NCT02854306

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
Last Updated

December 26, 2017

Status Verified

December 1, 2017

Enrollment Period

1.7 years

First QC Date

July 13, 2016

Last Update Submit

December 22, 2017

Conditions

Obesity

Keywords

Bariatric surgeryMindfulnessObese

Outcome Measures

Primary Outcomes (3)

  • Psychometric evaluation

    Tool : SBC-20 - Scale of Body Connexion

    About 15 minutes

  • Psychometric evaluation

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

    About 15 minutes

  • Psychometric evaluation

    Tool : BAQ-18- Body Awareness Questionnaire

    15 minutes

Study Arms (2)

Surgery

ACTIVE COMPARATOR

Obese patient without mindfulness program in parallel.

Procedure: Bariatric surgery

Surgery with mindfulness program

ACTIVE COMPARATOR

Obese patient following a mindfulness program in parallel.

Procedure: Bariatric surgery

Interventions

Bariatric surgeryPROCEDURE

With mindfulness programm

SurgerySurgery with mindfulness program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UniversityHospitalGrenoble

La Tronche, 38700, France

Location

Related Publications (20)

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    PMID: 12924747BACKGROUND

  • 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.

    PMID: 19260167BACKGROUND

  • 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.

    PMID: 1891520BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 15256293BACKGROUND

  • 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.

    PMID: 21802619BACKGROUND

  • 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.

    PMID: 10215292BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 23000783BACKGROUND

  • 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.

    PMID: 18329323BACKGROUND

  • 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.

    PMID: 20399590BACKGROUND

  • 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.

    PMID: 11691682BACKGROUND

  • 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.

    PMID: 16782231BACKGROUND

  • 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.

    PMID: 18387018BACKGROUND

  • 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.

    PMID: 22119181BACKGROUND

  • 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.

    PMID: 6375397BACKGROUND

  • 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.

    PMID: 16242809BACKGROUND

  • 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.

    PMID: 12711268BACKGROUND

  • 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.

    PMID: 24331170BACKGROUND

  • 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.

    PMID: 10445865BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Pierre Yves Benhamou, Professor

    Grenoble Hospital University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2016

First Posted

August 3, 2016

Study Start

March 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 14, 2014

Last Updated

December 26, 2017

Record last verified: 2017-12

Locations

FR(1)