Clinical trial NCT02854306: Mindfulness in Preparation to Bariatric Surgery
Official title: Psycho-sensorial Mindfulness and Top-down Control : Mindfulness Program for Obese Patients in Preparation to Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Bariatric surgery
Mindfulness
Obese
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Psychometric evaluation
timeFrame: About 15 minutes
measure: Psychometric evaluation
timeFrame: About 15 minutes
measure: Psychometric evaluation
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: La Tronche
country: France
facility: UniversityHospitalGrenoble
Study officials:
affiliation: Grenoble Hospital University
name: Pierre Yves Benhamou, Professor
role: PRINCIPAL_INVESTIGATOR
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