Menu
Recruiting NCT05149859

Compuls-BED-Severity

— Observational Binge-Eating Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Observational.
Who it may be relevant to
Registry conditions: Binge-Eating Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

* 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).

Interventions

  • Other Observational
    (no intervention)

Primary outcome measures

  • Physical and psychological comorbidities [Time frame: Inclusion]
  • Binge Eating Scale score [Time frame: Inclusion]
Secondary outcome measures (12)
  • Body Mass Index in kg.m-2 [Time frame: Inclusion]
  • Percentage of fat mass in % [Time frame: Inclusion]
  • Waist and hip circumferences in cm [Time frame: Inclusion]
  • Triglycerides in mmol/L [Time frame: Inclusion]
  • Cholesterol HDL and LDL in mmol/L [Time frame: Inclusion]
  • Fasting blood glucose in mmol/L [Time frame: Inclusion]
  • Glycated hemoglobin (HbA1C) in % [Time frame: Inclusion]
  • Insulin in pmol/L [Time frame: Inclusion]
  • Visceral Adiposity Index [Time frame: Inclusion]
  • UPPS-P Impulsive Behavior Scale short version, S-UPPS-P [Time frame: Inclusion]
  • Obsessive-Compulsive Inventory-Revised, OCI-R [Time frame: Inclusion]
  • Stop Signal Task [Time frame: Inclusion]

Eligibility criteria

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%.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Canada · 2 centers
  • Centre d'expertise Poids, Image et Alimentation (CEPIA) — Québec
  • IUCPQ — Québec

Identifiers

NCT: NCT05149859 · 2022-3743, 22144

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗