Clinical trial NCT06426290: Prediction of Response to Bariatric Surgery in Patients With Severe Obesity
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Body Weight Changes
Lead sponsor: Centre Hospitalier de Moulins Yzeure
Sponsor class: OTHER
First posted: 2024-05-23
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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

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.

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.

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

Primary outcomes:
measure: Determine the predictive value of depressive symptomatology dimension on the evolution of BMI.
timeFrame: At inclusion psychological consultation
Secondary outcomes:
measure: Determine the predictive value of anxiety symptomatology dimension on the evolution of BMI
timeFrame: At inclusion psychological consultation
measure: Determine the predictive value of eating behavior dimension on the evolution of BMI
timeFrame: At inclusion psychological consultation
measure: Determine the predictive value of quality of life dimension on the evolution of BMI
timeFrame: At inclusion psychological consultation
measure: Determine the predictive value of satisfaction and body perception dimensions on the evolution of BMI
timeFrame: At inclusion psychological consultation
measure: Determine typical profiles of patients who have finally denied surgery apart from medical contraindications
timeFrame: At inclusion psychological consultation
measure: Identify the risk factors for abandonment or difficulties after the intervention, in order to establish appropriate preoperative treatments before surgery
timeFrame: At inclusion psychological consultation
Other outcomes:
Locations:
city: Moulins
country: France
facility: Centre hospitalier Moulins-Yzeure
Study officials:
affiliation: Centre Hospitalier de Moulins Yzeure
name: Virginie ALLASSEUR, psychologist
role: PRINCIPAL_INVESTIGATOR
References: