Clinical trial NCT02571387: MindOb: A 12-month Computerized Mindfulness-based Intervention for Obese Individuals
Official title: Study of the Effects of Mindfulness on Impulsive Eating, Motivation Toward Exercise, and Weight Loss in Obese Patients: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Binge-Eating Disorder
Keywords: Motivation
Impulsive eating
Mindfulness
Self-help
Physical activity
Weight-loss
Lead sponsor: University of Paris 5 - Rene Descartes
Sponsor class: OTHER
Collaborators: name: Hospital Ambroise Paré Paris
name: Nestlé Foundation
First posted: 2015-10-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the efficacy of a daily 12-month computerized mindfulness-based intervention in obese patients diagnosed with Binge Eating Disorder (BED) on: impulsive eating, motivation toward exercise, and weight loss.


Eligibility criteria: Inclusion Criteria:

* Adult aged between 18 and 65 years
* 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:

* Already participating in a clinical trial
* 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

Primary outcomes:
measure: Change in impulsive eating (TFEQ-R18 "uncontrolled eating" subscale)
timeFrame: From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.
Secondary outcomes:
measure: Change in motivational regulation toward exercise (BREQ-II)
timeFrame: From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.
measure: Change in self-reported physical activity (IPAQ)
timeFrame: From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.
measure: Change in pedometers-measured physical activity
timeFrame: From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.
measure: Change in self-reported anxiety and depression (HADS)
timeFrame: From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.
measure: Change in mindfulness skills (MAAS, AAQ-II)
timeFrame: From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.
measure: Change in daily mindful responding (DMRS)
timeFrame: From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.
measure: Change in plasma concentration of leptin, adiponection and BDNF
timeFrame: From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.
measure: Change in body mass index (kg/m2)
timeFrame: From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.
measure: Change in food intake
timeFrame: From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.
Other outcomes:
measure: Compliance to the intervention (number of sessions done divided by number of session due)
timeFrame: From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.
Locations:
city: Boulogne-Billancourt
country: France
facility: Hôpital Ambroise Paré, Assistance Publique-Hôpitaux de Paris
Study officials:
affiliation: Hospital Ambroise Paré Paris
name: Sébastien Czernichow, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Paris 5 - Rene Descartes
name: Cécile Flahault, PhD
role: STUDY_DIRECTOR
References:
citation: 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.