Binge-Eating DisorderNCT05149859
Compuls-BED-Severity
An observational study of Binge-Eating Disorder, run by Laval University at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Binge-Eating Disorder
- What is being tested?
- Observational
- How many people
- 200 participants
- Where
- 2 sitesCanada
- Study dates
- 7 Mar 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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%.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Not yet recruiting
Centre d'expertise Poids, Image et Alimentation (CEPIA)
Québec
Catherine Bégin, PhD
- Recruiting
IUCPQ
Québec
sylvain Iceta
About this study
Official title: Reconsidering Severity Classification for Binge Eating Disorder (BED): the Role of Impulsivity, Compulsivity and Co-occurring Disorders
- 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
- Being tested
- Observational
- Keywords
- Binge-Eating Disorder, Impulsivity, Obesity, Attention, Emotional regulation
- Medical subject headings
- Binge-Eating Disorder, Impulsive Behavior, Obesity, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
(no intervention)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical and psychological comorbidities
Number of current associated comorbidities to patient with and without BED
Measured: Inclusion
Binge Eating Scale score
To assess binge eating severity based on the 16-item scale developed by Gormally et al in 1982
Measured: Inclusion
Secondary outcomes (18)
Body Mass Index in kg.m-2
[Anthropometric markers] weight and height will be combined to report BMI in kg/m^2
Measured: Inclusion
Percentage of fat mass in %
[Anthropometric markers] Based on impedance data, percentage fat mass will be reported when available
Measured: Inclusion
Waist and hip circumferences in cm
[Anthropometric markers] Waist, hip circumference and Waist-hip ratio will be reported in cm when available
Measured: Inclusion
Triglycerides in mmol/L
Routine clinical biological markers; part of lipidic profile (when available)
Measured: Inclusion
Cholesterol HDL and LDL in mmol/L
Routine clinical biological markers; part of lipidic profile (when available)
Measured: Inclusion
Fasting blood glucose in mmol/L
Routine clinical biological markers, when available.
Measured: Inclusion
Glycated hemoglobin (HbA1C) in %
Routine clinical biological markers, when available.
Measured: Inclusion
Insulin in pmol/L
Routine clinical biological markers, when available.
Measured: Inclusion
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.
Measured: Inclusion
UPPS-P Impulsive Behavior Scale short version, S-UPPS-P
To assess the Impulsivity-compulsivity spectrum
Measured: Inclusion
Obsessive-Compulsive Inventory-Revised, OCI-R
To assess the Impulsivity-compulsivity spectrum
Measured: Inclusion
Stop Signal Task
To assess the Impulsivity-compulsivity spectrum
Measured: Inclusion
Difficulties in emotion regulation scale short form, DERS
To assess the emotion regulation spectrum
Measured: Inclusion
Emotional Go / No-Go Task
To assess the emotion regulation spectrum
Measured: Inclusion
Adult Attention Deficit Hyperactivity Disorder Self-Report Scale, ASRS
To assess attentional functions
Measured: Inclusion
Integrated Visual and Auditory Continuous Performance Test, IVA-CPT
To assess attentional functions
Measured: Inclusion
General Anxiety Disorder (GAD)-7
To assess anxiety disorders risk
Measured: Inclusion
Patient Health Questionnaire (PHQ)-9
To assess depression disorder risk
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start7 Mar 2023
- Primary completion1 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge-Eating DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval, Centre d'expertise Poids, Image et Alimentation (CEPIA)
- Responsible party
- Principal investigator, Sylvain Iceta, Laval University
- Investigators
- Sylvain Iceta, Principal investigator, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149859
- Sponsor's protocol ID
- 2022-3743, 22144
- Status last verified
- Oct 2024
- First submitted
- 19 Nov 2021
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconsidering Severity Classification for Binge Eating Disorder (BED): the Role of Impulsivity, Compulsivity and Co-occurring Disorders
- ClinicalTrials.gov ID
- NCT05149859
- Acronym / sponsor ID
- 2022-3743, 22144
- Conditions
- Binge-Eating Disorder
- Keywords
- Binge-Eating Disorder, Impulsivity, Obesity, Attention, Emotional regulation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval, Centre d'expertise Poids, Image et Alimentation (CEPIA)
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BED+ : Participants with obesity and binge eating disorder | – | Other: ObservationalObesity 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 | – | Other: ObservationalObesity 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational(no intervention) | Other | BED+ : Participants with obesity and binge eating disorder, BED-: Participants with obesity but without binge eating disorder |
Primary outcome
Physical and psychological comorbidities
Time frame: Inclusion
Number of current associated comorbidities to patient with and without BED
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
18 secondary outcomes
Body Mass Index in kg.m-2
Time frame: Inclusion
Percentage of fat mass in %
Time frame: Inclusion
Waist and hip circumferences in cm
Time frame: Inclusion
Triglycerides in mmol/L
Time frame: Inclusion
Cholesterol HDL and LDL in mmol/L
Time frame: Inclusion
Fasting blood glucose in mmol/L
Time frame: Inclusion
Glycated hemoglobin (HbA1C) in %
Time frame: Inclusion
Insulin in pmol/L
Time frame: Inclusion
Visceral Adiposity Index
Time frame: Inclusion
UPPS-P Impulsive Behavior Scale short version, S-UPPS-P
Time frame: Inclusion
Obsessive-Compulsive Inventory-Revised, OCI-R
Time frame: Inclusion
Stop Signal Task
Time frame: Inclusion
Difficulties in emotion regulation scale short form, DERS
Time frame: Inclusion
Emotional Go / No-Go Task
Time frame: Inclusion
Adult Attention Deficit Hyperactivity Disorder Self-Report Scale, ASRS
Time frame: Inclusion
Integrated Visual and Auditory Continuous Performance Test, IVA-CPT
Time frame: Inclusion
General Anxiety Disorder (GAD)-7
Time frame: Inclusion
Patient Health Questionnaire (PHQ)-9
Time frame: Inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sylvain Iceta principal investigator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Binge-Eating Disorder, run by Laval University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sylvain Iceta, MD, PhD (+1 (418) 656-8711 ext. 4565, equipe.iceta@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical and psychological comorbidities (time frame: Inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.