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| Name | Class |
|---|---|
| Hospital Ambroise Paré Paris | OTHER |
| Nestlé Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness | Experimental | 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. |
|
| Sham meditation | Sham Comparator | 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. |
|
| Treatment as usual | No Intervention | Usual care in a nutrition pole in France: nutrition, diet, exercise. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-based intervention | Behavioral |
| ||
| Sham meditation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in impulsive eating (TFEQ-R18 "uncontrolled eating" subscale) | From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in motivational regulation toward exercise (BREQ-II) | Behavioral Regulation in Exercise Questionnaire-II (5 subscales): amotivation, external regulation, introjected regulation, identified regulation, intrinsic regulation | From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance to the intervention (number of sessions done divided by number of session due) | From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sébastien Czernichow, Pr | Hospital Ambroise Paré Paris | Principal Investigator |
| Cécile Flahault, PhD | University Paris 5 - Rene Descartes | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Ambroise Paré, Assistance Publique-Hôpitaux de Paris | Boulogne-Billancourt | 92100 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27370231 | Derived | 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. |
| Label | URL |
|---|---|
| Academic webpage of the PhD candidate running the study | View source |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D056912 | Binge-Eating Disorder |
| D009043 | Motor Activity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Change in self-reported physical activity (IPAQ) |
International Physical Activity Questionnaire short form |
| From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months. |
| Change in pedometers-measured physical activity | Pedometers on a daily basis for 7 days (ref: ONWalk100) | From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months. |
| Change in self-reported anxiety and depression (HADS) | Hospital Anxiety and Depression Scale (2 subscales): anxiety and depression | From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months. |
| Change in mindfulness skills (MAAS, AAQ-II) | Combination of scores in Mindful Attention Awareness Scale; Acceptance and Action Questionnaire-II | From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months. |
| Change in daily mindful responding (DMRS) | Daily Mindful Responding Scale on a daily basis for 7 days (at baseline, 6 months and 12 months) | From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months. |
| Change in plasma concentration of leptin, adiponection and BDNF | From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months. |
| Change in body mass index (kg/m2) | BMI as measured by a physician | From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months. |
| Change in food intake | Dietary survey on a daily basis for 7 days (at baseline, 6 months and 12 months) | From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
| D001836 | Body Weight Changes |