## Protocol Section
### Identification Module
**NCT ID:** NCT06426290

**Acronym:** PREDI-CHIRBA

**Brief Title:** 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

#### Organization Study ID Info
**ID:** CHMY-2021-06
#### Organization
**Class:** OTHER
**Full Name:** Centre Hospitalier de Moulins Yzeure
### Status Module
#### Completion Date
**Date:** 2027-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-03

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Centre Hospitalier de Moulins Yzeure

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Body Weight Changes

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** OTHER

#### Enrollment Info

**Count:** 360

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** 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)

**Name:** post-surgery psychological evaluation

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Depressive dimension assessed by the preoperative MMPI-2-RF questionnaire and compared to the same dimension from post-surgery psychological questionnaires.

**Measure:** Determine the predictive value of depressive symptomatology dimension on the evolution of BMI.

**Time Frame:** At inclusion psychological consultation

#### Secondary Outcomes

**Description:** Anxiety dimension assessed by the preoperative MMPI-2-RF questionnaire and compared to the same dimension from post-surgery psychological questionnaires.

**Measure:** Determine the predictive value of anxiety symptomatology dimension on the evolution of BMI

**Time Frame:** At inclusion psychological consultation

**Description:** Eating behaviour dimension assessed by the preoperative MMPI-2-RF questionnaire and compared to the same dimension from post-surgery psychological questionnaires.

**Measure:** Determine the predictive value of eating behavior dimension on the evolution of BMI

**Time Frame:** At inclusion psychological consultation

**Description:** Quality of life dimension assessed by the preoperative MMPI-2-RF questionnaire and compared to the same dimension from post-surgery psychological questionnaires.

**Measure:** Determine the predictive value of quality of life dimension on the evolution of BMI

**Time Frame:** At inclusion psychological consultation

**Description:** satisfaction and body perception dimensions assessed by the preoperative MMPI-2-RF questionnaire and compared to the same dimension from post-surgery psychological questionnaires.

**Measure:** Determine the predictive value of satisfaction and body perception dimensions on the evolution of BMI

**Time Frame:** At inclusion psychological consultation

**Description:** Using the MMPI-2-RF preoperative questionnaire

**Measure:** Determine typical profiles of patients who have finally denied surgery apart from medical contraindications

**Time Frame:** At inclusion psychological consultation

**Description:** Using the MMPI-2-RF preoperative questionnaire

**Measure:** Identify the risk factors for abandonment or difficulties after the intervention, in order to establish appropriate preoperative treatments before surgery

**Time Frame:** At inclusion psychological consultation

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** v.allasseur@ch-moulins-yzeure.fr

**Name:** Virginie ALLASSEUR, psychologist

**Phone:** 33478357884

**Role:** CONTACT

**Contact 2:**

**Email:** s.pagnon@ch-moulins-yzeure.fr

**Name:** Sophie PAGNON, CRA

**Phone:** 33470357822

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Moulins

**Contacts:**

***Contact 1:***

- **Email:** v.allasseur@ch-moulins-yzeure.fr

- **Name:** psychologist

- **Phone:** 33478357884

- **Role:** CONTACT

***Contact 2:***

- **Email:** s.pagnon@ch-moulins-yzeure.fr

- **Name:** Sophie PAGNON, CRA

- **Phone:** 33470357822

- **Role:** CONTACT

***Contact 3:***

- **Name:** Virginie ALLASSEUR

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** France

**Facility:** Centre hospitalier Moulins-Yzeure

**Status:** RECRUITING

**Zip:** 03000

#### Overall Officials

**Official 1:**

**Affiliation:** Centre Hospitalier de Moulins Yzeure

**Name:** Virginie ALLASSEUR, psychologist

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009765

- Term: Obesity

- ID: D000050177

- Term: Overweight

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M5114

- Name: Body Weight

- Relevance: HIGH

- As Found: Body Weight

- ID: M12702

- Name: Obesity, Morbid

- Relevance: HIGH

- As Found: Severe Obesity

- ID: M5115

- Name: Body Weight Changes

- Relevance: HIGH

- As Found: Body Weight Changes

- ID: M26186

- Name: Overweight

- Relevance: LOW

- As Found: Unknown

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009767

- Term: Obesity, Morbid

- ID: D000001835

- Term: Body Weight

- ID: D000001836

- Term: Body Weight Changes

### Misc Info Module

- Version Holder: 2024-05-31
