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NCT Number: NCT06426290

Prediction of Response to Bariatric Surgery in Patients With Severe Obesity

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Determine the predictive value of depressive symptomatology dimension on the evolution of BMI.

    Time frame: At inclusion psychological consultation

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

Secondary outcomes

  1. Determine the predictive value of anxiety symptomatology dimension on the evolution of BMI

    Time frame: At inclusion psychological consultation

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

  2. Determine the predictive value of eating behavior dimension on the evolution of BMI

    Time frame: At inclusion psychological consultation

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

  3. Determine the predictive value of quality of life dimension on the evolution of BMI

    Time frame: At inclusion psychological consultation

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

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

    Time frame: At inclusion psychological consultation

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

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

    Time frame: At inclusion psychological consultation

    Using the MMPI-2-RF preoperative questionnaire

  6. 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

    Using the MMPI-2-RF preoperative questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Sophie PAGNON, CRA

CONTACT

[email protected]

33470357822

Virginie ALLASSEUR, psychologist

CONTACT

[email protected]

33478357884

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Moulins Yzeure

Other

Registry information

Official study 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

Acronym: PREDI-CHIRBA

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 23, 2024
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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