Compuls-BED-Severity

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

• 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).

Study Overview

• Status: Recruiting
• Conditions: Binge-Eating Disorder
• Intervention / Treatment: Other: Observational

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Pelletier Melissa; Phone Number: 2136 +1 (418) 656-8711; Email: equipe.iceta@criucpq.ulaval.ca
• Study Contact Backup: Name: Sylvain Iceta, Md, PhD; Phone Number: 4565 +1 (418) 656-8711; Email: equipe.iceta@criucpq.ulaval.ca

Study Locations

• Canada
  • Québec, Canada
    • Not yet recruiting
    • Centre d'expertise Poids, Image et Alimentation (CEPIA)
    • Contact: Catherine Bégin, PhD
  • Québec, Canada
    • Recruiting
    • IUCPQ
    • Contact: sylvain Iceta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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%.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
BED+ : Participants with obesity and binge eating disorder; Obesity is define by a BMI ≥ 30 kg.m-2 Binge eating disorder is defined by Binge Eating Disorder Screener (BEDS)-7 positive score and a Binge Eating Scale score >16	Other: Observational; (no intervention)
BED-: Participants with obesity but without binge eating disorder; Obesity is define by a BMI ≥ 30 kg.m-2 Binge eating disorder is defined by Binge Eating Disorder Screener (BEDS)-7 negative score and a Binge Eating Scale score < 12	Other: Observational; (no intervention)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical and psychological comorbidities	Number of current associated comorbidities to patient with and without BED	Inclusion
Binge Eating Scale score	To assess binge eating severity based on the 16-item scale developed by Gormally et al in 1982	Inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index in kg.m-2	[Anthropometric markers] weight and height will be combined to report BMI in kg/m^2	Inclusion
Percentage of fat mass in %	[Anthropometric markers] Based on impedance data, percentage fat mass will be reported when available	Inclusion
Waist and hip circumferences in cm	[Anthropometric markers] Waist, hip circumference and Waist-hip ratio will be reported in cm when available	Inclusion
Triglycerides in mmol/L	Routine clinical biological markers; part of lipidic profile (when available)	Inclusion
Cholesterol HDL and LDL in mmol/L	Routine clinical biological markers; part of lipidic profile (when available)	Inclusion
Fasting blood glucose in mmol/L	Routine clinical biological markers, when available.	Inclusion
Glycated hemoglobin (HbA1C) in %	Routine clinical biological markers, when available.	Inclusion
Insulin in pmol/L	Routine clinical biological markers, when available.	Inclusion
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
UPPS-P Impulsive Behavior Scale short version, S-UPPS-P	To assess the Impulsivity-compulsivity spectrum	Inclusion
Obsessive-Compulsive Inventory-Revised, OCI-R	To assess the Impulsivity-compulsivity spectrum	Inclusion
Stop Signal Task	To assess the Impulsivity-compulsivity spectrum	Inclusion
Difficulties in emotion regulation scale short form, DERS	To assess the emotion regulation spectrum	Inclusion
Emotional Go / No-Go Task	To assess the emotion regulation spectrum	Inclusion
Adult Attention Deficit Hyperactivity Disorder Self-Report Scale, ASRS	To assess attentional functions	Inclusion
Integrated Visual and Auditory Continuous Performance Test, IVA-CPT	To assess attentional functions	Inclusion
General Anxiety Disorder (GAD)-7	To assess anxiety disorders risk	Inclusion
Patient Health Questionnaire (PHQ)-9	To assess depression disorder risk	Inclusion

Collaborators and Investigators

• Sponsor: Laval University
• Collaborators: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval; Centre d'expertise Poids, Image et Alimentation (CEPIA)
• Investigators: Principal Investigator: Sylvain Iceta, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 19, 2021
• First Submitted That Met QC Criteria: December 7, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; Emotional regulation; Attention; Impulsivity; Binge-Eating Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Hyperphagia; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
• Other Study ID Numbers: 2022-3743, 22144

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No