Compuls-BED-Severity

NCT ID: NCT05149859

Last Updated: 2024-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-07

Study Completion Date

2025-12-31

Brief Summary

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* 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).

Detailed Description

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Conditions

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Binge-Eating Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Observational

Intervention Type OTHER

(no intervention)

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

Observational

Intervention Type OTHER

(no intervention)

Interventions

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Observational

(no intervention)

Intervention Type OTHER

Eligibility Criteria

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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.


* 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%.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

OTHER

Sponsor Role collaborator

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

UNKNOWN

Sponsor Role collaborator

Laval University

OTHER

Sponsor Role lead

Responsible Party

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Sylvain Iceta

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sylvain Iceta

Role: PRINCIPAL_INVESTIGATOR

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Locations

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

Québec, , Canada

Site Status NOT_YET_RECRUITING

IUCPQ

Québec, , Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Sylvain Iceta, MD, PhD

Role: CONTACT

+1 (418) 656-8711 ext. 4565

Pelletier Melissa

Role: CONTACT

+1 (418) 656-8711 ext. 2136

Facility Contacts

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Catherine Bégin, PhD

Role: primary

sylvain Iceta

Role: primary

Other Identifiers

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2022-3743, 22144

Identifier Type: -

Identifier Source: org_study_id

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