PONE-D-24-05284Empowering Parents to Optimize Feeding Practices with Preschool Children (EPO-Feeding): Feasibility Randomized Controlled Trial Protocol for a Group-based Training ProgramPLOS ONE

Dear Dr. Wang,

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.

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Dear Dr. Wang,

Thank you for submitting the protocol entitled “Empowering Parents to Optimize Feeding Practices with Preschool Children (EPO-Feeding): Feasibility Randomized Controlled Trial Protocol for a Group-based Training Program.” Feeding practices and behaviors are shaped early in life yet, few intervention studies have assessed the effectiveness of parenting guidance and support on early feeding. This submission was reviewer by four reviewers. 

This protocol holds potential for publication in PLOS ONE. However, there are some minor issues that need addressing, and we request that you revise and resubmit the protocol for further consideration for publication. Below I summarize some key points, but please note that the reviewers’ comments provide detailed suggestions to revise the protocol.

• The reviewers point to minor points to expand on, or add, for the introductions and methods, including more information on prior responsive feeding studies, incidence of obesity and overweight in China for this age group (reviewer 1), as well as of feeding practices in the centers (reviewer 3), additional considerations for inclusion/exclusion (reviewer 3), more detail on the intervention and content (see reviewer 1 and 3), information on validity and reliability (see comments by reviewers 1 & 2), and on the qualitative study.
• For analyses, see comments by reviewer 1 on qualitative analyses, as well as by reviewer 2 in the presence of non-normality, for missing data, and for linear mixed-effect regression analyses.

In addition to the comments by reviewers, please address the following edits:

• Line 165. Who is XXW? Should this be XW according to the cover page? Same for lines 372 and 378.
• Line 170. Unmasking is needed for analyses. Should this say “Unmasking will not take place until the databases are closed, and the data collection has been finished.”?

I encourage you to address these issues and the other comments in the individual reviews and submit a revised manuscript. When you send the revised manuscript back to us, please be sure to also submit a detailed response letter that lists the changes made to the manuscript and how you addressed each of the reviewer and editor comments. I will likely send the revision back to the some of the original reviewers.

Thanks again for considering Plus ONE for your work. We look forward to the revised protocol.

Sincerely,

Dr. Milagros Nores

Academic Editor

PLUS ONE 

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Please submit your revised manuscript by May 21 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.

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We look forward to receiving your revised manuscript.

Kind regards,

Milagros Nores, Ph.D.

Academic Editor

PLOS ONE

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6. 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.

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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 #2: Partly

Reviewer #3: Yes

Reviewer #4: Yes

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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

Reviewer #3: Yes

Reviewer #4: Yes

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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: Yes

Reviewer #3: Yes

Reviewer #4: Yes

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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: Yes

Reviewer #3: Yes

Reviewer #4: Yes

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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

Reviewer #3: Yes

Reviewer #4: Yes

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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: Dietary choices and feeding behaviours are shaped early in life; however, few intervention studies investigate the effectiveness of parenting guidance and support on early feeding. The authors have developed an evidence-informed intervention (based on a review of the literature and formative interviews), which they now propose testing for feasibility and acceptance prior to implementing a larger scale efficacy trial. Overall, the protocol is presented clearly and aligns with the trial registration information documented in ClinicTrials.Gov. My comments are intended to further clarify the design and future analyses:

Introduction

- The introduction justifies the need for the intervention study. However, I would have liked to have seen more information from prior intervention studies on the promotion of responsive feeding to understand better the number of interventions implemented, effectiveness on feeding behaviours, and limitations in the evidence.

- Feeding behaviours are shaped by a number of factors, including culture. The authors describe the attitudes and perceptions on feeding preschoolers in this part of China. It will also be valuable to briefly note the general status of overweight and obesity in China in this age group.

Methods

- It will be useful to include the TIDier table (Hoffmann et al 2012, BMJ) to describe the intervention content and delivery in more detail for readers in the main paper.

- It will be useful to include information on questionnaire reliability and validity previously reported in the Chinese versions of instruments employed (e.g., CFQ, Parenting Sense of Competence Scale)

Qualitative Study: (1) More elaboration is needed on the design (i.e., what qualitative research design will be implemented)? (2) All qualitative study samples are 'purposive'. More information on the sampling strategy; for example, will sample include all intervention arm and control arm parents, how will the parents in one (or both) arm/s be selected? (3) Will analyses be supported by software? (4) Will coding be inductive, deductive or both?

Thank you for the opportunity to review this trial.

Reviewer #2: The title is a bit too long and could be improved. The word protocol is to be added.

Line 158, the word minimal is to be replaced with minimum.

Line 268, whether an existing questionnaire or newly developed questionnaire was used is to be clearly stated. Information on reliability and validity is to be provided.

Line 272, Line 347, the description of the pattern of missing data before the imputation method is to be described.

Line 299-302, spacing between the sentences is to be standardized.

Line 346, the word limit to be replaced with other word e.g. mitigate etc.

Line 353-354, the test is employed when data are skewed. An alternative test is to be mentioned if the data does not meet normality assumptions.

Line 354, an alternative statistical test is to be mentioned if the assumptions for the r x c contingency table/chi-square test are not met.

Line 355, the sentence requires revision.

For primary outcomes, the handling of missing data (if any) is to be described. Is the method of handling missing data and analyses approach for secondary outcomes will be similar for primary outcomes? The write-up for the data analysis plans requires improvement in terms of flow and clarity.

For linear mixed-effects regression analyses, the approach is not clear. Information on the time points (baseline, T1, and T2) (repeated measures), covariance structure, estimation method is to be mentioned. If there are covariates/confounding factors in the analysis, the proposed sample size may not have enough statistical power to detect the effects while controlling for these factors. This is to be considered in the discussion/limitation.

For the discussion section, some sentences are to be written in future tense.

The list of references did not conform to the journal format.

The numbering for each title/topic/subtitle/subtopic is to be omitted.

Figure 2, the dark background and white font are to be replaced with white and dark respectively.

Reviewer #3: This article presents a novel feasibility study protocol focusing on the EPO-Feeding Program. The study aims to assess the feasibility and acceptability of this program, thereby informing interventions to optimize parents' feeding practices in China. This well-designed study addresses a crucial topic and is poised to make a significant contribution to the literature, making it an ideal fit for PLOS One. My comments are, therefore, of a minor nature.

1. The background briefly mentions cultural differences in parental feeding practices, but some insights into the food environment in kindergarten could also be beneficial. For example, do they provide snacks or lunch for the children? If they do, this can also influence children’s food intake. If so, how will this be addressed in the study?

2. The sample for this study is intended to include parents proficient in both spoken and written Chinese. However, it is important to consider the parents who may not meet this criterion. Are we assuming that all parents in mainland China are literate? This clarification will help ensure the study's findings are representative.

3. For clarity, please define usual care when first mentioned in the text in line 215.

4. Self-reporting questionnaires can have reporting bias, which has been listed as one of the study's limitations. What measures will be undertaken to reduce such biases?

5. What is included in the homework assignment? Could you elaborate more on this?

6. A list of the exploratory variables that will be collected could be helpful.

Reviewer #4: Summary:

The paper evaluates the Empowering Parents to Optimize Feeding Practices (EPO-Feeding Program), a novel intervention aimed at improving parental feeding practices (PFPs) for preschoolers in Yangzhou, China, to mitigate childhood obesity risks. Utilizing a feasibility randomized controlled trial (RCT), it assesses the program's implementation feasibility and acceptability, with secondary outcomes including changes in PFPs, parental perceptions, children's eating behaviors, and BMI-Z scores.

Strengths: The study introduces a novel intervention targeting the critical issue of optimizing PFPs to prevent childhood obesity, a significant public health concern. Utilizes a mix of quantitative and qualitative analyses, including a feasibility RCT, thematic framework analysis, and detailed process evaluation, the authors providing a robust evaluation framework. In addition, based on the Behaviour Change Wheel and Social Cognitive Theory, the intervention is theoretically grounded, enhancing its potential effectiveness.

Comments:

1. Please add the description of measurements of children's height and weight in “4.2 Secondary objectives/outcomes”.

2. Please add information on the baseline assessment in the appendix.

3. Some of the details are wrong, please check carefully:

P2L20, “Backgrounds” changed to “Background”

P7L139, Yangzhou is a city under Jiangsu Province, please change “Yangzhou District, Jiangsu, China” to “Yangzhou, Jiangsu Province, China”

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Reviewer #1: No

Reviewer #2: No

Reviewer #3: Yes: Dr. Sophiya Dulal

Reviewer #4: No

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Empowering parents to optimize feeding practices with preschool children (EPO-Feeding): A study protocol for a feasibility randomized controlled trial

PONE-D-24-05284R1

Dear Dr. Wang,

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.

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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,

Milagros Nores, Ph.D.

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Dear Dr. Wang,

Thank you for submitting the protocol entitled “Empowering parents to optimize feeding practices with preschool children (EPOFeeding): A study protocol for a feasibility randomized controlled trial.” One of the reviewers and I have read the revised manuscript and feel you have been responsive to all the minor revisions requested. As a result, I am pleased to accept this protocol for publication.

I appreciate your hard work on this revision.

Thanks again for considering Plus ONE for your work. We look forward to the revised protocol.

Sincerely,

Dr. Milagros Nores

Academic Editor

PLUS ONE

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 #2: Partly

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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 #2: Partly

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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 #2: Yes

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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 #2: Yes

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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 #2: Yes

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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 #2: The authors have made significant efforts to address the feedback provided.

No further comments.

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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 #2: No

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Submitted filename: Editor Response PONE-D-24005284R1 - Accept.docx