Clinical trial
Identification of Pre-surgical Phenotypic Indicators Predictive of Quality of Life Trajectories in Obese Patients Following Bariatric Surgery
Recruiting now · Not applicable · 1 countries · Registry ID NCT06951893
What this study is about
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.
Basic eligibility
Full registry criteria
Treatments and study arms
Hospital Anxiety and Depression Scale
It is a self-assessment questionnaire to identify the existence of anxious and depressive symptoms and to assess their severity.
Dutch Eating Behaviour Questionnary
It allows the assessment of 3 distinct factors of eating behavior: cognitive restriction, emotional eating and externality. This tool was developed to better characterize the eating habits of obese subjects. 10min
Impact of Weight on Quality Of Life
The EQVOD is a validated French scale created from the Impact of Weight on Quality of Life (IWQOL) questionnaire. This self-administered questionnaire is specific to the sociocultural factors of obesity and its dietary treatment in France. The questionnaire is composed of five dimensions: physical impact (11 items), psychosocial impact (11 items), impact on sexual life (4 items), dietary well-being (5 items), and experience of diet/dietetics (5 items). The total number of items is 36.
body schema
Tactile assessment of the body schema using a motorized caliper applied to different parts of the individual's body. The caliper is connected to a touch pad on which the person can report the difference felt between the two pressure points on their skin, using their thumb and index finger.
body mass index
patient weighing at each visit
waist size
waist size measure
Primary outcomes
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.
Study locations
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