IUCPQ
Québec, Quebec, G1V4G5, Canada
Location status: Recruiting
Location contact
Sylvain Iceta, Md, PhD
CONTACT
NCT Number: NCT05602805
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Québec, Quebec, G1V4G5, Canada
Location status: Recruiting
Sylvain Iceta, Md, PhD
CONTACT
The specific research objectives pursued by BariaPsy are as follows:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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.
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.
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).
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.
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).
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.
Time frame: Baseline (Sociodemographic Questionnaire)
Choose from: Cisgender, Transgender, non-binary, Queer, I refuse to answer, Other
Time frame: Baseline (Sociodemographic Questionnaire)
Choose from: Black, East Asian, Latino, Middle Eastern, South Asian, Southeast Asian, South Asian descent, White, I refuse to answer, Other
Time frame: Baseline (Sociodemographic Questionnaire)
Choose from: Single, Common-law, Married, Divorced, Widowed, I refuse to answer, Other
Time frame: Baseline (Sociodemographic Questionnaire)
Choose from: None, High School, Cegep, Diploma of Vocational Studies, Vocational Technical, Undergraduate University, Graduate University, Postgraduate University or Other
Time frame: Baseline (Sociodemographic Questionnaire)
In dollars.
Time frame: Baseline (Sociodemographic Questionnaire)
Choose from: House/apartment/condominium, apartment or condominium for seniors, home of a relative or friend, retirement home, adult foster home, CHSLD, other
Time frame: Baseline (Sociodemographic Questionnaire)
Choose from: working full time, working part time, unemployed or laid off looking for work, unemployed not looking for work, homemaker, student, retired, disable
Time frame: Baseline (Sociodemographic Questionnaire)
Choose from: living alone, 1 person, 2 persons, 3 persons, 4 persons, 5 persons or more
Time frame: Baseline (Sociodemographic Questionnaire)
In kilograms (kg).
Time frame: Baseline (Sociodemographic Questionnaire)
In meters (m).
Time frame: Baseline (Bariatric Surgery Initial Assessment)
Open answer
Time frame: Baseline (Bariatric Surgery Initial Assessment)
Choice: tobacco products, electronic cigarettes (with or without nicotine), alcohol and/or drugs.
Quantity, frequency and cessation date, if applicable, are requested.
Time frame: Baseline (Bariatric Surgery Initial Assessment)
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.
Time frame: Baseline (Bariatric Surgery Initial Assessment)
Open-ended questions about obesity and bariatric surgeries in the applicant's family.
Time frame: Baseline (Bariatric Surgery Initial Assessment)
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.
Time frame: Baseline (Bariatric Surgery Initial Assessment)
Open-ended questions related to meal intake, meal frequency, food consumed and food-related behaviors.
Time frame: Baseline (Bariatric Surgery Initial Assessment)
Open-ended questions about physical activity, which ones are practiced, how often and what barriers are encountered.
Time frame: Baseline (Bariatric Surgery Initial Assessment)
Open-ended questions about body image and motivation to treat obesity.
Time frame: Baseline (Bariatric Surgery Initial Assessment)
Open-ended response to know the expectations towards health professionals in the management of their obesity.
Time frame: Baseline (Bariatric Surgery Initial Assessment)
Since when does he want to have surgery and for what reasons?
Time frame: Baseline (Bariatric Surgery Initial Assessment)
Three recommendations personally issued by a nutritionist are requested.
Time frame: Baseline (Bariatric Surgery Initial Assessment)
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.
Contact information is provided by the study sponsor or research team.
Laval University
Other
Mental Health, Eating Disorders and Obesity Databank
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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