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. 2025 Jun 2;20(5):e0324030. doi: 10.1371/journal.pone.0324030

Nutritional approach based in self-compassion versus energy-restricted diet approach in body dissatisfaction and disordered eating in adult women: a protocol for randomized clinical trial

Alessandra Behar Ramos 1, Vinícius Suedekum da Silva 1, Débora Viçosa Cardoso 1, Carolina Guerini de Souza 1,2,*,¤
Editor: Leonardo Vidal Andreato3
PMCID: PMC12129175  PMID: 40455797

Abstract

The proposed study protocol aims to compare the effect of a nutritional approach based on self-compassion techniques compared to the traditional method through dieting on body image dissatisfaction, caloric restriction, and dysfunctional eating in women who feel dissatisfied with their bodies.

Materials and methods

This protocol was developed according to the guidelines of the Standard Protocol Items: Recommendations for Interventional Trials 2013 Statement (SPIRIT) and presents a randomized clinical trial with women who are dissatisfied with their bodies and live in southern Brazil. Participants will be randomized to the self-compassion or diet group and attend eight-week weekly meetings. Body image dissatisfaction will be assessed using the Body Shape Questionnaire (BSQ), dysfunctional eating will be assessed using the Three Factor Eating Questionnaire (TFEQ-RS21), and levels of self-compassion will be measured using the Self-Compassion Scale (SCS). The participants will answer the tools at the beginning of the study, at the end of the 8-week intervention, and 3 and 6 months after the end of the meetings.

Discussion

This will be the first study to compare these two approaches using body dissatisfaction and eating behavior as outcomes, not just body weight. To date, only observational studies have evaluated the relationship between self-compassion, body dissatisfaction, and dysfunctional eating behavior.

Trial Registration: ClinicalTrials.gov NCT06084260

Introduction

Sociocultural factors greatly influence the female body, so to be considered beautiful, it must be slim, with a greater degree of muscle definition and as little fat as possible [1,2]. This standard of beauty has contributed to an increase in body dissatisfaction and low self-esteem in women [3,4]. Dissatisfaction with the body seems to be starting earlier and earlier, being present as early as childhood, and is more prevalent in women than in men [5–7].

Body dissatisfaction is a risk factor for the incessant search for the ideal body, dysfunctional eating behavior [8], as well as the practice of energy-restricted diets [9,10]. Weight loss programs and energy-restricted diets have been practiced for several years [11,12] to deal with body dissatisfaction. Although they show results in the short and medium term, such programs are ineffective in maintaining weight in the long term [11,12] and can contribute to weight regain [13]. In addition, these programs are considered harmful because they favor dysfunctional behaviors’ development involving cognitive restriction, binge eating, uncontrollable desire for food, worry, and guilt when eating [14]. Furthermore, such diets, together with the fear of gaining weight and exaggerated preoccupation with food, calories and physical appearance, can be related to a failure’s sense, lack of control over one’s own life, decreased self-esteem, guilt, irritability, anxiety, depression [12] and the incidence of eating disorders [15–17].

In recent years, approaches have emerged that aim to promote healthy eating behavior without focusing on losing body weight [18] as an alternative to weight loss programs based on food restriction. Interventions without the use of diets have shown psychological benefits, such as an improvement in general psychological well-being and a reduction in suffering, weight-related stigma and body dissatisfaction [19,20], as well as greater eating competence, intuitive eating [21], a reduction in cognitive restriction and lack of eating control, and long-term weight loss [18].

One of these approaches is self-compassion, a theory derived from Buddhism that has shown a positive association with better mental behavior and health parameters [22]. It is a practice that can be learned, accessible anytime, and may relieve suffering [23]. Being self-compassionate implies being moved by one’s own suffering and treating oneself with care and empathy [24]. Individuals with worse mental health tend to have less self-compassion [25] while being more self-compassionate tends to reduce psychopathology [26] and help with emotional regulation [27]. In this sense, one study showed a relationship between a higher self-compassion level and a reduction in negative thoughts related to the body [28], a reduction in eating psychopathology and concerns about body image, which may be an adaptive emotional regulation strategy in eating disorders and body dissatisfaction [29].

Other studies have also shown that self-compassionate individuals seem to worry less about their body weight and are less ashamed of their bodies, as well as having a greater self-image valuing and appreciation [29–31]. However, no intervention studies in the literature evaluate the effectiveness of an approach based on self-compassion techniques focused on food compared to the traditional approach with an energy-restricted diet and its impacts on body dissatisfaction. For this reason, the study’s main objective is to compare the effect of a nutritional approach using self-compassion techniques with the traditional diet method over eight weeks on body image dissatisfaction and eating behavior in women dissatisfied with their weight.

Materials and methods

This study protocol for a randomized clinical trial was developed under the guidelines proposed by the Standard Protocol Items: Recommendations for Interventional Trials 2013 Statement (SPIRIT) (S1 Table) [32]. Fig 1 shows the recruitment, intervention, and evaluation schedule.

Fig 1. Schedule of recruitment, intervention and evaluation.

Fig 1

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Participants, study setting, and eligibility criteria

The study will be conducted with Brazilian women experiencing weight-related body dissatisfaction. To be included in the study, participants must present body dissatisfaction, be between 25 and 50 years old, have access to a cell phone with communication apps (WhatsApp), and be available to attend face-to-face meetings once a week for eight weeks. Participants will be excluded from the study if they have a diagnosis of depression, mood disorders (anxiety, bipolar disorder, borderline), eating disorders, or a history of suicidal ideation; if they have chronic diseases such as diabetes, kidney disease, cardiovascular and/or neurological diseases; and if they are pregnant or have been pregnant for six months or less; and to conclude, if they are menopausal.

Recruitment

Recruitment will take place from March 4, 2024, to March 31, 2026, which is the estimated timeframe to achieve the calculated sample size. Participants will be recruited through posts on the researchers’ social networks, and those who express an interest will be contacted for an initial conversation via WhatsApp video call. This assessment will confirm the participant’s desire to participate in the study, the inclusion and exclusion criteria, and guidance on the study protocol. After confirming eligibility and signing the Informed Consent Form, the participants will be randomized and assigned to one of the two intervention groups: self-compassion or diet. The groups will take place weekly through face-to-face meetings, which will take place over eight weeks and will be one hour long. The group will be led by nutritionists previously trained in the two approaches. The adherence rate will be controlled, requiring a minimum participation of 75% (6 meetings) to be maintained in the entire study (baseline to eight weeks, three and six months follow-up).

Before the first meeting, all participants will answer an anamnesis and three validated scales for assessing eating behavior and body dissatisfaction, which will be available through the Google Forms platform. The same scales will be answered after the eight meetings (the end of the group), three months after the last meeting, and six months after the last meeting. Fig 2 shows the study flow diagram.

Fig 2. Flow diagram.

Fig 2

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Interventions

Self-Compassion Group: the group with a self-compassion approach will have its own protocol created for the study. This intervention was based on self-compassion exercises proposed in “The mindful self-compassion workbook: a proven way to accept yourself, build inner strength, and thrive” [33]. Table 1 shows the topics covered in each meeting.

Table 1. Description of the meetings in the Self-Compassion group.

Meeting Central theme Dynamics
Meeting 1:
How have I dealt with myself when it comes to my body and food?		 Presentation and measurement of anthropometric measurements (weight and height)
Self-criticism		 Reflection on self-criticism
Meeting 2:
Changing my relationship with my body through self-compassion“		 Self-compassion and self-kindness How do I treat a friend?
Mindfulness exercise (Gabi Damasceno) adapted
Meeting 3:
Where does it all come from? Looking at my history with food and my body		 Mindfulness What would you change about your body“video
Accepting our bodies with self-compassion
Meeting 4:
Shared humanity in body dissatisfaction and food: is it just me?		 Shared humanity Reflection exercise on shared humanity
Meeting 5:
Mindful eating: the power of observation		 Mindful eating Mindful eating exercise
Meeting 6:
Changing my eating habits in a compassionate way		 Self-compassion as a tool for changing habits Changing in a self-critical way vs. a self-compassionate way
Dynamics in pairs
Meeting 7:
Changing the way how I look at my body		 Mindfulness
Self-kindness		 Mindfulness exercise (describing vs. judging)
Self-compassionate letter to the body
100th birthday party“exercise
Meeting 8:
Cultivating self-compassion in my life - what I’ve changed in how I look at my food and body.		 Resumption of all previous subjects My Mad Fat Diary“video scene
Dynamics in pairs
Closing
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Diet group: in the diet group, participants will complete a 24-hour food recall (24HR). They will receive a food plan calculated by a nutritionist using the Estimated Energy Requirement calculation [34] as a reference and adjusted to their routine based on the 24HR. The necessary nutritional adjustments will be made to ensure adequate fiber, macro, and micronutrient intake according to the Dietary Reference Intakes [35] for women. The total energy value will depend on the participant’s goal, with a calorie deficit of 300 kcal for those wishing to lose weight and a surplus of between 300–500 kcal for those wishing to gain weight. The macronutrient distribution will be the AMDR of 45–65% carbohydrates, 10–35% proteins, and 20–35% lipids. Table 2 shows the topics covered at each meeting. In the fifth week of the study, the participants will have an individual online consultation to re-evaluate the proposed diet and adjust it if necessary instead of a group meeting.

Table 2. Description of meetings in the Diet group.

Meeting Central theme Dynamics
Meeting 1:
Presentation and performance of anthropometric measurements		 Presentation and measurement of anthropometric measurements (weight and height)
Application of anamnesis to calculate the diet plan		 Conversation about the purpose of the group and the participants
Meeting 2:
Motivation for weight loss		 Consequences of being overweight and sedentary and the importance of cultivating healthy lifestyle habits Written reflection
Meeting 3:
How to choose food?		 Classification of foods according to the Food Guide for the Brazilian population (2014) Food classification dynamics
Meeting 4:
How to read food labels?		 Reading food labels “Which food is healthier” dynamic
Meeting 5:
Guidance and monitoring of the diet plan		 Food plan Individual guidance on the diet plan (online)
Meeting 6:
Myths and truths about healthy eating		 Demystifying beliefs about healthy eating Dynamics of myths and truths
Meeting 7:
How to use carbohydrates to my advantage		 Glycemic index and glycemic load
Smart food combinations		 High-fiber foods vs. low-fiber foods
Meeting 8:
Cultivating healthy habits in my life		 Ways to cultivate healthy habits in the long term Clarification of doubts
Closing
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Adherence, modifications, and concomitant care

In both groups, the importance of attendance and commitment to the meetings will be discussed. It will also be emphasized that it will be a safe space for listening, welcoming, and confidentiality. Participants will be asked about their feelings and doubts about their study process. The meetings will always occur on the same predetermined day, time, and location. Participants will be notified via smartphone before each meeting as a reminder. To increase adherence and commitment to the study, participants will also be offered activities to practice at home, such as food records, observation, and reflection exercises, or they will be asked to bring materials related to the next meeting (e.g., food packaging).

Adherence to the proposed interventions will be checked at each meeting. However, the difficulty of carrying out what is proposed does not compromise remaining in the group meetings.

Participants cannot change the group they have been allocated to. However, they are free to leave the study as they wish. The meeting protocol for both groups cannot be modified, as this could bias the study.

Outcomes

Primary outcomes.

Body dissatisfaction will be assessed using the Body Shape Questionnaire (BSQ), translated to Portuguese [36], which is used to identify concerns about body shape and self-deprecation related to physical shape. It has 34 questions related to body image, with a scale from 1 to 6: 1-Never, 2-Rarely, 3-Sometimes, 4-Frequently, 5-Very Often, and 6-Always. The result is obtained by adding up all the scores. A score of less than 80 points means that the individual has no dissatisfaction. Between 80 and 110, there is mild dissatisfaction; between 111 and 140, moderate dissatisfaction, and over 140 severe dissatisfaction.

Dysfunctional eating behavior will be assessed using the instrument “The three-factor eating questionnaire - R21 (TFEQ-R21)” [37], a questionnaire developed to evaluate the eating behavior of obese and eutrophic individuals, translated and validated to Brazilian [38]. The instrument consists of 21 questions, with questions 1–20 having 4 alternatives (scoring from 1 to 4, from the highest severity of dysfunctional eating to the lowest) and the last question having a scale from 1 to 8 (from the lowest degree of food restriction to the highest). Three dimensions of eating behavior are assessed: cognitive restriction, uncontrolled eating and emotional eating. Cognitive restriction refers to a set of self-imposed food obligations and prohibitions in order to lose or maintain weight. However, when there is a limitation on food consumption, both qualitatively and quantitatively, these individuals, in certain situations such as exposure to a forbidden food, lose self-control and tend to overeat with or without the presence of hunger, characterizing uncontrolled eating. Finally, emotional eating refers to emotions influence on food intake, which can lead to less healthy choices. It is an appropriate instrument for its purpose and serves to support an approach that values the behaviors resulting from poor eating, such as external stimuli and emotions [38]. The higher the score, the more dysfunctional the behavior.

Secondary outcome.

Self-compassion levels: the Self-Compassion Scale (SCS) will be used, with 26 items, which was developed to measure self-compassion in three components: self-judgment versus self-kindness, sense of isolation versus common humanity and hyper-identification versus mindfulness [39]. The items are grouped into six subscales: Self-kindness (items 5, 12, 19, 23, 26); Self-judgment (items 1, 8, 11, 16, 21); Common Humanity (items 3, 7, 10, 15); Isolation (items 4, 13, 18, 25); Mindfulness (items 9, 14, 17, 22) and Over-identification (items 2, 6, 20, 24). Each item is rated on a 5-point Likert scale (1 = Almost never; 5 = Almost always). The total score is obtained from the average of the six subscales. Higher scores mean more self-compassion.

Sociodemographic characteristics: to gather information on the participants’ characteristics, an anamnesis form will be used, in which the participants will fill out questions on sociodemographic issues (name, age, gender, marital status and income, education), as well as general health and lifestyle questions such as: physical activity, smoking, alcohol use, psychological support, perceptions about the body and diet and any other information that the participant can provide to better conduct the research.

Sample size

Considering the study by Albertson, Neff and Dill-Shackleford (2014) [40], which found an improvement in body dissatisfaction from meditation based on self-compassion techniques with an effect size of 0.73 (high), a sample size of 76 people (38 for each group) was calculated. This calculation considered a power of 80%, a significance level of 5% and a Cohen’s d of 0.7 to test whether there is a minimal difference in the body dissatisfaction averages and self-compassion levels between the intervention and control groups, already including an addition of 10% for possible losses and refusals.

Randomization, allocation and masking of groups

Participants will be randomized to the Self-Compassion or Diet group with 1:1 allocation in the Random Group Generator (https://pt.rakko.tools/tools/59/). The nutritionists responsible for applying the interventions will have no contact with the randomization and will not know in advance who will go to which group, only the research coordinator.

Due to the nature of the intervention, it is not possible to blind the researchers and participants during the study’s conduction after the randomization process. However, the intervention and control groups will not interact in any way. Likewise, the statistical analysis will be blinded to the evaluator.

Statistical analysis

Baseline characteristics of the participants will be compared between groups (self-compassion and diet). For categorical variables, the Pearson Chi-square test will be used, with continuity correction for dichotomous variables or Fisher’s exact test when at least one cell has an expected count of less than five. For continuous numerical variables, the Shapiro-Wilk test will assess normality. If normality is accepted, results will be presented as mean and standard deviation and analyzed using Student’s t-test for independent samples. If the distribution is non-parametric, data will be expressed as median and interquartile range and analyzed using the Mann-Whitney U test. No significant differences between groups at baseline are expected due to the randomization process, which should provide similar groups. However, if significant differences are observed, these variables will be included as adjustments in multivariable analyses, as described below for primary and secondary outcomes.

Comparisons between baseline and follow-up for the primary and secondary outcomes will be tested using a General Linear Model (GLM) for repeated measures, considering the interaction between group (self-compassion and diet) and time (before and after). Separate analyses will be conducted for each follow-up point: from baseline to the end of the 8-week intervention, from baseline to 3 months after the intervention, and from baseline to 6 months after the intervention. Differences will be considered statistically significant at p < 0.05. The data will be analyzed using Statistical Package for the Social Sciences (SPSS) software, version 26.0.

Data management

The data will be collected by two independent authors and stored in an SPSS® file database. The tools used to obtain the outcomes will be evaluated at the beginning (week 0) and after the intervention (week 8) and again at three and six months follow-up. All forms will be made available via Google Forms.

One of the researchers will send a WhatsApp message every week to promote participant retention and complete follow-up, encouraging participants to come to the meetings. Also, the messages sent will be the same for both groups and will include reminders about the meeting days, location, time, and any materials participants may need to bring for the activities. To those who discontinue or deviate from the intervention protocol, all data exclusion will be necessary.

The data collected will be saved on an institutional drive linked to the researcher in charge and shared only with the other researchers in the study. The data are expected to be stored for two and a half years (until the end of 2025), following the study schedule.

An interim analysis could be conducted if preliminary results need to be presented at scientific events relevant to the institutions involved in the study’s development. However, if such analyses could compromise the reliability of the data, they will not be performed. All authors could have access to interim results, but only the study coordinator (CGS) could decide to terminate the trial.

The plans for investigators and sponsor to communicate trial results are: a) Individual disclosure of the basal and post-intervention results to each participant; b) A public seminar with grouped results at sponsor institution to healthcare professionals; c) Public disclosure in scientific events, preprint, and scientific article publication.

Ethical aspects

The study was conducted in accordance with the Declaration of Helsinki and approved through the Research Ethics Committee from Hospital de Clínicas de Porto Alegre (HCPA) under number 2022–0634, CAAE 67679423.0.0000.5327. All participants will provide written informed consent before data collection.

Any changes to the protocol that could have an impact on the study’s conduction, including changes to the objectives, sample size, tools or that affect the participants in any way, will be communicated immediately to the Ethics Committee via email. Participants will be asked to read and sign the Informed Consent Form (ICF) when they enter the study. Participants will be given full details of the study’s characteristics and interventions. They will also be informed that they are free to withdraw from the study at any time. The Research Ethics Committee, which approved the study, demands periodical reports for the trial’s auditing. This process occurs with the investigators’ participation.

Adverse events will be monitored weekly by researchers (ABR, DCV, VSS) in each meeting through conversations with the participants. According to the type of adverse event, referral to the health care service of the sponsor institution will be made. The health care service of the sponsor institution will provide post-trial care and compensation to those who suffer harm for trial participation.

Discussion

This study proposes a nutritional intervention protocol based on self-compassion techniques compared to a traditional approach with dieting, both for eight weeks, evaluating which has better results in body dissatisfaction and eating behavior in adult women with weight-related body dissatisfaction. Our hypothesis is that the intervention based on self-compassion techniques will be more effective in reducing body dissatisfaction and dysfunctional eating behavior in the participants.

Traditional weight loss programs, or restrictive diets, have been known and practiced for years [11,12]. These models encourage individuals to consciously restrict their diet and are effective in the short and medium term. However, studies indicate that the strategies generate emotional stress and develop dysfunctional behaviors in relation to food in the long term, compromising the individual’s physical and mental health [11,12,14]. In this sense, non-dietary interventions have shown important psychological benefits, such as improved well-being and decreased suffering, weight-related stigma, body dissatisfaction [19,20] greater eating competence [21] decreased cognitive restriction and lack of eating control [18]. For this reason, other approaches are needed to address body dissatisfaction issues and the relationship with food in adults.

To date, only observational studies have evaluated the relationship between self-compassion and body dissatisfaction and dysfunctional eating behavior. A study of 435 women, which aimed to relate self-compassion to the pressure for a thin body, indicated that self-compassion decreased the media pressure related to thinness, dysfunctional eating and the internalization of the thin ideal [41]. In women diagnosed with eating disorders who perceive themselves as disgusting and have an aversion to their bodies, self-compassion has also been shown to be positive [30]. More self-compassionate individuals seem to worry less about their bodies and weight and have more body appreciation [42], less body shame [31] and are less at risk of eating disorders and other harmful behaviors [43].

As strengths, it is important to note that this is the first study to compare these two approaches using body dissatisfaction and eating behavior as the outcome, not body weight. The intervention time of eight weeks can also be considered a strength, due to the depth of the intervention that can be made with a longer duration of the study, since similar studies have shorter intervention times, from three to a maximum of five meetings. In addition, it will be observed which approach is more effective in the follow-up after the face-to-face meetings have finished, with the participants answering the questionnaires again after three and six months. Limitations include the impossibility of blinding the study, due to the nature of the intervention, so it is not possible to blind the participants or the professionals who will conduct the meetings. As this is a face-to-face study, it can only include people who can go to the study site, which may limit the sample’s diversity and potential for generalization.

Supporting information

S1 Table. SPIRIT checklist.

(DOCX)

pone.0324030.s001.docx (22.3KB, docx)

Acknowledgments

The authors would like to thank the Universidade Federal do Rio Grande do Sul (UFRGS) for academic support, and Professor Vivian Cristine Luft for her assistance with statistical analyses.

Data Availability

No datasets were generated or analysed during the current study. All relevant data from this study will be made available on the Fighsare platform upon study completion.

Funding Statement

Initials of the authors who received each award : CGS Grant numbers awarded to each author: this grant has no nyumber The full name of each funder : Fundação Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (PROAP UFRGS) URL of each funder website: https://www.gov.br/capes/pt-br Did the sponsors or funders play any role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript? No.

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Decision Letter 0

Leonardo Andreato

22 Dec 2024

PONE-D-24-40704Nutritional approach based in self-compassion versus energy-restricted diet approach in body dissatisfaction and disordered eating in adult women: a protocol for randomized clinical trial.PLOS ONE

Dear Dr. de Souza,

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Comments to the Author

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Reviewer #1: Yes

Reviewer #2: 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: Partly

Reviewer #2: Partly

**********

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

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Reviewer #1: Yes

Reviewer #2: Yes

**********

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Reviewer #1: Yes

Reviewer #2: Yes

**********

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Reviewer #2: Yes

**********

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Reviewer #1: The authors present a protocol for a randomized trial evaluating self-compassion training versus a diet group among Brazilian women who are dissatisfied with their bodies. Both groups will attend weekly meetings for 8 weeks. Assessments will be made at baseline, 8 weeks, and 3 and 6 months after the end of the meetings. Primary outcomes are body image dissatisfaction and dysfunctional eating, while the secondary outcome will be level of self-compassion. The manuscript will be strengthened if the authors consider the following points.

1. Authors state that the study will be conducted in women who are dissatisfied with their bodies, yet there is no inclusion criterion regarding body dissatisfaction.

2. Authors mention the primary outcomes as body dissatisfaction and dysfunctional eating, but they do not specify the specific time point that will be the primary comparison. I'm guessing that will be after the meetings, so at 8 weeks, but this should be clarified.

3. In the power calculations/sample size justification, authors should specify the settings for the calculations (for example, two-sided or one-sided test, alpha level and power).

4. The statistical analysis section should provide more detail. For example, will authors compare characteristics of the groups at baseline? What will authors do if there are differences between the groups at baseline? Authors should clarify how the models they will use will handle the repeated measures across individuals. There are also 3 "after" time points. Based on Figure 2, it appears as though analyses will be repeated 3 times (at 8 weeks, at 3 months post intervention and at 6 months post intervention). It is not clear if each of those analyses will use baseline and the single follow-up time in the analysis.

5. Authors indicated weekly contact with participants to promote retention. Will that weekly contact continue throughout the follow-up period as well? Authors should indicate what sort of messages will be sent and whether they are the same for both groups.

6. In lines 262-263, authors indicate those who discontinue will be removed from analyses. Authors should clarify. For example, it might make sense to remove someone if they do not complete the 8 weeks of meetings, since all they will have is a baseline evaluation and are not providing any information regarding impact of either intervention. What about someone who drops out after the 8 weeks and doesn't return for the two additional follow-ups?

7. Authors indicate the interim analyses may be conducted to present results at scientific events and that all co-authors will have access to those results. Authors should indicate the timing of such interim analyses or requirements before even thinking about performing an interim analysis. Also, it is problematic if authors conduct an interim analysis with co-authors all seeing the results, since it is not clear if those authors are involved in delivering the intervention or contacting participants. Typically, an interim analysis is not widely shared to preserve an unbiased study team (and unbiased participants).

8. Authors mention that adverse events will be monitored. Will they also be recorded and reported on? Authors should also clarify what they will consider as adverse events (give examples).

Minor points:

1. lines 174-175 - this sentence is awkwardly phrased, so authors should consider rephrasing it or splitting it into two sentences.

2. line 265: "The data is" should be "The data are"

Reviewer #2: The study “Nutritional approach based on self-compassion versus energy-restricted diet approach in body dissatisfaction and disordered eating in adult women: a protocol for a randomized clinical trial” aimed to analyze the effects of a nutritional approach involving techniques that promote self-compassion compared to a traditional approach in women experiencing body image dissatisfaction, dietary restriction, and dysfunctional eating habits. I believe the article addresses an important and well-structured topic; however, I have a few questions discribe in the reviwer attachment.

**********

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Reviewer #1: No

Reviewer #2: Yes:  Gabriel Fassina Ladeia

**********

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Attachment

Submitted filename: Reviewer Attachments for Manuscript Number PONE-D-24-40704.docx

pone.0324030.s002.docx (13.6KB, docx)
PLoS One. 2025 Jun 2;20(5):e0324030. doi: 10.1371/journal.pone.0324030.r003

Author response to Decision Letter 1

26 Feb 2025

Porto Alegre, Feb 20th 2025

Response to reviewers of PLOS One ID PONE-D-24-40704: "Nutritional approach based in self-compassion versus energy-restricted diet approach in body dissatisfaction and disordered eating in adult women: a protocol for randomized clinical trial."

First, we thank the reviewers for the comments and suggestions that helped improve our manuscript’s quality. All alterations are highlighted in the text.

Reviewer #1: The authors present a protocol for a randomized trial evaluating self-compassion training versus a diet group among Brazilian women who are dissatisfied with their bodies. Both groups will attend weekly meetings for 8 weeks. Assessments will be made at baseline, 8 weeks, and 3 and 6 months after the end of the meetings. Primary outcomes are body image dissatisfaction and dysfunctional eating, while the secondary outcome will be level of self-compassion. The manuscript will be strengthened if the authors consider the following points.

1. Authors state that the study will be conducted in women who are dissatisfied with their bodies, yet there is no inclusion criterion regarding body dissatisfaction.

Response: We appreciate the observation. We have included body dissatisfaction as part of the inclusion criteria in the Participants, study setting, and eligibility criteria section.

2. Authors mention the primary outcomes as body dissatisfaction and dysfunctional eating, but they do not specify the specific time point that will be the primary comparison. I'm guessing that will be after the meetings, so at 8 weeks, but this should be clarified.

Response: Our intention is to compare the participants at baseline, after the 8 weeks, and to repeat the analyses 3 and 6 months after the intervention. This information is now highlighted at the end of Recruitment Section.

3. In the power calculations/sample size justification, authors should specify the settings for the calculations (for example, two-sided or one-sided test, alpha level and power).

Response: Thank you for this important observation. We have updated the information in the Sample Size section.

4. The statistical analysis section should provide more detail. For example, will authors compare characteristics of the groups at baseline? What will authors do if there are differences between the groups at baseline? Authors should clarify how the models they will use will handle the repeated measures across individuals. There are also 3 "after" time points. Based on Figure 2, it appears as though analyses will be repeated 3 times (at 8 weeks, at 3 months post intervention and at 6 months post intervention). It is not clear if each of those analyses will use baseline and the single follow-up time in the analysis.

Response: Once again, thank you for this valuable observation. The description of the statistical analysis has been improved, and you can find it in the section with the same title.

5. Authors indicated weekly contact with participants to promote retention. Will that weekly contact continue throughout the follow-up period as well? Authors should indicate what sort of messages will be sent and whether they are the same for both groups.

Response: We appreciate your observation. The messages will be the same for both groups and sent by WhatsApp. These messages will include reminders about the meeting days, location, time, and any materials participants may need to bring for the activities, according to the group they belong to. During the follow-up period, there will be no further contact, as we intend to assess the effectiveness of sustaining the practices without researcher supervision. We have included this information in the Data Management section.

6. In lines 262-263, authors indicate those who discontinue will be removed from analyses. Authors should clarify. For example, it might make sense to remove someone if they do not complete the 8 weeks of meetings, since all they will have is a baseline evaluation and are not providing any information regarding impact of either intervention. What about someone who drops out after the 8 weeks and doesn't return for the two additional follow-ups?

Response: A minimum attendance of 75% (6 meetings) will be required for participants to remain in the study. If a participant completes all the meetings but does not participate in the follow-up, their data will still be included in the analysis of the 8 weeks compared to the baseline. We inserted more information about this in Recruitment Section.

7. Authors indicate the interim analyses may be conducted to present results at scientific events and that all co-authors will have access to those results. Authors should indicate the timing of such interim analyses or requirements before even thinking about performing an interim analysis. Also, it is problematic if authors conduct an interim analysis with co-authors all seeing the results, since it is not clear if those authors are involved in delivering the intervention or contacting participants. Typically, an interim analysis is not widely shared to preserve an unbiased study team (and unbiased participants).

Response: We appreciate this observation. Interim analyses could be conducted if preliminary results need to be presented at scientific events relevant to the institutions involved in the study's development. However, if such analyses could compromise the reliability of the data, they will not be performed.

Study collaborators already have access to the individual results of each participant, as they are responsible for carrying out the interventions and collecting the data. One factor that minimizes measurement bias is that the data are self-reported. In other words, study collaborators do not influence the responses, as these are standardized according to the assessment instruments used in the study, which are completed online, separate from the intervention sessions. Therefore, the final outcome of the instrument application is entirely at the participant's discretion. The evaluator performing the statistical analyses is fully blinded, not involved in the intervention or data collection, and works exclusively with the fully anonymized database.Adittional information was inserted in

8. Authors mention that adverse events will be monitored. Will they also be recorded and reported on? Authors should also clarify what they will consider as adverse events (give examples).

Response: Thank you for your observation and concern. We hypothesize that participants in the diet group may experience gastrointestinal changes, such as flatulence, due to the increased fiber intake. As for participants in the self-compassion group, psychological discomfort related to body dissatisfaction, eating dysfunctions, or self-esteem issues may arise. Any cases requiring professional intervention will be referred to the public health system. All types of discomfort are monitored during each weekly meeting, documented, and reported biannually to the Ethics Committee.

Minor points:

1. lines 174-175 - this sentence is awkwardly phrased, so authors should consider rephrasing it or splitting it into two sentences.

Response: We appreciate your suggestion and have revised the sentences accordingly. You can find the changes in Adherence, modifications, and concomitant care Section.

2. line 265: "The data is" should be "The data are"

Response: Thank you for the correction. We have made the necessary changes to the text, and you can see them in the Data Management section.

===========================================================

Reviewer #2: The study “Nutritional approach based on self-compassion versus energy-restricted diet approach in body dissatisfaction and disordered eating in adult women: a protocol for a randomized clinical trial” aimed to analyze the effects of a nutritional approach involving techniques that promote self-compassion compared to a traditional approach in women experiencing body image dissatisfaction, dietary restriction, and dysfunctional eating habits. I believe the article addresses an important and well-structured topic; however, I have a few questions discribe in the reviwer attachment.

[Page 2 - Line 33]

Food restriction

Would this be the most appropriate term? What about using caloric restriction or caloric deficit instead?

Response: We appreciate your suggestion and changed the term to caloric restriction.

[Page 2 - Line 44]

“This will be the first study to compare these two approaches using body dissatisfaction and eating behavior as outcomes, not just body weight.”

In the discussion, it seems to justify the reasoning behind the authors' decision to conduct the study.

Response: We understand your point and will provide clarification. In the Discussion section, we aim to emphasize the central focus of the study: the comparison of two very different approaches. We will highlight two outcomes that are not typically prioritized, as body weight is often the primary focus in studies involving caloric restriction. With this statement, we intend to convey that our comparison of these two approaches goes beyond body weight, with a focus on the components of eating behavior;

[Page 3 - Line 60]

“Although they show results in the short and medium term, such programs are ineffective in maintaining weight in the long term and can contribute to weight regain.”

It seems to imply that the programs are ineffective.

Response: Thank you for the observation. Our searches have shown that weight loss programs through diets are effective for weight loss. However, studies indicate that, in the long term, these strategies do not maintain the same level of effectiveness and may contribute to regaining the lost weight. Our objective is not to compare which strategy is more effective for weight loss, but rather to assess their impact on improving body dissatisfaction.

[Page 4 - Line 78]

“It is a practice that can be learned, accessible anytime, and may relieve suffering [23].”

The meditation practice requires time to master, yet here it gives the impression of being "easy."

Response: We appreciate the observation and agree that meditation is a complex technique that takes time to master. However, the text refers to the practice of self-compassion and not meditation.

[Page 5 - Line 107]

“Be excluded from the study if they have a diagnosis of depression, mood disorders (anxiety, bipolar disorder, borderline), eating disorders, or a history of suicidal ideation;”

Wouldn’t this sample be too restrictive? This exclusion criterion omits a broad group, often associated with body dissatisfaction.

Response: We appreciate your comment and have previously discussed this same concern. Although body dissatisfaction is related to the factors mentioned, we chose to exclude such diagnoses to avoid any potential bias associated with these factors and to focus solely on analyzing the intervention’s impact on body dissatisfaction. This decision was made to prevent a selection bias.

[Page 5 - Line 116]

“Conversation via WhatsApp video call.”

Would it not be better to use Google Forms for registration to avoid needing to "disconnect" participants from the study? Calling each participant would be more time-consuming.

Response: We understand that calling each interested volunteer requires more time. However, we believe it is the best way to clarify how each stage of the study will be conducted and to align expectations to minimize dropouts.

[Page 7 - Line 144]

“24-hour food recall (24HR).”

Using this questionnaire might lead to discrepancies in dietary intake reports, as one patient could respond on a Monday while another respond on a Wednesday.

Response: We understand your concern and would like to clarify: the food recall will be completed by the participants during the first meeting of the study only used to gain insight into the participants' eating habits and assist in creating a dietary plan that is more closely aligned with their reality.

[Page 8 - Line 149]

“The total energy value will depend on the participant's goal, with a calorie deficit of 300 kcal for those wishing to lose weight and a surplus of between 300–500 kcal for those wishing to gain weight.”

What criteria were used to determine the 300 kcal deficit? And for the 300–500 kcal surplus? How will this be implemented?

Response: Thank you for your question. According to the “Clinical Protocol and Therapeutic Guidelines (PCDT) for Overweight and Obesity in Adults,” a guideline issued by the Ministry of Health of Brazil (Brazil, 2022), "the prescription of a diet that restricts 500 to 1,000 kcal/day from estimated energy expenditure has been shown to be effective in reducing body weight in overweight or obese individuals and can be recommended in the dietary plan." The same document also states, “A more flexible eating plan aimed at gradual changes is generally more successful. In general, individuals should be advised on how to strategically reduce their intake of certain foods within a healthy, appealing, and convenient eating pattern, tailored to their individual realities and cultural preferences.”

Based on the first premise of the guideline, we initially decided on a caloric restriction of 500 kcal. However, taking into account previous experiences from our research group and the advice provided by the second premise, we chose to reduce the restriction to 300 kcal in order to minimize the risk of non-adherence to the higher caloric restriction. This decision was also influenced by the fact that weight loss is not our primary or secondary outcome.

To implement the caloric restriction, the participant's energy needs are first estimated, and then 300 kcal are subtracted from this value. The meal plan is then calculated based on this adjusted energy requirement. For weight gain, after determining the energy estimate, 300 to 500 kcal are added, depending on the tolerance reported by the participant during the initial anamnesis conducted before the intervention begins.

1https://www.gov.br/saude/pt-br/composicao/saps/ecv/publicacoes/protocolo-clinico-e-diretrizes-terapeuticas-pcdt-para-sobrepeso-e-obesidade-em-adultos/view

[Page 10 - Line 177]

“Before each meeting, participants will be notified via smartphone about the day, time, and place of the next meeting.”

Would not using pre-scheduled dates for meetings increase the dropout rate?

Response: We appreciate the comment. The meetings will have predetermined days, times and locations, and these notifications will only be used as reminders to prevent participants from missing them due to possible forgetfulness. We have revised the sentence in the Adherence, modifications, and concomitant care Section to ensure better clarity.

[Page 10 - Line 191]

“Translated into Brazilian.”

Would “Translate to Portuguese” be a more appropriate term?

Response: Thank you for the observation. We have made the necessary changes to the sentence.

[Page 12 - Line 240]

“Random Group Generator (https://pt.rakko.tools/tools/59/).”

Is it necessary to include the link? It could make the text appear "cluttered."

Response: We understand your point. However, we believe that including the link is important to maintain transparency in the randomization process.

[Page 14 - Line 267]

“An interim analysis could be performed to present the study's preliminary results in scientific events. All authors could have access to interim results, but only the study coordinator (CGS) could decide to terminate the trial.”

Is it necessary to mention this?

Response: We are grateful for the observation. We designed our entire protocol based on the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT), which includes and requires explanations regarding a possible interim analysis. We thought mentioning it was best to ensure all items are addressed.

Attachment

Submitted filename: Response to reviewers.docx

pone.0324030.s004.docx (25.6KB, docx)

Decision Letter 1

Leonardo Andreato

21 Apr 2025

Nutritional approach based in self-compassion versus energy-restricted diet approach in body dissatisfaction and disordered eating in adult women: a protocol for randomized clinical trial.

PONE-D-24-40704R1

Dear Dr. de Souza,

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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Kind regards,

Leonardo Vidal Andreato, PhD

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

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: 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: 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

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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

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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

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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: The authors have addressed all of my earlier concerns. I have no further comments to raise and am satisfied with the current draft.

Reviewer #2: The study “Nutritional approach based on self-compassion versus energy-restricted diet approach in body dissatisfaction and disordered eating in adult women: a protocol for a randomized clinical trial” aimed to analyze the effects of a nutritional approach involving techniques that promote self-compassion compared to a traditional approach in women experiencing body image dissatisfaction, dietary restriction, and dysfunctional eating habits. I believe the article addresses an important and well-structured topic

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Reviewer #1: No

Reviewer #2: Yes:  Gabriel Fassina Ladeia

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Acceptance letter

Leonardo Andreato

PONE-D-24-40704R1

PLOS ONE

Dear Dr. de Souza,

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

You will receive further instructions from the production team, including instructions on how to review your proof when it is ready. Please keep in mind that we are working through a large volume of accepted articles, so please give us a few days 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. Leonardo Vidal Andreato

Academic Editor

PLOS ONE

Associated Data

    This section collects any data citations, data availability statements, or supplementary materials included in this article.

    Supplementary Materials

    S1 Table. SPIRIT checklist.

    (DOCX)

    pone.0324030.s001.docx (22.3KB, docx)
    Attachment

    Submitted filename: Reviewer Attachments for Manuscript Number PONE-D-24-40704.docx

    pone.0324030.s002.docx (13.6KB, docx)
    Attachment

    Submitted filename: Response to reviewers.docx

    pone.0324030.s004.docx (25.6KB, docx)

    Data Availability Statement

    No datasets were generated or analysed during the current study. All relevant data from this study will be made available on the Fighsare platform upon study completion.

    Articles from PLOS One are provided here courtesy of PLOS

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