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

Obesity Clinical Trial

— Obesity  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04193384
• Other study ID #: BAREG
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Bariatric Surgery
• Obesity

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