BariaPSY: The Data Bank

Obesity Clinical Trial

Official title:

Mental Health, Eating Disorders and Obesity Databank

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05602805
• Other study ID #: 2023-3886, 22254
• Status: Recruiting
• Start date: November 15, 2022
• Est. completion date: November 2072

Study information

• Verified date: May 2023
• Source: Laval University
• Contact: Sylvain Iceta, MD, PhD
• Phone: +1 (418) 656-8711
• Email: equipe.iceta[@]criucpq.ulaval.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: November 2072
• Est. primary completion date: November 2067
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Obesity

Locations

Country	Name	City	State
Canada	IUCPQ	Québec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binge Eating Disorder (BEDS-7)	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).	Baseline
Primary	Binge Eating Scale (BES)	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.	Baseline
Primary	Generalized Anxiety Disorder (GAD-7)	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.	Baseline
Primary	Patient Health Questionnaire (PHQ-9)	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).	Baseline
Primary	Adult ADHD Self-Report Scale (ASRS-5)	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.	Baseline
Primary	Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)	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).	Baseline
Primary	Impulsive Behavior Scale Short Form (UPPS-P)	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.	Baseline
Secondary	Gender identity	Choose from: Cisgender, Transgender, non-binary, Queer, I refuse to answer, Other	Baseline (Sociodemographic Questionnaire)
Secondary	Ethnic origin	Choose from: Black, East Asian, Latino, Middle Eastern, South Asian, Southeast Asian, South Asian descent, White, I refuse to answer, Other	Baseline (Sociodemographic Questionnaire)
Secondary	Marital status	Choose from: Single, Common-law, Married, Divorced, Widowed, I refuse to answer, Other	Baseline (Sociodemographic Questionnaire)
Secondary	Highest level of education	Choose from: None, High School, Cegep, Diploma of Vocational Studies, Vocational Technical, Undergraduate University, Graduate University, Postgraduate University or Other	Baseline (Sociodemographic Questionnaire)
Secondary	Average annual income	In dollars.	Baseline (Sociodemographic Questionnaire)
Secondary	Living space for most of the year	Choose from: House/apartment/condominium, apartment or condominium for seniors, home of a relative or friend, retirement home, adult foster home, CHSLD, other	Baseline (Sociodemographic Questionnaire)
Secondary	Current employment status	Choose from: working full time, working part time, unemployed or laid off looking for work, unemployed not looking for work, homemaker, student, retired, disable	Baseline (Sociodemographic Questionnaire)
Secondary	Number of person living at your place of residence	Choose from: living alone, 1 person, 2 persons, 3 persons, 4 persons, 5 persons or more	Baseline (Sociodemographic Questionnaire)
Secondary	Weight	In kilograms (kg).	Baseline (Sociodemographic Questionnaire)
Secondary	Height	In meters (m).	Baseline (Sociodemographic Questionnaire)
Secondary	Food allergies or intolerances	Open answer	Baseline (Bariatric Surgery Initial Assessment)
Secondary	Lifestyle habits	Choice: tobacco products, electronic cigarettes (with or without nicotine), alcohol and/or drugs.; Quantity, frequency and cessation date, if applicable, are requested.	Baseline (Bariatric Surgery Initial Assessment)
Secondary	Health history and conditions	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.	Baseline (Bariatric Surgery Initial Assessment)
Secondary	Family history of bariatric surgery	Open-ended questions about obesity and bariatric surgeries in the applicant's family.	Baseline (Bariatric Surgery Initial Assessment)
Secondary	Weight and diet history	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.	Baseline (Bariatric Surgery Initial Assessment)
Secondary	Food history	Open-ended questions related to meal intake, meal frequency, food consumed and food-related behaviors.	Baseline (Bariatric Surgery Initial Assessment)
Secondary	Physical activity History	Open-ended questions about physical activity, which ones are practiced, how often and what barriers are encountered.	Baseline (Bariatric Surgery Initial Assessment)
Secondary	Perception of body image	Open-ended questions about body image and motivation to treat obesity.	Baseline (Bariatric Surgery Initial Assessment)
Secondary	Expectations of health care professionals	Open-ended response to know the expectations towards health professionals in the management of their obesity.	Baseline (Bariatric Surgery Initial Assessment)
Secondary	Motivation to have surgery	Since when does he want to have surgery and for what reasons?	Baseline (Bariatric Surgery Initial Assessment)
Secondary	Nutritional recommendations	Three recommendations personally issued by a nutritionist are requested.	Baseline (Bariatric Surgery Initial Assessment)
Secondary	Knowledge of bariatric surgery	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.	Baseline (Bariatric Surgery Initial Assessment)