Compuls-BED-Severity

Binge-Eating Disorder Clinical Trial

Official title:

Reconsidering Severity Classification for Binge Eating Disorder (BED): the Role of Impulsivity, Compulsivity and Co-occurring Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05149859
• Other study ID #: 2022-3743, 22144
• Status: Recruiting
• Start date: March 7, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2023
• Source: Laval University
• Contact: Sylvain Iceta, MD, PhD
• Phone: +1 (418) 656-8711
• Email: equipe.iceta[@]criucpq.ulaval.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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%.

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Bulimia
• Feeding and Eating Disorders

Intervention

Other:
• Observational
(no intervention)

Locations

Country	Name	City	State
Canada	Centre d'expertise Poids, Image et Alimentation (CEPIA)	Québec
Canada	IUCPQ	Québec

Sponsors (3)

Lead Sponsor	Collaborator
Laval University	Centre d'expertise Poids, Image et Alimentation (CEPIA), Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical and psychological comorbidities	Number of current associated comorbidities to patient with and without BED	Inclusion
Primary	Binge Eating Scale score	To assess binge eating severity based on the 16-item scale developed by Gormally et al in 1982	Inclusion
Secondary	Body Mass Index in kg.m-2	[Anthropometric markers] weight and height will be combined to report BMI in kg/m^2	Inclusion
Secondary	Percentage of fat mass in %	[Anthropometric markers] Based on impedance data, percentage fat mass will be reported when available	Inclusion
Secondary	Waist and hip circumferences in cm	[Anthropometric markers] Waist, hip circumference and Waist-hip ratio will be reported in cm when available	Inclusion
Secondary	Triglycerides in mmol/L	Routine clinical biological markers; part of lipidic profile (when available)	Inclusion
Secondary	Cholesterol HDL and LDL in mmol/L	Routine clinical biological markers; part of lipidic profile (when available)	Inclusion
Secondary	Fasting blood glucose in mmol/L	Routine clinical biological markers, when available.	Inclusion
Secondary	Glycated hemoglobin (HbA1C) in %	Routine clinical biological markers, when available.	Inclusion
Secondary	Insulin in pmol/L	Routine clinical biological markers, when available.	Inclusion
Secondary	Visceral Adiposity Index	The Visceral Adiposity Index (VAI) is a sex-specific mathematical index, based on Waist Circumference (WC), Body Mass Index (BMI), triglycerides (TG) and HDL cholesterol (HDL) levels, indirectly expressing visceral adipose function and insulin sensitivity.	Inclusion
Secondary	UPPS-P Impulsive Behavior Scale short version, S-UPPS-P	To assess the Impulsivity-compulsivity spectrum	Inclusion
Secondary	Obsessive-Compulsive Inventory-Revised, OCI-R	To assess the Impulsivity-compulsivity spectrum	Inclusion
Secondary	Stop Signal Task	To assess the Impulsivity-compulsivity spectrum	Inclusion
Secondary	Difficulties in emotion regulation scale short form, DERS	To assess the emotion regulation spectrum	Inclusion
Secondary	Emotional Go / No-Go Task	To assess the emotion regulation spectrum	Inclusion
Secondary	Adult Attention Deficit Hyperactivity Disorder Self-Report Scale, ASRS	To assess attentional functions	Inclusion
Secondary	Integrated Visual and Auditory Continuous Performance Test, IVA-CPT	To assess attentional functions	Inclusion
Secondary	General Anxiety Disorder (GAD)-7	To assess anxiety disorders risk	Inclusion
Secondary	Patient Health Questionnaire (PHQ)-9	To assess depression disorder risk	Inclusion