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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHR Saint Pierre - maladies métaboliques
RECRUITING
La Réunion
Cécile GODEL
RECRUITING
Montpellier
Orléans University Hospital
RECRUITING
Orléans
Reims University Hospital
RECRUITING
Reims
Toulouse University Hospital
RECRUITING
Toulouse
Contact Information
Primary
Cécile GODEL, Dietetician
c-godel@chu-montpellier.fr
04.67.33.79.52
Backup
Mélanie DELOZE, CRA
m-deloze@chu-montpellier.fr
Time Frame
Start Date: 2019-03-29
Estimated Completion Date: 2026-10
Participants
Target number of participants: 70
Treatments
Other: Usual Care
The control group will benefit from a standard care dietary consultation in the service and 9 dietary consultations by phone every 15 days.
Other: Hypnosis
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.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov