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

December 22, 2018 updated by: Ruffault Alexis, University of Paris 5 - Rene Descartes

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Boulogne-Billancourt, France, 92100
        • Hôpital Ambroise Paré, Assistance Publique-Hôpitaux de Paris

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness
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
Sham Comparator: Sham meditation
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
No Intervention: Treatment as usual
Usual care in a nutrition pole in France: nutrition, diet, exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in impulsive eating (TFEQ-R18 "uncontrolled eating" subscale)
Time Frame: From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.
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)
Time Frame: 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
From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.
Change in self-reported physical activity (IPAQ)
Time Frame: From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.
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
Time Frame: 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)
From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.
Change in self-reported anxiety and depression (HADS)
Time Frame: 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
From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.
Change in mindfulness skills (MAAS, AAQ-II)
Time Frame: 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
From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.
Change in daily mindful responding (DMRS)
Time Frame: 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)
From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.
Change in plasma concentration of leptin, adiponection and BDNF
Time Frame: From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.
From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.
Change in body mass index (kg/m2)
Time Frame: From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.
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
Time Frame: 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)
From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.

Other Outcome Measures

Outcome Measure
Time Frame
Compliance to the intervention (number of sessions done divided by number of session due)
Time Frame: From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.
From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Paris 5 - Rene Descartes

Collaborators

Nestlé Foundation
Hospital Ambroise Paré Paris

Investigators

  • Principal Investigator: Sébastien Czernichow, Pr, Hospital Ambroise Paré Paris
  • Study Director: Cécile Flahault, PhD, University Paris 5 - Rene Descartes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

October 2, 2015

First Submitted That Met QC Criteria

October 6, 2015

First Posted (Estimate)

October 8, 2015

Study Record Updates

Last Update Posted (Actual)

December 26, 2018

Last Update Submitted That Met QC Criteria

December 22, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA4057-mindob

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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