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Clinical Trials/NCT04193384
NCT04193384
Completed
Not Applicable

Analysis of Weight Regain Rate and Predictive Factors in Patients Submitted to Bariatric Surgery.

Rio de Janeiro State University1 site in 1 country100 target enrollmentNovember 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Rio de Janeiro State University
Enrollment
100
Locations
1
Primary Endpoint
Analysis of the association between weight regain and alcohol abuse disorder
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2018
End Date
January 1, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Rio de Janeiro State University
Responsible Party
Principal Investigator
Principal Investigator

Luiz Guilherme Kraemer-Aguiar, MD

Professor

Rio de Janeiro State University

Eligibility Criteria

Inclusion Criteria

  • Bariatric patients without regular medical follow-up

Exclusion Criteria

  • Pregnancy
  • Bariatric patients under one year of surgery

Outcomes

Primary Outcomes

Analysis of the association between weight regain and alcohol abuse disorder

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Study Sites (1)

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