Predictive Factors of Regain in Bariatric Patients Without Outpatients Care Regular.

Completed

• Conditions: Bariatric Surgery; Obesity

• Registration Number: NCT04193384
• Lead Sponsor: Rio de Janeiro State University

Brief Summary

The bariatric surgery is recommended for treatment of patients with severe obesity, resulting in greater weight loss and improvement of cardiovascular and metabolic comorbidities. However, weight regain is observed in patients after surgery, leading to health adverse outcomes. The purpose of this study is to identify the rate of weight regain and predictive factors of regain in bariatric patients without outpatients care regular.

Detailed Description

Post-bariatric patients without care by health professional will be recruited. Patients will be divided, initially, in two groups by time after surgical procedure, as follows: Group 1≤ (G1≤) - patients that performed bariatric surgery for ≤ 1 year and Group 1\> (G1\>) - patients that performed bariatric surgery for \> 1 year. Patients will be seen in a medical set for the first time at the Policlínica Piquet Carneiro (PPC) for outpatients care, which will consist of anamnesis and physical examination, obtaining demographic, socioeconomic data, medications and clinical history. The TxR will be calculated by \[TxR = (current weight - minimum weight reported) x 100 / (weight preoperatively reported - minimum weight related)\] and information on predictive variables for weight regain will be obtained by Alcohol Use Disorders Identification Test (AUDIT), Beck Depression Inventory (BDI), International Physical Activity Questionnaire (IPAQ), ActiGraph GT3X + accelerometer, 36-Item Short-Form Health Survey (SF-36), Eating Disorder Examination-Questionnaire (EDE-Q) and Repetitive eating questionnaire (REP(EAT) Q). The inclusion period of new patients in the PPC Obesity Clinic will be one year.

Study Timeline

• Study Start: 2018-11-01
• Primary Completion: 2019-12-01
• Study First Submitted: 2019-12-04
• Study First Submitted QC: 2019-12-07
• Study First Posted: 2019-12-10
• Study Completion: 2020-01-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-21
• Last Update Posted: 2022-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Bariatric patients without regular medical follow-up

Exclusion Criteria

• Pregnancy
• Bariatric patients under one year of surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analysis of the association between weight regain and alcohol abuse disorder	through study completion, an average of 1 year	Analysis of the association between weight regain (weight in kg) and Alcohol abuse (avaliated by Alcohol Use Disorders Identification Test) in the first clinical evaluation
Analysis of the association between weight regain and eating Disorder	through study completion, an average of 1 year	Analysis of the association between weight regain (weight in kg) and eating disorder (avaliated by Eating Disorder Examination-Questionnaire and Repetitive eating questionnaire) in the first clinical evaluation
Analysis of the association between weight regain and physical activity level	through study completion, an average of 1 year	Analysis of the association between weight regain (weight in kg) and physical activity (avaliated by International Physical Activity Questionnaire and the ActiGraph accelerometer) in the first clinical evaluation
Analysis of the association between weight regain and general psychopathology	through study completion, an average of 1 year	Analysis of the association between weight regain (weight in kg) and general psychopathology (avaliated by Beck Depression Inventory) in the first clinical evaluation
Analysis of the association between weight regain and quality of life indicators	through study completion, an average of 1 year	Analysis of the association between weight regain (weight in kg) and quality of life (avaliated by the 36-Item Short-Form Health Survey Questionnaire) in the first clinical evaluation

Trial Locations

Locations (1)

Laboratory for Clinical and Experimental Research on Vascular Biology, Rio de Janeiro State University; 🇧🇷 Rio De Janeiro, Rio De Janeiro, Brazil, Brazil