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

NCT06951893 | Not Yet Recruiting

• 1 other identifier: CHMS24006
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

GEROM73; PHENOBEQOL73

Outcome Measures

Primary Outcomes (1)

• 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)

  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.

  one month befre surgery to 24 month post surgery

Secondary Outcomes (3)

• 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

Other Outcomes (2)

• 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.

  at 6 and 1 month before surgery, and at 12, 18 and 24 months before surgery

• 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

  at 6 and 1 month before surgery, and at 12, 18 and 24 months before surgery

Study Arms (1)

phenotype of patients during the GEROM73 program

EXPERIMENTAL

Anxiety, Depression, Eating disorders, Impact of Weight on Quality Of Life.Patients' weight, Body Mass index and Body schema

Other: Hospital Anxiety and Depression Scale; Other: Dutch Eating Behaviour Questionnary; Other: Impact of Weight on Quality Of Life; Other: body schema; Other: body mass index; Other: waist size

Interventions

Hospital Anxiety and Depression Scale OTHER

It is a self-assessment questionnaire to identify the existence of anxious and depressive symptoms and to assess their severity.

phenotype of patients during the GEROM73 program

Dutch Eating Behaviour Questionnary OTHER

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

phenotype of patients during the GEROM73 program

Impact of Weight on Quality Of Life OTHER

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.

phenotype of patients during the GEROM73 program

body schema OTHER

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.

phenotype of patients during the GEROM73 program

body mass index OTHER

patient weighing at each visit

phenotype of patients during the GEROM73 program

waist size OTHER

waist size measure

phenotype of patients during the GEROM73 program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Metropole Savoie: lead

Study Sites (1)

Centre Hospitalier Métropole Savoie

Chambéry, Savoie, 73011, France

Location

MeSH Terms

Conditions

Obesity, Morbid; Obesity; Overweight

Interventions

4-amino-4'-hydroxylaminodiphenylsulfone; Body Mass Index

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Anthropometry; Investigative Techniques; Physiological Phenomena; Biometry; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Cécile BOSSU ESTOUR

  CH Metropole Savoie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabienne PRIEUR

CONTACT

+33(0)479965999; urc@ch-metropole-savoie.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: each patient will complete questionary 6month before surgery, and then 12, 18 and 24 months after the surgery

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: April 30, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 1, 2030
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)