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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
50
Hôpital Ambroise Paré, Assistance Publique-Hôpitaux de Paris
Boulogne-Billancourt, France
Change in impulsive eating (TFEQ-R18 "uncontrolled eating" subscale)
Time frame: From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.
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
Time frame: From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.
Change in self-reported physical activity (IPAQ)
International Physical Activity Questionnaire short form
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.
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Change in daily mindful responding (DMRS)
Daily Mindful Responding Scale on a daily basis for 7 days (at baseline, 6 months and 12 months)
Time frame: From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.
Change in plasma concentration of leptin, adiponection and BDNF
Time frame: 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
Time frame: 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)
Time frame: From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.