RecruitingNCT05950698

Obesity and Bariatric Surgery According to a Biopsychosocial Perspective.

The Assessment of Psychophysiological Markers by Analyzing the Heart Rate Variability, Blood Pressure, Anxiety and Depression, Eating Behavior, and Quality of Life Before and After Bariatric Surgery.

Sponsor

Rio de Janeiro State University

Enrollment

50 participants

Start Date

Oct 20, 2022

Study Type

OBSERVATIONAL

Conditions

Obesity Quality of Life Depression Anxiety Disorders Heart Rate Variability

Summary

* The main goal of this prospective longitudinal observational study is to investigate the psychophysiological indicators by analyzing HRV, blood pressure, symptoms of anxiety and depression, eating behavior and quality of life during the follow-up of the general health status of patients with obesity undergoing the bariatric surgery by Roux-en-Y reconstruction reduction gastroplasty (GRYR) technique. * The main question it aims to answer is: Does bariatric surgery changes the variables studied (HRV, anxiety, depression, eating behavior, quality of life)? * Type of study: prospective longitudinal observational study * Participant population: 50 patients, both females and males, aged between 18 and 60 years, will be submitted to bariatric surgery with Roux-en-Y reconstruction reduction gastroplasty technique. Patients will be evaluated for five times: before the bariatric surgery and 3-6-12-24 months after the bariatric surgery.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is examining obesity and the experience of bariatric (weight-loss) surgery from a biopsychosocial perspective — meaning it looks at physical, psychological, and social factors together. Researchers want to understand how these different dimensions interact in people who are preparing for or have undergone weight-loss surgery. **You may be eligible if...** - You are between 18 and 60 years old - You are living with obesity and have been approved for bariatric surgery - You have provided written informed consent **You may NOT be eligible if...** - You are taking certain diabetes or blood sugar medications - You follow a very restrictive diet such as intermittent fasting or a ketogenic diet - You are pregnant - You have a history of neurological disorders, chronic lung, heart, liver, or kidney disease - You are being treated for alcohol or drug abuse, or are a current smoker - You have a severe psychiatric condition such as schizophrenia or bipolar disorder - You have vitamin B12 deficiency, iron deficiency anemia, or a neurodegenerative brain disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHolter Faros 360° EKG (Bittium Corporation)

Patients will lie down on the examination table, a five-lead ECG will be attached to their chest, and they should rest for 5 minutes before starting the ECG recording. ECG data will be collected for a 15-minute period Heart Rate Variability (HRV) recording will be performed between 09:00 and 12:00 in a fixed examination room to minimize environmental factors and diurnal fluctuations in autonomic nervous system functioning.

DIAGNOSTIC_TESTBeck Depression Inventory (BDI)

The BDI assesses the depression severity. It will be administered before bariatric surgery at time T0 and 3-6-12-24 months after bariatric surgery (T1-T2-T3-T4).

DIAGNOSTIC_TESTHospital Anxiety and Depression Scales - HADS

The HADS assesses the anxiety and depression symptoms. It will be administered before bariatric surgery at time T0 and 3-6-12-24 months after bariatric surgery (T1-T2-T3-T4).

DIAGNOSTIC_TESTThree Factor Eating Questionnaire-R21 - TFEQ-R21

The TFEQ-R21assesses the quality of eating behavior. It will be administered before bariatric surgery at time T0 and 3-6-12-24 months after bariatric surgery (T1-T2-T3-T4).

DIAGNOSTIC_TESThort-Form Health Survey-36 itens - SF-36

he TFEQ-R21assesses the quality of life Divided into different areas (functional capacity, general health status, pain, vitality, social aspects, emotional aspects, and mental health). It will be administered before bariatric surgery at time T0 and 3-6-12-24 months after bariatric surgery (T1-T2-T3-T4).