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Mindfulness in Preparation to Bariatric Surgery (PConscience)

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2016 by University Hospital, Grenoble
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT02854306
First received: July 13, 2016
Last updated: July 29, 2016
Last verified: July 2016
  Purpose

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 Intervention
Obesity Procedure: Bariatric surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

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

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

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


Estimated Enrollment: 100
Study Start Date: March 2013
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02854306

Contacts
Contact: Pierre Yves Benhamou, Professor 04 76 76 55 09 PYBenhamou@chu-grenoble.fr
Contact: Jacqueline Hubert 04 76 76 59 52 jhubert@chu-grenoble.fr

Locations
France
UniversityHospitalGrenoble Recruiting
La Tronche, France, 38700
Contact: Benhamou, Professor    04 76 76 55 09    PYBenhamou@chu-grenoble.fr   
Contact: Jacqueline Hubert    04 76 76 59 52    jhubert@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Pierre Yves Benhamou, Professor Grenoble Hospital University
  More Information

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
Study First Received: July 13, 2016
Last Updated: July 29, 2016

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

ClinicalTrials.gov processed this record on July 26, 2017