PONE-D-22-07220Effectiveness of a positive deviant intervention to improve appropriate feeding practices and nutritional outcomes in West Omo Zone, Maji District: South West Region, Ethiopia: A study protocol for a cluster randomized control trialPLOS ONE

Dear Dr. Gizaw,

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.

The investigators deserve to be complimented for attempting a challenging study. However there are major concerns that have been raised by the reviewers regarding several important issues in the study design, sample size calculation, ethics, data analysis and conclusions. These will have to be satisfactorily addressed by the authors before the manuscript can be considered for publication. 

Please submit your revised manuscript by Jul 01 2022 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,

Sourabh Dutta

Academic Editor

PLOS ONE

Journal Requirements:

When submitting your revision, we need you to address these additional requirements.

1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. 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 submitting the above manuscript to PLOS ONE. During our internal evaluation of the manuscript, we found significant text overlap between your submission and the following previously published works, some of which you are an author.

-   https://link.springer.com/article/10.1186/s12887-018-1278-5

We would like to make you aware that copying extracts from previous publications, especially outside the methods section, word-for-word is unacceptable. In addition, the reproduction of text from published reports has implications for the copyright that may apply to the publications.

Please revise the manuscript to rephrase the duplicated text, cite your sources, and provide details as to how the current manuscript advances on previous work. Please note that further consideration is dependent on the submission of a manuscript that addresses these concerns about the overlap in text with published work.

We will carefully review your manuscript upon resubmission, so please ensure that your revision is thorough.

3. 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.

4. Please include your full ethics statement in the ‘Methods’ section of your manuscript file. In your statement, please include the full name of the IRB or ethics committee who approved or waived your study, as well as whether or not you obtained informed written or verbal consent. If consent was waived for your study, please include this information in your statement as well.

5. We note you have included a table to which you do not refer in the text of your manuscript. Please ensure that you refer to Table 1 in your text; if accepted, production will need this reference to link the reader to the Table.

6. Please include a copy of Table 2 which you refer to in your text on page 9.

7. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information.

Additional Editor Comments:

The reviewers have asked for major changes in the manuscript. They have important concerns regarding the study design, sample size calculation, analysis and the conclusions drawn. The manuscript can be considered for publication if major revisions are made as requested by the reviewers, but the submission of a revised manuscript is not a guarantee for publication.

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: No

Reviewer #2: Yes

**********

2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #1: Yes

Reviewer #2: Partly

**********

3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #1: Yes

Reviewer #2: No

**********

4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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

**********

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: Yes

Reviewer #2: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Comments

The study protocol by Gizaw et al., is one of a kind which describes the effectiveness of a positive deviant intervention to improve appropriate feeding practices and nutritional outcomes in West Omo Zone, Maji District Ethiopia. But there are some revisions to be made in the paper, pertaining to which the manuscript would be suitable for publication:

Abstract:

Comment 1: The author used the word inclusion criteria in the abstract. A brief sentence can be added about how the author selected the paricipants based on inclusion and exclusion criteria.

Introduction:

Comment 2: Does the introduction provide sufficient background information for readers not in the immediate field to understand the problem/hypotheses?

The introduction provides a good, generalized background of the topic that quickly gives the reader an appreciation of the positive deviant to improve appropriate feeding practices and nutritional outcomes. However, to make the introduction more substantial, the author may wish to provide several references to substantiate the claim made in the second paragraph (that is, provide references to other groups who do or have done research in this area).

Methods

Comment 3: In the methods, a sentence could be added on the pilot survey after which the questionnaire and tools could be modified.

Comment 4: Before data collection among participants, how the reliability and validity of the translated questionnaire was checked?

Discussion

Comment 5: Limitations of the study could be added.

Reviewer #2: Review Comments to the Author

• I congratulate the authors for having decided to work in much needed field. The study design is appropriate for the problem identified, but needs some further work.

• Before getting into the specific comments of the study protocol per se, I would like to rise two concerns:

1. The Ethical Clearance body and the funding agency/ body seem to be the same.

2. The study lacks formative research such as KAP and Baseline data on the present feeding practice and nutritional outcomes. These are needed for an approach such as positive deviant study. These could be added in the methods.

• The abstract is well written and covers the main points of the study. The research question, the approach of the study, the intervention and the analysis are stated clearly. However, the authors mention using the experiences of the mothers who have come up with solutions to their IYCF problems. But later they say that they will use WHO IYCF guidelines. These are contradictory statements in the abstract.

• Introduction : The background information on the concept of Positive Deviance and the evidence of effectiveness of positive deviant nutritional education on the nutritional outcomes of the children are missing in the introduction. Need to be added.

• Health is often spelt as ‘hearth’

• The intervention describes the positive deviance/health nutrition education as an approach that identifies and transfers good behaviours shown by mothers of well-nourished children from disadvantaged households to others in the community with malnourished children. Therefore, the positive deviant mother should have a child with a similar age group to enable the positive deviant mother to show the effects of positive deviance. The study does not mention this as a criteria. Additionally, the protocol does not describe the method of assessing such as conducting anthropometry to assess growth and nutritional status of children, to select the successful mothers.

In the study protocol researchers have mentioned that the intervention is based on WHO Infant and young child feeding practices guidelines which will be developed by the researcher in the local language. The delivery of these guidelines is done by positive deviant mothers. Here mothers whose children are normal in nourishment are trained and made as health educators. [called as positive deviant mothers].

Practices used by such positive deviant mothers are not explored and used in correcting the malnourishment. Sustainability and locally followed ‘deviant’ and unique practices, which are the core principles of positive deviance. As this method is sustainable if such mothers are willing to act as the health educators, and the recipient mothers willing to accept their example.

Questions and concerns regarding the acceptance of the PD mothers as a motivation and authoritative educators need to be addressed. Measures to ensure the same is to be thought through. Moreover, which messages will the PD mother deliver ? Their own practices that were successful or the WHO guidelines. If the later, then this is not a PD method. It is only using successful mothers as the messengers.

• Eligibility criteria for cluster choosing, is vague. If the researcher is choosing non-adjacent, geographically accessible zone, it is a non-random selection of the zones purposively. Such a step may be necessary for hassle-free completion of the said study. However, it is not appropriate to mention such type of selection as random selection.

• As authors describe the protocol to be single blinded parallel cluster randomized trial, there has been no description on the methods used to ensure blinding and, at what stages blinding will be ensured.

• In the selection criteria of the participants, it is helpful to specify the conditions/diseases under severely ill [inclusion and exclusion criteria for severely ill].

• The age group of the study population is mentioned as 0-24 months. However, there are several components of the study like complimentary feeding, Minimum Meal Frequency, minimum dietary diversity cannot be assessed in the age group of 0-6 months owing to the period of exclusive breast feeding. A prior plan to address such issues, to have enough sample size for reliable results is needed.

• Sample Size estimation:

The p2 in the denominator for sample size calculation appears to be incorrect. There is a discrepancy in the value of the p2 mentioned and the one used in the formula. The number of clusters does not account for the total sample size that includes the additional loss to follow-up numbers. Therefore, it might be useful to check the math again.

The said sample size of 516 to be selected in each of the arms of the study. Sample size estimation formula is to provide the sample size for one arm. So, actual size should be 516 in the intervention arm and 516 in the control arm. So, the total sample will be 1032 if the said power of the study and reliable results is wished.

The intra cluster correlation coefficient of 0.03 seems low considering the nutritional and feeding practices within the said cluster remain similar.

• Sampling: Method of selection of the [non-positive deviant] women within the cluster is not mentioned i.e., How are 12 women in each of the clusters selected? What is the total expected number of mothers in each zone ? How the 12 will be selected from them ?

• Intervention

Although researcher has mentioned the selection criteria of the positive deviant mothers. However, how did the researcher identify the normal children of the selected positive deviant mothers? And what was the sampling techniques used to select the PD mothers amongst the mothers who have fulfilled the inclusion criteria mentioned?

The ratio of positive deviant mother to the selected non-positive deviant mothers is to be specified. The detailed session plan and the methods of delivery of health education sessions must be described including the time and place of demonstrations should be specified.

The outcome of change in the nutritional status of the child is being measured. But, How and who will be monitoring and/or measuring the behavioral change in the non-positive deviant mothers?

It is desired to mention the ratio of the supervisor to positive deviant mothers involved in the program and training and quality assurance of the work of the supervisors.

Issues related to protocol about the selection of mothers or positive deviant mothers must be addressed.

• Control

The researcher mentions that the control arm receives the standard care. It necessary to mention what comprises the standard care.

• In an RCT, there is need to show the baseline equivalence between the intervention and the control arm. i.e., that the baseline characteristics of both the arms are comparable and so, later the researcher can measure the effect of the intervention.

• Prior identification of possible bias and confounders can help in addressing such if present in the plan of analysis. Measures used in addressing the possibilities of Hawthorn effect in the control arm is not mentioned.

• Research hypothesis:

The research hypothesis mentioned that, there will be significant improvement. However, it is important the quantify the expected improvement.

The research hypothesis seems like a one-sided hypothesis with superiority trial. However, values of alpha and beta used in the sample size estimation and p value of the level of significance is taken of the two-sided hypothesis testing.

• Secondary objective: There is hardly any mention about the methodology viz. data collection methods or the qualitative methods to achieve secondary objectives.

• The study does not account for the possible programmatic issues that may arise in the even the positive deviant mother’s child falls ill and the solutions/programmatic implications it may have. Crisis management: If there are any children [who are participants] during the study period who fall severely ill or decrease in the weight becoming severely malnourished. What is the plan of action in such circumstances: in terms of care and treatment of such children and their continuation as participants in the study. Care should be taken to address growth faltering

• The ‘routene interventions’ – will they be continued in the intervention arm, as in the control arm ?

• Mention of the tools used for assessing complimentary feeding, description of such data and their plan analysis is needed.

• Mid Arm Circumference measurement is mentioned in the data collection. Please ensure that the specifics mentioned in the Table 2 match the description and are the same throughout the various sections of the paper. Although, the methods to be used for the measurement such as Shikar’s tape, Bangal test or Measuring with tape etc., is not described. Use of the same in achieving the objective and plan of analysis is to be mentioned.

• In the table of assessment, there is mention of diarrhea, cough and fever. However, throughout the methodology there is no mention of using clinical assessment of the children its accountability of the outcome assessment.

• In the table of assessment, mention of household food insecurity assessment, water, hygiene and sanitation, cultural food taboos are present. However, no description such variable in the objectives, tools of assessment and data analysis is present in the protocol.

• Plan of Analysis: Whenever we have two comparison in survival analysis [intervention and control arms], it appropriate to use Cox’s proportional hazard model for analysis instead of Kaplan Meir curve.

• More detailed description of the plan of analysis in comparison of the intervention and control group at three different time lines is desirable.

• References needs to be revisited in the view of using original references to quote the data. For example, the authors have referred to studies from Cambodia, Ethiopia for WHO recommendations (references 2 and 3). It would be useful to refer to the original WHO documents. Similarly, while quoting global figures, it would be useful to quote the latest available data rather than studies from Maharashtra, which is perhaps not the original source of global data on malnutrition. Also, the local data from the study area should constitute the background/baseline. These are missing.

**********

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: Yes: Dr Mona Duggal

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.

Attachments

Attachment

Submitted filename: Comments Plos one.docx

PONE-D-22-07220R1Effectiveness of a positive deviance approach to improve appropriate feeding and nutritional outcomes in South West Region, Ethiopia: A study protocol for a cluster randomized control trialPLOS ONE

Dear Dr. Gizaw,

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 Oct 14 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.

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,

Jianhong Zhou

Staff Editor

PLOS ONE

Journal Requirements:

1. 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.

Additional Editor Comments:

As reviewer 2 and reviewer 3 have hinted, the manuscript is rather confusing to follow. There are fundamental problems in understanding what exactly is the definition of "a positive deviant mother" . 

As per page 6, the NON-positive deviant mothers should have a infant/child aged 0-24 months, the child's Height-for-age Z (HAZ) scores HAZ < −2 and a child with NO severe malnutrition will be included in the study. Presumably <-2 z score means worse than -2. It is not clear from "a child with no severe malnutrition" whether this refers to the index child who is expected to be stunted or a sibling of the child. If it is the index child, then is the child supposed to have no severe malnutrition but be stunted at the same time, and if so, why?

On page 9, the POSITIVE deviant mothers are defined as those who have a number of positive attributes but their child should apparently have the following attributes which are all negative "was a big baby who is losing weight now", "have any severely malnourished sibling", "have any serious or typical social or health problem", "have families enrolled in a supplementary feeding program".  

Apart from the ambiguity about the definition of positive deviant and nonpositive deviant mothers, the manuscript lacks clarity in many places. 

The authors must take the help of a colleague whose primary language is English. There are many sentences in the manuscript that are challenging to understand. Perhaps the authors were not able to get their point across clearly because of a language barrier.

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: Yes

Reviewer #3: Yes

**********

2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #1: Yes

Reviewer #3: Partly

**********

3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #1: Yes

Reviewer #3: Yes

**********

4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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 #3: Yes

**********

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

Reviewer #3: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: The previous reviewer's comments have been addressed . The methodology has been strengthened and strengths and limitations of the stud have been added.

Reviewer #3: ​In this Randomized control trial, authors are trying to identify positive deviant mothers , utilise them to educate other mothers in the community whose children are stunted and then to study the effectiveness of the approach to improve feeding and nutritional outcomes in Ethiopia. This is a study addressed to improve a very important issue of the nation that is malnutrition.

Comment 1: The study design is stated to be a single blinded RCT . It is stated that because of the nature of intervention, mothers cannot be blinded but the intervention assignment is concealed from the interviewers collecting outcome data. But how will it be possible to conceal the intervention data from the interviewers as they are collecting data from mother herself who knows it? How is blinding possible in such a situation?

Comment 2: Regarding identification of positive deviant mother , the criteria from child’s side is stated to be a big baby who is losing weight now , have any severely malnourished sibling , have any social or health problem are taken as babies who will be considered. But should it not be other way round ? Their families should not be considered for positive deviance.

Comment 3: Though the authors tried to mention that every fortnightly positive deviant mothers will visit non positive deviant mothers, the practical aspects like how the they would be transported , the logistics , time taken to do so , how they are going to help other mothers need to be addressed.

**********

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: Yes: Mona Duggal

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.

Effectiveness of a positive deviance approach to improve appropriate feeding and nutritional status in South West Region, Ethiopia: A study protocol for a cluster randomized control trial

PONE-D-22-07220R2

Dear Dr. Gizaw,

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,

Sourabh Dutta

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

The manuscript is acceptable for publication. Although one of the reviewers has asked for a minor revision (that the eligibility criteria of the positive deviant mothers has to be mentioned), this is not necessary because the authors have laid down the process of identifying the positive deviant mothers in detail as a part of the 6 steps on page 11 of the manuscript.

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #3: Yes

Reviewer #4: Yes

**********

2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #3: Yes

Reviewer #4: Yes

**********

3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #3: Yes

Reviewer #4: Yes

**********

4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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 #3: Yes

Reviewer #4: Yes

**********

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 #3: Yes

Reviewer #4: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #3: The protocol is now comprehensible.It would be clear if the eligibility criteria contains information of all mothers to be included , not only non positive deviant mothers.

Reviewer #4: The manuscript is the study protocol of a cluster RCT aimed to assess the effectiveness of a positive deviance approach (PDA) to improve IYCF and nutritional status in South West region, Ethiopia. This is the second revision. Other than being very lengthy the protocol is well written

The study objectives are clear.

The rationale for the study is well described

The population, intervention and ouctomes are described well

The outcomes are defined and the analysis plan is presented

Sample size calculation is provided

The intervention – the positive deviant behaviours need to be identified and chosen to be delivered to the intervention clusters. The steps for this are provided in the protocol

Trial registration and ethical approvals are also provided.

**********

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 #3: Yes: Mandula Phani Priya

Reviewer #4: Yes: Sindhu Sivanandan

**********