Compuls-BED-Severity
- Conditions
- Binge-Eating Disorder
- Interventions
- Other: Observational
- Registration Number
- NCT05149859
- Lead Sponsor
- Laval University
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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%.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description BED+ : Participants with obesity and binge eating disorder Observational 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 BED-: Participants with obesity but without binge eating disorder Observational 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
- Primary Outcome Measures
Name Time Method Binge Eating Scale score Inclusion To assess binge eating severity based on the 16-item scale developed by Gormally et al in 1982
Physical and psychological comorbidities Inclusion Number of current associated comorbidities to patient with and without BED
- Secondary Outcome Measures
Name Time Method Glycated hemoglobin (HbA1C) in % Inclusion Routine clinical biological markers, when available.
Difficulties in emotion regulation scale short form, DERS Inclusion To assess the emotion regulation spectrum
Emotional Go / No-Go Task Inclusion To assess the emotion regulation spectrum
General Anxiety Disorder (GAD)-7 Inclusion To assess anxiety disorders risk
Body Mass Index in kg.m-2 Inclusion \[Anthropometric markers\] weight and height will be combined to report BMI in kg/m\^2
Waist and hip circumferences in cm Inclusion \[Anthropometric markers\] Waist, hip circumference and Waist-hip ratio will be reported in cm when available
Visceral Adiposity Index Inclusion 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.
Percentage of fat mass in % Inclusion \[Anthropometric markers\] Based on impedance data, percentage fat mass will be reported when available
Fasting blood glucose in mmol/L Inclusion Routine clinical biological markers, when available.
Insulin in pmol/L Inclusion Routine clinical biological markers, when available.
Stop Signal Task Inclusion To assess the Impulsivity-compulsivity spectrum
Cholesterol HDL and LDL in mmol/L Inclusion Routine clinical biological markers; part of lipidic profile (when available)
Obsessive-Compulsive Inventory-Revised, OCI-R Inclusion To assess the Impulsivity-compulsivity spectrum
Adult Attention Deficit Hyperactivity Disorder Self-Report Scale, ASRS Inclusion To assess attentional functions
Integrated Visual and Auditory Continuous Performance Test, IVA-CPT Inclusion To assess attentional functions
Triglycerides in mmol/L Inclusion Routine clinical biological markers; part of lipidic profile (when available)
UPPS-P Impulsive Behavior Scale short version, S-UPPS-P Inclusion To assess the Impulsivity-compulsivity spectrum
Patient Health Questionnaire (PHQ)-9 Inclusion To assess depression disorder risk
Trial Locations
- Locations (2)
IUCPQ
🇨🇦Québec, Canada
Centre d'expertise Poids, Image et Alimentation (CEPIA)
🇨🇦Québec, Canada