Prediction of Response to Bariatric Surgery in Patients With Severe Obesity

Body Weight Changes Clinical Trial

— PREDI-CHIRBA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06426290
• Other study ID #: CHMY-2021-06
• Status: Recruiting
• Start date: May 30, 2024
• Est. completion date: December 2027

Study information

• Verified date: May 2024
• Source: Centre Hospitalier de Moulins Yzeure
• Contact: Virginie ALLASSEUR, psychologist
• Phone: 33478357884
• Email: v.allasseur[@]ch-moulins-yzeure.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: December 2027
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Body Weight Changes
• Obesity, Morbid

Intervention

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)

Locations

Country	Name	City	State
France	Centre hospitalier Moulins-Yzeure	Moulins

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier de Moulins Yzeure

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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