Clinical trial NCT03485469: The Impact of the Hypnosis on the Loss of Weight at Patients in Failure of Bariatric Surgery
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Bariatric Surgery
Keywords: Obesity
bariatric surgery
Hypnosis
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-04-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in weight in 5 months
timeFrame: 5 months
Secondary outcomes:
measure: Change in weight in 12 months
timeFrame: 12 months
measure: Self-esteem
timeFrame: 12 months
measure: Evolution of Quality of life
timeFrame: 12 months
measure: Anxiety and depressive state
timeFrame: 12 months
measure: Feeding behavior
timeFrame: 12 months
measure: Patients' satisfaction with their care
timeFrame: 12 months
Other outcomes:
Locations:
city: La Réunion
country: France
facility: CHR Saint Pierre - maladies métaboliques
city: Montpellier
country: France
facility: Cécile GODEL
city: Orléans
country: France
facility: Orléans University Hospital
city: Reims
country: France
facility: Reims University Hospital
city: Toulouse
country: France
facility: Toulouse University Hospital
Study officials:
affiliation: University Hospital, Montpellier
name: David NOCCA, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: