Clinical trial NCT06951893: Identification of Pre-surgical Phenotypic Indicators Predictive of Quality of Life Trajectories in Obese Patients Following Bariatric Surgery
Official title: Identification of Pre-surgical Phenotypic Indicators Predictive of Quality of Life Trajectories in Obese Patients Following Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity, Morbid
Obesity and Overweight
Bariatric Surgery
Bariatric Surgery Patients
Bariatric Surgery Patient
Bariatric Surgery (Sleeve Gastrectomy )
Bypass, Gastric
Keywords: GEROM73
PHENOBEQOL73
Lead sponsor: Centre Hospitalier Metropole Savoie
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: each patient will complete questionary 6month before surgery, and then 12, 18 and 24 months after the surgery
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* patient \> 18years old
* Integrated into the GEROM73 surgical program and starting the intra-hospital program

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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)
timeFrame: one month befre surgery to 24 month post surgery
Secondary outcomes:
measure: 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.
timeFrame: 12, 18 and 24 month after surgery
measure: 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.
timeFrame: 12, 18 and 24 months after surgery
measure: 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.
timeFrame: 12, 18 and 24 month after surgery
Other outcomes:
measure: Body schema measured at pre-surgical (M-6 and end of pre-operative course M-1) and post-surgical (M+12 and M+24) assessments.
timeFrame: at 6 and 1 month before surgery, and at 12, 18 and 24 months before surgery
measure: Body schema measured at pre-surgical (M-6 and end of pre-operative course M-1) and post-surgical (M+12 and M+24) assessments compared between the quality of life trajectory groups defined by the analysis of the primary judgment criterion
timeFrame: at 6 and 1 month before surgery, and at 12, 18 and 24 months before surgery
Locations:
city: Chambery
country: France
facility: Centre Hospitalier Métropole Savoie
state: Savoie
Study officials:
affiliation: CH Metropole Savoie
name: Cécile BOSSU ESTOUR
role: PRINCIPAL_INVESTIGATOR
References: