Compuls-BED-Severity
ConditionBinge-Eating Disorder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorLaval University
About this trial
* 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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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;
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Observational
Other intervention(no intervention)
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: BED+ : Participants with obesity and binge eating disorder1 intervention
Group B: BED-: Participants with obesity but without binge eating disorder1 intervention
Trial outcomes
Primary outcomes
1
Physical and psychological comorbidities
Number of current associated comorbidities to patient with and without BED
Time frame
Inclusion2
Binge Eating Scale score
To assess binge eating severity based on the 16-item scale developed by Gormally et al in 1982
Time frame
InclusionSecondary outcomes
1
Body Mass Index in kg.m-2
\[Anthropometric markers\] weight and height will be combined to report BMI in kg/m\^2
Time frame
Inclusion2
Percentage of fat mass in %
\[Anthropometric markers\] Based on impedance data, percentage fat mass will be reported when available
Time frame
Inclusion3
Waist and hip circumferences in cm
\[Anthropometric markers\] Waist, hip circumference and Waist-hip ratio will be reported in cm when available
Time frame
Inclusion4
Triglycerides in mmol/L
Routine clinical biological markers; part of lipidic profile (when available)
Time frame
InclusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Laval University
Lead sponsor
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Collaborator
Centre d'expertise Poids, Image et Alimentation (CEPIA)
Collaborator
Source ClinicalTrials.gov