Obesity and Bariatric Surgery According to a Biopsychosocial Perspective.

Condition(s) studied

Investigational drug(s) / intervention(s)

Holter 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.

Beck 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).

Hospital 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).

Three 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).

hort-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).

Study 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

Primary outcome measure(s)

• Bariatric surgery changes measures of heart rate variability of patients — After 3-6-12-24 months after bariatric surgery
  Increased the parasympathetic activity measured through Respiratory sinus arrhythmia, High and low frequency (time domain measurements), and approximate entropy (non linear measurement) of the heart rate variability. Heart rate variability is recorded through Holter faros 360.
• Bariatric surgery changes measure of anxiety — After 3-6-12-24 months after bariatric surgery
  Decreased scores on the HAD scale items assessing anxiety
• Bariatric surgery changes measures of depression — After 3-6-12-24 months after bariatric surgery
  Decreased scores in the HAD scale and BDI questionnaire assessing depression
• Bariatric surgery changes measures of perceived quality of life — After 3-6-12-24 months after bariatric surgery
  Increased scores in the SF-36 questionnaire which assesses the perceived quality of life

Trial sites (1)

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