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

NCT04171713 | Unknown

• 1 other identifier: Mindfulness e reganho de peso
• Study Type: interventional
• Target: 456
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

bariatric surgery; weight regain; food behavior; mindfulness; compassion; empathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Mean Change from Baseline in quality of life level

  T0 (baseline), T1(end of treatment at 8 weeks) and T2 (six months after the end of treatment)

• Change from Baseline in self perception body image

  T0 (baseline), T1(end of treatment at 8 weeks) and T2 (six months after the end of treatment)

• Weight change

  T0 (baseline), T1(end of treatment at 8 weeks) and T2 (six months after the end of treatment)

Other Outcomes (3)

• Change from Baseline in Mindfulness score

  T0 (baseline), T1(end of treatment at 8 weeks) and T2 (six months after the end of treatment)

• Change from Baseline in Self-compassion score

  T0 (baseline), T1(end of treatment at 8 weeks) and T2 (six months after the end of treatment)

• Change from Baseline in anxiety score

  T0 (baseline), T1(end of treatment at 8 weeks) and T2 (six months after the end of treatment)

Study Arms (3)

Grup 1

EXPERIMENTAL

MBHP protocol + TAU

Behavioral: Mindfulness-Based Health Promotion + Treatment as usual; Behavioral: Treatment as usual

Grup 2

EXPERIMENTAL

ABCT protocol + TAU

Behavioral: Attachment-based compassion therapy + Treatment as usual; Behavioral: Treatment as usual

Grup 3

ACTIVE COMPARATOR

TAU

Behavioral: Treatment as usual

Interventions

Mindfulness-Based Health Promotion + Treatment as usual BEHAVIORAL

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.

Also known as: MBHP + TAU

Grup 1

Attachment-based compassion therapy + Treatment as usual BEHAVIORAL

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.

Also known as: ABCT + TAU

Grup 2

Treatment as usual BEHAVIORAL

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.

Also known as: TAU

Grup 1; Grup 2; Grup 3

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centro Mente Aberta de Mindfulness: lead

Study Sites (1)

Centro Mente Aberta de Mindfulness e Promoção de Saúde

São Paulo, São Paulo, 04753-060, Brazil

RECRUITING

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MeSH Terms

Conditions

Obesity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Erika BS Porto, Master

  Federal Univesity of São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcelo Demarzo, phD

CONTACT

+5516981214451; marcelodemarzo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 21, 2019
• Study Start: November 5, 2019
• Primary Completion: April 30, 2020
• Study Completion: March 30, 2021
• Last Updated: December 3, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: December, 2021. Will be available for 2 years
• Access Criteria: Access will be granted to those researchers who are interested in developing studies with objectives similar to this research.

Locations

BR (1)