BariaPSY: the Data Bank

NCT05602805 | Recruiting

• 1 other identifier: 2023-3886, 22254
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery Candidate; Obesity

Keywords

Obesity; Mental Health; Bariatric Surgery; Eating Disorder

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (22)

• Gender identity

  Baseline (Sociodemographic Questionnaire)

• Ethnic origin

  Baseline (Sociodemographic Questionnaire)

• Marital status

  Baseline (Sociodemographic Questionnaire)

• Highest level of education

  Baseline (Sociodemographic Questionnaire)

• Average annual income

  Baseline (Sociodemographic Questionnaire)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

IUCPQ

Québec, Quebec, G1V4G5, Canada

RECRUITING

MeSH Terms

Conditions

Obesity; Psychological Well-Being; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior; Signs and Symptoms, Digestive; Mental Disorders

Central Study Contacts

Sylvain Iceta, MD, PhD

CONTACT

+1 (418) 656-8711; equipe.iceta@criucpq.ulaval.ca

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator - Assistant professor

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 2, 2022
• Study Start: November 15, 2022
• Primary Completion (Estimated): November 1, 2067
• Study Completion (Estimated): November 1, 2072
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

CA (1)