Recruiting

Observational Study

Sponsor:

Laval University

Code:

NCT05149859

Conditions

Binge-Eating Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Observational

Study Details

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

Study ID

NCT05149859

Start date

Mar 7, 2023

Status verified date

Oct, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Oct 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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%.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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

Interventions

Observational

(no intervention)

Primary outcome measure

  • Physical and psychological comorbidities [ Time Frame: Inclusion ]
  • Binge Eating Scale score [ Time Frame: Inclusion ]

Central Contacts and Locations

Central contacts

Sylvain Iceta, MD, PhD

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

Pelletier Melissa

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

Locations

IUCPQ

Recruiting

Québec, Canada

More Information

Sponsor

Laval University

Last update posted

Oct 9, 2024

Last verified

Oct, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2024-10-09.