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

Primary Purpose

Obesity, Binge-Eating Disorder

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Mindfulness-based intervention
Sham meditation
Sponsored by
University of Paris 5 - Rene Descartes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obesity focused on measuring Motivation, Impulsive eating, Mindfulness, Self-help, Physical activity, Weight-loss

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hôpital Ambroise Paré, Assistance Publique-Hôpitaux de Paris

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

Mindfulness

Sham meditation

Treatment as usual

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

Change in impulsive eating (TFEQ-R18 "uncontrolled eating" subscale)

Secondary Outcome Measures

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
Change in self-reported physical activity (IPAQ)
International Physical Activity Questionnaire short form
Change in pedometers-measured physical activity
Pedometers on a daily basis for 7 days (ref: ONWalk100)
Change in self-reported anxiety and depression (HADS)
Hospital Anxiety and Depression Scale (2 subscales): anxiety and depression
Change in mindfulness skills (MAAS, AAQ-II)
Combination of scores in Mindful Attention Awareness Scale; Acceptance and Action Questionnaire-II
Change in daily mindful responding (DMRS)
Daily Mindful Responding Scale on a daily basis for 7 days (at baseline, 6 months and 12 months)
Change in plasma concentration of leptin, adiponection and BDNF
Change in body mass index (kg/m2)
BMI as measured by a physician
Change in food intake
Dietary survey on a daily basis for 7 days (at baseline, 6 months and 12 months)

Full Information

First Posted
October 2, 2015
Last Updated
December 22, 2018
Sponsor
University of Paris 5 - Rene Descartes
Collaborators
Hospital Ambroise Paré Paris, Nestlé Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02571387
Brief Title
MindOb: A 12-month Computerized Mindfulness-based Intervention for Obese Individuals
Acronym
MindOb
Official Title
Study of the Effects of Mindfulness on Impulsive Eating, Motivation Toward Exercise, and Weight Loss in Obese Patients: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Paris 5 - Rene Descartes
Collaborators
Hospital Ambroise Paré Paris, Nestlé Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Binge-Eating Disorder
Keywords
Motivation, Impulsive eating, Mindfulness, Self-help, Physical activity, Weight-loss

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness
Arm Type
Experimental
Arm 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.
Arm Title
Sham meditation
Arm Type
Sham Comparator
Arm 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.
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Usual care in a nutrition pole in France: nutrition, diet, exercise.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based intervention
Intervention Type
Behavioral
Intervention Name(s)
Sham meditation
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
Change in motivational regulation toward exercise (BREQ-II)
Description
Behavioral Regulation in Exercise Questionnaire-II (5 subscales): amotivation, external regulation, introjected regulation, identified regulation, intrinsic regulation
Time Frame
From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.
Title
Change in self-reported physical activity (IPAQ)
Description
International Physical Activity Questionnaire short form
Time Frame
From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.
Title
Change in pedometers-measured physical activity
Description
Pedometers on a daily basis for 7 days (ref: ONWalk100)
Time Frame
From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.
Title
Change in self-reported anxiety and depression (HADS)
Description
Hospital Anxiety and Depression Scale (2 subscales): anxiety and depression
Time Frame
From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.
Title
Change in mindfulness skills (MAAS, AAQ-II)
Description
Combination of scores in Mindful Attention Awareness Scale; Acceptance and Action Questionnaire-II
Time Frame
From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.
Title
Change in daily mindful responding (DMRS)
Description
Daily Mindful Responding Scale on a daily basis for 7 days (at baseline, 6 months and 12 months)
Time Frame
From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.
Title
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.
Title
Change in body mass index (kg/m2)
Description
BMI as measured by a physician
Time Frame
From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.
Title
Change in food intake
Description
Dietary survey on a daily basis for 7 days (at baseline, 6 months and 12 months)
Time Frame
From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.
Other Pre-specified Outcome Measures:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sébastien Czernichow, Pr
Organizational Affiliation
Hospital Ambroise Paré Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cécile Flahault, PhD
Organizational Affiliation
University Paris 5 - Rene Descartes
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Ambroise Paré, Assistance Publique-Hôpitaux de Paris
City
Boulogne-Billancourt
ZIP/Postal Code
92100
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27370231
Citation
Ruffault A, Carette C, Lurbe I Puerto K, Juge N, Beauchet A, Benoliel JJ, Lacorte JM, Fournier JF, Czernichow S, Flahault C. Randomized controlled trial of a 12-month computerized mindfulness-based intervention for obese patients with binge eating disorder: The MindOb study protocol. Contemp Clin Trials. 2016 Jul;49:126-33. doi: 10.1016/j.cct.2016.06.012. Epub 2016 Jun 29.
Results Reference
derived
Links:
URL
http://recherche.parisdescartes.fr/LPPS_esl/Membres/Doctorants/Alexis-Ruffault
Description
Academic webpage of the PhD candidate running the study

Learn more about this trial

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

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