Prediction of Response to Bariatric Surgery in Patients With Severe Obesity

NCT06426290 | Recruiting

• 1 other identifier: CHMY-2021-06
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Body Weight Changes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Determine the predictive value of anxiety symptomatology dimension on the evolution of BMI

  At inclusion psychological consultation

• Determine the predictive value of eating behavior dimension on the evolution of BMI

  At inclusion psychological consultation

• Determine the predictive value of quality of life dimension on the evolution of BMI

  At inclusion psychological consultation

• Determine the predictive value of satisfaction and body perception dimensions on the evolution of BMI

  At inclusion psychological consultation

• Determine typical profiles of patients who have finally denied surgery apart from medical contraindications

  At inclusion psychological consultation

Interventions

post-surgery psychological evaluation BEHAVIORAL

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier de Moulins Yzeure: lead

Study Sites (1)

Centre hospitalier Moulins-Yzeure

Moulins, 03000, France

RECRUITING

MeSH Terms

Conditions

Body Weight Changes

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Virginie ALLASSEUR, psychologist

  Centre Hospitalier de Moulins Yzeure

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Virginie ALLASSEUR, psychologist

CONTACT

33478357884; v.allasseur@ch-moulins-yzeure.fr

Sophie PAGNON, CRA

CONTACT

33470357822; s.pagnon@ch-moulins-yzeure.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 23, 2024
• Study Start: May 10, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

FR (1)