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Recruiting NCT06426290

Prediction of Response to Bariatric Surgery in Patients With Severe Obesity

— Observational Body Weight Changes

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: post-surgery psychological evaluation.
Who it may be relevant to
Registry conditions: Body Weight Changes. 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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Official title

Prediction of Response to Bariatric Surgery Treatment in Patients Suffering From Severe Obesity, Based on the Scales of the MMPI-2-RF Questionnaire Carried Out Preoperatively

Overview

This is an retrospective and prospective (ambispective) study with data collection from volunteer patients who passed an MMPI-2-RF (Minnesota Multiphasic Personality Inventory-2-Restructured form) questionnaire in the preoperative phase of a bariatric surgery project. The evolution of their BMI will be correlated to psychological dimensions collected in patient questionnaires, before and after bariatric surgery. The presence of possible risk factors such as depression, anxiety, eating disorders, quality of life, satisfaction and the perception of body, could make it possible to establish adapted therapies before surgery, in order to attenuate or eliminate the presence of these factors, and improve BMI evolution and bariatric surgery success.

Detailed description

A first phase of data collection will concern data from the MMPI-2-RF questionnaire as well as clinical data, collected during preoperative consultations.

For the second phase, post-operative data will be collected, during a routine follow-up consultation in the nutrition Department, where specific psychological questionnaires are taken by patients.

Interventions

  • Behavioral post-surgery psychological evaluation
    Following questionnaires will be done : Patient Health Questionnaire (PHQ-9) Generalized Anxiety Disorder (GAD-7) Three Factor Eating Questionnaire (TFEQ-R21) Quality of life for obesity and dietetic questionnaire (EQVOD) Body Esteem Scale (BES) Figure Rating Scale (auto-questionnaire)

Primary outcome measures

  • Determine the predictive value of depressive symptomatology dimension on the evolution of BMI. [Time frame: At inclusion psychological consultation]
Secondary outcome measures (6)
  • Determine the predictive value of anxiety symptomatology dimension on the evolution of BMI [Time frame: At inclusion psychological consultation]
  • Determine the predictive value of eating behavior dimension on the evolution of BMI [Time frame: At inclusion psychological consultation]
  • Determine the predictive value of quality of life dimension on the evolution of BMI [Time frame: At inclusion psychological consultation]
  • Determine the predictive value of satisfaction and body perception dimensions on the evolution of BMI [Time frame: At inclusion psychological consultation]
  • Determine typical profiles of patients who have finally denied surgery apart from medical contraindications [Time frame: At inclusion psychological consultation]
  • Identify the risk factors for abandonment or difficulties after the intervention, in order to establish appropriate preoperative treatments before surgery [Time frame: At inclusion psychological consultation]

Eligibility criteria

Inclusion criteria

  • Having been treated in the Nutrition department for severe obesity and considered for bariatric surgery because having met the criteria validating bariatric surgery:
  • Having passed the MMPI-2-RF questionnaire between January 1, 2014 and December 31, 2023 in the preoperative phase, as part of psychological follow-up
  • Having benefited from bariatric surgery or patients who have abandoned the surgery plan for a reason other than a medical contraindication.
  • Informed of the study, having agreed to participate and not having opposed the use of their data

Exclusion criteria

  • Subjects who generated an invalid MMPI-2-RF questionnaire, according to the test validity criteria (verified by the principal investigator)
  • Subjects who expressly objected to the use of their data for this study
  • Subjects who have not undergone bariatric surgery due to a medical contraindication.
  • Patient unable to understand the study or complete the post-operative phase visit
  • Persons under guardianship or curators or under legal protection

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

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Centre hospitalier Moulins-Yzeure — Moulins

Identifiers

NCT: NCT06426290 · CHMY-2021-06

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗