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ObesityOBéMONCT05131256

fMRI Study of Emotion Regulation in Patients Suffering From Obesity With or Without Binge Eating Disorder and Seeking Bariatric Surgery

A study testing Neurofunctional characterization of emotional regulation (fMRI) in people with Obesity and Binge-Eating Disorder, run by CHU de Reims at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Obesity is a major public health problem and Binge eating disorder (BED) is very frequently observed in patients considered for weight loss surgery and seems to influence their outcome critically. Literature highlights a global emotional overload in individuals with BED, but few are known on the mechanisms involved. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Binge-Eating Disorder
What is being tested?
Neurofunctional characterization of emotional regulation (fMRI)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteFrance
Study dates
20 Jul 2022to 20 Jul 2025
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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Patients between 18 and 60 years old, men or women, right-handed
  • Having a diagnosis of obesity class 2 or 3 and seeking bariatric surgery
  • With Binge eating disorder (BED)
  • Possibility to the use of MRI
  • Patients being a native French speaker
  • Patients enrolled in the national healthcare insurance program
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  • Patients consenting to participate to the study
  • Patients between 18 and 60 years old, men or women, right-handed
  • Having a diagnosis of obesity class 2 or 3 and seeking bariatric surgery
  • Without Binge eating disorder (BED)
  • Possibility to the use of MRI
  • Patients being a native French speaker
  • Patients enrolled in the national healthcare insurance program
  • Patients consenting to participate to the study
  • Men or women, right-handed, between 18 and 60 years old
  • Without overweight nor obesity
  • Native French speaker
  • Individuals enrolled in the national healthcare insurance program
  • Individuals consenting to participate to the study

Who cannot join

  • The presence of a current substance use disorder as defined by DSM-5 criteria
  • The presence of neurological disorders or head trauma
  • The presence of any intellectual disability, of pervasive developmental disorders or learning difficulties (especially of dysphasia and dyspraxia)
  • A current mood episode as defined by DSM-5 criteria
  • A diagnosis of schizophrenia or of bipolar disorder according to DSM-5 criteria
  • Handling of psychotropics substances
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  • A sensorial impairment uncorrected (visual and/or hearing)
  • Contraindication to the use of MRI
  • Pregnant woman and people particularly protected by the law
  • Group 2: Patients suffering from obesity, seeking bariatric surgery, and without BED.
  • The presence of a current substance use disorder as defined by DSM-5 criteria
  • The presence of neurological disorders or head trauma
  • The presence of any intellectual disability, of pervasive developmental disorders or learning difficulties (especially of dysphasia and dyspraxia)
  • A current mood episode as defined by DSM-5 criteria
  • A diagnosis of schizophrenia or of bipolar disorder according to DSM-5 criteria
  • Handling of psychotropics substances
  • A sensorial impairment uncorrected (visual and/or hearing)
  • Contraindication to the use of MRI
  • Pregnant woman and people particularly protected by the law
  • Group 3: Healthy participants.
  • Past obesity
  • The presence of neurological disorders or head trauma
  • The presence of any intellectual disability, of pervasive developmental disorders or learning difficulties (especially of dysphasia and dyspraxia)
  • Handling of psychotropics substances
  • A sensorial impairment uncorrected (visual and/or hearing)
  • Contraindication to the use of MRI
  • Pregnant woman and people particularly protected by the law
  • A current mood episode as defined by DSM-5 criteria
  • A diagnosis of schizophrenia or of bipolar disorder according to DSM-5 criteria
  • The presence of a current substance use disorder as defined by DSM-5 criteria
  • A diagnosis of eating disorder as defined by DSM-5 criteria

Trial locations and contacts

1 site in 1 country.

France1 site, 1 recruiting
  • Damien JOLLY

    Reims

    Farid BENZEROUK, 03 26 78 33 94 ext. 0033, fbenzerouk@chu-reims.fr

    Recruiting

Other trials in France

About this study

Official title: Neurofunctional Characterization of Emotional Regulation and Its Links With the Eating Behaviour of Patients Suffering From Obesity, With or Without Binge Eating Disorder and Seeking Bariatric Surgery. Pilot Study

Obesity is a major public health problem and Binge eating disorder (BED) is very frequently observed in patients considered for weight loss surgery and seems to influence their outcome critically. Literature highlights a global emotional overload in individuals with BED, but few are known on the mechanisms involved. The purpose of this study is to fill this gap by comparing the neurofunctional profiles of emotion regulation between patients suffering from obesity, with or without BED and healthy participants during the performance of emotion regulation tasks. Results may help to understand the neural bases of the impairments observed in patients with obesity, with or without BED, which may in turn help to propose, in the long term, potential new therapeutic approaches.

Read the detailed description

Obesity is a major public health problem and frequently associated with Binge eating disorder (BED) in patients considered for weight loss surgery and seems to influence their outcome critically. It may be due, in part, to an ineffective or a maladaptive emotional regulation. Emotion regulation is the ability to exert control over one's own emotional state. The relative absence of this ability would indicate the presence of difficulties in emotion regulation, or an emotion dysregulation. Individuals with disordered eating may have a greater vulnerability to use maladaptive emotion regulation strategies. In the eating behaviours, an emotion dysregulation can cause weight gain that can lead to overweight or obesity. Accordingly, patients suffering from obesity, and with BED may have a greater vulnerability to use maladaptive emotion regulation strategies. However, few studies have investigated the neurofunctional profiles of emotion regulation in patients suffering from obesity with and without BED and seeking bariatric surgery.

The aim of the study is to explore the neural correlates of emotion regulation in patients suffering from obesity, with or without BED, in comparison with those of healthy participants. We also aim to describe the relationship between the neural correlates, eating behaviours and assessed psychological profiles.

Being tested
Neurofunctional characterization of emotional regulation (fMRI)
Keywords
Obesity, Emotion, fMRI, Emotion regulation, Binge eating disorder
Medical subject headings
Obesity, Binge-Eating Disorder, Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neurofunctional characterization of emotional regulation (fMRI)Behavioural

    Investigation of neurofunctional characterization of emotional regulation and its links with the eating behaviours of patients suffering from obesity using a comprehensive, clinical, and cognitive assessment and task-based MRI exams.

Study groups in NCT05131256
Study groupRoleWhat they receive
patients suffering from obesity with BEDExperimentalNot described
Receives: Behavioral: Neurofunctional characterization of emotional regulation (fMRI)
patients suffering from obesity without BEDActive comparatorNot described
Receives: Behavioral: Neurofunctional characterization of emotional regulation (fMRI)
healthy participantsActive comparatorNot described
Receives: Behavioral: Neurofunctional characterization of emotional regulation (fMRI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. fMRI activations during an emotional regulation task (a cognitive reappraisal task)

    The participant either reappraises or passively watches negative or neutral pictures and rates his affect (visual analogue scale: 0 to 10, high scores mean negative feelings).

    Measured: Day 0

  2. fMRI activations during the inhibition of an ongoing motor response under an emotional condition (emotional stop signal task)

    The participant is presented with a series of images comprised of neutral, positive, and negative categories and is instructed to categorize the images according to their valence (Go trials). Some trials include a stop signal indicating that the participant should inhibit his behavioral response and associated emotional reaction (Stop trials).

    Measured: Day 0

  3. fMRI activations during the performance of an emotion regulation task (an emotional Stroop task)

    The participant is asked to count how many numbers are presented on the screen. Numbers may match the value of the number (congruent condition) or not (incongruent condition). The numbers are preceded by emotional stimuli (negative, positive, neutral). The participant also views the emotional stimuli pictures without counting numbers (view condition).

    Measured: Day 0

Secondary outcomes (7)
  1. Description of eating behaviours: Binge eating

    The Binge Eating Scale (BES) is a 16-item self-administered questionnaire used to assess the presence of binge eating behavior indicative of an eating disorder. Eight items describe behavioral manifestations (for example, eating fast or consuming large amounts of food) and eight items on associated feelings and cognitions (for example, fear of not stopping eating). Each item has a response range from 0 to 3 points (0 = no severity of the BES symptoms, 3 = serious problems on the BES symptoms). Marcus et al. (1988) created a range of scores for the BES from 0 to 46 points: a score of less than 17 points indicates minimal binge eating (BE) problems; a score between 18 and 26 points indicates moderate BE problems, and a score of more than 27 points indicates severe BE problems. We consider binge eating as a categorical variable (significant binge eating if BES score ≥18).

    Measured: Day 0

  2. Description of eating behaviours: Emotional eating, external eating, restraint eating

    The Dutch Eating Behavior Questionnaire (DEBQ) is administered using the French version to assess three components of eating behavior: emotional, external, and restrained eating. It is a self-report measure that contains 33 items. Thirteen items assess emotional eating, 10 items assess external eating, and 10 items assess restrained eating. Each item is rated on a 5-point Likert scale. Higher scores on each dimension mean worse eating behaviors.

    Measured: Day 0

  3. Description of eating behaviours: Bulimic symptomatology

    The Bulimic Investigatory Test, Edinburgh (BITE) is a self-report questionnaire used to evaluate the presence and severity of bulimic symptomatology. It is composed of 33 items divided into two different subscales: a symptom subscale (30 items) and a severity subscale (3 items). Henderson and Freeman (1987) considered a BITE score under 10 points as indicative of no problem with eating behavior, a score between 10 and 20 points as indicative of abnormal eating patterns (from 15 to 20 points warns us of the presence of a possible subthreshold bulimia nervosa), and a score higher than 20 points constitutes altered eating patterns with a possible bulimia nervosa.

    Measured: Day 0

  4. Description of psychological profiles (emotional, cognitive and personality): Emotion regulation

    The Difficulty in Emotion Regulation Scale (DERS) is a 36-item self-report questionnaire. It assesses six different aspects of emotional regulation including non-acceptance of emotional responses (Non-Acceptance), difficulty engaging in goal-directed behavior (Goals), impulse control difficulties (Impulse), lack of emotional awareness (Awareness), limited access to emotional regulation strategies (Strategies), and lack of emotional clarity (Clarity). Higher scores on each dimension indicate greater emotion dysregulation symptoms.

    Measured: Day 0

  5. Description of psychological profiles (emotional, cognitive and personality): Depression severity

    Depression severity is assessed with the shortened Beck Depression Inventory (BDI). This is a widely used self-report scale consisting of 13 items, which has been validated in French. The total score is obtained by adding the scores of the 13 items and ranges from 0 to 39, with higher scores indicating greater depression symptoms.

    Measured: Day 0

  6. Description of psychological profiles (emotional, cognitive and personality): Anxiety severity

    Anxiety severity is assessed with the Spielberger State-Trait Inventory (STAI) which is a 40-item scale, using a 4-point Likert scale for each item. This scale was used to measure both trait anxiety (how dispositionally anxious a person is across time and situations) and state anxiety (how anxious a person is feeling at a particular moment). Higher scores indicate greater anxiety symptoms.

    Measured: Day 0

  7. Description of psychological profiles (emotional, cognitive and personality): Impulsivity

    We use the UPPS-P Impulsive Behavior Scale to assess the facets of impulsivity, i.e., Negative Urgency, Positive Urgency, (lack of) Premeditation, (lack of) Perseverance, and Sensation Seeking. This shortened version (20 items) has 4 items per scale, and each item is responded to on a 4-point Likert-type scale. Higher scores on each scale indicate greater impulsivity symptoms. This self-report scale has received endorsement from the National Institutes of Health's (NIH) PhenX Toolkit as the recommended self-report measure of impulsigenic traits.

    Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2021
  2. Study start20 Jul 2022
  3. Primary completion20 Jul 2025 (estimated)
  4. Study completion20 Jul 2025 (estimated)

Resources

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
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05131256
Sponsor's protocol ID
PJ20148
Acronym
OBéMO
Status last verified
Jul 2022
First submitted
3 Aug 2021
Last updated
26 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Neurofunctional characterization of emotional regulation (fMRI) in people with Obesity and Binge-Eating Disorder, run by CHU de Reims 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 19 inclusion and 31 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 Jul 2022. 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. 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?

Contact Farid BENZEROUK (03 26 78 33 94 ext. 0033, fbenzerouk@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

fMRI activations during an emotional regulation task (a cognitive reappraisal task) (time frame: Day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 Jul 2022.

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