Clinical trial NCT04171713: Mindfulness and Compassion-based Programs on Food Behavior of Patients With Weight Regain After Bariatric Surgery
Official title: Compared Effects of Mindfulness and Compassion-based Programs on Food Behavior of Patients With Weight Regulation After Bariatric Surgery: a Controlled and Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: bariatric surgery
weight regain
food behavior
mindfulness
compassion
empathy
Lead sponsor: Centro Mente Aberta de Mindfulness
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 456
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Weight regain in patients after bariatric surgery has been reported as one of the main failure factors of these surgeries, has important health consequences, such as the return of associated comorbidities, and, until that moment, needs effective treatment. Among its probable causes is the maintenance of dysfunctional eating behavior, even after the procedure. In this context, contemporary, evidence-based mindfulness training protocols focusing on health promotion and socio-emotional skills (compassionate training) have the potential to assist in self-regulation of eating behavior, reducing eating. dysfunctional and facilitating weight self-management. The aim of this study is to compare the preliminary efficacy and feasibility of the Mindfulness-Based Health Promotion (MBHP) and Attachment-Based Compassion Therapy (ABCT) programs in the eating behavior of post-weight regained bariatric patients. The study will be divided into two phases: a cross-analytical study with patients who underwent bariatric surgery between 2012 and 2016, and a controlled and randomized study only with those who obtained weight regain, with mixed data collection. Regarding the intervention study, it is expected that there will be an improvement in eating behavior; weight, weight regain reversal, self-image classification; in the quality of life; and in the levels of mindfulness, self-pity and anxiety of these patients. This study hopes to gather preliminary evidence on the effectiveness of mindfulness and compassion training for the adjuvant treatment of weight regain in post-bariatric patients.

Detailed description: This is a randomized intervention study with four protocols (MBHP + TAU, ABCT + TAU and TAU) to be performed with patients who underwent at least two years of bariatric surgery in 2012 and 2017 in a private clinic for obesity treatment in Uberlândia - Minas Gerais and who had regained weight. The study site will consist of a private obesity treatment clinic located in Uberlândia - Minas Gerais, founded in 2011 and which has performed approximately 5000 gastroplasty. It has an integrated multidisciplinary team composed of 4 doctors (2 bariatric surgeons, 1 gastroenterologist and 1 pulmonologist), 3 nutritionists, 2 psychologists and 1 nurse, who values both the patient's physical and mental health. Participants will be the adult patients who underwent gastroplasty (sleeve gastrectomy or Roux-en-Y gastric Bypass) from the clinic. All patients will be invited to participate in two support group meetings - usual treatment (TAU) - provided by the bariatric surgery clinic of this study. Subsequently, participants will be allocated into four groups, MBHP, ABCT and TAU. Participants of the MBHP and ABCT groups will also be invited to participate in the respective intervention protocols. Participants who remain in the TAU group after phase 2 will be invited to participate in the intervention group that has the most benefit to patients. All travel / travel expenses incurred by participants will be reimbursed. Measurements and evaluations will be performed 1 week before baseline (T0), after 2 months, post-intervention period (T1) and 6 months after intervention (T2). The following interventions will be performed live and online as follows: Patients will meet at the Bariatric Surgery Clinic of that study and instructors will be available for each session on scheduled days and times. The MBHP model is a program designed to address universal human vulnerabilities, not focusing on any specific health condition. Structured and developed over eight weeks (8 sessions), participants meet weekly for an average of 2 hours to experience the techniques and conceptual learning about mindfulness, and can be adapted to one or 1.5 hour sessions. to be applicable within the contexts of health, education and organizations. Participants are also given suggested activities to be implemented in a home or work setting on a daily basis, lasting an average of 15-20 minutes and up to 45 minutes for more motivated and adherent participants. They are instructed to seek to incorporate the idea of mindfulness into their daily lives (activity called informal practice), making routine activities somehow an opportunity to use the state of mindfulness. The main mindfulness techniques used are mindfulness breathing practice, body scanning (technique relatively similar to progressive muscle relaxation), mindfulness walking, mindfulness movements, in which lightweight body activities are used. be performed by individuals with different levels of ability and with physical limitations. One of the sessions (sixth session) is held in silence, with the purpose of deepening the practices 37 The ABCT is a program based on one of the fundamental psychological constructs that explain the interpersonal relationships of individuals, attachment styles. It lasts 8 weeks in which participants meet for 2 or 2.5 hours in each meeting. ABCT teaches formal (sitting meditation) and informal (during daily life) self-compassion. There are experimental exercises and discussion periods in each session, as well as homework, to help participants learn how to be kind to themselves. The control group (TAU) and the other participants will receive the usual treatment for post-bariatric patients of the clinic in question, which is the participation in support groups offered by the bariatric surgery clinic with capacity for 40 participants, monthly frequency and duration of 2 hours In these meetings there is always the presence of a surgeon, a psychologist and another guest professional (endocrinologist, nutritionist, speech therapist or dentist), who give a thematic lecture and then there is the opening space for doubts and exchange of experiences. All protocol instructors will be certified by internationally validated mindfulness institutions with extensive experience in conducting MBHP and ABCT groups. The methodological procedures of the present work were prepared within the fundamental ethical and scientific procedures, as provided for in Resolution No. 466 of December 12, 2012 of the National Health Council of Ministry of Health, being approved by the Research Ethics Committee (CEP), by protocol 18529519.5.0000.5505. The primary outcome will be the modification of eating behavior (Three factor eating questionnaire and Repetitive Eating Questionnaire). Secondary outcomes will be the improvement in quality of life (Bariatric analysis and reporting outcome system), body image (Brazilian Silhouette Scales for adults and children) and better weight management (weight maintenance or reduction). And the explanatory variables are: Level of Mindful Attention Awareness Scale, Self-compassion Scale, anxiety, greater adherence to sessions and higher frequency of formal practice throughout the study.

Eligibility criteria: Inclusion Criteria:

* Weight regain ≥ 5% of the minimum achieved postoperatively
* Literate
* Consent to Randomization

Exclusion Criteria:

* Use of weight loss medication;
* Pregnancy;
* Substance abuse (alcohol or drugs);
* State of acute depression (\<6 months of diagnosis), diagnosed schizophrenia or psychotic disorders, use of drugs that cause cognitive loss of attention and concentration (such as potent anxiolytic medications)
* Prior mindfulness, meditation, yoga or similar practices in the last 6 months (with formal practice at least once a week).

Primary outcomes:
measure: Mean Change from Baseline in food behavior scores
timeFrame: T0 (baseline), T1(end of treatment at 8 weeks) and T2 (six months after the end of treatment)
Secondary outcomes:
measure: Mean Change from Baseline in quality of life level
timeFrame: T0 (baseline), T1(end of treatment at 8 weeks) and T2 (six months after the end of treatment)
measure: Change from Baseline in self perception body image
timeFrame: T0 (baseline), T1(end of treatment at 8 weeks) and T2 (six months after the end of treatment)
measure: Weight change
timeFrame: T0 (baseline), T1(end of treatment at 8 weeks) and T2 (six months after the end of treatment)
Other outcomes:
measure: Change from Baseline in Mindfulness score
timeFrame: T0 (baseline), T1(end of treatment at 8 weeks) and T2 (six months after the end of treatment)
measure: Change from Baseline in Self-compassion score
timeFrame: T0 (baseline), T1(end of treatment at 8 weeks) and T2 (six months after the end of treatment)
measure: Change from Baseline in anxiety score
timeFrame: T0 (baseline), T1(end of treatment at 8 weeks) and T2 (six months after the end of treatment)
Locations:
city: São Paulo
country: Brazil
facility: Centro Mente Aberta de Mindfulness e Promoção de Saúde
state: SP
Study officials:
affiliation: Federal Univesity of São Paulo
name: Erika BS Porto, Master
role: PRINCIPAL_INVESTIGATOR
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