Obesity and Bariatric Surgery According to a Biopsychosocial Perspective.

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.

Conditions

• Obesity
• Heart Rate Variability
• Anxiety Disorders
• Depression
• Quality of Life

Interventions

DEVICE

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.

DIAGNOSTIC_TEST

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).

DIAGNOSTIC_TEST

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).

DIAGNOSTIC_TEST

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).

DIAGNOSTIC_TEST

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).

Sponsors & Collaborators

• Rio de Janeiro State Research Supporting Foundation (FAPERJ)

  collaborator OTHER_GOV

• Universidade Federal Fluminense

  collaborator OTHER

• Rio de Janeiro State University

  lead OTHER

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-20

Primary Completion

2024-10-17

Completion

2026-10-20

FDA Device

Yes

Countries

• Brazil

Study Locations