Clincosm LogoSign in Get a demo

PConscience: Mindfulness in Preparation to Bariatric Surgery

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Completed
CT.gov ID
NCT02854306
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
20.5
Actual Duration (Months)
4.9
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: Bariatric surgery
  • Procedure: Bariatric surgery
 N/A

Study Design

Study Type:
Interventional
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 :
Mar 1, 2013
Actual Primary Completion Date :
Nov 1, 2014
Actual Study Completion Date :
Nov 14, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Psychometric evaluation [About 15 minutes]

    Tool : SBC-20 - Scale of Body Connexion

  2. Psychometric evaluation [About 15 minutes]

    Tool : TAS-20 - The twenty-item Toronto Alexithymia Scale

  3. Psychometric evaluation [15 minutes]

    Tool : BAQ-18- Body Awareness Questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 UniversityHospitalGrenoble La Tronche France 38700

Sponsors and Collaborators

  • University Hospital, Grenoble

Investigators

  • Principal Investigator: Pierre Yves Benhamou, Professor, Grenoble Hospital University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT02854306
Other Study ID Numbers:
  • 38RC12.215
First Posted:
Aug 3, 2016
Last Update Posted:
Dec 26, 2017
Last Verified:
Dec 1, 2017
Keywords provided by University Hospital, Grenoble
Bariatric surgery
Mindfulness
Obese

Study Results

No Results Posted as of Dec 26, 2017