Mental Health, Eating Disorders and Obesity Databank
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Generalized Anxiety Disorder (GAD-7)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Be an incapacitated or protected adult as defined by law
- •Not registered or eligible for RAMQ
结局指标
主要结局
Generalized Anxiety Disorder (GAD-7)
时间窗: 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)
时间窗: 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).
Binge Eating Disorder (BEDS-7)
时间窗: 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)
时间窗: 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.
Impulsive Behavior Scale Short Form (UPPS-P)
时间窗: 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.
Adult ADHD Self-Report Scale (ASRS-5)
时间窗: 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)
时间窗: 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).
次要结局
- Food allergies or intolerances(Baseline (Bariatric Surgery Initial Assessment))
- Marital status(Baseline (Sociodemographic Questionnaire))
- Highest level of education(Baseline (Sociodemographic Questionnaire))
- Number of person living at your place of residence(Baseline (Sociodemographic Questionnaire))
- Current employment status(Baseline (Sociodemographic Questionnaire))
- Health history and conditions(Baseline (Bariatric Surgery Initial Assessment))
- Knowledge of bariatric surgery(Baseline (Bariatric Surgery Initial Assessment))
- Ethnic origin(Baseline (Sociodemographic Questionnaire))
- Lifestyle habits(Baseline (Bariatric Surgery Initial Assessment))
- Family history of bariatric surgery(Baseline (Bariatric Surgery Initial Assessment))
- Perception of body image(Baseline (Bariatric Surgery Initial Assessment))
- Expectations of health care professionals(Baseline (Bariatric Surgery Initial Assessment))
- Gender identity(Baseline (Sociodemographic Questionnaire))
- Average annual income(Baseline (Sociodemographic Questionnaire))
- Living space for most of the year(Baseline (Sociodemographic Questionnaire))
- Weight(Baseline (Sociodemographic Questionnaire))
- Height(Baseline (Sociodemographic Questionnaire))
- Weight and diet history(Baseline (Bariatric Surgery Initial Assessment))
- Food history(Baseline (Bariatric Surgery Initial Assessment))
- Physical activity History(Baseline (Bariatric Surgery Initial Assessment))
- Motivation to have surgery(Baseline (Bariatric Surgery Initial Assessment))
- Nutritional recommendations(Baseline (Bariatric Surgery Initial Assessment))
研究者
Sylvain Iceta
Principal Investigator - Assistant professor
Laval University