Prediction of Response to Bariatric Surgery in Patients With Severe Obesity (PREDI-CHIRBA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Body Weight Changes
• Intervention / Treatment: Behavioral: post-surgery psychological evaluation

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.

• Study Type: Observational
• Enrollment (Estimated): 360

Contacts and Locations

• Study Contact: Name: Virginie ALLASSEUR, psychologist; Phone Number: 33478357884; Email: v.allasseur@ch-moulins-yzeure.fr
• Study Contact Backup: Name: Sophie PAGNON, CRA; Phone Number: 33470357822; Email: s.pagnon@ch-moulins-yzeure.fr

Study Locations

• France
  • Moulins, France, 03000
    • Recruiting
    • Centre hospitalier Moulins-Yzeure
    • Contact: Sophie PAGNON, CRA; Phone Number: 33470357822; Email: s.pagnon@ch-moulins-yzeure.fr
    • Contact: psychologist; Phone Number: 33478357884; Email: v.allasseur@ch-moulins-yzeure.fr
    • Principal Investigator: Virginie ALLASSEUR

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

Patients with severe obesity : BMI > 40 kg/m2 or > 35 kg/m2 associated with at least one comorbidity likely to be improved after surgery.

• Failure of well-conducted medical, nutritional, dietetic and psychotherapeutic monitoring for 6-12 months
• Lack of sufficient weight loss or failure to maintain weight loss

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the predictive value of depressive symptomatology dimension on the evolution of BMI.	Depressive dimension assessed by the preoperative MMPI-2-RF questionnaire and compared to the same dimension from post-surgery psychological questionnaires.	At inclusion psychological consultation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the predictive value of anxiety symptomatology dimension on the evolution of BMI	Anxiety dimension assessed by the preoperative MMPI-2-RF questionnaire and compared to the same dimension from post-surgery psychological questionnaires.	At inclusion psychological consultation
Determine the predictive value of eating behavior dimension on the evolution of BMI	Eating behaviour dimension assessed by the preoperative MMPI-2-RF questionnaire and compared to the same dimension from post-surgery psychological questionnaires.	At inclusion psychological consultation
Determine the predictive value of quality of life dimension on the evolution of BMI	Quality of life dimension assessed by the preoperative MMPI-2-RF questionnaire and compared to the same dimension from post-surgery psychological questionnaires.	At inclusion psychological consultation
Determine the predictive value of satisfaction and body perception dimensions on the evolution of BMI	satisfaction and body perception dimensions assessed by the preoperative MMPI-2-RF questionnaire and compared to the same dimension from post-surgery psychological questionnaires.	At inclusion psychological consultation
Determine typical profiles of patients who have finally denied surgery apart from medical contraindications	Using the MMPI-2-RF preoperative questionnaire	At inclusion psychological consultation
Identify the risk factors for abandonment or difficulties after the intervention, in order to establish appropriate preoperative treatments before surgery	Using the MMPI-2-RF preoperative questionnaire	At inclusion psychological consultation

Collaborators and Investigators

• Sponsor: Centre Hospitalier de Moulins Yzeure
• Investigators: Principal Investigator: Virginie ALLASSEUR, psychologist, Centre Hospitalier de Moulins Yzeure

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 16, 2024
• First Submitted That Met QC Criteria: May 21, 2024
• First Posted (Actual): May 23, 2024

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Obesity; Body Weight; Obesity, Morbid; Body Weight Changes
• Other Study ID Numbers: CHMY-2021-06

Drug and device information, study documents

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