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

Obesity Clinical Trial

— MindOb  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02571387
• Other study ID #: EA4057-mindob
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2016
• Est. completion date: October 2019

Study information

• Verified date: December 2018
• Source: University of Paris 5 - Rene Descartes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

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

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Bulimia
• Feeding and Eating Disorders
• Obesity

Intervention

Behavioral:
• Mindfulness-based intervention

• Sham meditation

Locations

Country	Name	City	State
France	Hôpital Ambroise Paré, Assistance Publique-Hôpitaux de Paris	Boulogne-Billancourt

Sponsors (3)

Lead Sponsor	Collaborator
University of Paris 5 - Rene Descartes	Hospital Ambroise Paré Paris, Nestlé Foundation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Change in plasma concentration of leptin, adiponection and BDNF		From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.
Secondary	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.
Secondary	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.

External Links

•   Academic webpage of the PhD candidate running the study