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

November 30, 2019 updated by: Marcelo Demarzo, MD, PhD, Centro Mente Aberta de Mindfulness

Compared Effects of Mindfulness and Compassion-based Programs on Food Behavior of Patients With Weight Regulation After Bariatric Surgery: a Controlled and Randomized Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
456

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 04753-060
        • Recruiting
        • Centro Mente Aberta de Mindfulness e Promoção de Saúde
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Grup 1
MBHP protocol + TAU
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.
Other Names:
  • MBHP + TAU
Behavioral: 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.
Other Names:
  • TAU
EXPERIMENTAL: Grup 2
ABCT protocol + TAU
Behavioral: 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.
Other Names:
  • TAU
Behavioral: 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.
Other Names:
  • ABCT + TAU
ACTIVE_COMPARATOR: Grup 3
TAU
Behavioral: 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.
Other Names:
  • TAU

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Change from Baseline in food behavior scores
Time Frame: T0 (baseline), T1(end of treatment at 8 weeks) and T2 (six months after the end of treatment)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Change from Baseline in quality of life level
Time Frame: T0 (baseline), T1(end of treatment at 8 weeks) and T2 (six months after the end of treatment)
Bariatric analysis and reporting outcome system
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
Time Frame: T0 (baseline), T1(end of treatment at 8 weeks) and T2 (six months after the end of treatment)
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)
Weight change
Time Frame: T0 (baseline), T1(end of treatment at 8 weeks) and T2 (six months after the end of treatment)
measure of weight
T0 (baseline), T1(end of treatment at 8 weeks) and T2 (six months after the end of treatment)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in Mindfulness score
Time Frame: T0 (baseline), T1(end of treatment at 8 weeks) and T2 (six months after the end of treatment)
Mindful Attention Awareness Scale
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
Time Frame: T0 (baseline), T1(end of treatment at 8 weeks) and T2 (six months after the end of treatment)
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)
Change from Baseline in anxiety score
Time Frame: T0 (baseline), T1(end of treatment at 8 weeks) and T2 (six months after the end of treatment)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centro Mente Aberta de Mindfulness

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Erika BS Porto, Master, Federal Univesity of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 5, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Mindfulness e reganho de peso

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared by research gate

IPD Sharing Time Frame

December, 2021. Will be available for 2 years

IPD Sharing Access Criteria

Access will be granted to those researchers who are interested in developing studies with objectives similar to this research.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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