Pre-/-post-analyses of a feasibility study of a peer-based club intervention among people living with type 2 diabetes in Vietnam’s rural communities

Ngoc-Anh Thi Dang; Tuc Phong Vu; Tine M. Gammeltoft; Ib Christian Bygbjerg; Dan W. Meyrowitsch; Jens Søndergaard

doi:10.1371/journal.pone.0290355

Peer Review History

Original SubmissionApril 24, 2023
19 Jun 2023 Decision Letter - Tahir Turk, Editor PONE-D-23-09542Pre-/-post-analyses of a feasibility study of a peer-based club intervention among people living with type 2 diabetes in Vietnam’s rural communitiesPLOS ONE Dear Dr. Dang, 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 Aug 03 2023 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. 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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. Thank you for stating the following in the Acknowledgments Section of your manuscript: “The present study is part of the interdisciplinary research project, Living Together with Chronic Disease: Informal Support for Diabetes Management in Vietnam (VALID) (17-M09-KU), funded by the Ministry of Foreign Affairs of Denmark (DANIDA).” We note that you have provided additional information within the Acknowledgements Section that is not currently declared in your Funding Statement. Please note that funding information should not appear in the Acknowledgments section or other areas of your manuscript. We will only publish funding information present in the Funding Statement section of the online submission form. 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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. Additional Editor Comments (if provided): Reviewer 1. Accepted with no revisions. Reviewer 2 Comments: This is an interesting study. I have some comments on some aspects of the manuscript. In the introduction, there is no information on the global prevalence of diabetes. It is useful to give the global picture before the burden of the disease in Vietnam On page 6 under the Intervention overview, authors mentioned a previous qualitative study on line 157 but information has not been provided on how this is linked with the current study. It will be useful to provide this information Materials and Methods Page. 10. Under sampling, 39 people in the pre-study refused to participate in the diabetes club intervention but mention has been made of this as a possible influencing factor of the outcome/results. Indicate the reasons why they refused to participate in the intervention. That may help the explanation. Results Combine Table 4 and 5 into one table as these are the self-management practices Combine table 6 and 7 into one table Discussion All the sub-sections under the discussion have been linked with the COVID-19 pandemic but there is not report on whether any of the participants suffered the COVID-19 It will be appropriate to mention this in order to put the discussion in the appropriate context as mentioned under the settings on page 7 line 145 - 154 For the discussion of the HbA1c changes, COVID-19 is used as a plausible reason for no significant difference but this did not seem to affect self-care practices including medication adherence. Self-care practices are known to have effect on the HbA1c levels. it will be useful to find explanations for the improvement in self-care practices but didn't reflect in the HbA1c On page 22 line 432 - 434, a possible reason for increase in HbA1c is indicated as less fear of diabetes complication. Support this statement with evidence [Note: HTML markup is below. Please do not edit.] 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: Yes Reviewer #2: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: 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: Yes Reviewer #2: No ****** 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 ****** 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: The topic is interesting and relevant to the present day as there has been a rapid increase in diabetes-related disease burden in most Asian countries and there is a dire need for approaches to treatment and care in diabetes management. Peer support group, use of positive deviant people within the community, use of lady health workers within the effected community intervention strategy has been employed previously and has shown good result for NCD and other lifestyle behaviours change. This is more useful particularly in resource-constrained rural communities where informal health support through community members or peer-based club intervention is a possible option for improving the quality of life for people living with diabetes. I enjoyed reading the paper which was well written with proper English and scientifically well laid out. Moreover, the results were negative in terms of primary objectives but the authors have published their results giving valid explanation. Introduction: good & comprehensive and recent literature incorporated. Was not sure if the introduction can have sub headings, as the author has 2-3 subheadings within the intro section. Methods: very well presented, however if the author can specify the name of the organization within the paper about the cutoffs for HbA1c goal for adults is 7 % or less, or for blood pressure so the reader can know how the author has decided on these cutoffs instead of looking at the references. She has done for other variables like BMI. Fig 1. The flow chart is blurred, and needs to be improved. Results: The authors table titles needs to be refined for example Table 1 title is Table 1. The respondent’s socio-demographic (n = 222). For example, A more appropriate title could be: Table 1. The socio-demographic characteristics of the participants of the VALID study 2019 (n 222) (Frequencies & percentages). I suggest the author reviews all table title and write it more scientifically. Also some tables may need additional footnotes instead of only statistical test name. Discussion: Does the Plos 1journal allow subsection in the discussion section? as currently the author has subsections with the discussion part. Otherwise well composed. References: suggest to go through these recent articles on similar topics: 1. Meyrowitsch DW, Nielsen J, Bygbjerg IC, Søndergaard J, Thi DK, Huyen DBT, Gammeltoft T, Duc TN Unmet needs for informal care among people with type 2 diabetes in rural communities in Vietnam. Public health in practice (Oxford, England). 2023. 2. Li S, Yin Z, Lesser J, Li C, Choi BY, Parra-Medina D, Flores B, Dennis B, Wang J Community Health Worker-Led mHealth-Enabled Diabetes Self-management Education and Support Intervention in Rural Latino Adults: Single-Arm Feasibility Trial. JMIR diabetes. 2022. 3. Development and evaluation of self-care intervention to improve self-care practices among people living with type 2 diabetes mellitus: a mixed-methods study protocol. BMJ open. 2021. 4. Shiyanbola OO, Maurer M, Mott M, Schwerer L, Sarkarati N, Sharp LK, Ward E A feasibility pilot trial of a peer-support educational behavioral intervention to improve diabetes medication adherence in African Americans. Pilot and feasibility studies. 2022 Reviewer #2: This is an interesting study. I have some comments on some aspects of the manuscript. In the introduction, there is no information on the global prevalence of diabetes. It is useful to give the global picture before the burden of the disease in Vietnam On page 6 under the Intervention overview, authors mentioned a previous qualitative study on line 157 but information has not been provided on how this is linked with the current study. It will be useful to provide this information Materials and Methods Page. 10. Under sampling, 39 people in the pre-study refused to participate in the diabetes club intervention but mention has been made of this as a possible influencing factor of the outcome/results. Indicate the reasons why they refused to participate in the intervention. That may help the explanation. Results Combine Table 4 and 5 into one table as these are the self-management practices Combine table 6 and 7 into one table Discussion All the sub-sections under the discussion have been linked with the COVID-19 pandemic but there is not report on whether any of the participants suffered the COVID-19 It will be appropriate to mentbionthis in order to put the discussion in the appropriate context as mentioned under the settings on page 7 line 145 - 154 For the discussion of the HbA1c changes, COVID-19 is used as a plausible reason for no significant difference but this did not seem to affect self-care practices including medication adherence. Self-care practices are known to have effect on the HbA1c levels. it will be useful to find explanations for the improvement in self-care practices but didn't reflect in the HbA1c On page 22 line 432 - 434, a possible reason for increase in HbA1c is indicated as less fear of diabetes complication. Support this statement with evidence ****** 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 ******** [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.0290355.r001
Revision 1
2 Aug 2023 Author Response Dr. Tahir Turk Academic Editor PLOS ONE Dear Editor, dr. Tahir Turk We would like to thank you and your reviewers for your thorough review of our manuscript “Pre-/-post-analyses of a feasibility study of a peer-based club intervention among people living with type 2 diabetes in Vietnam’s rural communities” (Manuscript ID PONE- D-23-09542) and for giving us the opportunity to revise it. We believe that this process has significantly improved our manuscript. A point-by-point response can be found below. Changes in the manuscript have been highlighted in italics. All authors have approved the contents of this manuscript as well as the revisions that we have made. Thank you for your continued consideration and the opportunity to publish in Plos One. Sincerely, Ngoc-Anh Thi Dang, MPH Department of Public Health Thai Binh University of Medicine and Pharmacy Thai Binh, Vietnam Journal Requirments Please remove any funding-related text from the manuscript and let us know how you would like to update your Funding Statement. We have deleted this part from the acknowledgment section and added a section to the manuscript: “Funding The study is funded by the Ministry of Foreign Affairs in Denmark (DANIDA) Grant no 17-M09-KU“ Reviewer #1: Accepted with no revisions. Thank you 1. Introduction: good & comprehensive and recent literature incorporated. Was not sure if the introduction can have sub headings, as the author has 2-3 subheadings within the intro section. Thank you. We have deleted the subheadings in the introduction section. Please see in the manuscript. 2. Methods: very well presented, however if the author can specify the name of the organization within the paper about the cutoffs for HbA1c goal for adults is 7 % or less, or for blood pressure so the reader can know how the author has decided on these cutoffs instead of looking at the references. She has done for other variables like BMI. We have added to the manuscript: “We used the recommended HbA1c Hb1Ac <7%) (1) and BP targets (<140/90mmHg) (2) for adults with T2D proposed by American Diabetes Association, 2020” 3. Fig 1. The flow chart is blurred, and needs to be improved. Thank you. We have updated a new flow chart 4. Results: The authors table titles needs to be refined Thank you. We have changed the titles of the tables Reviewer #2: 1. In the introduction, there is no information on the global prevalence of diabetes. It is useful to give the global picture before the burden of the disease in Vietnam. Thank you. We have added in line 67 -72: “T2D has become a frequent non-communicable disease, which continues to increase in incidence and prevalence globally, particularly in low-income and middle-income countries (3, 4). In 2021, an estimated 537 million adults, equivalent to 10.5% of the world's population aged 20-79, have diabetes, and 3 in 4 persons live in low- and middle-income countries (LMIC) (12). In South-East Asia alone, it is predicted that the number of adults with diabetes will reach 113 million and 151 million by 2030 and 2045, respectively (12).” 2. On page 6 under the Intervention overview, authors mentioned a previous qualitative study on line 157 but information has not been provided on how this is linked with the current study. It will be useful to provide this information Thank you. We have added in line 164 - 167: “In the qualitative study we identified obstacles, barriers and facilitations pertinent to having T2D and a strong desire for knowledge and peer support in self-management among people with T2D in rural communities (44, 45). This knowledge fed into the process of designing the diabetes management intervention, "Living healthy and well with diabetes,…." 3. Materials and Methods Page. 10. Under sampling, 39 people in the pre-study refused to participate in the diabetes club intervention but mention has been made of this as a possible influencing factor of the outcome/results. Indicate the reasons why they refused to participate in the intervention. That may help the explanation. Thank you for this very relevant question. We do not have solid information on why 39 refused to participate in the diabetes club intervention, but we believe that there are a plethora of reasons. We have added to the discussion in line 445 - 453 : “This pre-/-post-study aimed to assess the feasibility of a peer-based club intervention in influencing the HbA1c index and self-management among people living with T2D in rural communities. Albeit there were no effects on the primary outcome, the study still shows promising results that should be addressed in a randomized controlled study. A total of 39 persons refused to participate in the intervention. We have not systematically recorded the reasons for this nonparticipation, but believe that there is a plethora of reasons including logistics, reluctance to participate in new types of interventions, and the COVID-19 crisis probably also contributed to our intervention participants' dropout. Future studies should address how to reach out to these nonparticipants in order to increase participation.” 4. Results Combine Table 4 and 5 into one table as these are the self-management practices Combine table 6 and 7 into one table We have combined table 4 and 5 into one table. However, regarding combing table 6 and 7 into one table was a challenge as the measures in is N in table 7 vs biological measures. And we feel that combing the table will make it more difficult for the reader to understand the table. 5. Discussion All the sub-sections under the discussion have been linked with the COVID-19 pandemic but there is not report on whether any of the participants suffered the COVID-19 It will be appropriate to mention this in order to put the discussion in the appropriate context as mentioned under the settings on page 7 line 145 - 154 For the discussion of the HbA1c changes, COVID-19 is used as a plausible reason for no significant difference but this did not seem to affect self-care practices including medication adherence. Self-care practices are known to have effect on the HbA1c levels. it will be useful to find explanations for the improvement in self-care practices but didn't reflect in the HbA1c On page 22 line 432 - 434, a possible reason for increase in HbA1c is indicated as less fear of diabetes complication. Support this statement with evidence We changed the discussion as proposed by the reviewer The average HbA1C levels demonstrated an unexpected statistically significant though minimal and probably not clinically relevant increase from 6.9 to 7.24 % from pre-intervention to post-intervention. Our result contrasts with some previous studies in Cameroon (50), Uganda (25), and Guatemala (24), where peer support significantly improves HbA1c in people with T2D. One explanation for the slight increase in HbA1c was that our intervention was conducted during the delta variant outbreak of COVID-19 in Vietnam (43), not sparing Thai Binh Province. Albeit it is unknown how many of the participants were infected by COVID-19 but nationwide social distancing during COVID-19 (45-50) posed challenges like a more sedentary lifestyle and consequently inadequate diabetes self-management among people with T2D (21). Individuals with T2D also feared being more susceptible to COVID-19 infection due to comorbidity (21-23), leading to the delay or avoidance of regular check-ups at healthcare facilities (51-55). Further, we do not know the changes in HbA1C among patients who did not participate in our study. Another explanation for the small increase in HbA1c is that T2D is a progressive condition (56). In our study, the elderly predominated with 79.3% of respondents aged 60 and above; thus, although the normal patterns of development of T2D can be slowed down based on good self-management, they may still worsen with time. In addition, we might hypothesize that having less fear of diabetes complications may contribute to the small increase HbA1c index due to a slightly less adherence to recommendations. However, our data does not support this assumption and future analyses should look into this area. We also found similarities in the previous studies, which exhibited a non-significant difference in HbA1c level (29-31) after the intervention. Moreover, the number of studies with similar findings was limited, which may be caused by the fact that positive results tend to be published, while no results or negative tend to be unpublished (57). And “Unfortunately the improvement in self-management behaviors was not reflected in improved Hb1Ac.” Attachments Attachment Submitted filename: Response to reviewers.docx https://doi.org/10.1371/journal.pone.0290355.r002
7 Aug 2023 Decision Letter - Tahir Turk, Editor Pre-/-post-analyses of a feasibility study of a peer-based club intervention among people living with type 2 diabetes in Vietnam’s rural communities PONE-D-23-09542R1 Dear Dr. Dang, 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 for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, 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, Tahir Turk, PhD Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0290355.r003
Formally Accepted
6 Oct 2023 Acceptance Letter - Tahir Turk, Editor PONE-D-23-09542R1 Pre-/-post-analyses of a feasibility study of a peer-based club intervention among people living with type 2 diabetes in Vietnam’s rural communities Dear Dr. Dang: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. 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 plosone@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. Tahir Turk Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0290355.r004

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