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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02571387
Other study ID # EA4057-mindob
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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.
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