MindOb: A 12-month Computerized Mindfulness-based Intervention for Obese Individuals
NCT ID: NCT02571387
Last Updated: 2018-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2016-05-31
2019-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Mindfulness
Computerized mindfulness-based intervention. 10 minutes per day, every day for 12 months of MP3 listening. Guidelines are in line with main mindfulness-based interventions (MBSR, MBCT, ACT). Participants can choose between 4 audio recordings (sessions): awareness of the breathing, awareness of postures and bodily sensations, acceptance of thoughts and emotions, and awareness of bodily sensations and related thoughts and emotions while executing 5 squats.
Mindfulness-based intervention
Sham meditation
Computerized sham meditation intervention. 10 minutes per day, every day for 12 months of MP3 listening. The unique guideline is to "meditate" at the beginning of each session. Participants can choose between 4 audio backgrounds: forest, night, beach, and river.
Sham meditation
Treatment as usual
Usual care in a nutrition pole in France: nutrition, diet, exercise.
No interventions assigned to this group
Interventions
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Mindfulness-based intervention
Sham meditation
Eligibility Criteria
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Inclusion Criteria
* Obese (BMI \>= 30)
* Recruited from the nutrition pole of Ambroise Paré Hospital
* Diagnosed with Binge-Eating Disorder (BED) according to DSM5 criteria
* Informed consent provided during inclusion interview
Exclusion Criteria
* Bariatric surgery patients (except for gastric band removed at least 3 years before)
* Planned bariatric surgery
* Central obese (genetic)
* Pregnant women
* No internet access at home
* Difficulties to understand French language
* Patients under social protection
* Cognitive dysfunctions in understanding simple guidelines provided by the paramedical staff (e.g., diet or exercise guidelines)
* Auditory disorders not allowing to hear audio files
* Blurred vision not allowing to use Internet
18 Years
65 Years
ALL
No
Sponsors
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Hospital Ambroise Paré Paris
OTHER
Nestlé Foundation
OTHER
University of Paris 5 - Rene Descartes
OTHER
Responsible Party
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Ruffault Alexis
Doctoral candidate
Principal Investigators
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Sébastien Czernichow, Pr
Role: PRINCIPAL_INVESTIGATOR
Hospital Ambroise Paré Paris
Cécile Flahault, PhD
Role: STUDY_DIRECTOR
University Paris 5 - Rene Descartes
Locations
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Hôpital Ambroise Paré, Assistance Publique-Hôpitaux de Paris
Boulogne-Billancourt, , France
Countries
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References
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Ruffault A, Carette C, Lurbe I Puerto K, Juge N, Beauchet A, Benoliel JJ, Lacorte JM, Fournier JF, Czernichow S, Flahault C. Randomized controlled trial of a 12-month computerized mindfulness-based intervention for obese patients with binge eating disorder: The MindOb study protocol. Contemp Clin Trials. 2016 Jul;49:126-33. doi: 10.1016/j.cct.2016.06.012. Epub 2016 Jun 29.
Related Links
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Academic webpage of the PhD candidate running the study
Other Identifiers
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EA4057-mindob
Identifier Type: -
Identifier Source: org_study_id