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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Paris 5 - Rene Descartes

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nestlé Foundation
Hospital Ambroise Paré Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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