Prediction of Response to Bariatric Surgery in Patients With Severe Obesity

NCT ID: NCT06426290

Last Updated: 2024-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

360 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-10

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Body Weight Changes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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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)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier de Moulins Yzeure

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Virginie ALLASSEUR, psychologist

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier de Moulins Yzeure

Locations

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Centre hospitalier Moulins-Yzeure

Moulins, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Virginie ALLASSEUR, psychologist

Role: CONTACT

33478357884

Sophie PAGNON, CRA

Role: CONTACT

33470357822

Facility Contacts

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psychologist

Role: primary

33478357884

Sophie PAGNON, CRA

Role: backup

33470357822

Other Identifiers

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CHMY-2021-06

Identifier Type: -

Identifier Source: org_study_id

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