Identification of Pre-surgical Phenotypic Indicators Predictive of Quality of Life Trajectories in Obese Patients Following Bariatric Surgery (PHENOBEQOL73)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity, Morbid; Bariatric Surgery; Bariatric Surgery Patient; Obesity and Overweight; Bariatric Surgery Patients; Bariatric Surgery (Sleeve Gastrectomy ); Bypass, Gastric
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Estimated): 165
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fabienne PRIEUR; Phone Number: +33 +33(0)479965999; Email: urc@ch-metropole-savoie.fr

Study Locations

• France
  • Savoie
    • Chambery, Savoie, France, 73011
      • Centre Hospitalier Metropole Savoie
      • Contact: Phone Number: +33479965999; Email: fabienne.prieur@ch-metropole-savoie.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

Other: 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.; 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; 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.; 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.; Other: body mass index; patient weighing at each visit; Other: waist size; waist size measure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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: emotional eating,; external eating,; restrained eating. Items on the DEBQ range from 1 (never) to 5 (very often), with higher scores indicating greater endorsement of the eating behavior.	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.	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.	12, 18 and 24 month after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Body schema measured by SKIN. For each participant, an average difference between the perceived distance and the actual applied distance is calculated for each body part (thigh, abdomen, arm, shoulder (neutral zone)). A positive difference corresponds to an oversizing of the tactile surface of the body, while a negative difference corresponds to an undersizing of the tactile surface of the body	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	Body schema measured by SKIN. For each participant, an average difference between the perceived distance and the actual applied distance is calculated for each body part (thigh, abdomen, arm, shoulder (neutral zone)). A positive difference corresponds to an oversizing of the tactile surface of the body, while a negative difference corresponds to an undersizing of the tactile surface of the body	at 6 and 1 month before surgery, and at 12, 18 and 24 months before surgery

Collaborators and Investigators

• Sponsor: Centre Hospitalier Metropole Savoie
• Investigators: Principal Investigator: Cécile BOSSU ESTOUR, CH Métropole Savoie

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 1, 2030

Study Registration Dates

• First Submitted: April 23, 2025
• First Submitted That Met QC Criteria: April 23, 2025
• First Posted (Actual): April 30, 2025

Study Record Updates

• Last Update Posted (Actual): May 7, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: GEROM73; PHENOBEQOL73
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Obesity, Morbid
• Other Study ID Numbers: CHMS24006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No