- - 10990968, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1002/erv.2958 by Spanish Cochrane National Provision (Ministerio de Sanidad), Wiley Online Library on [21/11/2022]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License Received: 16 June 2022 Revised: 16 October 2022 Accepted: 4 November 2022 DOI: 10.1002/erv.2958 RESEARCH ARTICLE ‘Mindful eating’ for reducing emotional eating in patients with overweight or obesity in primary care settings: A randomized controlled trial Héctor Morillo‐Sarto1,2 | Yolanda López‐del‐Hoyo1,2,3 | Adrián Pérez‐Aranda3,4,5 | 1,2,3 3,6 1,2 Marta Modrego‐Alarcón | Alberto Barceló‐Soler | Luis Borao | 1,2,3 7,8 Marta Puebla‐Guedea | Marcelo Demarzo | Javier García‐Campayo1,2,3 | Jesús Montero‐Marin5,8 1 University of Zaragoza, Zaragoza, Spain 2 Abstract Research Network on Chronicity, Primary Care and Health Promotion Objective: The primary aim of this study was to analyse the efficacy of a RD21/0016/0005, RICAPPS, Zaragoza, ‘mindful eating’ programme for reducing emotional eating in patients with Spain 3 overweight or obesity. Aragon Institute for Health Research, IIS Aragon, Zaragoza, Spain Method: A cluster randomized controlled trial (reg. NCT03927534) was 4 Department of Basic, Developmental and conducted with 76 participants with overweight/obesity who were assigned to Educational Psychology, Autonomous ‘mindful eating’ (7 weeks) + treatment as usual (TAU), or to TAU alone. They University of Barcelona, Barcelona, Spain were assessed at baseline, posttreatment and 12‐month follow‐up. The main 5 AGORA Research Group, Teaching, Research & Innovation Unit, Parc Sanitari outcome was ‘emotional eating’ (Dutch Eating Behaviour Questionnaire, Sant Joan de Déu, St. Boi de Llobregat, DEBQ); other eating behaviours were also assessed along with psychological Spain and physiological variables. 6 Navarra Medical Research Institute Results: ‘Mindful eating’ + TAU reduced emotional eating both at posttreat- (IdiSNA), Pamplona, Spain 7 ment (B = −0.27; p = 0.006; d = 0.35) and follow‐up (B = −0.53; p < 0.001; Mente Aberta, Brazilian Center for Mindfulness and Health Promotion, d = 0.69) compared to the control group (TAU alone). ‘External eating’ (DEBQ) Department of Preventive Medicine, was also significantly improved by the intervention at both timepoints. Signif- Universidade Federal de São Paulo, São Paulo, Brazil icant effects at follow‐up were observed for some secondary outcomes related to 8 Department of Psychiatry, Warneford bulimic behaviours, mindful eating, mindfulness, and self‐compassion. Weight Hospital, University of Oxford, Oxford, UK and other physiological parameters were not significantly affected by ‘mindful eating’ + TAU. Abbreviations: ARR, Absolute risk reduction; BMI, Body mass index; BITE, Bulimic investigatory test Edinburgh; CBT, Cognitive‐behavioural therapy; CI, Confidence interval; DBP, Diastolic blood pressure; DEBQ, Dutch eating behaviour questionnaire; EAT‐26, Eating attitudes test‐26 item version; FFMQ, Five facets mindfulness questionnaire; GAD‐7, Generalised anxiety disorder questionnaire; GP, General practitioner; ICC, Intra‐ cluster correlation coefficient; MB‐EAT, Mindfulness‐based eating awareness training; MES, Mindful eating scale; NNT, Number needed to treat; PC, Primary care; PHQ9, Patient health questionnaire; RCI, Reliable change index; RCT, Randomized controlled trial; SBP, Systolic blood pressure; SCS, Self‐compassion scale; SD, Standard deviation; TAU, Treatment as usual; WHO, World Health Organisation. Héctor Morillo‐Sarto and Yolanda López‐del‐Hoyo authors should be considered co‐first authors. - This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. © 2022 The Authors. European Eating Disorders Review published by Eating Disorders Association and John Wiley & Sons Ltd. Eur Eat Disorders Rev. 2022;1–17. wileyonlinelibrary.com/journal/erv 1 10990968, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1002/erv.2958 by Spanish Cochrane National Provision (Ministerio de Sanidad), Wiley Online Library on [21/11/2022]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License 2 - MORILLO‐SARTO ET AL. Correspondence Adrián Pérez‐Aranda, Institute of Health Conclusions: These findings support the efficacy of the ‘mindful eating’ + TAU Research of Aragon (IIS), Avda San Juan programme for reducing emotional and external eating, along with some other Bosco, 13, 50009, Zaragoza, Spain. secondary measures, but no significant changes in weight reduction were Email: aparanda@iisaragon.es observed. Funding information Open Access Funding provided by KEYWORDS Universitat Autonomade Barcelona. emotional eating, mindful eating, mindfulness, obesity, overweight, RCT Highlights � ‘Mindful eating’ added to treatment as usual (TAU) is more effective than TAU alone for reducing the emotional eating pattern of obese and over- weight patients in primary care (PC) settings. � The programme produced improvements in secondary outcomes such as external eating, the severity of bulimic symptoms, the frequency of binge episodes, and some mindfulness and self‐compassion facets. � The body mass index (BMI) and other physiological variables were not significantly reduced by the ‘Mindful eating’ programme; future studies should try to overcome some methodological shortcomings of the present study. 1 | INTRODUCTION binge eating disorder, depression and poor emotion regulation skills, with studies suggesting that the treat- Recent public health approaches seek to deemphasise ment of overweight and obesity with this eating pattern weight loss as a main health goal, trying to reduce stigma should not focus on calorie‐restricted diets but on emotion towards those who are overweight or obese (Penney & regulation skills (Stojek et al., 2017; van Strien, 2018). Kirk, 2015). This is because traditional interventions Cognitive‐behavioural therapy (CBT) has been proved mainly focussed on weight loss, have not reliably produced effective for changing eating patterns such as emotional positive health outcomes (Brown, 2009). People experi- eating in patients with overweight and obesity (Jacob ence considerable difficulties in losing weight and main- et al., 2018). Cognitive‐behavioural therapy includes taining weight loss, and consequently, health is now different therapeutic targets, mainly related to the rela- considered more related to lifestyle behaviours and more tion that the individual establishes with food, rather than independent of body weight. Nevertheless, overweight and focussing at applying restrictive diets, which have proved obesity are still considered major public health concerns to be ineffective in the long‐term (Warren et al., 2017). In since they have been consistently associated with a higher the last decades, new approaches to the traditional CBT prevalence of hypertension (Landi et al., 2018), depression have been proposed under the term of ‘third wave’ psy- and anxiety (Wang et al., 2019), diabetes and cancer (Kang chotherapies, which are based on the practice of mind- et al., 2018), among others. The World Health Organisa- fulness, acceptance, compassion, and spirituality, and tion estimates that worldwide obesity has nearly tripled in which have proved to be effective for treating different the last 50 years, which accentuates the need of finding pathologies (Kahl et al., 2012). Mindfulness‐based pro- effective strategies to prevent and treat these conditions. grams (i.e., those addressed at developing a present‐ In PC settings, a multidisciplinary approach is often focussed, non‐judgemental awareness) teach emotion required to address the complexities that the treatment of regulation skills that can promote healthier eating be- patients with overweight and obesity may involve. These haviours since they affect behaviours and mood (Man- interventions often include reduced calorie diet, increased tzios & Wilson, 2015), but do not clearly lead to weight physical activity, and behavioural strategies to facilitate loss (Olson & Emery, 2015). adherence to diet and activity goals (Tronieri et al., 2019). The meta‐analysis conducted by Lawlor et al. (2020) In addition, some treatments are focussed at achieving indicated that mindfulness‐ and acceptance‐based in- changes in the unhealthy eating patterns of the individual. terventions are effective for changing eating behaviours, Emotional eating, which refers to overeating during along with producing benefits in mental health outcomes dysphoric mood (Karlsson et al., 2000), is a common such as anxiety or depression, and enhancing psycholog- pattern that is, in turn, associated with weight regain, ical facets such as mindfulness and self‐compassion, 10990968, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1002/erv.2958 by Spanish Cochrane National Provision (Ministerio de Sanidad), Wiley Online Library on [21/11/2022]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License MORILLO‐SARTO ET AL. - 3 defined as the ability to be considerate and kind towards were that, compared with TAU alone, ‘mindful eating’ + oneself, specifically when experiencing suffering TAU could produce improvements in the eating behav- (Neff, 2003). Moreover, some of the studies included in the iours and physiological parameters. meta‐analysis reported significant changes in physiolog- ical parameters such as reductions in blood pressure, fasting glucose, and triglycerides, which represents an 2 | METHODS objective outcome that underlines the therapeutic poten- tial of ‘third wave’ psychotherapies, although most of these 2.1 | Design findings need replication (Lawlor et al., 2020; Olson & Emery, 2015). The research design was a multicentre, two‐armed, par- Some programmes are specially focussed on applying allel, cluster randomized controlled trial with PC centres the principles of mindfulness and related concepts, such as as clusters, with equal allocation rate between groups and self‐compassion, on eating behaviours with the aim of equal cluster size. The two arms were ‘mindful eating’ + promoting ‘mindful eating’, which is defined as the TAU and TAU alone. Four PC centres in the city of Zar- enjoyment of food utilising all the senses without judge- agoza, Spain, were randomly allocated to one of the two ment (García‐Campayo, 2017). Such eating pattern would study arms. The participants were assessed in three occa- promote the conscious choice of food, developing aware- sions: baseline, posttreatment, and 12‐month follow‐up. ness of the differences between physical hunger and ‘emotional’ hunger, noticing the satiety signs, and eating healthily as a response to all those signals, which could 2.2 | Participants produce healthier lifestyle behaviours (Kristeller & Wolever, 2011; Warren et al., 2017). Some ‘mindful eating’ Participants were recruited from four PC centres in the programs have been studied with positive outcomes: sig- city of Zaragoza, Spain: ‘La Jota’, ‘Las Fuentes’, ‘Almo- nificant reductions in binges frequency, anxiety, and zara’ and ‘Parque Goya’. The general practitioners (GPs) depression (Kristeller & Hallett, 1999), improvements in of those centres had received indications for offering the food‐related self‐efficacy and cognitive control (Miller possibility to participate in the study to those patients et al., 2012), and improvements in reward‐driven eating who met the following inclusion criteria: (1) aged 45–75; (Mason et al., 2016), among others. However, a recent (2) a BMI higher than 25; and (3) fluent in Spanish. If the systematic review (Grider et al., 2021) considered that patient met these criteria and was interested in partici- there is still weak evidence on the efficacy of ‘mindful pating, an informed consent form was offered for them to eating’ programs and that future research using high sign along with detailed information of the study pro- quality study designs is needed. cedures. Then, a researcher who is not part of the study The main aim of this study was to evaluate the efficacy team assessed if they presented at least two of the of a ‘mindful eating’ programme, added to TAU, to reduce following three risk factors: sedentary lifestyle, poor‐ emotional eating patterns in adult patients, aged 45–75, quality diet, and at least two binge episodes in a week with overweight or obesity in Spanish PC settings, in order according to the Bulimic Investigatory Test Edinburgh to promote a healthy change in the relation with food (BITE; Henderson & Freeman, 1987). This assessment decreasing eating disorder behaviours. This age group was also considered the following exclusion criteria: (1) pre- chosen because they constitute the most common users of senting any diagnosis of an illness that could affect the the Spanish PC system, and this age range presents a high central nervous system (e.g., brain affectation, dementia); prevalence of overweight and obesity (Spanish Health (2) being diagnosed with a serious psychiatric condition Ministry, 2020). The secondary aims were to assess the (e.g., schizophrenia, acute‐phase depression, drug abuse) possible differences between groups in eating behaviours except for anxiety and personality disorders, since these such as external, restrained, binge, and mindful eating as conditions are commonly related to eating disorders; (3) well as eating disorder risk, anxiety, depression, mindful- presenting delusional ideas or hallucinations; (4) having ness facets, and self‐compassion. Finally, we explored the risk of suicide; and (5) being part of any other medical or potential differences in anthropometric, vital sign and psychological treatment focussed on changing the rela- blood test measures to determine the scope of the inter- tion with food or on weight reduction, apart from the vention on these physiological parameters. The main hy- TAU delivered by their GP. Presenting purging behav- pothesis was that ‘mindful eating’ + TAU would be more iours did not constitute an exclusion criterion in the effective than TAU alone in reducing emotional eating, present study. both posttreatment and in the 12‐month follow‐up; and The sample size calculation was based on the com- following Lawlor et al. (2020), the secondary hypotheses parison between the study groups on the primary 10990968, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1002/erv.2958 by Spanish Cochrane National Provision (Ministerio de Sanidad), Wiley Online Library on [21/11/2022]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License 4 - MORILLO‐SARTO ET AL. outcome. Considering what previous studies had reported were in accordance with the criteria of the 1964 Declara- (Alberts et al., 2012), it was assumed a large effect size tion of Helsinki and subsequent amendments. The data (standardized d = 0.80) of ‘mindful eating’ + TAU were treated anonymously and were only used for the compared to ‘TAU alone’ on the primary outcome (the purposes of the study. The confidentiality of participants ‘emotional eating’ subscale of the Dutch Eating Behaviour was guaranteed and protected by the Spanish Organic Law Questionnaire, DEBQ; van Strien, 2002) posttreatment. on Protection of Personal Data and Guarantee of Digi- Assuming a common standard deviation and accepting an tal Rights (3/2018 of December 7), and all relevant EU alpha of 0.05 and a statistical power of 80%, with a 1:1 legislation on privacy and data protection. This trial allocation rate, the sample size for each arm under indi- (ClinicalTrials.gov NCT03927534) was performed in vidual randomisation was 25. Then, this number was compliance with the study protocol, where more details of multiplied by the intra‐cluster correlation coefficient the procedures can be found (Morillo‐Sarto et al., 2019). (ICC) to calculate the minimum number of clusters (i.e., PC centres) required; the ICC was supposed to be 0.03 (Hemming et al., 2011). This resulted in one cluster per 2.4 | Interventions arm; however, it was decided to include 2 clusters per arm to determine the required cluster size. With the same as- 2.4.1 | ‘Mindful eating’ sumptions indicated previously, supposing that the cluster size would be at most ‘n/1’, we estimated that 16 partici- The ‘mindful eating’ programme was a 7‐week inter- pants per cluster would be needed, which would result in vention delivered once per week in 2‐h group sessions 64 participants in total. Taking into consideration an ex- (between 8 and 12 participants per group), conducted by pected attrition rate of 20% at 1‐year follow‐up (Nam & a clinical psychologist trained in the protocol of the Toneatto, 2016), the total sample size required was estab- intervention (García‐Campayo, 2017), which is based on lished at 76 participants (around 38 per group). other programs such as the mindfulness‐based eating awareness training (MB‐EAT; Kristeller & Hallett, 1999). Each session combines theoretical content with mind- 2.3 | Procedure and ethics fulness practices, and between‐session tasks are pre- scribed every week. The main aims of the programme are The study was conducted between January 2017 and May developing awareness about automatic processes, being 2018. Following the abovementioned procedure, once a conscious of the level of hunger, learning the relationship patient was enroled in the study, the baseline evaluation between eating patterns and emotions, differentiating was conducted. When all the participants were recruited, physiological hunger from external‐derived signals to eat, the cluster randomisation was produced by an external finding a balance that allows enjoying eating while being researcher. The study allocation was blind for the GPs, conscious, identifying the bodily sensations related to an who continued providing the TAU to the participants, as excessive intake, increasing knowledge about diet and well as for the evaluators to ensure the single‐blind na- nutrition, and learning how to take a compassionate ture of the study. Restricted randomisation was applied to approach to deal with binge episodes. Weight loss, on the balance clusters, creating comparable arms in terms of other hand, is not a primary target of the programme, the number of clusters but also in the average per capita although it could happen in the long term indirectly. The income of the assigned population to each PC centre, programme contents are summarised in Table 1. since this variable is inversely related to the presence of overweight and obesity (Newton et al., 2017) and to the ability to benefit from mindfulness‐based interventions 2.4.2 | Treatment as usual (Spears et al., 2017). Thus, the maximally homogeneous cluster pairs in terms of average per capita income at the Participants in both study arms continued receiving their level of PC centre was matched and randomly divided TAU, which is the treatment that GPs administer to pa- between the intervention and control arms. tients with overweight or obesity. General practitioners All study information was confined in secure drawers usually address their actions at reducing the BMI to a with limited access. Participant codes and personal infor- normal range (i.e., <25), using personalised prescriptions mation were stored in a separate password‐protected file, for each case depending on the patient's motivation and and electronic data files were password‐protected and disposition to change (e.g., psychoeducation, diet records, secured via advanced encryption standard. This study was goal setting, etc.). In this case, the TAU included two approved by the ethical committee of Aragon, Spain (PI19/ interviews with the GP and a nurse, the development of a 086; 27/04/2016). All procedures performed in this study nutritional plan and some talks on health and nutrition, 10990968, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1002/erv.2958 by Spanish Cochrane National Provision (Ministerio de Sanidad), Wiley Online Library on [21/11/2022]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License MORILLO‐SARTO ET AL. - 5 TABLE 1 Outline of the ‘Mindful eating’ intervention Content Practices Home practices 1. Introduction Brief introduction to the programme; Breathing practice. Breathing practice. importance of the present moment; Raisin practice. Reducing the eating rhythm. attention and motivation. Mini‐meditation. 2. Mindful eating What can we do with our body and your Body scan practice. Breathing practice. and mind while meditating; what is Healing self‐touch. Mini‐meditation.Body scan. compassion emotional eating and how to distinguish it from physical eating; using compassion to achieve change. 3. Integrating Body signals; hunger and satiety. Mindful eating practice. Breathing practice. consciousness Integrating consciousness Becoming aware of hunger and satiety practice. signals. Self‐acceptance. 4. Satiety and How to structure mindfulness practice Compassionate body scan. Breathing practice. appetite (formal and informal); eating Personal values practice. Mini‐meditation. values psychoeducation. Chocolate practice. Stopping in the middle of the meal. Body scan. 5. Conscious Compassionate coping; knowing when to Conscious choice. Breathing practice. choice and stop eating; potluck preparing. Full stomach practice. Conscious movements. forgiveness Forgiveness meditation. Becoming aware of the continuous feeling while eating until satiety. 6. New balance My Plate; potluck meal; nutrition and Mindful walking practice. Breathing practice. consciousness emotional eating triggers (chain). Emotional self‐regulation. Emotional eating chain. Potluck practice. Mindful walking. Becoming aware of our feelings and their adjustment. 7. Wisdom and Keeping up with the knowledge; facing Breaking the chain. ‐ future yourself after relapses. Wisdom meditation. Our inner critical voice. for a total of 7 sessions, one per week. A more detailed contribute to the development of overweight or obesity. It description of this approach can be found elsewhere is composed of three subscales, each measuring a (Morillo‐Sarto et al., 2019). different eating style: emotional, external, and restrained eating. The ‘emotional eating’ subscale was considered the primary outcome of the present study. It assesses the 2.5 | Measures degree to which the participant considers their eating to be emotionally driven and consists of 13 items that are The sociodemographic information collected at baseline scored in a 5‐point Likert scale; the total score of the was age, sex, nationality, marital status, employment subscale is the result of the average of the scores of its situation, education, and the PC centre. The primary and items and ranges between 1 and 5, where higher scores some secondary outcomes, along with the process mea- indicate greater tendencies towards emotional eating. sures, were assessed in the three time points: at baseline, The Spanish version of the DEBQ was used, which has posttreatment and 1‐year follow‐up. Anxiety and shown good psychometric properties, including high in- depression were assessed at baseline and follow‐up, along ternal consistency for the ‘emotional eating’ subscale with some physiological parameters. (α = 0.94) (Cebolla et al., 2014). 2.5.1 | Primary outcome 2.5.2 | Secondary outcomes The DEBQ (van Strien, 2002) is a 33‐item self‐reported The ‘external’ and ‘restrained eating’ subscales of the questionnaire that measures eating styles that may DEBQ were considered secondary outcomes; the first one 10990968, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1002/erv.2958 by Spanish Cochrane National Provision (Ministerio de Sanidad), Wiley Online Library on [21/11/2022]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License 6 - MORILLO‐SARTO ET AL. refers to the tendency towards eating more in the pres- adequate psychometric properties (α = 0.86) (Diez‐Que- ence of certain external stimuli such as the sight or smell vedo et al., 2001). of food, and the latter describes the tendency towards eating less than desired to lose or maintain body weight (van Strien, 2002). Both subscales include 10 items, and 2.5.3 | Process measures the scoring system and interpretation is the same that was described for the primary outcome. Both subscales The Mindful Eating Scale (MES; Hulbert‐Williams present good psychometric properties in the Spanish et al., 2014) is a 28‐item self‐reported measure that as- version of the DEBQ (α = 0.84 for ‘external’ and α = 0.93 sesses the levels of mindful awareness towards eating. for ‘restrained’). The following factors are evaluated: acceptance, aware- The BITE (Henderson & Freeman, 1987) is a 33‐item ness, non‐reactivity, acting with awareness, routine, and questionnaire that assesses bulimic behaviours in non‐ unstructured eating. Each item is rated on a 4‐point clinical samples. It includes two subscales: ‘symptoms’, Likert scale. The score of each subscale can be calcu- composed of 30 dichotomous items, and ‘severity’, which lated by summing the items; higher scores reflect higher includes 3 items that ask about how often the respon- tendencies to mindful eating. The psychometric proper- dent fasts for a whole day, uses different strategies to ties of the MES have been reported to be adequate lose weight and binges. The total score of the ‘symp- (α > 0.75 for all the subscales but ‘unstructured eating’). toms’ subscale ranges from 0 to 30, and the ‘severity’ The Five Facets Mindfulness Questionnaire‐24 subscale can range from 0 to 39, with higher scores (FFMQ‐SF; Bohlmeijer et al., 2011) is an adaptation of indicating higher bulimic tendencies. In addition, item the original FFMQ that consists of 24 items addressed at number 27 was also independently used as a measure of evaluating the mindfulness facets of observing, frequency of binging in the last month, which is also describing, acting with awareness, non‐judging, and non‐ scored in a 6‐point Likert scale with higher scores reacting to the inner experience. Each item is scored on a indicating higher frequency to binging. The Spanish 5‐point Likert scale. The score of each subscale can be version of the BITE has been reported to present validity calculated by summing its items, which results in a score in assessing specific symptoms of bulimia (α = 0.82 for between 5 and 25 for all the subscales except for ‘symptoms’ and α = 0.63 for ‘severity’) (Rivas‐Moya ‘Observing’, which is composed of 4 items (range: 4–20). et al., 2004). The Spanish version of the FFMQ‐24 has presented The Eating Attitudes Test‐26 item version (EAT‐26; acceptable psychometric properties (α = 0.65 to 0.80) Garner et al., 1982) is an adaptation of the original 40‐ (Asensio‐Martínez et al., 2019). item questionnaire addressed at assessing eating disor- The Self‐Compassion Scale (SCS; Neff, 2003) was used der risk. The EAT‐26 includes three subscales: ‘dieting’, to evaluate individual's tendency to treat themselves in a ‘bulimia and food preoccupation’, and ‘oral control’. Each compassionate way in times of difficulty. The SCS is a 26‐ item is scored in a 6‐point Likert scale. The Spanish item questionnaire that assesses self‐kindness, common version of the EAT‐26 has good psychometric properties humanity, and mindfulness. The SCS uses a 5‐point (α = 0.76 to 0.89) (Constaín et al., 2014). Likert‐type scale, with higher scores indicating greater The Generalised Anxiety Disorder questionnaire levels of each self‐compassion facet. The SCS Spanish (GAD‐7; Spitzer et al., 2006) is a common measure to version is a reliable instrument (α = 0.72 to 0.79) (Garcia‐ assess anxiety severity during the last 2 weeks. It is Campayo et al., 2014). composed of 7 items which are rated on a 4‐point Likert scale. The GAD‐7 presents strong sensitivity and speci- ficity rates for discriminating patients suffering from 2.5.4 | Physiological parameters generalised anxiety disorder. The Spanish version of the questionnaire has shown appropriate psychometric Both at baseline and in the follow‐up assessment, weight properties (α = 0.94) (García‐Campayo et al., 2010). (kg), height, and waist circumference (cm) were The Patient Health Questionnaire (PHQ9; Kroenke measured the same day and just before the psychological et al., 2001) is a 9‐item self‐reported measure that assesses assessment. Blood tests were conducted to evaluate the depressive symptoms during the previous 2 weeks. Each levels of total cholesterol (as well as high‐density lipo- item is scored in a 4‐point Likert scale, and the total score protein (HDL) and low‐density lipoprotein), triglycerides, is calculated by summing the scores of the items. It alanine aminotransferase, glucose, and glycated haemo- ranges between 0 and 27 (higher scores indicate greater globin. The blood test was performed in the morning (8–9 severity). The sensitivity and specificity rates of the am), and all participants had fasted for 8 h prior to the PHQ9 are high, and the Spanish version has shown test. Vital signs such as diastolic blood pressure and 10990968, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1002/erv.2958 by Spanish Cochrane National Provision (Ministerio de Sanidad), Wiley Online Library on [21/11/2022]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License MORILLO‐SARTO ET AL. - 7 systolic blood pressure were also assessed. To evaluate 3 | RESULTS vital signs, we used a vascular screening system (VaSera VS‐1500). 3.1 | Participant flow and compliance The four PC centres were randomized following the 2.6 | Data analysis abovementioned procedure. At least 16 participants of each PC centre were enroled in the study (see Figure 1). Sociodemographic and clinical data at baseline were In total, 41 participants received the intervention and 35 described using means and SDs for continuous variables, were allocated in the control group. In the posttreatment and frequencies and percentages for categorical variables. and follow‐up assessments, 37 (90.2%) participants in the Treatment conditions were compared at baseline by vi- intervention group and 100% of those in the control sual inspection to ensure the success of randomisation. group provided outcome data. In the intervention group, The main analysis and primary endpoint were the participants attended an average of 5.20 sessions comparison of the effectiveness of ‘Mindful eating’ + (SD = 1.55) out of 7; 10 patients (24.4%) attended all TAU versus TAU alone at posttreatment in the main sessions. outcome (i.e., DEBQ ‘emotional eating’), which was considered a continuous variable at the individual level. Multilevel mixed‐effect regression models, including 3.2 | Baseline characteristics of the subjects and clusters (PC centres) as random effect vari- study sample ables, were developed by means of a repeated measures design. An intention‐to‐treat basis was considered using Groups were similar in terms of PC centre‐related vari- the restricted maximum likelihood method, which is ables. The groups were also balanced in terms of sex, age, robust in the case of small or unbalanced sample sizes marital status, education, or employment situation. Most (Egbewale et al., 2014). Non‐standardized and unadjusted of the study participants were females, mostly married, slopes were calculated along with the 95% confidence and had completed primary education. The baseline interval. The Group � Time interaction was calculated to characteristics of the sample, including clinical variables determine the potential differences between the groups. and physiological parameters, are summarised in Table 2. The effect size was calculated using Cohen's d (d ≤ 0.2 In general, participants in the ‘mindful eating’ + TAU indicates small effects; d = 0.5 moderate; d ≥ 0.8 large). group presented less favourable mean (SD) scores at Secondary analyses included the comparison of the baseline than TAU controls on DEBQ emotional eating effects of the interventions on the main outcome at 1‐year (2.65 (0.78) versus 1.97 (0.66)). follow‐up, following the same analytical strategy described above. In the same line, both study arms were compared in the secondary outcomes, process variables, and physical 3.3 | Effects on the primary outcome parameters. Sensitivity analyses of the main outcome with sex and the baseline levels of anxiety and depression as Sixty‐eight (89.5%) participants completed the primary covariates were computed, considering the existing evi- outcome posttreatment. The unadjusted model showed dence regarding the potential influence that these vari- that the intervention group had significantly decreased ables imply in terms of emotional eating (Braden their scores in ‘emotional eating’ compared with the et al., 2018; Frayn et al., 2018). As more than 85% of par- control group (B = −0.27; p = 0.006) with small effects ticipants attended >50% of the sessions we did not develop (d = 0.35). At 12‐month follow‐up, the comparison re- per‐protocol analyses. The clinical significance of the po- flected that the intervention group significantly reduced tential changes produced by the interventions was further their scores in ‘emotional eating’ (B = −0.53; p < 0.001) explored by calculating the absolute risk reduction (ARR) with a medium effect size (d = 0.69). These results are and the number needed to treat (NNT), along with their detailed in Table 3. respective 95% CIs. The two criteria used for considering After including sex and the baseline levels of anxiety improvement were: (1) changing to a less severe quartile in (GAD‐7) and depression (PHQ9) as covariates, the model the main outcome compared to baseline; and (2) the reli- reflected a similar degree of superiority of ‘mindful able change index (RCI; Jacobson & Truax, 1991). eating’ + TAU versus TAU alone, both posttreatment and An alpha level of 0.05 was set, using a two‐tailed test. in the follow‐up assessment. These results, along with the Data analyses were computed using STATA v17.0, and rest of secondary analyses with adjusted models, are IBM SPSS v26.0 statistical software. detailed in Supplementary Table 1. 10990968, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1002/erv.2958 by Spanish Cochrane National Provision (Ministerio de Sanidad), Wiley Online Library on [21/11/2022]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License 8 - MORILLO‐SARTO ET AL. FIGURE 1 Flow chart of participants in the study 3.4 | Effects on the secondary outcomes posttreatment. The rest of secondary outcomes did not present any significant effect. As shown in Table 3, ‘external eating’ (DEBQ) experi- enced a similar effect compared to the primary outcome; the intervention group was more effective for reducing the 3.5 | Effects on the process variables scores in this subscale posttreatment (B = −0.19, and physiological parameters p = 0.035, d = 0.31), and in the follow‐up assessment (B = −0.50, p < 0.001, d = 0.85); the adjusted model Posttreatment, the only significant effect was found for (Supplementary Table 1) also reflected a similar effect. the FFMQ ‘Observing’ subscale, reflecting an increase in Two other secondary outcomes presented significant ef- the intervention group (B = 1.44, p = 0.022, d = 0.44). In fects both in the unadjusted and the adjusted models: the the follow‐up assessment, the same effect of the inter- BITE severity scale (B = −1.13, p = 0.004, d = 0.65), and vention group was found for ‘Observing’ (B = 1.39, the frequency of binging (BITE item 27) (B = −0.96, p = 0.027, d = 0.32), and for some other process variables: p = 0.001, d = 0.53) presented significant effects in favour the MES subscales ‘Nonreactivity’ (B = 1.18, p = 0.034, of ‘mindful eating’ + TAU in the follow‐up assessment, d = 0.28) and ‘Unstructured eating’ (B = 0.87, p = 0.022, while no significant differences were appreciated d = 0.30), the FFMQ ‘Nonreacting’ subscale (B = 1.31, 10990968, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1002/erv.2958 by Spanish Cochrane National Provision (Ministerio de Sanidad), Wiley Online Library on [21/11/2022]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License MORILLO‐SARTO ET AL. - 9 TABLE 2 Baseline characteristics of primary care (PC) centres and participants by study arm Mindful eating + TAU (n = 41) TAU alone (n = 35) TOTAL (n = 76) PC centre characteristics k=2 k=2 k=4 Socioeconomic status, mean in € (SD) 10,959 (796.20) 10,090.50 (907.22) 10,524.75 (858.54) Patients assisted per year, mean (SD) 16,776.50 (9017.73) 16,690 (8821.86) 16,733.25 (7283.60) Percentage of immigrant population, mean (SD) 12.44 (2.04)s 11.50 (7.78) 11.97 (4.67) Index of dependency, mean (SD) 49.15 (3.34) 49.94 (11.50) 49.55 (6.93) Participant sociodemographic characteristics Sex, n (%) Females 24 (58.5%) 24 (68.6%) 48 (63.2%) Males 17 (41.5%) 11 (31.4%) 28 (36.8%) Age, mean (SD 58.00 (6.65) 59.09 (8.60) 58.50 (7.58) Marital status, n (%) Single 5 (12.2%) 2 (5.7%) 7 (9.2%) Married 32 (78%) 26 (74.3%) 58 (76.3%) Divorced 2 (4.9%) 4 (11.4%) 6 (7.9%) Widowed 2 (4.9%) 2 (5.7%) 4 (5.3%) Other 0 (0%) 1 (2.9%) 1 (1.3%) Education level, n (%) None 0 (0%) 2 (5.7%) 2 (2.6%) Primary 24 (58.5%) 15 (42.9%) 39 (51.3%) Secondary 13 (31.7%) 14 (40%) 27 (35.5%) University 4 (9.8%) 4 (11.4%) 8 (10.5%) Employment status, n (%) Employed 14 (34.1%) 13 (37.1%) 27 (35.5%) Self‐employed 1 (2.4%) 2 (5.7%) 3 (3.9%) Sick leave 1 (2.4%) 1 (2.9%) 2 (2.6%) Unemployed with subsidy 2 (4.9%) 0 (0%) 2 (2.6%) Unemployed without subsidy 2 (4.9%) 2 (5.7%) 4 (5.3%) Housekeeper 8 (19.5%) 7 (20%) 15 (19.7%) Retired 9 (22%) 10 (28.6%) 19 (25%) Permanent inability 4 (9.8%) 0 (0%) 4 (5.3%) Participant clinical characteristics DEBQ, mean (SD) Emotional eating 2.65 (0.87) 1.97 (0.66) 2.34 (0.85) External eating 2.89 (0.66) 2.36 (0.59) 2.64 (0.68) Restrained eating 2.73 (0.60) 2.56 (0.80) 2.64 (0.71) BITE, mean (SD) Symptoms 7.38 (5.96) 5.49 (4.33) 6.49 (5.32) Severity 2.78 (1.79) 2.57 (1.67) 2.78 (1.73) Frequency of binging (item 27) 2.35 (1.42) 1.97 (1.40) 2.17 (1.42) (Continues) 10990968, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1002/erv.2958 by Spanish Cochrane National Provision (Ministerio de Sanidad), Wiley Online Library on [21/11/2022]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License 10 - MORILLO‐SARTO ET AL. T A B L E 2 (Continued) Participant clinical characteristics EAT‐26, mean (SD) Dieting 7.93 (5.92) 10.00 (5.91) 8.89 (5.96) Bulimia and food preoccupation 1.33 (1.80) 1.80 (2.41) 1.55 (2.11) Oral control 2.15 (2.23) 3.00 (2.61) 2.55 (2.43) GAD‐7, mean (SD) 3.49 (4.51) 4.00 (3.96) 3.72 (4.24) PHQ‐9, mean (SD) 4.00 (5.34) 2.89 (2.45) 3.49 (4.27) Participant physiological parameters Weight, mean in kg (SD) 89.59 (16.83) 83.89 (14.59) 86.96 (15.99) Height, mean in cm (SD) 164.71 (10.31) 163.63 (8.21) 164.21 (9.36) Waist circumference, mean in cm (SD) 108.68 (20.96) 100.49 (13.31) 104.85 (18.16) BMI, mean (SD) 32.93 (4.39) 31.32 (4.86) 32.19 (4.65) Blood test markers Cholesterol, mean in mg/dL (SD) 197.82 (37.43) 211.34 (34.41) 204.00 (36.46) HDL, mean in mg/dL (SD) 55.00 (13.27) 53.91 (10.88) 54.49 (12.14) LDL, mean in mg/dL (SD) 118.22 (31.60) 134.41 (27.43) 125.72 (30.62) Triglycerides, mean in mg/dL (SD) 122.76 (60.06) 131.59 (66.32) 126.80 (62.69) Alanine aminotransferase, mean in U/L (SD) 23.05 (15.58) 21.13 (10.83) 22.17 (13.56) Glucose, mean in mg/dL (SD) 99.66 (15.17) 108.31 (40.51) 103.61 (29.66) Glycated haemoglobin, mean in % (SD) 7.06 (0.83) 6.88 (0.89) 6.96 (0.84) Vital signs, mean in mmHg (SD) DBP 82.95 (7.21) 81.83 (12.74) 82.43 (10.08) SBP 135.39 (13.83) 140.46 (24.37) 137.72 (19.43) Abbreviations: HDL, high‐density lipoprotein; LDL, low‐density lipoprotein. p = 0.025, d = 0.40), and the SCS ‘Common humanity’ were established at 1.56 (Q1), 2.50 (Q2), and 2.85 (Q3). subscale (B = 0.37, p < 0.001, d = 0.60). These results are Posttreatment, 15 individuals (44.1%) in the experimental detailed in Supplementary Table 2 along with the rest of group reduced their score to an inferior quartile. In the process variables. control group, only 2 patients (5.7%) experienced such The physiological parameters that experienced some improvement. The ARR obtained was 37.67% (95% significant effect in the follow‐up assessment were CI = 18.87%–56.46%), with a NNT of 3 (95%CI = 1.8–5.3). cholesterol (total) (B = 22.08, p = 0.040, d = 0.57) and In the follow‐up assessment, 17 participants (48.6%) in HDL cholesterol (B = 4.92, p = 0.043, d = 0.43), both the experimental group experienced an improvement favouring TAU. No study group experienced significant compared to 2 (6.1%) in the control group, which resulted reductions in the BMI. These results are presented in in an ARR of 42.51% (95%CI = 24.06%–60.96%), with a Supplementary Table 3. NNT of 3 (95%CI = 1.6–4.2). The second criterion used to calculate the NNT was the RCI, which was established at 0.72 points posttreatment. 3.6 | Number needed to treat With this criterion, 5 individuals (14.7%) in the interven- tion group experienced a reliable improvement. In the Changing to a less severe quartile in the main outcome control group, no reliable changes were appreciated. The compared to the participant's baseline score was consid- ARR obtained in this case was 14.71% (95%CI = 2.80%– ered a criterion to define responders to the intervention. 26.61%), with a NNT of 7 (95%CI = 3.8–35.7). In the follow‐ The quartiles of ‘emotional eating’ (DEBQ) at baseline up assessment, the RCI was established at 1.10 points, and 10990968, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1002/erv.2958 by Spanish Cochrane National Provision (Ministerio de Sanidad), Wiley Online Library on [21/11/2022]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License MORILLO‐SARTO ET AL. - 11 TABLE 3 Unadjusted between‐group analyses for primary and secondary outcomes Mindful eating + TAU versus TAU Mindful eating + TAU Mean (SD) TAU Mean (SD) d Z (p) B (95% CI) DEBQ ‘Emotional eating’ n = 39 n = 33 Baseline 2.65 (0.87) 1.97 (0.66) Post‐treatment † 2.40 (0.63) 2.07 (0.70) 0.35 −2.78 (0.006) −0.27 (−0.46 to −0.08) Follow‐up 2.27 (0.64) 2.19 (0.68) 0.69 −4.17 (<0.001) −0.53 (−0.78 to −0.28) DEBQ ‘External eating’ n = 40 n = 35 Baseline 2.89 (0.66) 2.36 (0.59) Post‐treatment 2.77 (0.52) 2.43 (0.54) 0.31 −2.11 (0.035) −0.19 (−0.036 to −0.01) Follow‐up 2.55 (0.46) 2.51 (0.58) 0.85 −5.68 (<0.001) −0.50 (−0.67 to −0.33) DEBQ ‘Restrained eating’ n = 35 n = 34 Baseline 2.73 (0.60) 2.56 (0.80) Post‐treatment 2.82 (0.62) 2.58 (0.78) 0.03 0.34 (0.735) 0.04 (−0.18–0.25) Follow‐up 2.73 (0.50) 2.54 (0.78) 0.12 −0.26 (0.792) −0.03 (−0.24 to 0.18) BITE symptoms n = 40 n = 35 Baseline 7.38 (5.96) 5.49 (4.33) Post‐treatment 8.67 (4.79) 7.12 (3.87) 0.02 −0.50 (0.620) −0.45 (−2.23–1.33) Follow‐up 5.58 (5.40) 4.89 (3.46) 0.14 −1.30 (0.192) −1.18 (−2.95 to 0.59) BITE severity n = 40 n = 35 Baseline 2.78 (1.79) 2.57 (1.67) Post‐treatment 2.69 (1.53) 2.40 (1.67) 0.06 0.14 (0.888) 0.06 (−0.71–0.82) Follow‐up 1.97 (1.80) 2.89 (2.73) 0.65 −2.89 (0.004) −1.13 (−1.89 to −0.36) BITE item 27 n = 40 n = 35 Baseline 2.35 (1.42) 1.97 (1.40) Post‐treatment 2.11 (1.29) 2.00 (1.41) 0.14 −0.87 (0.385) −0.26 (−0.84 to 0.32) Follow‐up 1.63 (1.37) 2.20 (1.69) 0.53 −3.26 (0.001) −0.96 (−1.54 to −0.38) EAT‐26 dieting n = 40 n = 35 Baseline 7.93 (5.92) 10.00 (5.91) Post‐treatment 7.79 (6.95) 9.76 (5.93) 0.01 −0.12 (0.903) −0.13 (−2.25–1.99) Follow‐up 7.75 (6.09) 9.34 (5.92) 0.11 0.19 (0.852) 0.20 (−1.89–2.28) EAT‐26 bulimia n = 40 n = 35 Baseline 1.33 (1.80) 1.80 (2.41) Post‐treatment 1.15 (1.35) 1.62 (2.22) 0.08 0.20 (0.840) 0.07 (−0.65–0.80) Follow‐up 0.78 (1.31) 1.57 (1.96) 0.06 −0.84 (0.399) −0.31 (−1.02–0.41) EAT‐26 oral control n = 40 n = 35 Baseline 2.15 (2.23) 3.00 (2.61) Post‐treatment 1.97 (2.43) 2.76 (2.57) 0.08 −0.25 (0.803) −0.10 (−0.89 to 0.69) Follow‐up 2.00 (2.19) 2.57 (2.36) 0.02 0.33 (0.745) 0.13 (−0.64–0.90) GAD‐7 n = 41 n = 35 Baseline 3.49 (4.51) 4.00 (3.96) (Continues) 10990968, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1002/erv.2958 by Spanish Cochrane National Provision (Ministerio de Sanidad), Wiley Online Library on [21/11/2022]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License 12 - MORILLO‐SARTO ET AL. T A B L E 3 (Continued) Mindful eating + TAU versus TAU Mindful eating + TAU Mean (SD) TAU Mean (SD) d Z (p) B (95% CI) Follow‐up 2.66 (3.98) 2.86 (4.64) 0.07 0.26 (0.797) 0.29 (−1.93–2.52) PHQ9 n = 41 n = 35 Baseline 4.00 (5.34) 2.89 (2.45) Follow‐up 2.49 (3.39) 2.96 (4.19) 0.36 −1.48 (0.139) −1.62 (−3.78 to 0.53) Note: † Main outcome at the primary endpoint. In bold, statistically significant results. in this case, 3 individuals in the ‘Mindful eating’ group as a generic aspect could enhance the effectiveness of the (8.6%) experienced a reliable improvement. The control intervention in this specific target. group, again, showed no reliable changes. A not statisti- Although the focus of the present study was the cally significant ARR was obtained (8.57%; 95%CI = emotional eating pattern, other eating behaviours were −0.70%–17.85%), and therefore, the NNT was not assessed and some of them were also improved by the calculated. ‘mindful eating’ programme. That was the case of external eating, defined as the tendency towards eating more in the presence of certain external stimuli such as 4 | DISCUSSION the sight or smell of food (Karlsson et al., 2000). The intervention significantly reduced the levels of external Our findings support the main hypothesis of the present eating both posttreatment and in the follow‐up, and again study: the ‘mindful eating’ programme, added to TAU, was the change in the long‐term presented a higher effect effective for reducing emotional eating in adults with size. Previous studies have already reported significant overweight or obesity in a PC setting, compared to TAU effects of ‘mindful eating’ programs on external eating; alone. Posttreatment, the effect of the intervention was for instance, Winkens et al. (2019) found that reductions small, although significant when compared to the control on this eating behaviour mediated the effects of the group, as corroborated by the adjusted models and the intervention on depressive symptoms. On the other hand, significant NNT that was calculated. In the follow‐up, the in our study, bulimic behaviours were partially improved effect presented a medium effect size, even after control- by the intervention: while bulimic symptoms did not ling variables such as sex and baseline levels of anxiety and show any significant changes, their severity and the fre- depression that have been reported to play a role on quency of binging was reduced at 1‐year follow‐up, in emotional eating patterns (Braden et al., 2018; Frayn line with what previous studies have reported (Godfrey et al., 2018). et al., 2015; Katterman et al., 2014; Kristeller et al., 2014; These results go in line with the ones reported in pre- Kristeller & Wolever, 2011). The other eating behaviours vious studies regarding the efficacy of mindfulness‐based assessed did not show any significant effects, which can and, particularly, ‘mindful eating’ programs on changing be attributed to the fact that this sample presented low eating behaviours such as emotional eating. Different baseline levels of these outcomes, possibly more directly systematic reviews have concluded that these in- associated with other eating disorders such as anorexia terventions have the potential to address problematic and bulimia nervosa (Garner et al., 1982). The same eating behaviours (Carrière et al., 2018; Katterman et al., happened for anxiety and depression, which presented 2014; Warren et al., 2017). Emotional eating, as previously low scores at baseline and did not experience any sig- explained, is a common eating pattern among people with nificant changes, despite being variables that have been overweight and obesity, for which it has been considered a associated with overweight, obesity, and emotional eating main target of interventions (Stojek et al., 2017; van (Sharafi et al., 2020). Strien, 2018). It needs to be noted, however, that not all According to our results, the ‘mindful eating’ pro- mindfulness‐based interventions have achieved signifi- gramme achieved notably higher effects in the follow‐up cant effects on emotional eating. Kearny et al. (2012) tested assessment than in the posttreatment evaluation. We the efficacy of the Mindfulness‐Based Stress Reduction hypothesise that these findings could be at least partially programme and found no significant effects on emotional justified by the well‐known difficulties for implementing eating. This could be possibly indicating that focussing on changes in health‐related daily habits in the short‐term mindful eating rather than on the practice of mindfulness (Kelly & Barker, 2016), which would explain the small 10990968, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1002/erv.2958 by Spanish Cochrane National Provision (Ministerio de Sanidad), Wiley Online Library on [21/11/2022]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License MORILLO‐SARTO ET AL. - 13 effects achieved posttreatment; however, the ‘mindful waist circumference. It was expected that reductions in eating’ programme could be slowly promoting some emotional eating would lead to reductions in weight deeper changes in the relation that the individuals (Stojek et al., 2017; van Strien, 2018); the fact that our establish with food and their eating habits, resulting in results do not corroborate this hypothesis may be related more significant effects in the future. Previous studies to the relatively small sample size since this was calcu- have observed that these interventions produce effects in lated considering the effects of the intervention on the follow‐up assessments, although Carriere et al. (2018) primary outcome (DEBQ ‘emotional eating’), but not on observed that the average follow‐up time in the studies the BMI, which could possibly require a larger number of included in their review was 16.25 weeks, suggesting that participants to present significant results. Another pos- not many studies have analysed actual long‐term effects sibility is that the reported changes in eating patterns of these interventions on eating behaviours of people were partially due to the patients' expectancies and/or with overweight or obesity. social desirability since they may had understood the On the other hand, short‐term effects of the ‘mindful purpose of the intervention although they were not eating’ programme were found for the mindfulness facet of capable of applying those concepts in their day‐to‐day. ‘Observing’, which were maintained in the follow‐up Comparing ‘mindful eating’ to another programme that assessment. ‘Observing’ is defined as the tendency to addresses emotional regulation would be a possible way noticing or attending to internal and external experiences of overcoming this limitation in future studies. such as sensations, thoughts, or emotions (Baer Nevertheless, evidence regarding the efficacy of et al., 2006). The rest of effects on process variables were ‘mindful eating’ programs or, generally, mindfulness‐ only presented in the follow‐up; that was the case of based interventions for reducing BMI is unclear; our re- ‘Nonreacting to the inner experience’, which would reflect sults go in line with some previous research (Daubenmier that patients who participated in the ‘mindful eating’ et al., 2011; Davis, 2008; Fletcher, 2011; Forman et al., programme were more capable of allowing thoughts and 2013; Miller et al., 2012), although one meta‐analysis has feelings to come and go, without getting caught up in or concluded that ‘third wave’ psychotherapies might have carried away by them (Baer et al., 2006). Both observing effects on weight compared to control groups (Lawlor and nonreacting seem clearly related to the contents that et al., 2020). It needs to be noted that, in our study, TAU were practiced during the intervention, such as being was not effective for producing a significant weight more conscious of the level of hunger, learning the dif- reduction, which suggests that different therapeutic ap- ference between physiological hunger and external‐ proaches should be considered in PC centres for treating derived signals to eat, or identifying bodily sensations patients with overweight and obesity. The control group related to satiety (García‐Campayo, 2017). Some other experienced significant improvements in their cholesterol process variables presented changes in the follow‐up, such levels, but the exploratory nature of the analyses con- as the ‘common humanity’ subscale of the SCS, suggesting ducted on biological samples in our study undermines the that the intervention enhanced self‐compassionate ten- significance of this finding. Our study also assessed other dencies in the participants, who would recognise their physiological parameters for which the meta‐analysis suffering as part of the shared human experience (Neff, conducted by Lawlor et al. (2020) found promising evi- 2003), which is again related to the intervention's contents dence, but no significant changes were observed in our (García‐Campayo, 2017). Regarding the MES, significant case. effects were observed in the ‘nonreactivity’ subscale – Some limitations of this study need to be acknowl- clearly related to the mindfulness facet previously edged; first, regarding the study sample, the external val- described– and ‘unstructured eating’, indicating that pa- idity of our findings is limited considering the relatively tients reduced their tendencies to multitask while eating small sample size, which probably hindered the observa- or snack when they felt bored (Hulbert‐Williams et al., tion of expected changes such as reductions in the BMI, 2014). It needs to be noted, however, that most of these and the demographic and geographic profile of our sam- effects presented small‐to‐medium effect sizes, which ple. Also, patients who presented severe psychiatric dis- relativises the actual impact of the intervention on these orders (e.g., schizophrenia, acute‐phase depression, drug outcomes. abuse) were excluded, which could have led to a not Despite achieving significant changes in eating pat- completely representative sample of the obese and over- terns, the sample who underwent the ‘mindful eating’ weight patients that are treated in Spanish PC centres. programme did not show a significant change in weight: Second, many of the measures that we used were self‐ while it was reduced in the 1‐year follow‐up assessment, reported and the Spanish version of the MES was not this change was not significant compared to the control previously validated. Regarding the interventions, the group, and the same happened with the reduction in participants knew the study arm they were assigned, 10990968, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1002/erv.2958 by Spanish Cochrane National Provision (Ministerio de Sanidad), Wiley Online Library on [21/11/2022]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License 14 - MORILLO‐SARTO ET AL. which may have affected their expectancies, and TAU was C L I NI C A L T R I AL R EG I ST R AT I O N clearly less effective than expected, at least in terms of NCT03927534. weight reduction. Patients in the intervention group were more exposed to treatment (i.e., ‘mindful eating’ and TAU) O R CI D than those in the control group (only TAU). Participants Adrián Pérez‐Aranda https://orcid.org/0000-0002- presented low baseline levels of different outcomes, which 1602-3413 hindered observing effects of the intervention due to po- tential floor effects, and participants in the ‘mindful R E F E R E NC E S Alberts, H. J. E. M., Thewissen, R., & Raes, L. (2012). Dealing with eating’ + TAU group showed less favourable scores in problematic eating behaviour. The effects of a mindfulness‐ emotional eating at baseline, and thus presenting a greater based intervention on eating behaviour, food cravings, dichot- range of possible improvements than the control group. In omous thinking and body image concern. Appetite, 58(3), addition, our study did not register the frequency of 847–851. https://doi.org/10.1016/j.appet.2012.01.009 mindfulness practice during the intervention or in the Asensio‐Martínez, Á., Masluk, B., Montero‐Marin, J., Olivan‐Bláz- follow‐up period; therefore, a hypothesis regarding the quez, B., Navarro‐Gil, M. T., García‐Campayo, J., & Magallón‐ impact of home‐based mindfulness practice on the main- Botaya, R. (2019). Validation of Five Facets Mindfulness tenance of improvements could not be tested. Questionnaire—Short form, in Spanish, general health care services patients sample: Prediction of depression through In conclusion, the ‘mindful eating’ programme added mindfulness scale. PLoS One, 14(4), e0214503. https://doi.org/ to TAU seems effective for reducing the emotional eating 10.1371/journal.pone.0214503 behaviour, along with improving the external eating, the Baer, R. A., Smith, G. T., Hopkins, J., Krietemeyer, J., & Toney, L. severity of bulimic behaviours, the frequency of binge (2006). Using self‐report assessment methods to explore facets episodes and some mindfulness and self‐compassion of mindfulness. Assessment, 13(1), 27–45. https://doi.org/10. facets in adults with overweight or obesity in a PC 1177/1073191105283504 setting. However, the changes observed in the sample's Bohlmeijer, E., Klooster, P. M., Fledderus, M., Veehof, M., & Baer, eating patterns were not matched with significant re- R. (2011). Psychometric properties of the five facet mindful- ness questionnaire in depressed adults and development of a ductions in their weight. To overcome potential meth- short form. Assessment, 18(3), 308–320. https://doi.org/10. odological shortcomings of the present study, future 1177/1073191111408231 works should use larger samples and compare the Braden, A., Musher‐Eizenman, D., Watford, T., & Emley, E. (2018). ‘mindful eating’ programme with others which also Eating when depressed, anxious, bored, or happy: Are address emotional eating using different strategies. If the emotional eating types associated with unique psychological aim is weight reduction of patients with overweight or and physical health correlates? Appetite, 125, 410–417. https:// obesity, these programs should be complemented with doi.org/10.1016/j.appet.2018.02.022 Brown, L. B. (2009). Teaching the “health at every size” paradigm other strategies such as dieting and physical activity. benefits future fitness and health professionals. Journal of Nutrition Education and Behavior, 41(2), 144–145. https://doi. A CK N OWL EDG E ME NT S org/10.1016/j.jneb.2008.04.358 APA has a ‘Sara Borrell’ research contract from the Carrière, K., Khoury, B., Günak, M. M., & Knäuper, B. (2018). Instituto de Salud Carlos III (CD20/00181). JMM has a Mindfulness‐based interventions for weight loss: A systematic ‘Miguel Servet’ research contract from the Instituto de review and meta‐analysis. Obesity Reviews, 19(2), 164–177. Salud Carlos III (CP21/00080). https://doi.org/10.1111/obr.12623 Open Access Funding provided by Universitat Auton- Cebolla, A., Barrada, J. R., van Strien, T., Oliver, E., & Baños, R. (2014). Validation of the Dutch eating behavior questionnaire oma de Barcelona. (DEBQ) in a sample of Spanish women. Appetite, 73, 58–64. https://doi.org/10.1016/j.appet.2013.10.014 CON F L IC T O F I NT ER EST Constaín, G. A., Ricardo Ramírez, C., Rodríguez‐Gázquez, M. D. L. The author declares that there is no conflict of interest Á., Álvarez Gómez, M., Marín Múnera, C., & Agudelo Acosta, that could be perceived as prejudicing the impartiality of C. (2014). Validez y utilidad diagnóstica de la escala EAT‐26 the research reported. para la evaluación del riesgo de trastornos de la conducta alimentaria en población femenina de Medellín, Colombia. DAT A A VA I L A B I LI T Y ST A T E M E N T Atención Primaria, 46(6), 283–289. https://doi.org/10.1016/j. aprim.2013.11.009 The data presented in this study are available on request Daubenmier, J., Kristeller, J., Hecht, F. M., Maninger, N., from the corresponding author. Kuwata, M., Jhaveri, K., Lustig, R. H., Kemeny, M., Karan, L., & Epel, E. 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European Eating Disorders Review, in the Supporting Information section at the end of this 1–17. https://doi.org/10.1002/erv.2958 article.