ClinicalTrials.gg
RecruitingNCT05149859Updated Oct 9, 2024

Compuls-BED-Severity

An observational study in Binge-Eating Disorder, sponsored by Laval University. Recruiting at 2 sites in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-10-09.

Sponsored by Laval University · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Mar 2023; still recruiting 3 years 8 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 65 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Binge-Eating Disorder

Keywords

  • Binge-Eating Disorder
  • Impulsivity
  • Obesity
  • Attention
  • Emotional regulation
03

In context

Binge-Eating Disorder

233 studies on the registry are indexed under Binge-Eating Disorder; 53 are open to participants now.

This study's planned enrollment of 200 is above the median of 118 across 35 observational studies indexed under Binge-Eating Disorder.

Browse Binge-Eating Disorder studies →

Lead sponsor

Laval University is the lead sponsor of 380 studies on the registry; 67 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • men or women aged 1
  • participants eligible for bariatric surgery (>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

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%.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherObservational

    (no intervention)

06

What researchers measure

Primary outcomes

  1. Physical and psychological comorbidities

    Number of current associated comorbidities to patient with and without BED

    Time frame: Inclusion

  2. Binge Eating Scale score

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

    Time frame: Inclusion

Secondary outcomes

  1. Body Mass Index in kg.m-2

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

    Time frame: Inclusion

  2. Percentage of fat mass in %

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

    Time frame: Inclusion

  3. Waist and hip circumferences in cm

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

    Time frame: Inclusion

  4. Triglycerides in mmol/L

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

    Time frame: Inclusion

  5. Cholesterol HDL and LDL in mmol/L

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

    Time frame: Inclusion

  6. Fasting blood glucose in mmol/L

    Routine clinical biological markers, when available.

    Time frame: Inclusion

  7. Glycated hemoglobin (HbA1C) in %

    Routine clinical biological markers, when available.

    Time frame: Inclusion

  8. Insulin in pmol/L

    Routine clinical biological markers, when available.

    Time frame: Inclusion

  9. Visceral Adiposity Index

    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.

    Time frame: Inclusion

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

    To assess the Impulsivity-compulsivity spectrum

    Time frame: Inclusion

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

    To assess the Impulsivity-compulsivity spectrum

    Time frame: Inclusion

  12. Stop Signal Task

    To assess the Impulsivity-compulsivity spectrum

    Time frame: Inclusion

  13. Difficulties in emotion regulation scale short form, DERS

    To assess the emotion regulation spectrum

    Time frame: Inclusion

  14. Emotional Go / No-Go Task

    To assess the emotion regulation spectrum

    Time frame: Inclusion

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

    To assess attentional functions

    Time frame: Inclusion

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

    To assess attentional functions

    Time frame: Inclusion

  17. General Anxiety Disorder (GAD)-7

    To assess anxiety disorders risk

    Time frame: Inclusion

  18. Patient Health Questionnaire (PHQ)-9

    To assess depression disorder risk

    Time frame: Inclusion

07

Study locations

1 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05149859
Lead sponsor
Laval University
Collaborators
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval, Centre d'expertise Poids, Image et Alimentation (CEPIA)
Responsible party
Sylvain Iceta (Principal Investigator, Laval University) — Principal investigator
First posted
Dec 8, 2021
Start date
Mar 7, 2023
Primary completion
Oct 1, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Oct 9, 2024

Study contacts

Sylvain Iceta, MD, PhD
Contact
equipe.iceta@criucpq.ulaval.ca
+1 (418) 656-8711 ext. 4565
Pelletier Melissa
Contact
equipe.iceta@criucpq.ulaval.ca
+1 (418) 656-8711 ext. 2136
Sylvain Iceta
principal investigator · Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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