ClinicalTrials.gg
RecruitingNCT06426290PREDI-CHIRBAUpdated Aug 20, 2024

Prediction of Response to Bariatric Surgery in Patients With Severe Obesity

An observational study in Body Weight Changes, sponsored by Centre Hospitalier de Moulins Yzeure. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-20.

Sponsored by Centre Hospitalier de Moulins Yzeure · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started May 2024; still recruiting 2 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
360
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Body Weight Changes

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03

In context

Body Weight Changes

231 studies on the registry are indexed under Body Weight Changes; 30 are open to participants now.

This study's planned enrollment of 360 is above the median of 180 across 45 observational studies indexed under Body Weight Changes.

Browse Body Weight Changes studies →

Lead sponsor

This is the only study on the registry with Centre Hospitalier de Moulins Yzeure as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
  • Informed of the study, having agreed to participate and not having opposed the use of their data

Exclusion criteria

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 .
  • Patient unable to understand the study or complete the post-operative phase visit
  • Persons under guardianship or curators or under legal protection
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
360 participants (estimated)
Patient registry
No

Interventions

  • Behavioralpost-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)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At inclusion psychological consultation

Secondary outcomes

  1. 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.

    Time frame: At inclusion psychological consultation

  2. 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.

    Time frame: At inclusion psychological consultation

  3. 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.

    Time frame: At inclusion psychological consultation

  4. 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.

    Time frame: At inclusion psychological consultation

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

    Using the MMPI-2-RF preoperative questionnaire

    Time frame: At inclusion psychological consultation

  6. 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

    Time frame: At inclusion psychological consultation

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06426290
Lead sponsor
Centre Hospitalier de Moulins Yzeure
Responsible party
Sponsor
First posted
May 23, 2024
Start date
May 10, 2024
Primary completion
Mar 2026 (estimated)
Completion
Dec 2027 (estimated)
Last update
Aug 20, 2024

Study contacts

Virginie ALLASSEUR, psychologist
Contact
v.allasseur@ch-moulins-yzeure.fr
33478357884
Sophie PAGNON, CRA
Contact
s.pagnon@ch-moulins-yzeure.fr
33470357822
Virginie ALLASSEUR, psychologist
principal investigator · Centre Hospitalier de Moulins Yzeure

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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