ObesityMindObNCT02571387
MindOb: A 12-month Computerized Mindfulness-based Intervention for Obese Individuals
A study testing Mindfulness-based intervention in people with Obesity and Binge-Eating Disorder, run by University of Paris 5 - Rene Descartes at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Binge-Eating Disorder
- What is being tested?
- Mindfulness-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- May 2016to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Ambroise Paré, Assistance Publique-Hôpitaux de Paris
Boulogne-Billancourt, 92100
About this study
Official title: 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.
- Conditions
- Obesity, Binge-Eating Disorder
- Being tested
- Mindfulness-based intervention, Sham meditation
- Keywords
- Motivation, Impulsive eating, Mindfulness, Self-help, Physical activity, Weight-loss
- Medical subject headings
- Obesity, Binge-Eating Disorder, Motor Activity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based interventionBehavioural
Sham meditationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness | Experimental | 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. Receives: Behavioral: Mindfulness-based intervention |
| Sham meditation | Sham comparator | 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. Receives: Behavioral: Sham meditation |
| Treatment as usual | No intervention | Usual care in a nutrition pole in France: nutrition, diet, exercise. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in impulsive eating (TFEQ-R18 "uncontrolled eating" subscale)
Measured: From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.
Secondary outcomes (9)
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
Measured: From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.
Change in self-reported physical activity (IPAQ)
International Physical Activity Questionnaire short form
Measured: From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.
Change in pedometers-measured physical activity
Pedometers on a daily basis for 7 days (ref: ONWalk100)
Measured: From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.
Change in self-reported anxiety and depression (HADS)
Hospital Anxiety and Depression Scale (2 subscales): anxiety and depression
Measured: From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.
Change in mindfulness skills (MAAS, AAQ-II)
Combination of scores in Mindful Attention Awareness Scale; Acceptance and Action Questionnaire-II
Measured: From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.
Change in daily mindful responding (DMRS)
Daily Mindful Responding Scale on a daily basis for 7 days (at baseline, 6 months and 12 months)
Measured: From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.
Change in plasma concentration of leptin, adiponection and BDNF
Measured: From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.
Change in body mass index (kg/m2)
BMI as measured by a physician
Measured: From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.
Change in food intake
Dietary survey on a daily basis for 7 days (at baseline, 6 months and 12 months)
Measured: From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startMay 2016
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Paris 5 - Rene Descartes
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Ambroise Paré Paris, Nestlé Foundation
- Responsible party
- Principal investigator, Ruffault Alexis, University of Paris 5 - Rene Descartes
- Investigators
- Sébastien Czernichow, Pr, Principal investigator, Hospital Ambroise Paré ParisCécile Flahault, PhD, Study director, University Paris 5 - Rene Descartes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571387
- Sponsor's protocol ID
- EA4057-mindob
- Acronym
- MindOb
- Status last verified
- Dec 2018
- First submitted
- 2 Oct 2015
- Last updated
- 26 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 27370231
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects of Mindfulness on Impulsive Eating, Motivation Toward Exercise, and Weight Loss in Obese Patients: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02571387
- Acronym / sponsor ID
- MindOb / EA4057-mindob
- Conditions
- Obesity, Binge-Eating Disorder
- Keywords
- Motivation, Impulsive eating, Mindfulness, Self-help, Physical activity, Weight-loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Paris 5 - Rene DescartesUniversity, hospital or other
- Collaborators
- Hospital Ambroise Paré Paris, Nestlé Foundation
- Study start
- May 2016
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 8 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Behavioral: Mindfulness-based interventionComputerized 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. |
| Sham meditation | Sham comparator | Behavioral: Sham meditationComputerized 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. |
| Treatment as usual | No intervention | –Usual care in a nutrition pole in France: nutrition, diet, exercise. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based intervention | Behavioural | Mindfulness |
| Sham meditation | Behavioural | Sham meditation |
Primary outcome
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.
9 secondary outcomes
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.
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.
Change in pedometers-measured physical activity
Time frame: 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.
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.
Change in daily mindful responding (DMRS)
Time frame: 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.
Change in body mass index (kg/m2)
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2018.
- Derived from this study: PubMed 27370231Ruffault 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.
- Academic webpage of the PhD candidate running the studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sébastien Czernichow, Pr principal investigator
Hospital Ambroise Paré Paris
Cécile Flahault, PhD study director
University Paris 5 - Rene Descartes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based intervention in people with Obesity and Binge-Eating Disorder, run by University of Paris 5 - Rene Descartes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02571387, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2018; AzTrials last refreshed its copy on 28 Oct 2026.