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Mindfulness in Preparation to Bariatric Surgery (PConscience)

Grenoble Alpes University Hospital Center (CHU) logo

Grenoble Alpes University Hospital Center (CHU)

Status

Completed

Conditions

Obesity

Treatments

Procedure: Bariatric surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT02854306
38RC12.215

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Surgery
Active Comparator group
Description:
Obese patient without mindfulness program in parallel.
Treatment:
Procedure: Bariatric surgery
Procedure: Bariatric surgery
Surgery with mindfulness program
Active Comparator group
Description:
Obese patient following a mindfulness program in parallel.
Treatment:
Procedure: Bariatric surgery
Procedure: Bariatric surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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