Binge-Eating Disorder, Obesity
Conditions
Keywords
Motivation, Impulsive eating, Mindfulness, Self-help, Physical activity, Weight-loss
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.
Interventions
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in motivational regulation toward exercise (BREQ-II) | From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months. | Behavioral Regulation in Exercise Questionnaire-II (5 subscales): amotivation, external regulation, introjected regulation, identified regulation, intrinsic regulation |
| Change in self-reported physical activity (IPAQ) | From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months. | International Physical Activity Questionnaire short form |
| Change in pedometers-measured physical activity | From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months. | Pedometers on a daily basis for 7 days (ref: ONWalk100) |
| Change in self-reported anxiety and depression (HADS) | From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months. | Hospital Anxiety and Depression Scale (2 subscales): anxiety and depression |
| Change in daily mindful responding (DMRS) | From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months. | Daily Mindful Responding Scale on a daily basis for 7 days (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) | From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months. | BMI as measured by a physician |
| Change in food intake | From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months. | Dietary survey on a daily basis for 7 days (at baseline, 6 months and 12 months) |
| Change in mindfulness skills (MAAS, AAQ-II) | From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months. | Combination of scores in Mindful Attention Awareness Scale; Acceptance and Action Questionnaire-II |
Other
| Measure | 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. |
Countries
France