Using hypnosis to help patients lose weight after failed bariatric surgery

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

This study is testing whether using hypnosis along with diet support can help people who didn’t succeed with weight loss after bariatric surgery to lose weight and feel better about themselves.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University Hospital, Montpellier (other)
• Locations: 5 sites (La Réunion and 4 other locations)
• Trial ID: NCT03485469 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of hypnotherapy combined with standard dietary monitoring on weight loss and psychological well-being in patients who have failed bariatric surgery. It aims to address the psychological factors that contribute to obesity, such as anxiety and low self-esteem, which are prevalent in this population. Participants will receive hypnotherapeutic management to modify their eating habits and improve their overall quality of life. The study will assess changes in weight, self-esteem, stress, and anxiety levels over time.

Who should consider this trial

Good fit: Ideal candidates are obese individuals aged 18-65 who have experienced failure of bariatric surgery and are not eligible for surgical revision.

Not a fit: Patients with severe psychiatric disorders, significant cognitive deficits, or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a non-surgical intervention for patients struggling with weight loss after bariatric surgery.

How similar studies have performed: While there is limited research specifically on hypnotherapy for this population, studies have shown positive outcomes of hypnosis in weight management and psychological support in other contexts.

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)

Where this trial is running

La Réunion and 4 other locations

• CHR Saint Pierre - maladies métaboliques — La Réunion, France (RECRUITING)
• Cécile GODEL — Montpellier, France (RECRUITING)
• Orléans University Hospital — Orléans, France (RECRUITING)
• Reims University Hospital — Reims, France (RECRUITING)
• Toulouse University Hospital — Toulouse, France (RECRUITING)

Study contacts

• Principal investigator: David NOCCA, PU-PH — University Hospital, Montpellier
• Study coordinator: Cécile GODEL, Dietetician

Conditions: Obesity, Bariatric Surgery, bariatric surgery, Hypnosis