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

NCT ID: NCT06951893

Last Updated: 2025-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2030-11-01

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

each patient will complete questionary 6month before surgery, and then 12, 18 and 24 months after the surgery
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Hospital Anxiety and Depression Scale

Intervention Type OTHER

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

Dutch Eating Behaviour Questionnary

Intervention Type 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

Impact of Weight on Quality Of Life

Intervention Type 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.

body schema

Intervention Type 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.

body mass index

Intervention Type OTHER

patient weighing at each visit

waist size

Intervention Type OTHER

waist size measure

Interventions

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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.

Intervention Type OTHER

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

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

body mass index

patient weighing at each visit

Intervention Type OTHER

waist size

waist size measure

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Metropole Savoie

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cécile BOSSU ESTOUR

Role: PRINCIPAL_INVESTIGATOR

CH Metropole Savoie

Locations

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Centre Hospitalier Métropole Savoie

Chambéry, Savoie, France

Site Status

Countries

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France

Central Contacts

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Fabienne PRIEUR

Role: CONTACT

+33(0)479965999 ext. +33

Facility Contacts

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Role: primary

+33479965999

Other Identifiers

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CHMS24006

Identifier Type: -

Identifier Source: org_study_id

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