“Dare to feel full”—A group treatment method for sustainable weight reduction in overweight and obese adults: A randomized controlled trial with 5-years follow-up

Sara Holmberg; Lena Lendahls; Kjell-Åke Alle

doi:10.1371/journal.pone.0303021

Peer Review History

Original SubmissionDecember 8, 2023
24 Jan 2024 Decision Letter - Aleksandra Klisic, Editor PONE-D-23-38830“Dare to feel full” - A group treatment method for sustainable weight reduction in overweight and obese adults: A randomized controlled trial with 5-years follow-upPLOS ONE Dear Dr. Holmberg, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by Mar 09 2024 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. Please include the following items when submitting your revised manuscript: A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. 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The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf 2. We note that the grant information you provided in the ‘Funding Information’ and ‘Financial Disclosure’ sections do not match. When you resubmit, please ensure that you provide the correct grant numbers for the awards you received for your study in the ‘Funding Information’ section. 3. Please note that in order to use the direct billing option the corresponding author must be affiliated with the chosen institute. Please either amend your manuscript to change the affiliation or corresponding author, or email us at plosone@plos.org with a request to remove this option. 4. We note that you have included the phrase “data not shown” in your manuscript. Unfortunately, this does not meet our data sharing requirements. PLOS does not permit references to inaccessible data. We require that authors provide all relevant data within the paper, Supporting Information files, or in an acceptable, public repository. Please add a citation to support this phrase or upload the data that corresponds with these findings to a stable repository (such as Figshare or Dryad) and provide and URLs, DOIs, or accession numbers that may be used to access these data. Or, if the data are not a core part of the research being presented in your study, we ask that you remove the phrase that refers to these data. Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Partly Reviewer #2: Yes Reviewer #3: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: No Reviewer #2: Yes Reviewer #3: Yes ****** 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: No Reviewer #2: Yes Reviewer #3: Yes ****** 4. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes Reviewer #2: Yes Reviewer #3: Yes ****** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: 1. Clarify what test was used for sample size calculation. Better use a method for repeated measures. 2. The statistical analysis is not acceptable. For a longitudinal study with repeated measures, better consider longitudinal models such as mixed model and GLIMMIX models. 3. Specify primary endpoint (e.g. >5% reduction) and secondary endpoint. P value can be adjusted for secondary endpoint so power will not be reduced. Reviewer #2: The study titled "“Dare to feel full” - A group treatment method for sustainable weight reduction in overweight and obese adults: A randomized controlled trial with 5-years follow-up" is well written. I have some comments for improvement: 1- Define abbreviations used in tables/figures in the figure caption. 2- Mention the strengths and limitations of your study in a separate paragraph before the conclusions paragraph. 3- Add the clinical relevance of your study. 4- Add a new heading for conclusions paragraph. Reviewer #3: Main remarks: • Authors should specify the randomization process. • How is the eligibility criterion “being essentially healthy” is defined? • Some tables (e.g. table 4, tables 7-8) should be moved to the supplementary appendix. • Could you provide in detail the classes of drugs taken “regularly” by 64% of enrolled subjects, according to data provided in table 2 (antihypertensives, hypolipidemic, antidiabetics?)? • Despite the absence of an effect on HbA1c levels after 5 years of follow-up in both treatment arms, it would be interesting to know how many participants developed type 2 diabetes during study course. ****** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No Reviewer #2: No Reviewer #3: No ******** [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0303021.r001
Revision 1
1 Mar 2024 Author Response Response to reviewers We thank the reviewers for reading critically and thereby contributing to improvement of our manuscript. Please find our response point-by-point below. Reviewer #1 1. Clarify what test was used for sample size calculation. Better use a method for repeated measures. Answer:We have added the test name in the method section. 2. The statistical analysis is not acceptable. For a longitudinal study with repeated measures, better consider longitudinal models such as mixed model and GLIMMIX models. Answer:We consider our statistical analysis the most appropriate given the dataset, the size of the data material and the drop-out rate. The proposed methods would render estimated data results and we argue that such method would not alter the main results and it would not give more accuracy to the analysis. 3. Specify primary endpoint (e.g. >5% reduction) and secondary endpoint. P value can be adjusted for secondary endpoint so power will not be reduced. Answer: Primary outcome is already specified under statistical analysis in the method section. We have added all the additional secondary outcomes in the same place in the text. All p-values were repeated analysis were performed have been adjusted with Bonferroni correction. Reviewer #2 The study is well written 1. Define abbreviations used in tables/figures in the figure caption. Answer: We have excluded abbreviations from table 1. In table 3, 4 and 7 we have added definition of abbreviations in footnotes. 2. Mention the strengths and limitations of your study in a separate paragraph before the conclusions paragraph. Answer: We have moved the paragraph about strengths and limitations of our study to just before the conclusion. We added a sub-heading “Strengths and limitations”. 3. Add the clinical relevance of your study. Answer: The clinical relevance of our findings is already presented in the last sentence of the first paragraph of the discussion and in the last five rows in the second paragraph of the discussion. We do not consider it relevant to elaborate further on this issue given the aim of the study. 4. Add a new heading for conclusions paragraph. Answer: We have added the suggested sub-heading. Reviewer #3 Specify the randomization process Answer: We have clarified the writing on the randomization in the method section. How is the eligibility criterion “being essentially healthy” is defined? Answer: The definition was “not fulfilling exclusion criteria” and this has been added in a parenthesis. Some tables (e.g. table 4, tables 7-8) should be moved to the supplementary appendix Answer: We disagree with the proposal. We prefer to keep all the tables in the main manuscript. Regarding table 4 we consider these results important for the evaluation of the study due to the high drop-out rate. Table 7 and 8 reports some of the secondary outcomes and we consider the secondary outcomes equally relevant. Could you provide in detail the classes of drugs taken “regularly” by 64% of enrolled subjects, according to data provided in table 2 (antihypertensives, hypolipidemic, antidiabetics?)? Answer: We have provided brief information on type of medication in the first paragraph in the result section. Despite the absence of an effect on HbA1c levels after 5 years of follow-up in both treatment arms, it would be interesting to know how many participants developed type 2 diabetes during study course. Answer: We do not have access to complete diagnostic data or diagnoses within ordinary health care. Although of clinical interest data to answer this question was not part of our data collection. Attachments Attachment Submitted filename: Response to reviewers.docx https://doi.org/10.1371/journal.pone.0303021.r002
12 Mar 2024 Decision Letter - Aleksandra Klisic, Editor PONE-D-23-38830R1“Dare to feel full” - A group treatment method for sustainable weight reduction in overweight and obese adults: A randomized controlled trial with 5-years follow-upPLOS ONE Dear Dr. Holmberg, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by Apr 26 2024 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. Please include the following items when submitting your revised manuscript: A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols. We look forward to receiving your revised manuscript. Kind regards, Aleksandra Klisic Academic Editor PLOS ONE Journal Requirements: Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #1: (No Response) Reviewer #2: All comments have been addressed Reviewer #3: (No Response) ******** 2. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: (No Response) Reviewer #2: (No Response) Reviewer #3: (No Response) ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: (No Response) Reviewer #2: (No Response) Reviewer #3: (No Response) ****** 4. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: (No Response) Reviewer #2: (No Response) Reviewer #3: (No Response) ****** 5. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: (No Response) Reviewer #2: (No Response) Reviewer #3: (No Response) ****** 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: Tables 1-3 can be combined. If a nonparametric method is used, better report median (IQR) instead of mean (SD). Table 4: this table can be omitted or moved to supplemental. If a nonparametric method is used, better report median (IQR) instead of mean (SD). Add percentages to treatment and sex. MCV superscript can be removed. Add “Abbreviations” to the footnote. Table 5: Why sample sizes are different for weight change, % change and reduction >=5% in control? E.g. 6m, 2 yr.. Table 5: my calculation for the p value of reduction >=2% is 0.01. Are other pvalues accurate? Weight % change and >=5% are secondary endpoint and p values may need to be adjusted. They can be presented in the table with other secondary endpoints. Tables 6 and 7 can be combined. Figure 2. bars are overlapping between two groups. Reviewer #2: (No Response) Reviewer #3: I would like to thank the authors for adequately responding to all comments and performing appropriate amendments in the manuscript. ****** 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No Reviewer #2: No Reviewer #3: No ******** [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0303021.r003
Revision 2
8 Apr 2024 Author Response We are thankful to all the reviewers for valuable comments on our manuscript and we have now revised the manuscript further in accordance with the comments from Reviewer #1. We hope that with these amendments to our manuscript it will be suitable for publication. Please find our point by point response below. Reviewer #1 Tables 1-3 can be combined. If a nonparametric method is used, better report median (IQR) instead of mean (SD). Answer: Table 1 and 3 has been combined to a new table 1. Table 2 is left unchanged since it has another structure and a combination would be hard to read. We have changed to Median and IQR. Figure 2. bars are overlapping between two groups. Answer: The bars in Figure 2 have been separated and the color changed to grey and black. Table 4: this table can be omitted or moved to supplemental. If a nonparametric method is used, better report median (IQR) instead of mean (SD). Add percentages to treatment and sex. MCV superscript can be removed. Add “Abbreviations” to the footnote. Answer: Previous Table 4 is now Table 3. We believe that this data should be kept in the manuscript for the best understanding of the data. We have changed to Median and IQR. We have added percentages to treatment and sex. The MCV superscript has been corrected indicating statistical significance. Abbreviations are included in the footnote. Table 5: Why sample sizes are different for weight change, % change and reduction >=5% in control? E.g. 6m, 2 yr.. Answer: Previous Table 5 is now Table 4. Sample sizes have been corrected. Thank for the attention, we discovered a mistake in our registry. Table 5: my calculation for the p value of reduction >=2% is 0.01. Are other pvalues accurate? Weight % change and >=5% are secondary endpoint and p values may need to be adjusted. They can be presented in the table with other secondary endpoints. Answer: We have only calculated for a reduction of >=5%, not 2%. Misunderstanding? The p-value after Fisher exact test is 0.0063 but after correction with Bonferroni the p-value is 0.03 which is now stated. The other p-values have also been checked and are correct. For best readability, we want to keep the secondary weight-related outcomes in Table 4 and have added this is the table heading. Tables 6 and 7 can be combined. Answer: Previous Table 6 and Table 7 have been combined and are now Table 5. The p-values in the previous Table 8 which is now Table 6 have been corrected according to Bonferroni in accordance with the analyses with corrected numbers as for table 4. Attachments Attachment Submitted filename: Response to reviewers.docx https://doi.org/10.1371/journal.pone.0303021.r004
18 Apr 2024 Decision Letter - Aleksandra Klisic, Editor “Dare to feel full” - A group treatment method for sustainable weight reduction in overweight and obese adults: A randomized controlled trial with 5-years follow-up PONE-D-23-38830R2 Dear Dr. Holmberg, We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice will be generated when your article is formally accepted. Please note, if your institution has a publishing partnership with PLOS and your article meets the relevant criteria, all or part of your publication costs will be covered. Please make sure your user information is up-to-date by logging into Editorial Manager at Editorial Manager® and clicking the ‘Update My Information' link at the top of the page. If you have any questions relating to publication charges, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Aleksandra Klisic Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #1: All comments have been addressed ******** 2. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: (No Response) ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: (No Response) ****** 4. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: (No Response) ****** 5. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: (No Response) ****** 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: All my comments are addressed. The statistics are acceptable now. ****** 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No ******** https://doi.org/10.1371/journal.pone.0303021.r005
Formally Accepted
26 Apr 2024 Acceptance Letter - Aleksandra Klisic, Editor PONE-D-23-38830R2 PLOS ONE Dear Dr. Holmberg, I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now being handed over to our production team. At this stage, our production department will prepare your paper for publication. This includes ensuring the following: * All references, tables, and figures are properly cited * All relevant supporting information is included in the manuscript submission, * There are no issues that prevent the paper from being properly typeset If revisions are needed, the production department will contact you directly to resolve them. If no revisions are needed, you will receive an email when the publication date has been set. At this time, we do not offer pre-publication proofs to authors during production of the accepted work. Please keep in mind that we are working through a large volume of accepted articles, so please give us a few weeks to review your paper and let you know the next and final steps. Lastly, if your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. If we can help with anything else, please email us at customercare@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Aleksandra Klisic Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0303021.r006

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