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临床试验/NCT04193384
NCT04193384已完成不适用

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

Rio de Janeiro State University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Analysis of the association between weight regain and alcohol abuse disorder

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Bariatric patients without regular medical follow-up

排除标准

  • Pregnancy
  • Bariatric patients under one year of surgery

结局指标

主要结局

Analysis of the association between weight regain and alcohol abuse disorder

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Rio de Janeiro State University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luiz Guilherme Kraemer-Aguiar, MD

Professor

Rio de Janeiro State University

研究点 (1)

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