Mindfulness and Compassion-based Programs on Food Behavior of Patients With Weight Regain After Bariatric Surgery

Obesity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04171713
• Other study ID #: Mindfulness e reganho de peso
• Status: Recruiting
• Phase: N/A
• Start date: November 5, 2019
• Est. completion date: March 30, 2021

Study information

• Verified date: November 2019
• Source: Centro Mente Aberta de Mindfulness
• Contact: Marcelo Demarzo, phD
• Phone: +5516981214451
• Email: marcelodemarzo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 456
• Est. completion date: March 30, 2021
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Mindfulness-Based Health Promotion + Treatment as usual
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. Plus participation in support groups offered by the bariatric surgery clinic with capacity for 40 participants, monthly attendance and duration of 2 hours. In these meetings, there is always the presence of a surgeon, a psychologist and another invited 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.
• Attachment-based compassion therapy + Treatment as usual
It is a program based on one of the fundamental psychological constructs that explain individuals' interpersonal relationships, attachment styles. It lasts 8 weeks in which participants meet for 2 or 2.5 hours at each meeting.
• Treatment as usual
participation in support groups offered by the bariatric surgery clinic with capacity for 40 participants, monthly attendance and duration of 2 hours. In these meetings, there is always the presence of a surgeon, a psychologist and another invited 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.

Locations

Country	Name	City	State
Brazil	Centro Mente Aberta de Mindfulness e Promoção de Saúde	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Centro Mente Aberta de Mindfulness

Country where clinical trial is conducted

Brazil, 

References & Publications (39)

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* Note: There are 39 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from Baseline in Mindfulness score	Mindful Attention Awareness Scale	T0 (baseline), T1(end of treatment at 8 weeks) and T2 (six months after the end of treatment)
Other	Change from Baseline in Self-compassion score	Self-compassion Scale (12-60: higher scores indicate more self-compassion. Scores closest to 60 indicate a better outcome)	T0 (baseline), T1(end of treatment at 8 weeks) and T2 (six months after the end of treatment)
Other	Change from Baseline in anxiety score	Mindful Attention Awareness Scale (1-6: higher scores indicate more mindfuness. Scores closest to 6 indicate a better outcome)	T0 (baseline), T1(end of treatment at 8 weeks) and T2 (six months after the end of treatment)
Primary	Mean Change from Baseline in food behavior scores	The Three factor eating questionnaire (1-100: higher scores indicate more uncontrolled, restraint and emotional eating. Scores closest to 100 indicate a worse outcome) and Repetitive eating questionnaire (higher scores indicate more repetitive eating. Scores closest to 6 indicate a worse outcome)	T0 (baseline), T1(end of treatment at 8 weeks) and T2 (six months after the end of treatment)
Secondary	Mean Change from Baseline in quality of life level	Bariatric analysis and reporting outcome system	T0 (baseline), T1(end of treatment at 8 weeks) and T2 (six months after the end of treatment)
Secondary	Change from Baseline in self perception body image	Brazilian Silhouette Scales for Adults (1-15: higher scores indicate higher perceived Body Mass Index, which is neither good nor bad).	T0 (baseline), T1(end of treatment at 8 weeks) and T2 (six months after the end of treatment)
Secondary	Weight change	measure of weight	T0 (baseline), T1(end of treatment at 8 weeks) and T2 (six months after the end of treatment)