Compuls-BED-Severity

NCT05149859 | Recruiting

• 1 other identifier: 2022-3743, 22144
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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).

Conditions

Binge-Eating Disorder

Keywords

Binge-Eating Disorder; Impulsivity; Obesity; Attention; Emotional regulation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (18)

• Body Mass Index in kg.m-2

  Inclusion

• Percentage of fat mass in %

  Inclusion

• Waist and hip circumferences in cm

  Inclusion

• Triglycerides in mmol/L

  Inclusion

• Cholesterol HDL and LDL in mmol/L

  Inclusion

Study Arms (2)

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

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

Interventions

Observational OTHER

(no intervention)

BED+ : Participants with obesity and binge eating disorder; BED-: Participants with obesity but without binge eating disorder

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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%.

Sponsors & Collaborators

• Laval University: lead
• Institut universitaire de cardiologie et de pneumologie de Québec, University Laval: collaborator
• Centre d'expertise Poids, Image et Alimentation (CEPIA): collaborator

Study Sites (2)

Centre d'expertise Poids, Image et Alimentation (CEPIA)

Québec, Canada

NOT YET RECRUITING

IUCPQ

Québec, Canada

RECRUITING

MeSH Terms

Conditions

Binge-Eating Disorder; Impulsive Behavior; Obesity; Emotional Regulation

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Self-Control; Social Behavior

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Sylvain Iceta

  Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvain Iceta, MD, PhD

CONTACT

+1 (418) 656-8711; equipe.iceta@criucpq.ulaval.ca

Pelletier Melissa

CONTACT

+1 (418) 656-8711; equipe.iceta@criucpq.ulaval.ca

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 8, 2021
• Study Start: March 7, 2023
• Primary Completion: October 1, 2025
• Study Completion: December 31, 2025
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

CA (2)