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BariaPSY: the Data Bank

— Наблюдательное Bariatric Surgery Candidate Obesity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Bariatric Surgery Candidate, Obesity. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Mental Health, Eating Disorders and Obesity Databank

Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • Binge Eating Disorder (BEDS-7) [Срок оценки: Baseline]
  • Binge Eating Scale (BES) [Срок оценки: Baseline]
  • Generalized Anxiety Disorder (GAD-7) [Срок оценки: Baseline]
  • Patient Health Questionnaire (PHQ-9) [Срок оценки: Baseline]
  • Adult ADHD Self-Report Scale (ASRS-5) [Срок оценки: Baseline]
  • Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0) [Срок оценки: Baseline]
  • Impulsive Behavior Scale Short Form (UPPS-P) [Срок оценки: Baseline]
Вторичные конечные точки (12)
  • Gender identity [Срок оценки: Baseline (Sociodemographic Questionnaire)]
  • Ethnic origin [Срок оценки: Baseline (Sociodemographic Questionnaire)]
  • Marital status [Срок оценки: Baseline (Sociodemographic Questionnaire)]
  • Highest level of education [Срок оценки: Baseline (Sociodemographic Questionnaire)]
  • Average annual income [Срок оценки: Baseline (Sociodemographic Questionnaire)]
  • Living space for most of the year [Срок оценки: Baseline (Sociodemographic Questionnaire)]
  • Current employment status [Срок оценки: Baseline (Sociodemographic Questionnaire)]
  • Number of person living at your place of residence [Срок оценки: Baseline (Sociodemographic Questionnaire)]
  • Weight [Срок оценки: Baseline (Sociodemographic Questionnaire)]
  • Height [Срок оценки: Baseline (Sociodemographic Questionnaire)]
  • Food allergies or intolerances [Срок оценки: Baseline (Bariatric Surgery Initial Assessment)]
  • Lifestyle habits [Срок оценки: Baseline (Bariatric Surgery Initial Assessment)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Канада · 1 центр
  • IUCPQ — Québec

Идентификаторы

NCT: NCT05602805 · 2023-3886, 22254

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗