BariaPSY: the Data Bank
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Bariatric Surgery Candidate, Obesity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Mental Health, Eating Disorders and Obesity Databank
Overview
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.
Primary outcome measures
- Binge Eating Disorder (BEDS-7) [Time frame: Baseline]
- Binge Eating Scale (BES) [Time frame: Baseline]
- Generalized Anxiety Disorder (GAD-7) [Time frame: Baseline]
- Patient Health Questionnaire (PHQ-9) [Time frame: Baseline]
- Adult ADHD Self-Report Scale (ASRS-5) [Time frame: Baseline]
- Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0) [Time frame: Baseline]
- Impulsive Behavior Scale Short Form (UPPS-P) [Time frame: Baseline]
Secondary outcome measures (12)
- 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)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Canada · 1 center
- IUCPQ — Québec
Identifiers
NCT: NCT05602805 · 2023-3886, 22254