Clinical trial NCT05602805: BariaPSY: the Data Bank
Official title: Mental Health, Eating Disorders and Obesity Databank
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bariatric Surgery Candidate
Obesity
Keywords: Obesity
Mental Health
Bariatric Surgery
Eating Disorder
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2022-11-02
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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:

1. 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.
2. To evaluate the interest of such an evaluation device on the effectiveness and tolerance of the management proposed to the participants.
3. To better characterize patients with physical-mental multimorbidity and the impact of this phenotype on management, in order to issue appropriate recommendations.
4. 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.
5. 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).
6. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Be an incapacitated or protected adult as defined by law
* Not registered or eligible for RAMQ

Primary outcomes:
measure: Binge Eating Disorder (BEDS-7)
timeFrame: Baseline
measure: Binge Eating Scale (BES)
timeFrame: Baseline
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: Baseline
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline
measure: Adult ADHD Self-Report Scale (ASRS-5)
timeFrame: Baseline
measure: Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)
timeFrame: Baseline
measure: Impulsive Behavior Scale Short Form (UPPS-P)
timeFrame: Baseline
Secondary outcomes:
measure: Gender identity
timeFrame: Baseline (Sociodemographic Questionnaire)
measure: Ethnic origin
timeFrame: Baseline (Sociodemographic Questionnaire)
measure: Marital status
timeFrame: Baseline (Sociodemographic Questionnaire)
measure: Highest level of education
timeFrame: Baseline (Sociodemographic Questionnaire)
measure: Average annual income
timeFrame: Baseline (Sociodemographic Questionnaire)
measure: Living space for most of the year
timeFrame: Baseline (Sociodemographic Questionnaire)
measure: Current employment status
timeFrame: Baseline (Sociodemographic Questionnaire)
measure: Number of person living at your place of residence
timeFrame: Baseline (Sociodemographic Questionnaire)
measure: Weight
timeFrame: Baseline (Sociodemographic Questionnaire)
measure: Height
timeFrame: Baseline (Sociodemographic Questionnaire)
measure: Food allergies or intolerances
timeFrame: Baseline (Bariatric Surgery Initial Assessment)
measure: Lifestyle habits
timeFrame: Baseline (Bariatric Surgery Initial Assessment)
measure: Health history and conditions
timeFrame: Baseline (Bariatric Surgery Initial Assessment)
measure: Family history of bariatric surgery
timeFrame: Baseline (Bariatric Surgery Initial Assessment)
measure: Weight and diet history
timeFrame: Baseline (Bariatric Surgery Initial Assessment)
measure: Food history
timeFrame: Baseline (Bariatric Surgery Initial Assessment)
measure: Physical activity History
timeFrame: Baseline (Bariatric Surgery Initial Assessment)
measure: Perception of body image
timeFrame: Baseline (Bariatric Surgery Initial Assessment)
measure: Expectations of health care professionals
timeFrame: Baseline (Bariatric Surgery Initial Assessment)
measure: Motivation to have surgery
timeFrame: Baseline (Bariatric Surgery Initial Assessment)
measure: Nutritional recommendations
timeFrame: Baseline (Bariatric Surgery Initial Assessment)
measure: Knowledge of bariatric surgery
timeFrame: Baseline (Bariatric Surgery Initial Assessment)
Other outcomes:
Locations:
city: Québec
country: Canada
facility: IUCPQ
state: Quebec
Study officials:
References: