Clinical trial NCT05149859: Compuls-BED-Severity
Official title: Reconsidering Severity Classification for Binge Eating Disorder (BED): the Role of Impulsivity, Compulsivity and Co-occurring Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Binge-Eating Disorder
Keywords: Binge-Eating Disorder
Impulsivity
Obesity
Attention
Emotional regulation
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
name: Centre d'expertise Poids, Image et Alimentation (CEPIA)
First posted: 2021-12-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from 2 sites: 1) the Institut Universitaire de Cardiologie et Pneumologie de Québec (IUCPQ; pre-bariatric surgery consultation and obesity care consultation); 2) the Centre d'Expertise Poids, Image et Alimentation (CEPIA), a clinic of the Institute of Nutrition and Functional Foods of Laval University (eatinig disorders consultation). The pre-selection of participants will be done using available data and screening tests deployed through the management frameworks already in place at the two sites. If needed, patients will be recruited by advertisement.

Brief summary: * Binge Eating Disorder (BED) has been fairly recently introduced into the Diagnostic and Statistical Manual 5 psychiatric classification and its severity criteria are still not well established.
* Moreover, it remains unclear whether BED is associated with greater metabolic severity or more somatic comorbidities, especially in obesity.
* Improved BED severity staging could lead to a better definition of management strategies and , therefore, facilitate screening and care.

The investigators' hypothesis is that an improved assessment of the impulsivity-compulsivity spectrum, emotional regulation, attentional impairment and somatic or psychiatric comorbidities will result in a better distinction between the severe form of BED (e.g., highly impulsive and somatically complicated) from milder form (e.g., more compulsive and less somatically complicated).


Eligibility criteria: Inclusion Criteria:

* men or women aged 1
* participants eligible for bariatric surgery (BMI\>40, or BMI\>35 with severe comorbidities)
* participants scheduled for medical evaluation and treatment of obesity at the IUCPQ Obesity Clinic (BMI≥30)
* participants scheduled for evaluation and treatment of BED at the CEPIA with obesity (BMI≥30)
* for the group with BED: positive BEDS-7 screen and Binge Eating Scale score \>16;
* for the control group: have a negative BEDS-7 screen and Binge Eating Scale score\<12
* be fluent in French and able to consent.

Exclusion criteria :

* participants with severe neurological disorder and/or major neurocognitive deficits;
* participants with previous bariatric surgery or with introduction or change of anti-obesity medication (liraglutide or naltrexone/bupropion) in the previous 3 months;
* participants who cannot read and/or understand French;
* participants under guardianship or curatorship;
* participants already included in a study with a conflict of interest with this study;
* inability to use a computer or iPad;
* inability to access an Internet connection or to visit one of the inclusion sites.

Secondary exclusion criteria:

* participants with a discordance between BEDS-7 (positive) and Binge Eating Scale (score ≤ 16) results found secondarily
* participants who did not participate in part of the assessments (e.g., self-questionnaires or neurocognitive tests) and participants with a rate of missing data\>10%.

Primary outcomes:
measure: Physical and psychological comorbidities
timeFrame: Inclusion
measure: Binge Eating Scale score
timeFrame: Inclusion
Secondary outcomes:
measure: Body Mass Index in kg.m-2
timeFrame: Inclusion
measure: Percentage of fat mass in %
timeFrame: Inclusion
measure: Waist and hip circumferences in cm
timeFrame: Inclusion
measure: Triglycerides in mmol/L
timeFrame: Inclusion
measure: Cholesterol HDL and LDL in mmol/L
timeFrame: Inclusion
measure: Fasting blood glucose in mmol/L
timeFrame: Inclusion
measure: Glycated hemoglobin (HbA1C) in %
timeFrame: Inclusion
measure: Insulin in pmol/L
timeFrame: Inclusion
measure: Visceral Adiposity Index
timeFrame: Inclusion
measure: UPPS-P Impulsive Behavior Scale short version, S-UPPS-P
timeFrame: Inclusion
measure: Obsessive-Compulsive Inventory-Revised, OCI-R
timeFrame: Inclusion
measure: Stop Signal Task
timeFrame: Inclusion
measure: Difficulties in emotion regulation scale short form, DERS
timeFrame: Inclusion
measure: Emotional Go / No-Go Task
timeFrame: Inclusion
measure: Adult Attention Deficit Hyperactivity Disorder Self-Report Scale, ASRS
timeFrame: Inclusion
measure: Integrated Visual and Auditory Continuous Performance Test, IVA-CPT
timeFrame: Inclusion
measure: General Anxiety Disorder (GAD)-7
timeFrame: Inclusion
measure: Patient Health Questionnaire (PHQ)-9
timeFrame: Inclusion
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Centre d'expertise Poids, Image et Alimentation (CEPIA)
city: Québec
country: Canada
facility: IUCPQ
Study officials:
affiliation: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
name: Sylvain Iceta
role: PRINCIPAL_INVESTIGATOR
References: