Bariatric Surgery CandidateNCT05602805
BariaPSY: the Data Bank
An observational study of Bariatric Surgery Candidate and Obesity, run by Laval University at 1 site in Canada.
Trial summary
Multimorbidity, the co-occurrence of several chronic conditions, is a growing phenomenon that poses new challenges for clinicians and researchers. The association between a mental health disorder and a physical health disorder represents a particularly frequent subtype of multimorbidity and is associated with greater… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery Candidate, Obesity
- How many people
- 10,000 participants
- Where
- 1 siteCanada
- Study dates
- 15 Nov 2022to Nov 2072
- How long will I take part?
- 9 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients referred to the IUCPQ for management of overweight or obesity, thus having a body mass index (BMI) ≥25 kg/m2, and older than 18 years of age can be included in the database. This therefore implies, but is not limited to, the bariatric surgery, medicine, and psychiatry tracks of the IUCPQ. It is not necessary to have a psychiatric diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) to be eligible.
Who may be able to join
- Be a patient referred to the IUCPQ for management of overweight or obesity
- Have a body mass index (BMI) ≥25 kg/m2
- Be 18 years old or older
Who cannot join
- Be an incapacitated or protected adult as defined by law
- Not registered or eligible for RAMQ
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
IUCPQ
Québec, Quebec, G1V4G5
Sylvain Iceta, Md, PhD
About this study
Official title: Mental Health, Eating Disorders and Obesity Databank
Multimorbidity, the co-occurrence of several chronic conditions, is a growing phenomenon that poses new challenges for clinicians and researchers. The association between a mental health disorder and a physical health disorder represents a particularly frequent subtype of multimorbidity and is associated with greater severity and higher consumption of care. It is essential and urgent to explore the specific pathophysiology of this subtype of multimorbidity in order to develop adapted therapeutic strategies.
Psychiatric disorders, such as mood disorders, anxiety disorders, attention deficit disorder and binge eating disorder, are common in people with obesity. For example, although most of these disorders may improve after bariatric surgery, some components of these disorders, such as emotional dysregulation and impulsivity, need to be addressed as they appear to be involved in the development of addiction and suicidality after bariatric surgery. Therefore, screening and vigilance of these risks appear increasingly necessary.
To address this challenge, the BariaPsy databank aims to explore the screening of certain mental health disorders frequently observed in adults with obesity through an innovative approach that explores behaviors in the form of dimensions. It will help clinicians to quickly identify markers of certain disorders, thus helping them to further investigate the problem and provide personalized resources to their patient.
Read the detailed description
The specific research objectives pursued by BariaPsy are as follows:
- To develop a comprehensive screening tool to support the health professionals (surgeon, physician, specialized practice nurse) in their consultation regarding the mental health of the candidate for overweight or obesity management, helping them to delve deeper into the problem and to give personalized resources to their patient so that they can be well supported.
- To evaluate the interest of such an evaluation device on the effectiveness and tolerance of the management proposed to the participants.
- To better characterize patients with physical-mental multimorbidity and the impact of this phenotype on management, in order to issue appropriate recommendations.
- To identify the prevalence of psychiatric disorders, including mood disorders, anxiety disorders, attention deficit disorder, and binge eating disorder, in the hospital setting, in the overweight/obese population.
- To identify potential pathophysiological mechanisms to explain the links between mental health and obesity by relating the affected psychological dimensions to the anthropometric, metabolic and sociodemographic parameters of the participants (through information contained in the medical records).
- Identify potential pathophysiological mechanisms to explain the links between mental health and obesity by relating the affected psychological dimensions to the parameters of current biology available in the medical record (liver, inflammatory, carbohydrate and lipid balance, etc.), but also biological and histological parameters (e.g., adipose tissue samples) in relation to the biobank or management frameworks that are already in place (e.g., in the bariatric surgery service).
Also, the participant's authorization will be requested in the Information and Consent Form to have access to their IUCPQ medical record, which contains a collection of sociodemographic, anthropometric and biological information as well as information related to their obesity management (data collection by the bariatric surgery program nurse and/or data collection carried out when the questionnaire is sent to the bariatric medicine or psychiatry programs).
The BariaPsy databank will improve the screening of certain mental health disorders frequently observed in the context of overweight or obesity in adults. The data collected will be used for several research studies with the objective of better characterizing patients with physical-mental multimorbidity and the impact of this phenotype on management, in order to issue appropriate recommendations.
- Conditions
- Bariatric Surgery Candidate, Obesity
- Keywords
- Obesity, Mental Health, Bariatric Surgery, Eating Disorder
- Medical subject headings
- Obesity, Psychological Well-Being, Feeding and Eating Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Binge Eating Disorder (BEDS-7)
A screening tool that has been designed to screen adults who may have binge eating disorder.
The results indicate whether or not the test screens for binge eating behaviors (yes or no).
Measured: Baseline
Binge Eating Scale (BES)
To assess the presence of certain binge eating behaviors that may be indicative of an eating disorder.
The higher the score, the more binge eating behaviors is observed. The minimum score is 0 while the maximum score is 46. The final result allows to say if the person has an absent (less than 17), moderate (between 18 and 26) or severe (more than 27) binging level.
Measured: Baseline
Generalized Anxiety Disorder (GAD-7)
A screening tool and severity measure for generalised anxiety disorder.
The higher the score, the higher the level of anxiety. The minimum score is 0 and the maximum score is 21. The clinically significant score is 15.
Measured: Baseline
Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a multipurpose instrument for screening, monitoring and measuring the severity of depression.
The higher the score, the more depressive symptoms are present. The minimum score is 0 and the maximum score is 27. It allows to evaluate if there is no depression (9 and less), a major depression (between 10 and 19) or a severe major depression (20 and more).
Measured: Baseline
Adult ADHD Self-Report Scale (ASRS-5)
To evaluate the manifestations and behaviors of attention deficit and hyperactivity disorder in adults.
The higher the final score, the more evidence of ADHD is present. The minimum score is 6 and the maximum score is 30.
Measured: Baseline
Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)
The mYFAS 2.0 was designed to assess food addiction using a shorter version than the YFAS 2.0.It assesses the symptoms of food addiction and the resulting distress and impaired functioning.
The higher the level of symptoms, the more severe the food addiction. Impaired functioning and distress are scored from 0 to 2. Symptoms are scored from 0 to 11. If the functioning and distress score is 1 and above, the food addiction may be mild (2-3 symptoms), moderate (4-5 symptoms), or severe (6+ symptoms).
Measured: Baseline
Impulsive Behavior Scale Short Form (UPPS-P)
Measurement of factors that can lead to impulsive behavior. There are five subscales: Positive Urgency, Negative Urgency, Lack of Premeditation, Lack of Perseverance, and Sensation Seeking.
A higher score on the scale or subscale corresponds to a higher level of impulsivity. The minimum total score is 1 and the maximum total score is 4.
Measured: Baseline
Secondary outcomes (22)
Gender identity
Choose from: Cisgender, Transgender, non-binary, Queer, I refuse to answer, Other
Measured: Baseline (Sociodemographic Questionnaire)
Ethnic origin
Choose from: Black, East Asian, Latino, Middle Eastern, South Asian, Southeast Asian, South Asian descent, White, I refuse to answer, Other
Measured: Baseline (Sociodemographic Questionnaire)
Marital status
Choose from: Single, Common-law, Married, Divorced, Widowed, I refuse to answer, Other
Measured: Baseline (Sociodemographic Questionnaire)
Highest level of education
Choose from: None, High School, Cegep, Diploma of Vocational Studies, Vocational Technical, Undergraduate University, Graduate University, Postgraduate University or Other
Measured: Baseline (Sociodemographic Questionnaire)
Average annual income
In dollars.
Measured: Baseline (Sociodemographic Questionnaire)
Living space for most of the year
Choose from: House/apartment/condominium, apartment or condominium for seniors, home of a relative or friend, retirement home, adult foster home, CHSLD, other
Measured: Baseline (Sociodemographic Questionnaire)
Current employment status
Choose from: working full time, working part time, unemployed or laid off looking for work, unemployed not looking for work, homemaker, student, retired, disable
Measured: Baseline (Sociodemographic Questionnaire)
Number of person living at your place of residence
Choose from: living alone, 1 person, 2 persons, 3 persons, 4 persons, 5 persons or more
Measured: Baseline (Sociodemographic Questionnaire)
Weight
In kilograms (kg).
Measured: Baseline (Sociodemographic Questionnaire)
Height
In meters (m).
Measured: Baseline (Sociodemographic Questionnaire)
Food allergies or intolerances
Open answer
Measured: Baseline (Bariatric Surgery Initial Assessment)
Lifestyle habits
Choice: tobacco products, electronic cigarettes (with or without nicotine), alcohol and/or drugs.
Quantity, frequency and cessation date, if applicable, are requested.
Measured: Baseline (Bariatric Surgery Initial Assessment)
Health history and conditions
Choice: Type 1 or 2 diabetes, hypothyroidism, hyperthyroidism, thyroid nodules, cirrhosis, inflammatory bowel disease, recent prior digestive investigation (less than 5 years), colonoscopy, abdominal surgery, bariatric surgery, other surgery, asthma, COPD, home oxygen, sleep apnea, menstruation (hysterectomy, hormone therapy, pills or IUD), coronary angioplasty (with or without stent), myocardial infarction, cardiac surgery, thrombophlebitis, coagulopathy, pulmonary embolism, renal lithiasis, CKD, psychiatric hospitalization, suicide attempt, mental health diagnosis, eating disorders, neoplasia, chronic pain, other health conditions
If applicable, since when and followed by whom.
Measured: Baseline (Bariatric Surgery Initial Assessment)
Family history of bariatric surgery
Open-ended questions about obesity and bariatric surgeries in the applicant's family.
Measured: Baseline (Bariatric Surgery Initial Assessment)
Weight and diet history
Open-ended questions about current and past weight and dieting to get a sense of the person's history over time in relation to their weight.
Measured: Baseline (Bariatric Surgery Initial Assessment)
Food history
Open-ended questions related to meal intake, meal frequency, food consumed and food-related behaviors.
Measured: Baseline (Bariatric Surgery Initial Assessment)
Physical activity History
Open-ended questions about physical activity, which ones are practiced, how often and what barriers are encountered.
Measured: Baseline (Bariatric Surgery Initial Assessment)
Perception of body image
Open-ended questions about body image and motivation to treat obesity.
Measured: Baseline (Bariatric Surgery Initial Assessment)
Expectations of health care professionals
Open-ended response to know the expectations towards health professionals in the management of their obesity.
Measured: Baseline (Bariatric Surgery Initial Assessment)
Motivation to have surgery
Since when does he want to have surgery and for what reasons?
Measured: Baseline (Bariatric Surgery Initial Assessment)
Nutritional recommendations
Three recommendations personally issued by a nutritionist are requested.
Measured: Baseline (Bariatric Surgery Initial Assessment)
Knowledge of bariatric surgery
Open-ended questions about the different resources that should have been consulted as well as the knowledge required (side effects, recommendations, complication and percentage of failure) are asked.
Measured: Baseline (Bariatric Surgery Initial Assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start15 Nov 2022
- Primary completionNov 2067 (estimated)
- Study completionNov 2072 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sylvain Iceta, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602805
- Sponsor's protocol ID
- 2023-3886, 22254
- Status last verified
- Oct 2024
- First submitted
- 27 Oct 2022
- 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
- Mental Health, Eating Disorders and Obesity Databank
- ClinicalTrials.gov ID
- NCT05602805
- Acronym / sponsor ID
- 2023-3886, 22254
- Conditions
- Bariatric Surgery Candidate, Obesity
- Keywords
- Obesity, Mental Health, Bariatric Surgery, Eating Disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- Nov 2067 (estimated)
- Study completion
- Nov 2072 (estimated)
- First posted
- 2 Nov 2022 (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.
Multimorbidity, the co-occurrence of several chronic conditions, is a growing phenomenon that poses new challenges for clinicians and researchers. The association between a mental health disorder and a physical health disorder represents a particularly frequent subtype of multimorbidity and is associated with greater severity and higher consumption of care. It is essential and urgent to explore the specific pathophysiology of this subtype of multimorbidity in order to develop adapted therapeutic strategies.
Psychiatric disorders, such as mood disorders, anxiety disorders, attention deficit disorder and binge eating disorder, are common in people with obesity. For example, although most of these disorders may improve after bariatric surgery, some components of these disorders, such as emotional dysregulation and impulsivity, need to be addressed as they appear to be involved in the development of addiction and suicidality after bariatric surgery. Therefore, screening and vigilance of these risks appear increasingly necessary.
To address this challenge, the BariaPsy databank aims to explore the screening of certain mental health disorders frequently observed in adults with obesity through an innovative approach that explores behaviors in the form of dimensions. It will help clinicians to quickly identify markers of certain disorders, thus helping them to further investigate the problem and provide personalized resources to their patient.
Detailed description
The specific research objectives pursued by BariaPsy are as follows:
- To develop a comprehensive screening tool to support the health professionals (surgeon, physician, specialized practice nurse) in their consultation regarding the mental health of the candidate for overweight or obesity management, helping them to delve deeper into the problem and to give personalized resources to their patient so that they can be well supported.
- To evaluate the interest of such an evaluation device on the effectiveness and tolerance of the management proposed to the participants.
- To better characterize patients with physical-mental multimorbidity and the impact of this phenotype on management, in order to issue appropriate recommendations.
- To identify the prevalence of psychiatric disorders, including mood disorders, anxiety disorders, attention deficit disorder, and binge eating disorder, in the hospital setting, in the overweight/obese population.
- To identify potential pathophysiological mechanisms to explain the links between mental health and obesity by relating the affected psychological dimensions to the anthropometric, metabolic and sociodemographic parameters of the participants (through information contained in the medical records).
- Identify potential pathophysiological mechanisms to explain the links between mental health and obesity by relating the affected psychological dimensions to the parameters of current biology available in the medical record (liver, inflammatory, carbohydrate and lipid balance, etc.), but also biological and histological parameters (e.g., adipose tissue samples) in relation to the biobank or management frameworks that are already in place (e.g., in the bariatric surgery service).
Also, the participant's authorization will be requested in the Information and Consent Form to have access to their IUCPQ medical record, which contains a collection of sociodemographic, anthropometric and biological information as well as information related to their obesity management (data collection by the bariatric surgery program nurse and/or data collection carried out when the questionnaire is sent to the bariatric medicine or psychiatry programs).
The BariaPsy databank will improve the screening of certain mental health disorders frequently observed in the context of overweight or obesity in adults. The data collected will be used for several research studies with the objective of better characterizing patients with physical-mental multimorbidity and the impact of this phenotype on management, in order to issue appropriate recommendations.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 9 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients referred to the IUCPQ for management of overweight or obesity, thus having a body mass index (BMI) ≥25 kg/m2, and older than 18 years of age can be included in the database. This therefore implies, but is not limited to, the bariatric surgery, medicine, and psychiatry tracks of the IUCPQ. It is not necessary to have a psychiatric diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) to be eligible.
Key inclusion criteria (3 listed)
- Be a patient referred to the IUCPQ for management of overweight or obesity
- Have a body mass index (BMI) ≥25 kg/m2
- Be 18 years old or older
Key exclusion criteria (2 listed)
- Be an incapacitated or protected adult as defined by law
- Not registered or eligible for RAMQ
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Binge Eating Disorder (BEDS-7)
Time frame: Baseline
A screening tool that has been designed to screen adults who may have binge eating disorder. The results indicate whether or not the test screens for binge eating behaviors (yes or no).
Binge Eating Scale (BES)
Time frame: Baseline
To assess the presence of certain binge eating behaviors that may be indicative of an eating disorder. The higher the score, the more binge eating behaviors is observed. The minimum score is 0 while the maximum score is 46. The final result allows to say if the person has an absent (less than 17), moderate (between 18 and 26) or severe (more than 27) binging level.
Generalized Anxiety Disorder (GAD-7)
Time frame: Baseline
A screening tool and severity measure for generalised anxiety disorder. The higher the score, the higher the level of anxiety. The minimum score is 0 and the maximum score is 21. The clinically significant score is 15.
Patient Health Questionnaire (PHQ-9)
Time frame: Baseline
The PHQ-9 is a multipurpose instrument for screening, monitoring and measuring the severity of depression. The higher the score, the more depressive symptoms are present. The minimum score is 0 and the maximum score is 27. It allows to evaluate if there is no depression (9 and less), a major depression (between 10 and 19) or a severe major depression (20 and more).
Adult ADHD Self-Report Scale (ASRS-5)
Time frame: Baseline
To evaluate the manifestations and behaviors of attention deficit and hyperactivity disorder in adults. The higher the final score, the more evidence of ADHD is present. The minimum score is 6 and the maximum score is 30.
Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)
Time frame: Baseline
The mYFAS 2.0 was designed to assess food addiction using a shorter version than the YFAS 2.0.It assesses the symptoms of food addiction and the resulting distress and impaired functioning. The higher the level of symptoms, the more severe the food addiction. Impaired functioning and distress are scored from 0 to 2. Symptoms are scored from 0 to 11. If the functioning and distress score is 1 and above, the food addiction may be mild (2-3 symptoms), moderate (4-5 symptoms), or severe (6+ symptoms).
Impulsive Behavior Scale Short Form (UPPS-P)
Time frame: Baseline
Measurement of factors that can lead to impulsive behavior. There are five subscales: Positive Urgency, Negative Urgency, Lack of Premeditation, Lack of Perseverance, and Sensation Seeking. A higher score on the scale or subscale corresponds to a higher level of impulsivity. The minimum total score is 1 and the maximum total score is 4.
22 secondary outcomes
Gender identity
Time frame: Baseline (Sociodemographic Questionnaire)
Ethnic origin
Time frame: Baseline (Sociodemographic Questionnaire)
Marital status
Time frame: Baseline (Sociodemographic Questionnaire)
Highest level of education
Time frame: Baseline (Sociodemographic Questionnaire)
Average annual income
Time frame: Baseline (Sociodemographic Questionnaire)
Living space for most of the year
Time frame: Baseline (Sociodemographic Questionnaire)
Current employment status
Time frame: Baseline (Sociodemographic Questionnaire)
Number of person living at your place of residence
Time frame: Baseline (Sociodemographic Questionnaire)
Weight
Time frame: Baseline (Sociodemographic Questionnaire)
Height
Time frame: Baseline (Sociodemographic Questionnaire)
Food allergies or intolerances
Time frame: Baseline (Bariatric Surgery Initial Assessment)
Lifestyle habits
Time frame: Baseline (Bariatric Surgery Initial Assessment)
Health history and conditions
Time frame: Baseline (Bariatric Surgery Initial Assessment)
Family history of bariatric surgery
Time frame: Baseline (Bariatric Surgery Initial Assessment)
Weight and diet history
Time frame: Baseline (Bariatric Surgery Initial Assessment)
Food history
Time frame: Baseline (Bariatric Surgery Initial Assessment)
Physical activity History
Time frame: Baseline (Bariatric Surgery Initial Assessment)
Perception of body image
Time frame: Baseline (Bariatric Surgery Initial Assessment)
Expectations of health care professionals
Time frame: Baseline (Bariatric Surgery Initial Assessment)
Motivation to have surgery
Time frame: Baseline (Bariatric Surgery Initial Assessment)
Nutritional recommendations
Time frame: Baseline (Bariatric Surgery Initial Assessment)
Knowledge of bariatric surgery
Time frame: Baseline (Bariatric Surgery Initial Assessment)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery Candidate and Obesity, run by Laval University at 1 site 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 3 inclusion and 2 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 1 site 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?
Binge Eating Disorder (BEDS-7) (time frame: Baseline). The study lists 7 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; AzTrials last refreshed its copy on 27 Oct 2026.