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Mindfulness in Preparation to Bariatric Surgery (PConscience)

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ClinicalTrials.gov Identifier: NCT02854306
Recruitment Status : Completed
First Posted : August 3, 2016
Last Update Posted : December 26, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:

Mindfulness is a common practice already widely used, that has shown benefits in terms of psychological and physical health. It is about learning or learn again to be self present and aware to the environment, across breathing, sensations, emotions and thought centering exercises, in the present moment without any judgement.

The goal is to evaluate the efficacy of "mindfulness" versus an active control group in bariatric surgery.


Condition or disease Intervention/treatment Phase
Obesity Procedure: Bariatric surgery Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Psycho-sensorial Mindfulness and Top-down Control : Mindfulness Program for Obese Patients in Preparation to Bariatric Surgery
Actual Study Start Date : March 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 14, 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Surgery
Obese patient without mindfulness program in parallel.
Procedure: Bariatric surgery
With mindfulness programm
Procedure: Bariatric surgery
Without mindfulness programm
Active Comparator: Surgery with mindfulness program
Obese patient following a mindfulness program in parallel.
Procedure: Bariatric surgery
With mindfulness programm
Procedure: Bariatric surgery
Without mindfulness programm



Primary Outcome Measures :
  1. Psychometric evaluation [ Time Frame: About 15 minutes ]
    Tool : SBC-20 - Scale of Body Connexion

  2. Psychometric evaluation [ Time Frame: About 15 minutes ]
    Tool : TAS-20 - The twenty-item Toronto Alexithymia Scale

  3. Psychometric evaluation [ Time Frame: 15 minutes ]
    Tool : BAQ-18- Body Awareness Questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients: over 18 years
  • Patients suffering from morbid obesity (BMI ≥ 40 kg/m²), or severe obesity (BMI ≥ 35 kg/m²) associate with at least a comorbidity likely to be improved by surgery
  • Patient revised in second-line after the failure of a well conducted medical treatment, nutritional, dietetic and psychotherapeutic during 6 to 12 months : absence of enough weight loss or absence of maintain of weight loss
  • Absence of any psychiatric counter-argument

Exclusion Criteria:

  • Subjects responding to inclusion criteria of the French National Authority for Health
  • Subjects without agoraphobia, or obsessive-compulsive disorder, in post-traumatic stress disorder, alcohol or drugs dependant, without psychotic disorders, major depressive disorder, or suffering from anti-social personality disorder
  • Patient registered for social security
  • Free, signed and informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02854306


Locations
France
UniversityHospitalGrenoble
La Tronche, France, 38700
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Pierre Yves Benhamou, Professor Grenoble Hospital University

Publications:
Jon-Kabat-Zinn. (2009) Au cœur de la tourmente, la pleine conscience : MBSR, la réduction du stress basée sur la mindfulness, Bruxelles, De Boeck, coll. Carrefour des Psychothérapies
Leahey T.M., Crowther J. H., Irwin S.R. (2008) A cognitive-behavioral mindfulness group therapy intervention for the treatment of binge eating in bariatric surgery patients. Cognitive and Behavioral Practice, 15(4), p.364-375.

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02854306     History of Changes
Other Study ID Numbers: 38RC12.215
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017

Keywords provided by University Hospital, Grenoble:
Bariatric surgery
Mindfulness
Obese