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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04193384
Other study ID # BAREG
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2018
Est. completion date January 1, 2020

Study information

Verified date March 2022
Source Rio de Janeiro State University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date January 1, 2020
Est. primary completion date December 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Bariatric patients without regular medical follow-up Exclusion Criteria: - Pregnancy - Bariatric patients under one year of surgery

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Brazil Laboratory for Clinical and Experimental Research on Vascular Biology, Rio de Janeiro State University Rio De Janeiro Rio De Janeiro, Brazil

Sponsors (1)

Lead Sponsor Collaborator
Rio de Janeiro State University

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Analysis of the association between weight regain and alcohol abuse disorder 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 through study completion, an average of 1 year
Primary Analysis of the association between weight regain and general psychopathology Analysis of the association between weight regain (weight in kg) and general psychopathology (avaliated by Beck Depression Inventory) in the first clinical evaluation through study completion, an average of 1 year
Primary Analysis of the association between weight regain and physical activity level 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 through study completion, an average of 1 year
Primary Analysis of the association between weight regain and quality of life indicators 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 through study completion, an average of 1 year
Primary Analysis of the association between weight regain and eating Disorder 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 through study completion, an average of 1 year
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