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CompletedNCT02854306PConscienceUpdated Dec 26, 2017

Mindfulness in Preparation to Bariatric Surgery

An interventional study of Bariatric surgery and Bariatric surgery in Obesity, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-26.

Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 years 4 months after the study started (first participant enrolled Mar 2013, registered Jul 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity

Keywords

  • Bariatric surgery
  • Mindfulness
  • Obese
03

In context

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    Surgery

    Obese patient without mindfulness program in parallel.

    Procedure: Bariatric surgery

  • Active comparator
    Surgery with mindfulness program

    Obese patient following a mindfulness program in parallel.

    Procedure: Bariatric surgery

Interventions

  • ProcedureBariatric surgery

    With mindfulness programm

  • ProcedureBariatric surgery

    Without mindfulness programm

06

What researchers measure

Primary outcomes

  1. Psychometric evaluation

    Tool : SBC-20 - Scale of Body Connexion

    Time frame: About 15 minutes

  2. Psychometric evaluation

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

    Time frame: About 15 minutes

  3. Psychometric evaluation

    Tool : BAQ-18- Body Awareness Questionnaire

    Time frame: 15 minutes

07

Study locations

1 site
  • UniversityHospitalGrenoble
    La Tronche, 38700, France
08

References and documents

Publications

  • Breslin KT, Reed MR, Malone SB. An holistic approach to substance abuse treatment. J Psychoactive Drugs. 2003 Apr-Jun;35(2):247-51. doi: 10.1080/02791072.2003.10400006. PubMed 12924747 ↗
  • Cserjesi R, Luminet O, Poncelet AS, Lenard L. Altered executive function in obesity. Exploration of the role of affective states on cognitive abilities. Appetite. 2009 Apr;52(2):535-9. doi: 10.1016/j.appet.2009.01.003. PubMed 19260167 ↗
  • Heatherton TF, Baumeister RF. Binge eating as escape from self-awareness. Psychol Bull. 1991 Jul;110(1):86-108. doi: 10.1037/0033-2909.110.1.86. PubMed 1891520 ↗
  • 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
  • Grossman P, Niemann L, Schmidt S, Walach H. Mindfulness-based stress reduction and health benefits. A meta-analysis. J Psychosom Res. 2004 Jul;57(1):35-43. doi: 10.1016/S0022-3999(03)00573-7. PubMed 15256293 ↗
  • Keng SL, Smoski MJ, Robins CJ. Effects of mindfulness on psychological health: a review of empirical studies. Clin Psychol Rev. 2011 Aug;31(6):1041-56. doi: 10.1016/j.cpr.2011.04.006. Epub 2011 May 13. PubMed 21802619 ↗
  • Karason K, Molgaard H, Wikstrand J, Sjostrom L. Heart rate variability in obesity and the effect of weight loss. Am J Cardiol. 1999 Apr 15;83(8):1242-7. doi: 10.1016/s0002-9149(99)00066-1. PubMed 10215292 ↗
  • 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.
  • Lutz A, McFarlin DR, Perlman DM, Salomons TV, Davidson RJ. Altered anterior insula activation during anticipation and experience of painful stimuli in expert meditators. Neuroimage. 2013 Jan 1;64:538-46. doi: 10.1016/j.neuroimage.2012.09.030. Epub 2012 Sep 19. PubMed 23000783 ↗
  • Lutz A, Slagter HA, Dunne JD, Davidson RJ. Attention regulation and monitoring in meditation. Trends Cogn Sci. 2008 Apr;12(4):163-9. doi: 10.1016/j.tics.2008.01.005. Epub 2008 Mar 10. PubMed 18329323 ↗
  • Mobbs O, Crepin C, Thiery C, Golay A, Van der Linden M. Obesity and the four facets of impulsivity. Patient Educ Couns. 2010 Jun;79(3):372-7. doi: 10.1016/j.pec.2010.03.003. Epub 2010 Apr 18. PubMed 20399590 ↗
  • Moeller FG, Barratt ES, Dougherty DM, Schmitz JM, Swann AC. Psychiatric aspects of impulsivity. Am J Psychiatry. 2001 Nov;158(11):1783-93. doi: 10.1176/appi.ajp.158.11.1783. PubMed 11691682 ↗
  • Nederkoorn C, Smulders FT, Havermans RC, Roefs A, Jansen A. Impulsivity in obese women. Appetite. 2006 Sep;47(2):253-6. doi: 10.1016/j.appet.2006.05.008. Epub 2006 Jun 19. PubMed 16782231 ↗
  • Praissman S. Mindfulness-based stress reduction: a literature review and clinician's guide. J Am Acad Nurse Pract. 2008 Apr;20(4):212-6. doi: 10.1111/j.1745-7599.2008.00306.x. PubMed 18387018 ↗
  • Price CJ, Wells EA, Donovan DM, Rue T. Mindful awareness in body-oriented therapy as an adjunct to women's substance use disorder treatment: a pilot feasibility study. J Subst Abuse Treat. 2012 Jul;43(1):94-107. doi: 10.1016/j.jsat.2011.09.016. Epub 2011 Nov 25. PubMed 22119181 ↗
  • Taylor GJ. Alexithymia: concept, measurement, and implications for treatment. Am J Psychiatry. 1984 Jun;141(6):725-32. doi: 10.1176/ajp.141.6.725. PubMed 6375397 ↗
  • Van Strien T, Engels RC, Van Leeuwe J, Snoek HM. The Stice model of overeating: tests in clinical and non-clinical samples. Appetite. 2005 Dec;45(3):205-13. doi: 10.1016/j.appet.2005.08.004. Epub 2005 Oct 20. PubMed 16242809 ↗
  • Waller G, Babbs M, Wright F, Potterton C, Meyer C, Leung N. Somatoform dissociation in eating-disordered patients. Behav Res Ther. 2003 May;41(5):619-27. doi: 10.1016/s0005-7967(03)00019-6. PubMed 12711268 ↗
  • Weineland S, Arvidsson D, Kakoulidis TP, Dahl J. Acceptance and commitment therapy for bariatric surgery patients, a pilot RCT. Obes Res Clin Pract. 2012 Jan-Mar;6(1):e1-e90. doi: 10.1016/j.orcp.2011.04.004. PubMed 24331170 ↗
  • Wiser S, Telch CF. Dialectical behavior therapy for Binge-Eating Disorder. J Clin Psychol. 1999 Jun;55(6):755-68. doi: 10.1002/(sici)1097-4679(199906)55:63.0.co;2-r. PubMed 10445865 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02854306
Lead sponsor
University Hospital, Grenoble
Responsible party
Sponsor
First posted
Aug 3, 2016
Start date
Mar 2013
Primary completion
Nov 2014
Completion
Nov 14, 2014
Last update
Dec 26, 2017

Study contacts

Pierre Yves Benhamou, Professor
principal investigator · Grenoble Hospital University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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