Identification of Pre-surgical Phenotypic Indicators Predictive of Quality of Life Trajectories in Obese Patients Following Bariatric Surgery

Not Applicable

Not yet recruiting

• Conditions: Obesity, Morbid; Obesity and Overweight; Bariatric Surgery; Bariatric Surgery Patients; Bariatric Surgery Patient; Bariatric Surgery (Sleeve Gastrectomy ); Bypass, Gastric

• Registration Number: NCT06951893
• Lead Sponsor: Centre Hospitalier Metropole Savoie

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-23
• Study First Submitted QC: 2025-04-23
• Study First Posted: 2025-04-30
• Status Verified: 2025-05
• Study Start: 2025-05-01
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-07
• Primary Completion: 2030-11-01
• Study Completion: 2030-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 165

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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)	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.

Secondary Outcome Measures

Name	Time	Method
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	score of anxiety depression (HADS). The HAD (Hospital Anxiety and Depression Scale) assesses anxiety and depressive disorders (its use has been validated in French in the general population as well as in patients undergoing antidepressant treatment). This scale consists of 14 items rated from 0 to 3, of which 7 relate to anxiety and 7 to depression. Two scores are obtained and vary between 0 and 21.; Interpretation takes into account two thresholds: the first, less than or equal to 7, corresponds to the absence of symptoms, and the second, greater than or equal to 11, indicates the presence of anxiety and/or depressive symptoms.
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	Dutch Eating Behavior Questionnaire = DEBQ; The Dutch Eating Behavior Questionnaire (DEBQ) is a 33-item self-report questionnaire developed by Van Strien et al. (1986), to assess three distinct eating behaviors in adults: 1. emotional eating,; 2. external eating,; 3. restrained eating. Items on the DEBQ range from 1 (never) to 5 (very often), with higher scores indicating greater endorsement of the eating behavior.
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	Impact of Weight on Quality Of Life : IWQOL It includes 36 items divided into five dimensions: physical, sexual, psychosocial,relationship with food, and experience of the diet.; It allows us to assess the effects of dietary treatments on quality of life.. Each item is rated from 1 to 5, and each dimension is weighted to obtain a score out of 100. A high score indicates a good perceived quality of life related to obesity.

Trial Locations

Locations (1)

Centre Hospitalier Métropole Savoie; 🇫🇷 Chambery, Savoie, France