ObesityBARIATHYPNOSENCT03485469
The Impact of the Hypnosis on the Loss of Weight at Patients in Failure of Bariatric Surgery
A study testing Hypnosis in people with Obesity and Bariatric Surgery, run by University Hospital, Montpellier at 5 sites in France.
Trial summary
The therapeutic problem of obesity is weight control, a major difficulty, involving a significant change in eating behavior. A number of studies show that there are many factors of resistance to weight loss whether they are physiological, genetic, environmental pressure related, or psychological and behavioral. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Bariatric Surgery
- What is being tested?
- Hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesFrance
- Study dates
- 29 Mar 2019to 23 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obese patient (BMI = 30 kg / m ²)
- 18 - 65 years ( inclusive borders)
- Patient in failure of bariatric surgery and in which no surgical resumption can be proposed (in view of Reinhold's classification, the failure will be considered as a loss of overweight lower than 50 % in two years further to a bariatric surgery).
- Informed consent
- Patient in measure to realize all the visits and to follow the procedures of the study - Subject affiliated to a social security system
Who cannot join
- Pregnancy current or planned during the duration of the study, pregnant or breast-feeding women
- Craniopharyngioma or any other evolutionary malignant pathology, or chronic illness in decompensation phase
- Strong probability of not compliance to the protocol or drop-out
- Psychiatric pathology of dissociated type (schizophrenia; psychosis, bipolarity …)
- Sensory (hearing, visual) or cognitive deficits susceptible to hinder the progress of the sessions.
- Incapacity to understand the nature and the purpose of the study and\or communication difficulties with the investigator
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- Patient having already benefited from a coverage by hypnotherapy for loss of weight
- Taken by treatment having an impact on the loss of weight (corticoid, antithyroid …)
- Major protected by the law or considered vulnerable (under guardianship)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHR Saint Pierre - maladies métaboliques
La Réunion
Cécile GODEL
Montpellier
Orléans University Hospital
Orléans
Reims University Hospital
Reims
Toulouse University Hospital
Toulouse
About this study
Official title: A Prospective Randomized Clinical Trial, in Open-label, Multicenter, Estimating the Impact of the Hypnosis on the Loss of Weight at Patients in Failure of Bariatric Surgery
The therapeutic problem of obesity is weight control, a major difficulty, involving a significant change in eating behavior. A number of studies show that there are many factors of resistance to weight loss whether they are physiological, genetic, environmental pressure related, or psychological and behavioral. For some patients, the surgical approach seems the best alternative. Indeed, bariatric surgery is an effective therapeutic weapon in patients with morbid obesity. However, it has been shown that approximately 25% of patients are failing at two years of this surgery (Reinhold's index). Some of the failed subjects may benefit from surgical revision. As for the others, no intervention is currently proposed to them. Studies have shown that the psychological profile of patients who are candidates for bariatric surgery is predominantly impulsive, very anxious with a tendency to depression. The stress level of these patients would be important, and they would have low self-esteem. This study hypothesize that, in these patients, the establishment of hypnotherapeutic management associated with the usual dietary monitoring could modify eating habits thus promoting weight loss and an improvement in self-esteem , stress and anxiety compared to dietary monitoring alone.
Read the detailed description
he therapeutic problem of obesity is weight control, a major difficulty, involving a significant change in eating behavior. A number of studies show that there are many factors of resistance to weight loss whether they are physiological, genetic, environmental pressure related, or psychological and behavioral. For some patients, the surgical approach seems the best alternative. Indeed, bariatric surgery is an effective therapeutic weapon in patients with morbid obesity. However, it has been shown that approximately 25% of patients are failing at two years of this surgery (Reinhold's index). Some of the failed subjects may benefit from surgical revision. As for the others, no intervention is currently proposed to them. Studies have shown that the psychological profile of patients who are candidates for bariatric surgery is predominantly impulsive, very anxious with a tendency to depression. The stress level of these patients would be important, and they would have low self-esteem. This study hypothesize that, in these patients, the establishment of hypnotherapeutic management associated with the usual dietary monitoring could modify eating habits thus promoting weight loss and an improvement in self-esteem , stress and anxiety compared to dietary monitoring alone.
There are still no studies assessing the impact of hypnotherapeutic management and self-hypnosis on the weight curve, self-esteem, stress, anxiety, or the quality of life of patients Obese in failure of bariatric surgery.
It is an Interventional, prospective, multi-center, controlled, randomized, open-label study with 2 parallel arms, evaluating the efficacy of hypnotherapeutic management in patients with bariatric surgery failure, compared to dietary monitoring alone.
Number of visits: 13 visits are planned: 1 visit of inclusion, a visit ensuring the first dietary follow-up, 9 hypnosis sessions (for the experimental group), two visits dedicated to the collection of the judgment criteria. Each patient is followed for 12 months.
The estimated duration of recruitment is 18 months.
- Conditions
- Obesity, Bariatric Surgery
- Being tested
- Hypnosis, Standard Care
- Keywords
- Obesity, bariatric surgery, Hypnosis
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisBehavioural
There ar 10 hypnosis sessions :
- 1st session of hypnosis : relaxation and orientation towards "emotional cleansing".
- 2nd session of hypnosis: oriented towards digestion, physical and psychological
- 3rd session of hypnosis: oriented towards the feeling of security.
- 4th session of hypnosis: self-esteem oriented.
- 5th hypnosis session: oriented towards emotional management.
- 6th hypnosis session: oriented towards self-confidence.
- 7th hypnosis session: oriented towards the completion of the projects.
- 8th, 9th and 10th sessions: concern the learning of self-hypnosis and autonomy. A USB key containing the induction of a session of autohypnosis will be given to the subject to promote the continuation of home-made auto-hypnosis.
Standard CareBehavioural
The dietary advice given during these dietary consultations is part of the standard care adapted to patients who have undergone bariatric surgery while increasing the frequency of consultations (Fractionation of meals, Volume of meals, Taking meals, Drinks, Food diversity)
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Other | The control group will benefit from a standard care dietary consultation in the service and 9 dietary consultations by phone every 15 days. Receives: Behavioral: Standard Care |
| Hypnosis | Other | The experimental group will benefit from a dietary consultation in the service, 9 dietary consultations by telephone every 15 days to which will be associated 7 individual sessions of hypnosis and 3 individual sessions of learning to autohypnosis. A recording containing the induction of a self-hypnosis session will be given to the subject at the end of the 10 sessions, in order to promote the continuation of home-made autohypnosis. Receives: Behavioral: Hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight in 5 months
Patient weight (in kg) measurement will be performed on the same scale by staff who are unaware of the patient's randomization group.
Measured: 5 months
Secondary outcomes (6)
Change in weight in 12 months
Patient weight (in kg) measurement will be performed on the same scale by staff who are unaware of the patient's randomization group.
Measured: 12 months
Self-esteem
It will be evaluated by the scale of "Rosenberg's Self Esteem Scale" (1965) validated in French. It represents an assessment of the overall self-esteem that the person can have of herself. The scale includes 10 statements measured on a scale of 1 to 4.
Measured: 12 months
Evolution of Quality of life
it will be evaluated by the variation of the scores obtained in the self-questionnaire EQVOD (Echelle de Qualité de Vie, Obésité et Diététique) of O. Ziegler et al (2005). It's a specific quality of life questionnaire for obese people.
Measured: 12 months
Anxiety and depressive state
It will be evaluated by the Hospital Anxiety and Depression Scale - HAD (Sigmond et al, 1983). It is a self-administered 14-item questionnaire that assesses the current level of depressive and anxious symptomatology by eliminating somatic depressions that may skew assessments.
Measured: 12 months
Feeding behavior
It will be evaluated by the TFEQ-R21 (Three-Factor Eating Questionnaire) self-questionnaire (Cappelleri et al, 2009).
TFEQ has been validated in the general population and has been used in many studies. It explores three components of eating behavior: cognitive restriction, uncontrolled eating, and emotional eating.
Measured: 12 months
Patients' satisfaction with their care
It will be evaluated the Likert scales of the self-satisfaction questionnaire. It is composed of 5 Likert scales coded from 1 to 5 which will be analyzed separately
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start29 Mar 2019
- Primary completion25 Jan 2024
- Study completion23 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David NOCCA, PU-PH, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485469
- Sponsor's protocol ID
- RECHMPL17_0024
- Other IDs
- UF 9793
- Acronym
- BARIATHYPNOSE
- Status last verified
- Jun 2026
- First submitted
- 26 Mar 2018
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Clinical Trial, in Open-label, Multicenter, Estimating the Impact of the Hypnosis on the Loss of Weight at Patients in Failure of Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03485469
- Acronym / sponsor ID
- BARIATHYPNOSE / RECHMPL17_0024
- Conditions
- Obesity, Bariatric Surgery
- Keywords
- Obesity, bariatric surgery, Hypnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 29 Mar 2019 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 23 Jan 2025 (actual)
- First posted
- 2 Apr 2018 (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.
The therapeutic problem of obesity is weight control, a major difficulty, involving a significant change in eating behavior. A number of studies show that there are many factors of resistance to weight loss whether they are physiological, genetic, environmental pressure related, or psychological and behavioral. For some patients, the surgical approach seems the best alternative. Indeed, bariatric surgery is an effective therapeutic weapon in patients with morbid obesity. However, it has been shown that approximately 25% of patients are failing at two years of this surgery (Reinhold's index). Some of the failed subjects may benefit from surgical revision. As for the others, no intervention is currently proposed to them. Studies have shown that the psychological profile of patients who are candidates for bariatric surgery is predominantly impulsive, very anxious with a tendency to depression. The stress level of these patients would be important, and they would have low self-esteem. This study hypothesize that, in these patients, the establishment of hypnotherapeutic management associated with the usual dietary monitoring could modify eating habits thus promoting weight loss and an improvement in self-esteem , stress and anxiety compared to dietary monitoring alone.
Detailed description
he therapeutic problem of obesity is weight control, a major difficulty, involving a significant change in eating behavior. A number of studies show that there are many factors of resistance to weight loss whether they are physiological, genetic, environmental pressure related, or psychological and behavioral. For some patients, the surgical approach seems the best alternative. Indeed, bariatric surgery is an effective therapeutic weapon in patients with morbid obesity. However, it has been shown that approximately 25% of patients are failing at two years of this surgery (Reinhold's index). Some of the failed subjects may benefit from surgical revision. As for the others, no intervention is currently proposed to them. Studies have shown that the psychological profile of patients who are candidates for bariatric surgery is predominantly impulsive, very anxious with a tendency to depression. The stress level of these patients would be important, and they would have low self-esteem. This study hypothesize that, in these patients, the establishment of hypnotherapeutic management associated with the usual dietary monitoring could modify eating habits thus promoting weight loss and an improvement in self-esteem , stress and anxiety compared to dietary monitoring alone.
There are still no studies assessing the impact of hypnotherapeutic management and self-hypnosis on the weight curve, self-esteem, stress, anxiety, or the quality of life of patients Obese in failure of bariatric surgery.
It is an Interventional, prospective, multi-center, controlled, randomized, open-label study with 2 parallel arms, evaluating the efficacy of hypnotherapeutic management in patients with bariatric surgery failure, compared to dietary monitoring alone.
Number of visits: 13 visits are planned: 1 visit of inclusion, a visit ensuring the first dietary follow-up, 9 hypnosis sessions (for the experimental group), two visits dedicated to the collection of the judgment criteria. Each patient is followed for 12 months.
The estimated duration of recruitment is 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Other | Behavioral: Standard CareThe control group will benefit from a standard care dietary consultation in the service and 9 dietary consultations by phone every 15 days. |
| Hypnosis | Other | Behavioral: HypnosisThe experimental group will benefit from a dietary consultation in the service, 9 dietary consultations by telephone every 15 days to which will be associated 7 individual sessions of hypnosis and 3 individual sessions of learning to autohypnosis. A recording containing the induction of a self-hypnosis session will be given to the subject at the end of the 10 sessions, in order to promote the continuation of home-made autohypnosis. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Obese patient (BMI = 30 kg / m ²)
- 18 - 65 years ( inclusive borders)
- Patient in failure of bariatric surgery and in which no surgical resumption can be proposed (in view of Reinhold's classification, the failure will be considered as a loss of overweight lower than 50 % in two years further to a bariatric surgery).
- Informed consent
- Patient in measure to realize all the visits and to follow the procedures of the study - Subject affiliated to a social security system
Key exclusion criteria (9 listed)
- Pregnancy current or planned during the duration of the study, pregnant or breast-feeding women
- Craniopharyngioma or any other evolutionary malignant pathology, or chronic illness in decompensation phase
- Strong probability of not compliance to the protocol or drop-out
- Psychiatric pathology of dissociated type (schizophrenia; psychosis, bipolarity …)
- Sensory (hearing, visual) or cognitive deficits susceptible to hinder the progress of the sessions.
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 |
|---|---|---|
| HypnosisThere ar 10 hypnosis sessions : * 1st session of hypnosis : relaxation and orientation towards "emotional cleansing". * 2nd session of hypnosis: oriented towards digestion, physical and psychological * 3rd session of hypnosis: oriented towards the feeling of security. * 4th session of hypnosis: self-esteem oriented. * 5th hypnosis session: oriented towards emotional management. * 6th hypnosis session: oriented towards self-confidence. * 7th hypnosis session: oriented towards the completion of the projects. * 8th, 9th and 10th sessions: concern the learning of self-hypnosis and autonomy. A USB key containing the induction of a session of autohypnosis will be given to the subject to promote the continuation of home-made auto-hypnosis. | Behavioural | Hypnosis |
| Standard CareThe dietary advice given during these dietary consultations is part of the standard care adapted to patients who have undergone bariatric surgery while increasing the frequency of consultations (Fractionation of meals, Volume of meals, Taking meals, Drinks, Food diversity) | Behavioural | Usual Care |
Primary outcome
Change in weight in 5 months
Time frame: 5 months
Patient weight (in kg) measurement will be performed on the same scale by staff who are unaware of the patient's randomization group.
6 secondary outcomes
Change in weight in 12 months
Time frame: 12 months
Self-esteem
Time frame: 12 months
Evolution of Quality of life
Time frame: 12 months
Anxiety and depressive state
Time frame: 12 months
Feeding behavior
Time frame: 12 months
Patients' satisfaction with their care
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
David NOCCA, PU-PH principal investigator
University Hospital, Montpellier
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis in people with Obesity and Bariatric Surgery, run by University Hospital, Montpellier at 5 sites 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight in 5 months (time frame: 5 months). 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 22 Jun 2026.