The Impact of the Hypnosis on the Loss of Weight at Patients in Failure of Bariatric Surgery

Obesity Clinical Trial

— BARIATHYPNOSE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03485469
• Other study ID #: RECHMPL17_0024
• Secondary ID: UF 9793
• Status: Recruiting
• Phase: N/A
• Start date: March 29, 2019
• Est. completion date: October 2024

Study information

• Verified date: January 2024
• Source: University Hospital, Montpellier
• Contact: Cécile GODEL, Dietetician
• Phone: 04.67.33.79.52
• Email: c-godel[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion criteria:

• 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

Exclusion criteria:

• 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

• 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)

Related Conditions & MeSH terms

• Bariatric Surgery
• Obesity
• Weight Loss

Intervention

Behavioral:
• Hypnosis
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 Care
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)

Locations

Country	Name	City	State
France	CHR Saint Pierre - maladies métaboliques	La Réunion
France	Cécile GODEL	Montpellier
France	Orléans University Hospital	Orléans
France	Reims University Hospital	Reims
France	Toulouse University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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	12 months