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

University of Paris 5 - Rene Descartes

Status: Unknown

Conditions: Binge-Eating Disorder; Obesity

Treatments: Behavioral: Sham meditation; Behavioral: Mindfulness-based intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02571387

EA4057-mindob

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

Mindfulness

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness-based intervention

Sham meditation

Sham Comparator group

Description:

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:

Behavioral: Sham meditation

Treatment as usual

No Intervention group

Description:

Usual care in a nutrition pole in France: nutrition, diet, exercise.