Identification of Pre-surgical Phenotypic Indicators Predictive of Quality of Life Trajectories in Obese Patients Following Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- Time trajectories of EQVOD score during the 24 months post-surgery from measurements at M12, M18 and M24 according to phenotypic characteristics measured during the final pre-surgical assessment (M-1 of bariatric surgery)
研究概览
简要总结
This study aims to identify pre-operative phenotypic determinants predictive of quality of life trajectories in post-bariatric surgery patients. In addition, this study will have as a secondary objective the highlighting of a potential link between post-surgery quality of life trajectories and those of anxiety/depression scores, eating behaviors and body mass indices.
This study will be conducted during the usual care of patients undergoing the GEROM73 program, lasting a total of 30 months.
The GEROM73 program includes care for the six months preceding bariatric surgery and the 24 months following surgery. This program supports patients throughout their bariatric care..
Throughout the GEROM73 program, patients will complete questionnaires on anxiety, depression, eating disorders, Impact of Weight on Quality Of Life.
Patients' weight, body mass index and body schema will also be measured throughout the GEROM program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient > 18years old
- •Integrated into the GEROM73 surgical program and starting the intra-hospital program
排除标准
- •Patients in a state of psychiatric decompensation
- •Patients with cognitive disorders
- •Patients with difficulties understanding the French language, spoken or written
- •Pregnant, parturient, or breastfeeding women
研究组 & 干预措施
phenotype of patients during the GEROM73 program
Anxiety, Depression, Eating disorders, Impact of Weight on Quality Of Life.Patients' weight, Body Mass index and Body schema
干预措施: Hospital Anxiety and Depression Scale (Other)
phenotype of patients during the GEROM73 program
Anxiety, Depression, Eating disorders, Impact of Weight on Quality Of Life.Patients' weight, Body Mass index and Body schema
干预措施: Dutch Eating Behaviour Questionnary (Other)
phenotype of patients during the GEROM73 program
Anxiety, Depression, Eating disorders, Impact of Weight on Quality Of Life.Patients' weight, Body Mass index and Body schema
干预措施: Impact of Weight on Quality Of Life (Other)
phenotype of patients during the GEROM73 program
Anxiety, Depression, Eating disorders, Impact of Weight on Quality Of Life.Patients' weight, Body Mass index and Body schema
干预措施: body schema (Other)
phenotype of patients during the GEROM73 program
Anxiety, Depression, Eating disorders, Impact of Weight on Quality Of Life.Patients' weight, Body Mass index and Body schema
干预措施: body mass index (Other)
phenotype of patients during the GEROM73 program
Anxiety, Depression, Eating disorders, Impact of Weight on Quality Of Life.Patients' weight, Body Mass index and Body schema
干预措施: waist size (Other)
结局指标
主要结局
Time trajectories of EQVOD score during the 24 months post-surgery from measurements at M12, M18 and M24 according to phenotypic characteristics measured during the final pre-surgical assessment (M-1 of bariatric surgery)
时间窗: one month befre surgery to 24 month post surgery
Trajectory identification using latent class mixed models to classify patients into distinct EQVOD score trajectories over the 24 months post-surgery. The relationship between the 7 pre-surgery phenotypic characteristics and membership in the different trajectory classes will be tested in a multinomial logistic regression.
次要结局
- quality of life trajectory groups defined by the analysis of the primary outcome measure, comparated to anxiety and depression measured at 12, 18 and 24 months.(12, 18 and 24 month after surgery)
- quality of life trajectory groups defined by the analysis of the primary outcome measure, comparated to Dutch Eating Behavior measured at 12, 18 and 24 months.(12, 18 and 24 months after surgery)
- quality of life trajectory groups defined by the analysis of the primary outcome measure, comparated to Impact of Weight on Quality Of Life at 12, 18 and 24 months.(12, 18 and 24 month after surgery)