MindOb: A 12-month Computerized Mindfulness-based Intervention for Obese Individuals

Study Overview
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Brief Summary
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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.

Official Title
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Study of the Effects of Mindfulness on Impulsive Eating, Motivation Toward Exercise, and Weight Loss in Obese Patients: Randomized Controlled Trial

Conditions
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Obesity, Binge-Eating Disorder

Intervention / Treatment
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* Behavioral: Mindfulness-based intervention
* Behavioral: Sham meditation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness<br>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. | Behavioral: Mindfulness-based intervention<br> <br> |
| Sham Comparator: Sham meditation<br>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. | Behavioral: Sham meditation<br> <br> |
| No Intervention: Treatment as usual<br>Usual care in a nutrition pole in France: nutrition, diet, exercise. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Motivation, Impulsive eating, Mindfulness, Self-help, Physical activity, Weight-loss