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OpenTrials
Completed

NCT Number: NCT02854306

Mindfulness in Preparation to Bariatric Surgery

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UniversityHospitalGrenoble

La Tronche, 38700, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bariatric surgery

Procedure

With mindfulness programm

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Psycho-sensorial Mindfulness and Top-down Control : Mindfulness Program for Obese Patients in Preparation to Bariatric Surgery

Acronym: PConscience

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 3, 2016
Registry last updated
Dec 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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