https://doi.org/10.

1017/S0007114522003932 Published online by Cambridge University Press

Accepted manuscript

Mindful eating for weight loss in women with obesity: a randomized controlled trial

Renata Bressan Pepe1, Graziele Souza de Menezes Amorim Coelho1, Flavia da Silva
Miguel1, Ana Carolina Gualassi1, Marcela Mosconi Sarvas1, Cintia Cercato1,2, Marcio C.
Mancini1,3, Maria Edna de Melo1

1
Grupo de Obesidade e Sindrome Metabolica, Hospital das Clinicas HCFMUSP, Faculdade
de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR
2
Laboratorio de Lipides (LIM/10), Faculdade de Medicina, Universidade de Sao Paulo, Sao
Paulo, SP, BR
3
Laboratorio de Carboidratos e Radioimunoensaios (LIM/18), Faculdade de Medicina,
Universidade de Sao Paulo, Sao Paulo, SP, BR

Corresponding Author: Renata Bressan Pepe -Address: Rua Dr. Eneas de Carvalho Aguiar,
155 – 5º andar – Bloco 4B – Sala 11A, Sao Paulo, SP - CEP 05403-000 - Brazil
[email protected], Tel: + 55 11 2661 3358

Keywords: Obesity; Weight loss; Diet; Mindfulness; Feeding behavior; Depression;

Anxiety; Stress, Psychological.

This peer-reviewed article has been accepted for publication but not yet copyedited or
typeset, and so may be subject to change during the production process. The article is
considered published and may be cited using its DOI
10.1017/S0007114522003932
The British Journal of Nutrition is published by Cambridge University Press on behalf of The
Nutrition Society
 https://doi.org/10.1017/S0007114522003932 Published online by Cambridge University Press
Accepted manuscript

Abstract

Mindful eating has been linked to improvement in binge eating disorder, but this
approach in obesity management has shown conflicting results. Our aim was to assess the
effect of mindful eating associated with moderate calorie restriction on weight loss in women
with obesity. Metabolic parameters, dietary assessment, eating behavior, depression, anxiety,
and stress were also evaluated. A total of 138 women with obesity were randomly assigned to
three intervention groups: mindful eating associated with moderate calorie restriction (ME +
MCR), moderate calorie restriction (MCR), and mindful eating (ME), and they were followed
up monthly for 6 months. ME + MCR joined seven monthly mindfulness-based intervention
group sessions each lasting 90 minutes and received an individualized food plan with
moderate calorie restriction (deficit of 500 kcal/d). MCR received an individualized food plan
with moderate calorie restriction (deficit of 500 kcal/d), and ME joined seven monthly
mindfulness-based intervention group sessions each lasting 90 minutes. Seventy patients
completed the intervention. Weight loss was significant, but no statistically significant
difference was found between the groups. There was a greater reduction in uncontrolled
eating in the ME group than in the MCR group and a greater reduction in emotional eating in
the ME group than in both the MCR and the ME+MCR groups. No statistically significant
differences were found in the other variables evaluated between groups. The association
between mindful eating with calorie restriction did not promote greater weight loss than
mindful eating or moderate calorie restriction.
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1. Introduction

Obesity is a chronic disease that results from the interaction of genes, environment,
behavior, culture, and socioeconomic factors(1) and it is associated with a wide range of
health problems, such as cardiovascular disease, diabetes, and some cancers2. Mental health
is also a concern in individuals with obesity, with studies reporting high rates of
depression(3,4), stress(5), and anxiety(6) among this population. Both physical, metabolic, and
mental comorbidities determine reduction in quality of life and life expectancy(2). The
multifactorial etiology of obesity renders its treatment complex.
In the last years, anti-diet movements have emerged that advocate that obesity is not a
disease and that individuals with overweight should not adhere to hypocaloric diets(7,8), and
that they should eat based on hunger, satiety, nutritional needs, and pleasure8. In this sense,
the mindfulness-based eating awareness training (MB-EAT) program brings awareness of the
physical sensations of hunger and satiety, and through practice, aims that the individual
achieves hedonic pleasure with small amounts of food and remains cognizant of the triggers
that lead to eating and making food-related choices, while being aware of their emotions and
seeking to find healthy ways to manage these emotions(9). MB-EAT was originally developed
for the treatment of binge eating disorder(8); however, other factors beyond the benefits for
binge eating have begun being studied in recent decades such as the impact of mindful eating
on reduced caloric intake; reduction of automatic or emotional eating; weight loss; reduction
in symptoms of depression, anxiety and stress; and improvement of biochemical
parameters(10-16); yet, the designs and outcomes of studies that analyze the mindfulness-based
interventions have remained quite heterogeneous to date, with some including nutritional
guidance or an eating plan aimed at weight loss(11-13), while others aim at controlling binge
eating without necessarily promoting weight loss(14,17-21).
The guidelines for the treatment of obesity recommend an energy-restricted diet with
an energy deficit of 500 kcal/d or 750 kcal/d according to individual energy requirements to
promote a negative energy balance and, consequently, weight loss(22,23). However, appetite
regulation is impaired in individuals with obesity, with hyperactivation of the reward system
and a weakening in executive functions(24,25); therefore the perception of signs of hunger and
satiety may also be altered. This population may also engage in maladaptive eating behaviors,
such as binge eating(26), rigid cognitive restraint, and uncontrolled and emotional eating(27,28).
Thus, simply instructing the patient with obesity to perceive their body signals may not be an
appropriate strategy. Although mindful eating has been developed to cultivate attention and
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food awareness, in addition to increasing the perception of the senses (sight, taste, smell,
touch, hearing) and of sensations (hunger, satiety) related to the act of eating, we hypothesize
that adding a more structured nutritional guidance via an energy-restricted diet to mindful
eating should improve weight loss in women with obesity. Furthermore, a MB-EAT program
with monthly visits would be more convenient to the participants, which may improve
adherence to the program.

Therefore, the aim of the study was to assess the effect of mindful eating associated
with calorie restriction on weight loss in women with obesity, and also on cardiometabolic
parameters, food intake, eating behaviors, symptoms of depression, anxiety, and stress.

2. Subjects and Methods

2.1 Participants and procedures

This study was approved by the ethics committee of the institution (Comitê de Ética
em Pesquisa – CEP; CAEE: 81114217.2.0000.0068) and was conducted according to the
guidelines set forth in the Helsinki Declaration. The trial is registered with the
ensaiosclinicos.gov.br/ identifier RBR-22p3nn2, UTN: U1111-1207-7666
(https://ensaiosclinicos.gov.br/rg/RBR-22p3nn2). The registration process began during the
intervention and was completed after the end of the study. Informed consent was obtained
from all participants for inclusion in the study. The study was performed from March, 2018,
to August, 2019, at the outpatient clinic of Hospital das Clinicas, Sao Paulo University. The
MB-EAT program(9) was adapted to the conditions of the service (Sistema Único de Saúde -
SUS), for which weekly monitoring would be impractical, considering the limitations of
health services (availability of professionals, attendance rooms and time) and patients
(availability of time, travel costs, absenteeism). Thus, the mindfulness-based eating
awareness training (MB-EAT) occurred during monthly visits. After screening, patients were
enrolled and assigned randomly in a 1:1:1 ratio to three groups: mindful eating + moderate
calorie restriction (ME + MCR), moderate calorie restriction (MCR), and mindful eating
(ME). Each group had a specified day of attendance that did not coincide with the other
groups. This model was adopted to maintain the groups separated to avoid the exchange of
intervention-related information between participants in the waiting room, which could
corrupt the validity of the resultant data. To perform the sample size calculation, weight loss
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was considered the main outcome. One-way ANOVA was used with an effect size of 0.365, a
significance level of 5%, and test power of 95%. The effect size was estimated based on the
literature related to weight-loss programs, in which the variance explained by the effect was
0.065 and the variance between groups was 0.5. Using the G*Power 3.1.97 software and the
parameters listed above, the sample was calculated at 32 individuals per group(29).
Considering that dropout is common in this type of intervention, we recruited 40% more
individuals.

The eligibility criteria comprised women with a body mass index of 30.0-39.9 kg/m2
and aged 18-50 years. The exclusion criteria comprised pregnancy, breastfeeding,
menopause, illiteracy, cognitive deficit, non-adherence to the study protocol, bariatric
surgery, current participation in a weight-loss program, endocrine disease or genetic
syndromes that cause obesity, cardiac, renal or hepatic failure, use of medications that may
affect weight, drug addiction and active psychiatric disorder.

2.2 Study design

MCR subjects were attended by a registered dietitian and received an individualized

food plan with moderate calorie restriction (deficit of 500 kcal/d), balanced in macro and
micronutrients, according to the routine, schedules, preferences, and aversions of individual
participants. Total energy expenditure was calculated by multiplying the resting metabolic
rate obtained through indirect calorimetry by the physical activity level(30). Women in this
group also received orientations to modify eating behaviors throughout meals, such as eating
while seated at the table, removing dishes from the table, eating food slowly, resting the
cutlery while eating, eating without distractions (e.g., television, computer, smartphone),
which is part of standard weight-loss programs.
ME group participants joined seven mindfulness-based intervention group sessions
lasting 90 minutes once per month, when MB-EAT(9) and exercises from the workbook Eat,
Drink and Be Mindful(31) were applied. The original 10-week program protocol was adapted
for seven monthly sessions. The content of each group session can be found in the
Supplementary Information. During the sessions, participants were trained in mindfulness
and mindful eating exercises.
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ME + MCR individuals took part in seven mindfulness-based intervention group

sessions lasting 90 minutes once per month, and also received an individualized hypocaloric
food plan and orientations to modify eating behaviors, identical to MCR subjects.
Each mindful eating session was conducted by the main registered dietitian (RB) and
addressed topics such as awareness, being in the moment, non-judgement and acceptance
along with mindfulness practice (e.g., mindfulness of the breath, mindful eating exercises).
Besides this, all patients in the ME and ME + MCR groups received audio recordings of the
exercises through smartphone message or email for daily at-home practice.
All groups received guidance on healthy eating via the food pyramid adapted to the
Brazilian population(32), as well as healthy recipes to support changes in eating habits. The
follow-up frequency was monthly, and contact was also made via smartphone message,
email, or telephone every 15 days to help maximize adherence to treatment between visits.
Patients were encouraged to engage at least 150 minutes of physical activity per week.

2.3 Measurements

Height, weight, body mass index, and waist circumference were measured. Body fat
percentage was measured using bioelectrical impedance analysis (InBody 720 - Biospace Co.
Ltd, Seoul, Korea). Resting metabolic rate was assessed through indirect calorimetry
(Analyzer Assembly Vmax Encore 29 - Viasys Respiratory Care Inc., Palm Springs, CA,
USA). All of these measurements were performed at baseline and at the end of the study (6
months).
Weekly physical activity energy expenditure was determined using metabolic
equivalents of task using the equation: kcal = metabolic equivalents of task x weight (kg) x
duration (h)(33). Participants in the ME and ME + MCR groups were asked at each visit to
report the daily time spent on mindful eating exercises.
Dietary intake was evaluated through a three-day food registry(34), which was
delivered on every visit. We compared the records of the last visit with those of the first and
used the Avanutri® software version 3.0 (2019) to perform the analysis. All foods were
registered in the program, applying as reference the Brazilian Table of Food Composition;
when the food was not listed, the USDA table was used.
Patients were evaluated regarding clinical and metabolic parameters at the beginning
and end of the intervention.
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Eating behavior was assessed using the Binge Eating Scale(35) and the Three Factor
Eating Questionnaire-R21(32). Depression, anxiety and stress symptoms were assessed using
the Depression, Anxiety and Stress Scale(36). Mindfulness was assessed using the Mindful
Attention Awareness Scale(37,38). Each of these questionnaires was self-administered at
baseline and at the end of the study.

2.4 Statistical analysis

Categorial variables are presented in absolute and relative frequencies and the
difference between groups were assessed using the Chi-square test. The comparisons between
groups using ANOVA for the variables with parametric distribution, with the Bonferroni post
hoc test. The differences between variables with non-parametric distribution were assessed
using the Kruskal-Wallis test.
Comparison of weight loss between groups was performed using the intention-to-treat
analysis, with missing data being dealt with using the last observation carried forward
method), and per protocol analysis. This analysis was performed using two-way,
nonparametric ANOVA. The software R version 3.6.0 and SPSS version 17.0 were used to
perform the analyses. For all analyses, a difference of P <0.05 was considered statistically
significant.

3. Results

3.1 Participants characteristics

Three-hundred-and-ten women responded to the advertisement of this trial. Of those,

138 met the inclusion criteria for the study and were randomly assigned to one of three
intervention groups: (MCR) (n = 49), (ME) (n = 46), or (ME + MCR) (n = 43) (Fig. 1).
Baseline sociodemographic and anthropometric characteristics of the patients are
shown in Table 1 and did not differ significantly, except for the weight between MCR and
ME groups, as well as the waist circumference between the ME and ME + MCR groups
(Table 1).

3.2 Anthropometric and cardiometabolic outcomes

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There was significant weight loss among the three groups (ME + MCR, P = 0.006;
ME, P = 0.026; MCR, P = 0.001), without difference between groups (Table 2), and the
intention-to-treat analysis (P = 0.749) and per protocol analysis (P = 0.833) also did not
reveal statistically significant differences in the percentage of weight loss between groups
(Fig. 2). Reduction in waist circumference, fat mass, and body fat percentage were also
similar between the three groups (Table 2).
At the end of the study 13 (41.9%) MCR participants, 4 (21.1%) ME participants and
4 (20%) ME + MCR participants lost ≥ 5% of their initial weight. Four (12.9%) MCR
participants, 1 (5.2%) ME participant and 1 (5.0%) ME + MCR participant lost ≥10% of their
initial weight. The weight reduction ≥ 5% and ≥ 10% of participants was similar between
groups (P > 0.05).
Clinical and laboratory analyses indicated that the mean blood pressure, heart rate,
blood glucose, insulin, HOMA-IR, total cholesterol and fractions and hepatic enzymes were
within the normal range at both the beginning and end of treatment and remained similar
across the three groups, except for total cholesterol, which was higher at the end of the study
in ME group than in ME + MCR group (P = 0.042; Table 3).

3.3 Dietary intake, eating behavior, psychosocial assessment

At the onset of the study, dietary intake was similar between the three groups, except
for the consumption of polyunsaturated fats, which was higher in the ME group (7.3% ±
2.0%) compared to the ME + MCR group (6.1% ± 2.0%) (P = 0.031). At the end of the study,
the energy and nutrients intake were similar between groups.
Screening for binge eating was positive in 61 (44.5%) patients at the beginning of the
study and in 10 patients (14.9%) at the end of the follow-up. Reductions in the mean Binge
Eating Scale are presented in Table 4.
At the beginning of the intervention, patients had a similar mean score related to
uncontrolled eating, emotional eating, and cognitive restraint on the Three Factor Eating
Questionnaire-R21. Variations observed at the end of the study in the three groups are shown
in Table 4.
The frequency of depression, anxiety and stress was high in all groups at the
beginning of the intervention. At the end of the study, improvement in these variables was
observed in the MCR and ME groups, but these were not statistically significant between
groups (Table 5).
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When evaluating the mindfulness practice comparing patients in tertiles of meditation

time, there was no difference regarding weight loss (ME, P = 0.108; ME + MCR, P = 0.262),
uncontrolled eating (ME, P = 0.114; ME + MCR, P = 0.266), emotional eating (ME, P =
0.207; ME + MCR, P = 0.052), and cognitive restraint (ME, P = 0,473; ME + MCR, P =
0.518).
At the end of the intervention, there was an increase in the level of mindfulness in the
ME group relative to baseline (3.3 ± 0.8, 4.1 ± 0.6, P < 0.001). Applied only at the end of the
study in MCR (4.2 ± 0.9) and ME + MCR (4.3 ± 0.8), the mean Mindful Attention
Awareness Scale score did not differ between the two groups (P = 0.673).

3.4 Attrition

The attrition rate observed was higher than expected. Eighteen (36.7%) participants in
the MCR group, 27 (58.7%) in the ME group, and 23 (53.5%) in the ME + MCR group
dropped out of the intervention. There was a statistical difference between the MCR and ME
groups (P = 0.030).
The reasons for dropping out of the study were withdrawal from treatment (36,
52.9%), unavailability to continue to participate in the study (16, 23.5%), health problems (6,
8.8%), personal problems (5, 7.4%), non-adherence (3, 4.4%), opting for bariatric surgery (1,
1.5%), and becoming pregnant during the study (1, 1.5%).

4. Discussion

Unlike other studies evaluating mindfulness-based interventions versus standard

weight-loss programs or no treatment, the present study compared three types of monthly
approaches to weight loss in women with obesity: calorie restriction, mindful eating and
association of mindful eating with calorie restriction in women with obesity. Patients in all
groups had significant weight loss, an outcome that corroborates those of previous studies on
calorie restriction or mindful eating(11,13,18,39). Furthermore, it is possible that the ME group,
simply by being more vigilant and more careful about food choices, achieved greater control
in food intake, thereby accounting for the observed weight loss.
The average percentage of weight loss observed in the three groups was similar
between groups in the two applied statistical methods (intention-to-treat and per protocol).
The similar results of the two analyses validate the observed outcomes. It is well documented
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in the literature that no one diet suits everyone ideally(40) and, in less intensive approaches,
patients show individualized responses.
Although the weight loss was significant in the three groups, the weight loss observed
in our study is smaller than in other studies based on the lifestyle changes approach already
reported. A meta-analysis showed that, after 6 months of follow-up with conventional diet
programs, the mean loss is 5% of the initial weight(41).
Studies that evaluate intervention intensity between healthcare professionals and
patients show that more frequent contact promotes greater weight loss(42). A study that
compared behavioral treatment with 16 (low intensity), 32 (moderate intensity) and 48 (high
intensity) sessions over 2 years found that a moderate intensity intervention produced weight
losses similar to the high intensity intervention and significantly greater than the low intensity
intervention and control(43). Therefore, it is possible that a shorter interval between visits is
more important for weight loss than the approach itself.
Published findings on the effect of mindful eating on weight loss are
conflicting(16,44,45). Systematic reviews indicate a significant weight loss with mindfulness-
based interventions mainly when weight loss is the primary outcome(46), and when the
mindfulness-based interventions is compared with a control group without diet
intervention(47).
At the beginning and end of the present intervention, the average of the metabolic
parameters was within normal limits. This fact is probably due to the relatively young
sample, whose mean age is 36.7 ± 7.2 years. In fact, in other large studies, such as The Multi-
Ethnic Study of Atherosclerosis(48) and The Atherosclerosis Risk in Communities (ARIC)(49),
in addition to some meta-analyses, it was observed that individuals with obesity (either
metabolically healthy or not) are at increased risk of cardiovascular events during the follow-
up period(50,51). Although no significant difference in weight loss was observed between
groups, improvement in metabolic parameters was more pronounced in the control group. It
is not possible to state, because the analysis of food intake was similar between the three
groups, but it is possible that a more structured nutritional guidance expands the patient's
knowledge, allowing him or her to make healthier choices, which could explain the better
metabolic evolution of the control group.
Reduction in binge eating was observed in all study groups, with no advantage being
noticed with mindful eating, nor worsening with calorie restriction. In most studies that
evaluated mindfulness-based interventions, a reduction in the frequency and intensity of
binge eating was observed(17-19). Improvement or remission of binges is observed with other
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weight loss strategies, such as intensive lifestyle changes(52), pharmacological treatment

associated with lifestyle changes(53,54), as well as in individuals undergoing bariatric
surgery(55).
The weight loss observed in our study may also be related to the reduction of
uncontrolled eating and emotional eating, which has already been observed in other
studies(10,14,17-19). The reduction in cognitive restraint in the ME group did not appear to
impact weight loss. In fact, emotional eating seems to be a better indicator of increased
stress-induced food intake than is cognitive restraint(27), and there was actually a reduction in
the emotional eating scale for all groups. The reduction in cognitive restraint in the ME group
differs from that of other studies that evaluated mindfulness-based interventions, in which an
increase was observed(10,13,14,19). Studies that evaluated the association between cognitive
restraint and weight yielded conflicting results(27,56-58). Since patients with obesity have
reduced activity in the prefrontal cortex, which is responsible for decision making and
cognitive control(25), a greater cognitive restraint would be protective, facilitating weight loss.
Furthermore, previous studies have already observed that a flexible restraint, which is
implicated in greater knowledge related to the effects of food on energy balance, predicts
greater weight loss than a rigid restraint, which is a type of restraint that comes with a
dichotomous approach, emphasizing food restriction, and generating an emotional response
and, as a consequence, compensatory behaviors such as a more rigid cognitive restraint,
binging or compulsive exercising(56,57).
As well as for metabolic parameters, the positive outcomes related to eating behaviors
in the control group could be explained by the structured nutritional guidance, which also
informs about food choices, thereby allowing healthier habits.
Another factor that likely influenced the weight loss in our study participants may
have been an increased level of awareness and attention. Although Mindful Attention
Awareness Scale evaluates awareness and attention in everyday experience37, this
consciousness can also be reflected at mealtimes.
At the end of the intervention, there was a reduction in depression, anxiety, and stress
scores only in the ME and MCR groups. It is known that there is a positive association
between obesity and depression(59), and a meta-analysis of cross-sectional and cohort studies
also demonstrated an association between obesity and anxiety(60). Therefore, it is expected
that weight loss will ensure a reduction in depression symptoms and anxiety, as demonstrated
in studies in which lifestyle changes(61,62), pharmacotherapy associated with lifestyle
changes(53), or bariatric surgery(55,63) were applied.
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Chronic stress is related to worse food choices, favoring weight gain(64), via
hyperactivity of the hypothalamic-pituitary-adrenal axis, which leads to increased food
consumption(65). Mindfulness-based interventions also showed improvement in depression,
anxiety, and stress symptoms, regardless of weight loss(10,17-19). Despite this, modest weight
loss may not have been sufficient to improve mental health in all groups. Furthermore, the
mindfulness component, unlike other studies, failed to bring significant improvement in
depression, anxiety, and stress in all groups. Moreover, the low adherence to this approach
may have impacted the results.
In contrast with our results that showed little adherence from patients in the ME and
ME + MCR groups, it has been described that subjects who participate in mindfulness-based
interventions are able to comply with the recommendation of home practice and continue to
practice regularly after the end of the intervention(66). It is possible that in the studied
population, low adherence to mindfulness practice may be due to the lack of interest in the
approach. Even in studies with good adherence to the mindfulness approach, the results are
divergent(13,14,18).
Additionally, the dropout rate in our study was higher than expected. In the literature,
dropout rates vary widely. A study comparing weight loss between seven types of treatment
(diet, exercise, exercise-associated diet, meal replacements, very low-calorie diet,
sibutramine, and orlistat) found a mean dropout rate of 29% after 1 year of follow-up41.
Mindfulness-based interventions shows varying dropout rates (0-40%), after 6 to 16 weeks of
treatment(46). It is worth mentioning that in some mindfulness-based interventions,
participants received financial compensation when completing each assessment and/or at the
end of the intervention(12,13,17), which may have resulted in lower attrition rates.

Limitations
The attendance and/or sessions were held monthly to facilitate adherence to treatment,
considering that patients had other daily obligations and travel expenses. Thus, a monthly
face-to-face contact seemed more feasible than a weekly intervention. However, even
considering telephone contact between visits, the longer period between visits may have
impacted both the lower adherence to treatment and the higher attrition rate in our study.

Mindful eating associated with calorie restriction is a more complex approach,

demands more personnel and higher costs, and has not led to better outcomes than the other
two approaches. All groups presented improvements in binge eating, independent of the
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approach. Mindful eating exclusively led to greater reduction in uncontrolled eating and
emotional eating and, in contrast to the other groups, promoted reduction in cognitive
restraint. The attrition rate in the study was higher in the exclusively mindful eating approach,
indicating greater difficulty in adhering to this type of strategy. Further research is needed to
evaluate the long-term impact of mindfulness-based interventions on obesity treatment.

Acknowledgements
We are very grateful to the patients who volunteered to participate in this study.

Funding Disclosures
The authors have not received any specific grant from funding agencies in the public,
commercial, or not-for-profit sectors for this research.

Conflict of interest Disclosures

Conflicts of interest: None

Author contributions
The study was conceived and designed by RBP and MEM. RBP carried out the
patients care, the data collection and conducted de mindful eating sessions. ACG, FSM,
GSMAC and MMS carried out the patients care along with RBP. MEM analyzed the data.
RBP wrote the paper. CC and MCM reviewed the project and the paper. All authors read and
approved the final version.
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6. References

1. Office of the Surgeon General (US); Office of Disease Prevention and Health Promotion
(US); Centers for Disease Control and Prevention (US); National Institutes of Health (US)
(2001) The Surgeon General's call to action to prevent and decrease overweight and obesity.
Rockville (MD): Office of the Surgeon General (US).
2. World Health Organization (2020) Obesity and Overweight. https://www.who.int/news-
room/fact-sheets/detail/obesity-and-overweight (acessed June 2020).
3. Ha H, Han C, Kim B (2017) Can Obesity Cause Depression? A Pseudo-panel Analysis. J
Prev Med Public Health 50, 262-7.
4. Marcus M, Yasamy MT, Van Ommeren M, et al. (2012) Depression: a global public health
concern. WHO Department of Mental Health and Substance Abuse. 6-8.
5. Tomiyama AJ (2019) Stress and Obesity. Ann Rev Psychol 70, 703-718.

6. Fulton S, Décarie-Spain L, Fioramonti X, et al. (2022) The menace of obesity to

depression and anxiety prevalence. Trends Endocrinol Metab 33, 18-35.
7. Bray GA, Kim KK, Wilding JPH; World Obesity Federation (2017) Obesity: a chronic
relapsing progressive disease process. A position statement of the World Obesity Federation.
Obes Rev 18, 715-723.
8. Association for Size Diversity and Health (2013) The Health at Every Size®
(HAES®) Approach. https://asdah.org/health-at-every-size-haes-approach/ (acessed February
2021).
9. Kristeller JL, Wolever RQ (2011) Mindfulness-based eating awareness training for
treating binge eating disorder: the conceptual foundation. Eat Disord 19, 49-61.

10. Daubenmier J, Kristeller J, Hecht FM, et al. (2011) Mindfulness Intervention for Stress
Eating to Reduce Cortisol and Abdominal Fat among Overweight and Obese Women: An
Exploratory Randomized Controlled Study. J Obes 11, 651936.
11. Daubenmier J, Moran PJ, Kristeller J, et al. (2016). Effects of a mindfulness-based weight
loss intervention in adults with obesity: A randomized clinical trial. Obesity (Silver Spring)
24, 794-804.
12. Niemeier HM, Leahey T, Palm Reed K, et al. (2012) An acceptance-based behavioral
intervention for weight loss: a pilot study. Behav Ther 43, 427-35.
13. Spadaro KC, Davis KK, Sereika SM, et al (2017) Effect of mindfulness meditation on
short-term weight loss and eating behaviors in overweight and obese adults: A randomized
 https://doi.org/10.1017/S0007114522003932 Published online by Cambridge University Press
Accepted manuscript

controlled trial. J Complement Integr Med 15, j/jcim.2018.15.issue-2/jcim-2016-0048/jcim-

2016-0048.xml.
14. Alberts HJ, Thewissen R, Raes L (2012) Dealing with problematic eating behaviour. The
effects of a mindfulness-based intervention on eating behaviour, food cravings, dichotomous
thinking and body image concern. Appetite 58, 847-51.
15. Tapper K, Shaw C, Ilsley J, et al. (2009) Exploratory randomised controlled trial of a
mindfulness-based weight loss intervention for women. Appetite 52, 396-404.
16. Miller CK, Kristeller JL, Headings A, et al. (2012) Comparative effectiveness of a
mindful eating intervention to a diabetes self-management intervention among adults with
type 2 diabetes: a pilot study. J Acad Nutr Diet 112, 1835-42.
17. Kristeller JL, Hallett CB (1999) An Exploratory Study of a Meditation-based Intervention
for Binge Eating Disorder. J Health Psychol 4, 357-63.
18. Kristeller J, Wolever RQ, Sheets V (2014) Mindfulness-based eating awareness training
(MB-EAT) for binge eating: a randomized clinical trial. Mindfulness 5, 282-97.
19. Dalen J, Smith BW, Shelley BM, et al. (2010) Pilot study: Mindful Eating and Living
(MEAL): weight, eating behavior, and psychological outcomes associated with a
mindfulness-based intervention for people with obesity. Complement Ther Med 18, 260-4.
20. Woolhouse H, Knowles A, Crafti N (2012) Adding mindfulness to CBT programs for
binge eating: a mixed-methods evaluation. Eat Disord 20, 321-39.
21. Baer RA, Fischer S, Huss DB (2005). Mindfulness and acceptance in the treatment of
disordered eating. J Ration Emot Cogn Behav Ther 23, 281–300.
22. Jensen MD, Ryan DH, Apovian CM, et al.; American College of
Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society
(2014) 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in
adults: a report of the American College of Cardiology/American Heart Association Task
Force on Practice Guidelines and The Obesity Society. Circulation 129, S102-38.
23. Raynor HA, Champagne CM (2016) Position of the Academy of Nutrition and
Dietetics: Interventions for the Treatment of Overweight and Obesity in Adults. J Acad Nutr
Diet 116, 129-147.
24. Egecioglu E, Skibicka KP, Hansson C, et al. (2011) Hedonic and incentive signals for
body weight control. Rev Endocr Metab Disord 12, 141-51.
25. Yang Y, Shields GS, Guo C, et al. (2018) Executive function performance in obesity
and overweight individuals: A meta-analysis and review. Neurosci Biobehav Rev 84, 225-44.
 https://doi.org/10.1017/S0007114522003932 Published online by Cambridge University Press
Accepted manuscript

26. American Psychiatric Association (2014). Manual diagnóstico e estatístico de transtornos

mentais. 5ª ed. Porto Alegre: Artmed.
27. Natacci L, Ferreira Junior M (2011) The three factor eating questionnaire - R21:
translation and administration to Brazilian women. Rev Nutr Campinas 24, 383-94.
28. Lowe MR, Doshi SD, Katterman SN, et al. (2013) Dieting and restrained eating as
prospective predictors of weight gain. Front Psychol 4, 577.
29. Armitage P, Berry G, Mathews JNS (2002). Statiscal methods in medical research. 4
ed. Oxford: Blackwell Science.

30. National Research Council (US) Subcommittee on the Tenth Edition of The
Recommended Dietary Allowances (1989) Recommended Dietary Allowances. 10th ed.
Washington (D.C.): National Academy Press (US).
31. Albers S (2008) Eat, drink and be mindful. Oakland: New Harbinger Publications, Inc.
32. Philippi S (2014) Alimentação saudável e o redesenho da pirâmide dos alimentos.
Pirâmide dos alimentos: fundamentos básicos da nutrição. Barueri, SP: Manole.
33. Ainsworth BE, Haskell WL, Herrmann SD, et al. (2011) 2011 Compendium of
Physical Activities: a second update of codes and MET values. Med Sci Sports Exerc 43,
1575-81.
34. Fisberg RM, Marchioni DML, Colucci ACA (2009) Avaliação do consumo alimentar
e da ingestão de nutrientes na prática clínica. Arq Bras Endocrinol Metab 53, 617-24.
35. Freitas S, Lopes CS, Coutinho W, et al. (2001) Tradução e adaptação para o português
da escala de compulsão alimentar periódica. Rev Bras Psiquiatr 23, 215-20.
36. Vignola RC, Tucci AM (2014) Adaptation and validation of the depression, anxiety
and stress scale (DASS) to Brazilian Portuguese. J Affect Disord 155, 104-9.

37. Brown KW, Ryan RM (2003) The benefits of being present: mindfulness and its role
in psychological well-being. J Pers Soc Psychol 84, 822-48.
38. de Barros VV, Kozasa EH, Souza ICW, et al. (2015) Evidências de validade da
versão brasileira da Escala de Atenção e Consciência Plenas (MAAS). Psicol Reflex Crit 28,
87-95.
39. Pi-Sunyer X (2014) The Look AHEAD Trial: A Review and Discussion Of Its
Outcomes. Curr Nutr Rep 3, 387-91.
40. Thom G, Lean M (2017) Is There an Optimal Diet for Weight Management and
Metabolic Health? Gastroenterology 152, 1739-51.
 https://doi.org/10.1017/S0007114522003932 Published online by Cambridge University Press
Accepted manuscript

41. Franz MJ, VanWormer JJ, Crain AL, et al. (2007) Weight-loss outcomes: a systematic
review and meta-analysis of weight-loss clinical trials with a minimum 1-year follow-up. J
Am Diet Assoc 107, 1755-67.
42. McTigue KM, Harris R, Hemphill B, et al. (2003) Screening and interventions for
obesity in adults: summary of the evidence for the U.S. Preventive Services Task Force. Ann
Intern Med 139, 933-49.
43. Perri MG, Limacher MC, von Castel-Roberts K, et al. (2014) Comparative
effectiveness of three doses of weight-loss counseling: two-year findings from the rural LITE
trial. Obesity (Silver Spring) 22, 2293-300.
44. Kearney DJ, Milton ML, Malte CA, et al. (2012) Participation in mindfulness-based
stress reduction is not associated with reductions in emotional eating or uncontrolled eating.
Nutr Res 32, 413-20.
45. Mason AE, Epel ES, Aschbacher K, et al. (2016) Reduced reward-driven eating
accounts for the impact of a mindfulness-based diet and exercise intervention on weight loss:
Data from the SHINE randomized controlled trial. Appetite 100, 86-93.
46. Katterman SN, Kleinman BM, Hood MM, et al. (2014) Mindfulness meditation as an
intervention for binge eating, emotional eating, and weight loss: a systematic review. Eat
Behav 15, 197-204.
47. Fuentes Artiles R, Staub K, Aldakak L, et al. (2019) Mindful eating and common diet
programs lower body weight similarly: Systematic review and meta-analysis. Obes Rev 20,
1619-27.
48. Mongraw-Chaffin M, Foster MC, Anderson CAM, et al. (2018) Metabolically Healthy
Obesity, Transition to Metabolic Syndrome, and Cardiovascular Risk. J Am Coll Cardiol 71,
1857-65.
49. Bradshaw PT, Reynolds KR, Wagenknecht LE, et al. (2018) Incidence of components of
metabolic syndrome in the metabolically healthy obese over 9 years follow-up: the
Atherosclerosis Risk In Communities study. Int J Obes (Lond) 42, 295-301.
50. Eckel N, Meidtner K, Kalle-Uhlmann T, et al. (2016) Metabolically healthy obesity and
cardiovascular events: A systematic review and meta-analysis. Eur J Prev Cardiol 23, 956-
66.
51. Fan J, Song Y, Chen Y, et al. (2013) Combined effect of obesity and cardio-metabolic
abnormality on the risk of cardiovascular disease: a meta-analysis of prospective cohort
studies. Int J Cardiol 168, 4761-8.
 https://doi.org/10.1017/S0007114522003932 Published online by Cambridge University Press
Accepted manuscript

52. Chao AM, Wadden TA, Gorin AA, et al. (2017) Binge Eating and Weight Loss Outcomes
in Individuals with Type 2 Diabetes: 4-Year Results from the Look AHEAD Study. Obesity
(Silver Spring) 25, 1830-7.
53. Suplicy H, Boguszewski CL, dos Santos CM, et al. (2014) A comparative study of
five centrally acting drugs on the pharmacological treatment of obesity. Int J Obes (Lond) 38,
1097-103.
54. Chao AM, Wadden TA, Walsh OA, et al. (2019) Effects of Liraglutide and
Behavioral Weight Loss on Food Cravings, Eating Behaviors, and Eating Disorder
Psychopathology. Obesity (Silver Spring) 27, 2005-10.
55. Castellini G, Godini L, Amedei SG, et al. (2014) Psychological effects and outcome
predictors of three bariatric surgery interventions: a 1-year follow-up study. Eat Weight
Disord 19, 217-24.
56. Teixeira PJ, Silva MN, Coutinho SR, et al. (2010) Mediators of weight loss and
weight loss maintenance in middle-aged women. Obesity (Silver Spring) 18, 725-35.
57. Westenhoefer J, Engel D, Holst C, et al. (2013) Cognitive and weight-related
correlates of flexible and rigid restrained eating behaviour. Eat Behav 14, 69-72.
58. Fielding-Singh P, Patel ML, King AC, et al. (2019) Baseline Psychosocial and
Demographic Factors Associated with Study Attrition and 12-Month Weight Gain in the
DIETFITS Trial. Obesity (Silver Spring) 27, 1997-2004.
59. de Wit L, Luppino F, van Straten A, et al. (2010) Depression and obesity: a meta-
analysis of community-based studies. Psychiatry Res 178, 230-5.
60. Amiri S, Behnezhad S (2019) Obesity and anxiety symptoms: a systematic review and
meta-analysis. Neuropsychiatr 33, 72-89.
61. Rubin RR, Wadden TA, Bahnson JL, et al. (2014) Impact of intensive lifestyle
intervention on depression and health-related quality of life in type 2 diabetes: the Look
AHEAD Trial. Diabetes Care 37, 1544-53.

62. Rodriguez-Lozada C, Cuervo M, Cuevas-Sierra A, et al. (2019) Changes in Anxiety

and Depression Traits Induced by Energy Restriction: Predictive Value of the Baseline
Status. Nutrients 11, 1206.

63. Ribeiro GANA, Giapietro HB, Belarmino LB, et al. (2018) Depression, anxiety, and
binge esating before and after bariatric surgery: problems that remain. Arq Bras Cir Dig 31,
e1356.
 https://doi.org/10.1017/S0007114522003932 Published online by Cambridge University Press
Accepted manuscript

64. Adam TC, Epel ES (2007). Stress, eating and the reward system. Physiol Behav 91,
449-58.

65. Maniam J, Morris MJ (2012). The link between stress and feeding behaviour.
Neuropharmacology 63, 97-110.

66. Reibel DK, Greeson JM, Brainard GC, et al. (2001) Mindfulness-based stress
reduction and health-related quality of life in a heterogeneous patient population. Gen Hosp
Psychiatry 23, 183-92.
 https://doi.org/10.1017/S0007114522003932 Published online by Cambridge University Press
Accepted manuscript

Table 1. Baseline sociodemographic and anthropometric characteristics

Variable/Group MCR ME ME + MCR P
(n = 49) (n = 46) (n = 43)
Mean/ SD/IQR CI(%) Mean/ SD/IQR CI(%) Mean/ SD/IQR CI(%)
Median Median Median
36.6 6.8 34.65 - 38.58 37.0 ± 7.2 34.88 – 36.4 7.7 33.98 –
Age (years) 0.907
7.2 39.16 38.72
Ethnic Origin 0.579
28 23 20
Caucasian
(57.1%) (50.0%) (46.5%)
21 23 23
Non-caucasian
(42.9%) (50.0%) (53.5%)
9.2 84.62 – 89.91 9.1 89.68 – 7.3 86.38 – 90.9
Weight (kg) 87.3 92.4 88.6 0.014*
95.08
Height (m) 1.61 0.07 1.59-1.63 1.63 0.06 1.61.1.65 1.63 0.05 1.62-1.64 0.181
(31.4- 32.94 – 34.42 (32.4- 33.92 – (31.5- 32.73 –
BMI (kg/m²) 32.5 34.4 33.4 0.091
35.9) 37.5) 35.56 35.6) 34.31
5.7 100.13 – 8.6 101.82 – 7.5 97.74 –
WC (cm) 101.8 104.4 100.1 0.022†
103.34 106.9 102.37
SMM (kg) 26.2 3.2 25.3 – 21.14 27.6 3.2 26.69 – 28.6 26.7 2.9 25.8 – 27.58 0.081
 https://doi.org/10.1017/S0007114522003932 Published online by Cambridge University Press
Accepted manuscript

5.9 37.95 – 41.34 6.9 40.44 – 6.6 38.38 –

FM (kg) 39.6 42.4 40.4 0.100
44.36 42.45
3.8 44.31 – 46.52 4.6 44.51 – 4.9 43.91 –
BFP (%) 45.4 45.8 45.4 0.888
47.22 46.96
METs 1050.8 1500.6- 1 212.8 1977.3- 619.1 1055.9-
1802.4 2 337.5 1 246.4 0.782
(kcal/week) 2104.2 2697.7 1436.9
302.2 1764.7- 294.5 1765.3- 232.0 1724-1866.8
TEE (kcal/day) 1851.5 1 852.8 1 795.4 0.357
1938.3 1940.3
BFP, body fat percentage; BMI, body mass index; FM, fat mass; METs, metabolic equivalents of task; SMM, skeletal muscle mass; TEE,
total energy expenditure; WC, waist circumference.
*P = 0.014 between MCR and ME; †P = 0.019 between ME and ME + MCR.
 https://doi.org/10.1017/S0007114522003932 Published online by Cambridge University Press
Accepted manuscript

Table 2. Variation in anthropometric and energy expenditure outcomes by group

Variable/Group MCR ME ME + MCR P
Mean/ SD/IQR CI(%) Mean/ SD/IQR CI(%) Mean/ SD/IQR CI(%)
Median Median Median
Weight (δ% kg) -3.9 5.7 -6.03 - -1.83 -3.3 5.8 -5.45 - -0.27 -2.6 3.8 -4.43 - -0.85 0.692
WC (δ% cm) -4.2 5.2 -6.05 - -2.41 -3.4 6.2 -5.84 - -0.38 -3.6 3.6 -5.29 - -1.87 0.844
(-3.2- -2.32 - -0.35 (-2.9- -3.26 – 3.5 (-1.7- -1.26 - 4.06
SMM (δ% kg) -1.4 -0.3 -0.2 0.182
0.5) 1.7) 2.4)
10.9 -11.57 - -3.54 9.3 -10.72 - - 8.9 -11.32 - -2.99
FM (δ% kg) -7.6 -6.2 -7.2 0.899
1.72
BFP (δ% %) -4.1 6.3 -6.43 - -1.79 -3.7 5.9 -6.05 - -0.77 -4.8 6.6 - 7.27 - -1.91 0.864
METs 1129.7 -496.77 – 1274.3 -824.6 – 1062.7 -95.56 –
-82.4 -210.4 401.8 0.372
(kcal/week) 331.97 403.8 899.16
TEE (kcal/day) -11.8 10.0 -15.42 - -8.07 -0.7 8.0 -4,58 – 3.15 -5.0 14.0 -11.54 - -8.07 0.003*
BFP, body fat percentage; FM, fat mass; METs, metabolic equivalents of task; SMM, skeletal muscle mass; TEE, total energy expenditure;
WC, waist circumference. *P = 0.003 between MCR and ME
 https://doi.org/10.1017/S0007114522003932 Published online by Cambridge University Press
Accepted manuscript

Table 3. Variation in cardiometabolic outcomes by group

Variable/Group MCR ME ME + MCR P
Mean/ SD/IQR CI(%) Mean/ SD/IQR CI(%) Mean/ SD/IQR CI(%)
Median Median Median
11.0 -8.63 - - 8.5 -3.56 – 9.1 -0.97 – 9.14
SBP (δ% mm Hg) -5.0 1.0 4.1 0.015*
0.43 5.46
(-8.6-7.4) -7.86 – (-4.9- -3.01 – (-5.2-9.2) -54.05 –
DBP (δ% mm Hg) -2.0 0.2 -1.1 0.520
11.86 8.1) 7.58 114.01
10.0 -4.53 – 15.6 -3.36 – 27.7 -2.6 – 34.56
HR (δ% bpm) -0.7 5.3 16.0 0.020†
3.07 13.94
10.3 -4.69 – 8.9 -6.52 – 12.0 0.03 – 11.28
Glucose (δ% mg/dL) -0.7 -2.1 5.7 0.050
3.25 2.31
49.5 -15.9 – 47.7 -19.67 – 36.2 -32.29 - -
Insulin (δ% mU/L) 5.0 3.6 -14.9 0.327
25.94 20.97 0.08
50.3 -14.67 – 49.3 -22.13 – 49.9 -31.05 –
HOMA-IR (δ%) 5.8 2.1 -6.5 0.728
25.05 20.32 14.15
Total cholesterol (δ% (-11.3- -7.6 – 2.07 (-0.4- 0.66 – (-7.1-7.1) -11.04 –
-4.1 3.2 0.7 0.075
mg/dL) 6.3) 14.3) 13.84 19.89
LDL-c (δ% mg/dL) -5.1 20.8 -13.1 – 13.1 26.9 -0.7 – 1.6 23.6 -9.41 – 0.047ǂ
2.99 26.99 12.65
 https://doi.org/10.1017/S0007114522003932 Published online by Cambridge University Press
Accepted manuscript

Non-HDL-c (δ% 18.7 -15,41 - - 20.4 1.47 – 22.1 -10.19 –

-7.8 11.1 0.1 0.013§
mg/dL) 0.28 18.91 10.45
15.3 1.9 – 13.75 13.1 -3.42 – 16.8 -3.87 –
HDL-c (δ% mg/dL) 7.8 3.1 4.0 0.525
9.58 11.85
Triglycerides (δ% (-28.1- - -26.07 - - (-29.5- -21.47 – (-28.6- -32.1 –
-17.9 -2.7 -4.0 0.235
mg/dL) 2.9) 7.52 9.4) 15.75 17.5) 66.22
25.4 -6.21 – 28.8 -16.18 – 24.3 -13.33 –
AST (δ% U/L) 3.7 -1.9 -2.0 0.692
13.52 12.43 9.37
33.9 -19.66 – 4- 25.3 -16.1 – 9.1 23.5 -25.81 - -
ALT (δ% U/L) -6.2 -3.5 -14.8 0.439
84 3.85
25.4 -19.13 – 24.6 -12.06 – 22.6 -24.4 - -3.21
GGT (δ% U/L) -9.1 0.2 -13.8 0.208
0.93 12.41
ALT, alanine aminotransferase; AST, aspartate aminotransferase; DBP, diastolic blood pressure; GGT, gamma glutamyl transferase; HDL-c,
high density lipoprotein; HOMA-IR, homeostatic model assessment for insulin resistance; HR, heart rate; LDL-c, low density lipoprotein;
non-HDL-c, non-high-density lipoprotein cholesterol; SBP, systolic blood pressure;
*P = 0.018 between control and intervention 2 groups; †P = 0.017 between control and intervention 2 groups; ǂP = 0.041 between control and
intervention 1 groups; §P = 0.010 between control and intervention 1 groups
 https://doi.org/10.1017/S0007114522003932 Published online by Cambridge University Press
Accepted manuscript

Table 4. Changes in eating behavior by group

Variable/Group MCR ME ME + MCR P
Mean/ SD/IQR CI(%) Mean/ SD/IQR CI(%) Mean/ SD/IQR CI(%)
Median Median Median
UE (δ%) -19.6 42.4 -35.71 - - -54.6 33.2 -72.9 - - -31.2 47.2 -54.69 – - 0.024*
3.47 42.33 7.77
55.4 12.24 – 18.6 -72.3 - - 64.7 5.25 – 63.48
CR (δ%) 35.1 -63.9 38.8 <0.001†
51.94 56.76
46.0 -32.68 – 20.1 -82.21 - - 50.1 -43.77 –
EE(δ%) -15.2 -72.4 -17.1 <0.001‡
2.33 64.87 9.67
(-63.6- -54.29 – (-72.9-- -62.34 - - (-85.4-- -74.28 - -
BES (δ%) -37.5 -42.9 -53.6 0.141
4.4) 19.05 32.2) 22.75 43.9) 38.74
BES, binge eating scale; CR, cognitive restraint; EE, emotional eating; UE, uncontrolled eating.
*P = 0.020 between MCR and ME + MCR; †P<0.001 between MCR and ME and between ME and ME + MCR, ‡P<0.001 between MCR and
ME and between ME and ME + MCR.
 https://doi.org/10.1017/S0007114522003932 Published online by Cambridge University Press
Accepted manuscript

Table 5. Changes in symptoms of depression, anxiety, and stress by group

Variable/Group MCR ME ME + MCR P
Median IQR CI(%) Median IQR CI(%) Median IQR CI(%)
(-70,0- -43.93 – -66,7 (-80,0- - -76.34 - - (-100,0- -78.66 –
Depression (δ%) -42,0 -45,0 0,514
44,6) 12.96 40,0) 11.67 21,4) 78.54
(-75,0- -92.9 – -46,7 (-75,0- - -92.45 – (-66,7- - -83.58 –
Anxiety (δ%) -50,0 -50,0 0,993
0,0) 143.08 15,0) 67.24 25,0) 23.05
(-53,3- -27.92 – -26,1 (-52,2- - -44.69 – (-35,7-7,1) -39.14 –
Stress (δ%) -22,2 -23,6 0,817
7,7) 40.01 2,1) 7.48 17.65
 https://doi.org/10.1017/S0007114522003932 Published online by Cambridge University Press
Enrollment Assessed for eligibility (n=310)

Excluded (n=172)
 Not meeting inclusion criteria (n=163)
Declined to participate (n= 6 )
 Other reasons (n= 3)

Randomized (n= 138)

Allocation

Allocated to ME (n= 46) Allocated to ME+MCR (n= 43)

Allocated to MCR (n=49)
 Received allocated  Received allocated
 Received allocated
intervention (n=46) intervention (n= 43)
intervention (n=49)

Follow-Up

Lost to follow-up (withdrawal Lost to follow-up (withdrawal Lost to follow-up (withdrawal

from treatment, unavailability from treatment, unavailability from treatment, unavailability
to continue to participate in the to continue to participate in the to continue to participate in the
study, health or personal study, health or personal study, health or personal
problems) (n=17) problems) (n=25) problems) (n=22)

Discontinued intervention Discontinued intervention Discontinued intervention

(non-adherence reasons) (non-adherence, pregnancy, (non-adherence) (n=1)
(n=1) bariatric surgery) (n= 2)

Analysis

Analysed (n= 31) Analysed (n=19) Analysed (n= 20)

Figure 1. Participants’ disposition in the study

 https://doi.org/10.1017/S0007114522003932 Published online by Cambridge University Press
Figure 2. Average percentage variation with standard deviation by group, ITT (left) and PP (right) analysis.