Body Weight ChangesPREDI-CHIRBANCT06426290
Prediction of Response to Bariatric Surgery in Patients With Severe Obesity
An observational study of Body Weight Changes, run by Centre Hospitalier de Moulins Yzeure at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Body Weight Changes
- What is being tested?
- post-surgery psychological evaluation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 360 participants
- Where
- 1 siteFrance
- Study dates
- 10 May 2024to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre hospitalier Moulins-Yzeure
Moulins, 03000
psychologist, 33478357884, v.allasseur@ch-moulins-yzeure.fr
Sophie PAGNON, CRA, 33470357822, s.pagnon@ch-moulins-yzeure.fr
About this study
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
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.
- Conditions
- Body Weight Changes
- Being tested
- post-surgery psychological evaluation
- Medical subject headings
- Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
post-surgery psychological evaluationBehavioural
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At inclusion psychological consultation
Secondary outcomes (6)
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.
Measured: At inclusion psychological consultation
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.
Measured: At inclusion psychological consultation
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.
Measured: At inclusion psychological consultation
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.
Measured: At inclusion psychological consultation
Determine typical profiles of patients who have finally denied surgery apart from medical contraindications
Using the MMPI-2-RF preoperative questionnaire
Measured: At inclusion psychological consultation
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
Measured: At inclusion psychological consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start10 May 2024
- Primary completionMar 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Weight ChangesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Moulins Yzeure
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Virginie ALLASSEUR, psychologist, Principal investigator, Centre Hospitalier de Moulins Yzeure
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426290
- Sponsor's protocol ID
- CHMY-2021-06
- Acronym
- PREDI-CHIRBA
- Status last verified
- Aug 2024
- First submitted
- 16 May 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06426290
- Acronym / sponsor ID
- PREDI-CHIRBA / CHMY-2021-06
- Conditions
- Body Weight Changes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Centre Hospitalier de Moulins YzeureUniversity, hospital or other
- Study start
- 10 May 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| post-surgery psychological evaluationFollowing 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) | Behavioural | – |
Primary outcome
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.
6 secondary outcomes
Determine the predictive value of anxiety symptomatology dimension on the evolution of BMI
Time frame: At inclusion psychological consultation
Determine the predictive value of eating behavior dimension on the evolution of BMI
Time frame: At inclusion psychological consultation
Determine the predictive value of quality of life dimension on the evolution of BMI
Time frame: At inclusion psychological consultation
Determine the predictive value of satisfaction and body perception dimensions on the evolution of BMI
Time frame: At inclusion psychological consultation
Determine typical profiles of patients who have finally denied surgery apart from medical contraindications
Time frame: At inclusion psychological consultation
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Virginie ALLASSEUR, psychologist principal investigator
Centre Hospitalier de Moulins Yzeure
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Weight Changes, run by Centre Hospitalier de Moulins Yzeure at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Virginie ALLASSEUR, psychologist (33478357884, v.allasseur@ch-moulins-yzeure.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the predictive value of depressive symptomatology dimension on the evolution of BMI. (time frame: At inclusion psychological consultation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.