difference (all P>.46). Conclusions Compared to usual care, digital lifestyle coaching can induce significant weight loss for people living with obesity, both with and without type 2 diabetes, after 12 months. Trial Registration ClinicalTrials.gov NCT03788915; https://clinicaltrials.gov/ct2/show/NCT03788915

The CONSORT-EHEALTH checklist is intended for authors of randomized trials evaluating web-based and Internet-based applications/interventions, including mobile interventions, electronic games (incl multiplayer games), social media, certain telehealth applications, and other interactive and/or networked electronic applications. Some of the items (e.g. all subitems under item 5 -description of the intervention) may also be applicable for other study designs.
The goal of the CONSORT EHEALTH checklist and guideline is to be a) a guide for reporting for authors of RCTs, b) to form a basis for appraisal of an ehealth trial (in terms of validity) CONSORT-EHEALTH items/subitems are MANDATORY reporting items for studies published in the Journal of Medical Internet Research and other journals / scientific societies endorsing the checklist.
As the CONSORT-EHEALTH checklist is still considered in a formative stage, we would ask that you also RATE ON A SCALE OF 1-5 how important/useful you feel each item is FOR THE PURPOSE OF THE CHECKLIST and reporting guideline (optional).
Mandatory reporting items are marked with a red *. In the textboxes, either copy & paste the relevant sections from your manuscript into this form -please include any quotes from your manuscript in QUOTATION MARKS, or answer directly by providing additional information not in the manuscript, or elaborating on why the item was not relevant for this study. Are there any other outcomes the intervention is expected to affect?
Our secondary outcomes were changes in HbA1c. Tertiary outcomes were body composition (BMI and waist/hip ratio), lipids (total cholesterol, LDL-C, HDL-C, and TG) and blood pressure (systolic and diastolic), changes in Mental health, and Quality of life yes: all primary outcomes were significantly better in intervention group vs control partly: SOME primary outcomes were significantly better in intervention group vs control no statistically significant difference between control and intervention potentially harmful: control was significantly better than intervention in one or more outcomes inconclusive: more research is needed Andet: not submitted yet -in early draft status not submitted yet -in late draft status, just before submission submitted to a journal but not reviewed yet submitted to a journal and after receiving initial reviewer comments submitted to a journal and accepted, but not published yet 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) 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 offline 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.  T  R  A  C  T  :  S  t  r  u  c  t  u  r  e  d  s  u  m  m  a  r  y  o  f  t  r  i  a  l  d  e  s  i  g  n  ,  m  e  t  h  o  d  s  ,  r  e  s  u  l  t  s  ,  a  n  d  c  o  n  c  l  u  s  i  o  n  s   N  P  T  e  x  t  e  n  s  i  o  n  :  D  e  s  c  r  i  p  t  i  o  n  o  f  e  x  p  e  r  i  m  e  n  t  a  l  t  r  e  a  t  m  e  n  t  ,  c  o  m  p  a  r  a  t  o  r  ,  c  a  r  e  p  r  o  v  i  d  e  r  s  ,  c  e  n  t  e  r  s  ,  a  n  d  b  l  i  n  d  i  n  g  s  t  a  t  u  s  . subitem not at all important 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 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). 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 Our intervention involved a health care professional (human) which is mentioned in the abstract "an initial one-hour face-to-face motivational interview". Afterward the intervention was asynchronous digital coaching "followed by digital coaching using behavioral change techniques enabled by individual live monitoring" 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 Yes first in the methods like this "In a randomized controlled trial that took place in 50 municipalities in Denmark, 340 subjects with obesity with or without T2D were enrolled from April 16, 2018 to April 1, 2019, and randomized via an automated computer algorithm to an intervention (200) or a control (140)" and afterwards in the results section more specified for this paper "Data were assessed for 235 participants, 149 from the intervention group and 86 from the control group who completed 6 and/or 12 months follow-up" Conclusions/Discussions in abstract for negative trials: Discuss the primary outcome -if the trial is negative (primary outcome not changed), and the intervention was not used, discuss whether negative results are attributable to lack of uptake and discuss reasons. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Copy and paste relevant sections from the manuscript (include quotes in quotation 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 Describing the problem "Unfortunately, it is difficult for people with obesity and T2D to achieve and maintain a long-term weight loss" which is why this study focused on a population of obese participants with and without Type 2 diabetes (T2D), and another problem mentioned in this paper "Even though general practice is supposed to support selfmanagement and healthy lifestyle, studies have shown that the annual consultations seldom address lifestyle issues" Copy and paste relevant sections from the manuscript (include quotes in quotation 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 "Metanalyses and systematic reviews show that electronic health (eHealth) and mobile health (mHealth) solutions are significantly better than usual care defined as routine diabetes self-care with no personalized feedback at supporting weight loss short term over 3-6 months for motivated patients with obesity [8,9]. An essential component of effective solutions is behavioral change techniques (BCT) involving automated, semi-automated, and/or human digital feedback [9,10]. Human feedback, particularly from healthcare professionals (HCPs), is most effective [11]" But as mentioned in the last part of out introduction "However, limited evidence exists about the potential for such solutions to lead to weight loss long term over 6 months" ? * Copy and paste relevant sections from the manuscript (include quotes in quotation 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: "In this randomized controlled trial (RCT), we aimed to investigate whether digital coaching through a multifaceted eHealth tool can help subjects with obesity with and without T2D to achieve and sustain a more significant long term weight loss compared to an equally motivated control group receiving usual care." Copy and paste relevant sections from the manuscript (include quotes in quotation 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, due to COVID-19 restrictions: "Due to the COVID-19 lockdown and national restrictions, some participants could not attend their 12-months assessment. Therefore, the 12-months assessment period was extended with four months, covering 12-16 months follow-up after baseline" subitem not at all important Copy and paste relevant sections from the manuscript (include quotes in quotation 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 both our few inclusion criteria and exclusion criteria "After registration participants were contacted by phone by a research assistant, who made sure the participants met the inclusion criteria on BMI (BMI 30-45 kg/m2) and age (aged 18-70 years). Exclusion criteria were: 1) lack of internet access through computer or smartphone, 2) pregnancy or planned pregnancy, and 3) serious or life-threatening disease defined as less than one-year lifetime expectancy." Copy and paste relevant sections from the manuscript (include quotes in quotation 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 as an exclusion criteria "Exclusion criteria were: 1) lack of internet access through computer or smartphone" a c e a s s e s s m e n t s : 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 webbased trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email confirmation, phone calls) were used to detect/prevent these. Copy and paste relevant sections from the manuscript (include quotes in quotation 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 participants were recruited online and offline "recruited through their local health care centers and general practitioners (GPs), the Danish diabetes organization and social media" Blinding was not possible "Blinding the participants, the research assistant, and the health coach who provided lifestyle coaching for all participants receiving the intervention was not possible after randomization. The research assistant and health coach had no role in analyzing or interpreting data." 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. Copy and paste relevant sections from the manuscript (include quotes in quotation 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 "After registration participants were contacted by phone by a research assistant, who made sure the participants met the inclusion criteria" and regarding consent "At the baseline meeting, participants gave written informed consent and informed the research assistant about their use of medication." Copy and paste relevant sections from the manuscript (include quotes in quotation 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 Only that it was assessed at baseline, 6 months and 12 months "At the baseline meeting, participants gave written informed consent and informed the research assistant about their use of medication. Afterwards, a brief medical examination was performed." Copy and paste relevant sections from the manuscript (include quotes in quotation 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 Outcomes in mental health score and Quality of Life was assessed by a online questionaire "All participants filled out an online questionnaire on sociodemographic characteristics, the European Quality of life -5 Dimensions scheme (EQ-5D-5L) and the Short-Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) [19,20]"

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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 Copy and paste relevant sections from the manuscript (include quotes in quotation 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 update form version 0.1 to version 0.2 is mentioned.
Provide information on quality assurance methods to ensure accuracy and quality of information Copy and paste relevant sections from the manuscript (include quotes in quotation 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 Dit svar 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. Copy and paste relevant sections from the manuscript (include quotes in quotation 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 Dit svar 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.
Copy and paste relevant sections from the manuscript (include quotes in quotation 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 Dit svar 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 Copy and paste relevant sections from the manuscript (include quotes in quotation 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 It is only briefly described with a reference to the papers study protocol: "Participants who would like to participate could then register at the eHealth tool URL." Copy and paste relevant sections from the manuscript (include quotes in quotation 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 "Based on the individual goal setting created using the SMART (specific, measurable, attainable, relevant, timely) model [21] the health coach provided weekly asynchronous digital coaching for each participant inspiring, commending goal attainment and seeking to help them stay motivated [13]. The subsequent asynchronous eHealth coaching sessions was carried out once a week in the first 6 months and then every month for the last 6 months for maintenance" 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 Copy and paste relevant sections from the manuscript (include quotes in quotation 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 Initially face-to-face and afterwards asynchronous digital coaching: "After an initial 45-60 minutes consultation with the HCP the intervention group received the individualized digital lifestyle coaching using an eHealth tool to complete daily records and to send remarks directly to the HCP. Based on the individual goal setting created using the SMART ( Copy and paste relevant sections from the manuscript (include quotes in quotation 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 primary outcome was reduction in mean body weight (BW) assessed as the difference between BW at baseline to 6 months and baseline to 12 months and as the difference divided by baseline BW. The proportion of participants who had a significant weight loss of > 5% of baseline BW [22] were also assessed at 6 and 12 months. Our secondary outcomes were changes in HbA1c from baseline to 6 and 12 months, respectively. Tertiary outcomes were body composition (BMI and waist/hip ratio), lipids (total cholesterol, LDL-C, HDL-C, and TG) and blood pressure (systolic and diastolic), changes in Mental health and Quality of life. All differences in tertiary outcomes were calculated from baseline to 6 months and baseline to 12 months." subitem not at all important We looked into use of the app. As the participants had to do daily remarks a participants who fully used the app in 12 months = 365 days or more. "In addition, we have performed a per protocol analysis by using only data from participants who had been using the eHealth tool for 365 days or more" Copy and paste relevant sections from the manuscript (include quotes in quotation 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: "in groups of 10 at a ration 6:4 where 60% of the recruited participants were randomized to the intervention group and the remaining 40% were included in the control group based on a pilot RCT [16] as described in our protocol article [12]. Randomization was controlled to ensure that 50% of participants in the intervention group and control group would be obese citizens, who have not been previously diagnosed with T2D, and the other 50% of participants in the intervention group and control group would be pa diagnosed with  Copy and paste relevant sections from the manuscript (include quotes in quotation 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 Patients were enrolled at baseline by a research assistent: "At the baseline meeting, participants gave written informed consent and informed the research assistant about their use of medication. Afterwards, a brief medical examination was performed" but "The research assistant and health coach who preformed the digital lifestyle coaching had no role in randomization, analyzing or interpreting data" Copy and paste relevant sections from the manuscript (include quotes in quotation 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 statistical significance of between-group differences in outcomes at 6 and 12 months was assessed with either one-way ANOVA or chi-squared test. Statistical significance was set at two-tailed P < 0.05" 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] Copy and paste relevant sections from the manuscript (include quotes in quotation 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 results and number of participant in each group is included in table 2. Results are described in text. "235 participants came to follow-up after 6 or 12 months, 232 at 6 months and 200 at 12 months" and "BW was our primary outcome which was at 6 months significantly reduced by -4.0 (95% CI, -4.9; -3.2) kg in the intervention group and insignificant by -0.4 (95% CI, -1.2; 0.3) kg in the control group. The between-group difference was statistically significant (P<.005). After 12 months the BW was significantly reduced in both the intervention group (-4.6 (95% CI -5.7; -3.4) kg) and in the control group (-1.4 (95% CI, -2.6; -0.1) kg), but still more in the intervention group (P<.005)." * Copy and paste relevant sections from the manuscript (include quotes in quotation 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. It is shown and described in Figure 1.
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. 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 shown in Figure 1.
Copy and paste relevant sections from the manuscript (include quotes in quotation 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. First of all "The study was carried out from April 2019 to October 2021". Participants were enrolled (baseline) from "April 16, 2018 to April 1, 2019". 6 months follow up and 12 month follow up was preformed "This examination was equally completed after 6 and 12 months." and "The participants answered both questionnaires at baseline, 6-and 12-months follow up." Copy and paste relevant sections from the manuscript (include quotes in quotation 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. COVID-19. "Due to the COVID-19 lockdown and national restrictions, some participants could not attend their 12-months assessment. Therefore, the 12-months assessment period was extended with four months, covering 12-16 months follow-up after baseline" 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 intervention. Copy and paste relevant sections from the manuscript (include quotes in quotation 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. In the tables and figures in the article the number analyzed is those who either completed 6 and/or 12 month. In supplementary the same analyses is preformed on the participants completing 12 months. We also preformed a per protocol analysis on those who used the app in at least 365 days = 12 months. 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) Copy and paste relevant sections from the manuscript (include quotes in quotation 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. In the text and in figure 2. "Within the intervention group the effect over time on BW reduction were equal in participants with and without T2D, but in the control group participants without T2D did not achieve a significant weight change ( Figure 2)"  c  o  n  s  i  d  e  r  i  n  g  o  t  h  e  r  r  e  l  e  v  a  n  t  e  v  i  d  e  n  c  e   N  P  T  :  I  n  a  d  d  i  t  i  o  n  ,  t  a  k  e  i  n  t  o  a  c  c  o  u  n  t  t  h  e  c  h  o  i  c  e  o  f  t  h  e  c  o  m  p  a  r  a  t  o  r  ,  l  a  c  k  o  f  o  r  p  a  r  t  i  a  l  b  l  i  n  d  i  n  g  ,  a  n  d  u  n  e  q  u  a  l  e  x  p  e  r  t  i  s  e  o  f  c  a  r  e  p  r  o  v  i  d  e  r  s  o  r  c  e  n  t  e  r  s  i  n  e  a  c  h  g  r  o  u  Copy and paste relevant sections from the manuscript (include quotes in quotation 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. First the aim and primary outcome "The objective of this 12 months RCT, which was to see if individualized digital lifestyle coaching enabled by an eHealth tool could support obese participants with or without T2D to achieve and maintain a significant weight loss, was met after 12 months with a mean weight loss of 4.6 kg in the intervention group compared to 1.4 kg in the control group. " Later on the other outcomes " From baseline to 12 months, HbA1c was reduced in both the intervention and control group without a significant difference between the groups. This lack of difference was in contrast to a prior metaanalysis (25) and could not be explained by the small decrease in DPP4 use in the intervention group." and "Systolic blood pressure was significantly reduced in both groups at 12 months follow-up and without significant between-group difference, which might reflect that the blood pressure reduction was a consequence of participating in the study (healthy participator effect) and secondary to the weight loss" Copy and paste relevant sections from the manuscript (include quotes in quotation 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 dropout rate at 12 months was 40.8%, which is similar to attrition rates, reported in other studies (9). Although this could create attrition bias, the characteristics of participants who remained in the intervention and control group at 12 months did not differ from each other." and "Another limitation of this study is the number of participants missing either 6-or 12-months follow-up visit possibly due to COVID-19 restrictions." Copy and paste relevant sections from the manuscript (include quotes in quotation 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. "All the participants randomized to intervention and who stayed in the study used the eHealth tool indicating that if the eHealth tool is used in the future, the therapist will quickly be able to identify who is not satisfied by using the individualized digital coaching. For these subjects, it will be possible for the therapist to recommend other treatment strategies." and with the relatively low cost of the intervention a large scale up seems possible.