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Recruiting NCT06951893

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

No phase Interventional Obesity, Morbid Obesity and Overweight Bariatric Surgery Bariatric Surgery Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hospital Anxiety and Depression Scale, Dutch Eating Behaviour Questionnary, Impact of Weight on Quality Of Life, body schema.
Who it may be relevant to
Registry conditions: Obesity, Morbid, Obesity and Overweight, Bariatric Surgery, Bariatric Surgery Patients. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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

Primary outcome measures

  • 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) [Time frame: one month befre surgery to 24 month post surgery]
Secondary outcome measures (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. [Time frame: 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. [Time frame: 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. [Time frame: 12, 18 and 24 month after surgery]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • Centre Hospitalier Métropole Savoie — Chambéry

Identifiers

NCT: NCT06951893 · CHMS24006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗