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NCT Number: NCT05149859

Compuls-BED-Severity

* 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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%.

Treatment and study plan

Observational

Other

(no intervention)

Primary outcomes

  1. Physical and psychological comorbidities

    Time frame: Inclusion

    Number of current associated comorbidities to patient with and without BED

  2. Binge Eating Scale score

    Time frame: Inclusion

    To assess binge eating severity based on the 16-item scale developed by Gormally et al in 1982

Secondary outcomes

  1. Body Mass Index in kg.m-2

    Time frame: Inclusion

    [Anthropometric markers] weight and height will be combined to report BMI in kg/m^2

  2. Percentage of fat mass in %

    Time frame: Inclusion

    [Anthropometric markers] Based on impedance data, percentage fat mass will be reported when available

  3. Waist and hip circumferences in cm

    Time frame: Inclusion

    [Anthropometric markers] Waist, hip circumference and Waist-hip ratio will be reported in cm when available

  4. Triglycerides in mmol/L

    Time frame: Inclusion

    Routine clinical biological markers; part of lipidic profile (when available)

  5. Cholesterol HDL and LDL in mmol/L

    Time frame: Inclusion

    Routine clinical biological markers; part of lipidic profile (when available)

  6. Fasting blood glucose in mmol/L

    Time frame: Inclusion

    Routine clinical biological markers, when available.

  7. Glycated hemoglobin (HbA1C) in %

    Time frame: Inclusion

    Routine clinical biological markers, when available.

  8. Insulin in pmol/L

    Time frame: Inclusion

    Routine clinical biological markers, when available.

  9. Visceral Adiposity Index

    Time frame: 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.

  10. UPPS-P Impulsive Behavior Scale short version, S-UPPS-P

    Time frame: Inclusion

    To assess the Impulsivity-compulsivity spectrum

  11. Obsessive-Compulsive Inventory-Revised, OCI-R

    Time frame: Inclusion

    To assess the Impulsivity-compulsivity spectrum

  12. Stop Signal Task

    Time frame: Inclusion

    To assess the Impulsivity-compulsivity spectrum

  13. Difficulties in emotion regulation scale short form, DERS

    Time frame: Inclusion

    To assess the emotion regulation spectrum

  14. Emotional Go / No-Go Task

    Time frame: Inclusion

    To assess the emotion regulation spectrum

  15. Adult Attention Deficit Hyperactivity Disorder Self-Report Scale, ASRS

    Time frame: Inclusion

    To assess attentional functions

  16. Integrated Visual and Auditory Continuous Performance Test, IVA-CPT

    Time frame: Inclusion

    To assess attentional functions

  17. General Anxiety Disorder (GAD)-7

    Time frame: Inclusion

    To assess anxiety disorders risk

  18. Patient Health Questionnaire (PHQ)-9

    Time frame: Inclusion

    To assess depression disorder risk

Study contacts

Contact information is provided by the study sponsor or research team.

Pelletier Melissa

CONTACT

[email protected]

+1 (418) 656-8711 ext. 2136

Sylvain Iceta, MD, PhD

CONTACT

[email protected]

+1 (418) 656-8711 ext. 4565

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 8, 2021
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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