Back to resultsfMRI Study of Emotion Regulation in Patients Suffering From Obesity With or Without Binge Eating Disorder and Seeking Bariatric Surgery (OBéMO)
Primary Purpose
Obesity, Binge-Eating Disorder
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neurofunctional characterization of emotional regulation (fMRI)
Sponsored by
About this trial
This is an interventional basic science trial for Obesity focused on measuring Obesity, Emotion, fMRI, Emotion regulation, Binge eating disorder
Eligibility Criteria
Group 1: Patients suffering from obesity, seeking bariatric surgery, and with BED.
Inclusion criteria:
- 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
- Patients consenting to participate to the study
Exclusion criteria:
- 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 2: Patients suffering from obesity, seeking bariatric surgery, and without BED.
Inclusion criteria:
- 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
Exclusion criteria:
- 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.
Inclusion criteria:
- 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
Exclusion criteria:
- 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
Sites / Locations
- Damien JOLLYRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
patients suffering from obesity with BED
patients suffering from obesity without BED
healthy participants
Arm Description
Outcomes
Primary Outcome Measures
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).
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).
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).
Secondary Outcome Measures
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).
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05131256
Brief Title
fMRI Study of Emotion Regulation in Patients Suffering From Obesity With or Without Binge Eating Disorder and Seeking Bariatric Surgery
Acronym
OBéMO
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2022 (Actual)
Primary Completion Date
July 20, 2025 (Anticipated)
Study Completion Date
July 20, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Binge-Eating Disorder
Keywords
Obesity, Emotion, fMRI, Emotion regulation, Binge eating disorder
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients suffering from obesity with BED
Arm Type
Experimental
Arm Title
patients suffering from obesity without BED
Arm Type
Active Comparator
Arm Title
healthy participants
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Neurofunctional characterization of emotional regulation (fMRI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
fMRI activations during an emotional regulation task (a cognitive reappraisal task)
Description
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).
Time Frame
Day 0
Title
fMRI activations during the inhibition of an ongoing motor response under an emotional condition (emotional stop signal task)
Description
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).
Time Frame
Day 0
Title
fMRI activations during the performance of an emotion regulation task (an emotional Stroop task)
Description
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).
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Description of eating behaviours: Binge eating
Description
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).
Time Frame
Day 0
Title
Description of eating behaviours: Emotional eating, external eating, restraint eating
Description
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.
Time Frame
Day 0
Title
Description of eating behaviours: Bulimic symptomatology
Description
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.
Time Frame
Day 0
Title
Description of psychological profiles (emotional, cognitive and personality): Emotion regulation
Description
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.
Time Frame
Day 0
Title
Description of psychological profiles (emotional, cognitive and personality): Depression severity
Description
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.
Time Frame
Day 0
Title
Description of psychological profiles (emotional, cognitive and personality): Anxiety severity
Description
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.
Time Frame
Day 0
Title
Description of psychological profiles (emotional, cognitive and personality): Impulsivity
Description
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.
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Group 1: Patients suffering from obesity, seeking bariatric surgery, and with BED.
Inclusion criteria:
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
Patients consenting to participate to the study
Exclusion criteria:
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 2: Patients suffering from obesity, seeking bariatric surgery, and without BED.
Inclusion criteria:
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
Exclusion criteria:
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.
Inclusion criteria:
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
Exclusion criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Farid BENZEROUK
Phone
03 26 78 33 94
Ext
0033
Email
fbenzerouk@chu-reims.fr
Facility Information:
Facility Name
Damien JOLLY
City
Reims
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Farid BENZEROUK
Phone
03 26 78 33 94
Ext
0033
Email
fbenzerouk@chu-reims.fr
12. IPD Sharing Statement
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fMRI Study of Emotion Regulation in Patients Suffering From Obesity With or Without Binge Eating Disorder and Seeking Bariatric Surgery
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