Compuls-BED-Severity

Официальное название

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

Обзор

* 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).

Вмешательства

• Другое Observational
  (no intervention)

Первичные конечные точки

• Physical and psychological comorbidities [Срок оценки: Inclusion]
• Binge Eating Scale score [Срок оценки: Inclusion]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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%.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Канада · 2 центра

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

Идентификаторы

NCT: NCT05149859 · 2022-3743, 22144

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗