Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID03485469

Impact of Hypnosis on Weight Loss in Patients with Bariatric Surgery Failure A Prospective Randomized Open-Label Multi-Center Clinical Trial

Led by University Hospital, Montpellier · Updated on 2025-01-17

70

Participants Needed

5

Research Sites

391 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating weight control challenges in patients who have not succeeded in losing weight after bariatric surgery, a common treatment for morbid obesity. This study focuses on patients whose weight loss was less than 50% of their excess weight two years after surgery, considering factors like impulsivity, anxiety, depression, stress, and low self-esteem. The goal is to assess whether adding hypnotherapy to standard dietary care can improve weight loss, self-esteem, stress, and anxiety compared to dietary care alone. Participants are randomly assigned to one of two groups: one receiving hypnotherapy combined with dietary monitoring and the other receiving dietary monitoring alone. The hypnotherapy group will attend 10 sessions, each targeting different psychological aspects such as relaxation, emotional management, self-esteem, and self-confidence, including training in self-hypnosis with a USB key for home practice. Dietary advice follows standard care adapted for bariatric surgery patients, focusing on meal fractionation, volume, timing, drinks, and food diversity. Each participant will attend 13 visits over 12 months, including an initial inclusion visit, dietary follow-ups, nine hypnosis sessions (for the experimental group), and two visits to collect outcome data. Researchers will measure changes in weight over 5 months and monitor psychological factors throughout the study. The recruitment period is expected to last 18 months, with ongoing assessments to evaluate the impact of hypnotherapy on weight loss and psychological well-being.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Obese patient with BMI of 30 kg/m² or higher
  • Age between 18 and 65 years inclusive
  • Failure of bariatric surgery defined as less than 50% loss of excess weight in two years
  • No surgical revision possible according to Reinhold's classification
  • Able to give informed consent
  • Able to attend all study visits and follow study procedures
  • Affiliated with a social security system
Not Eligible

You will not qualify if you...

  • Currently pregnant, planning pregnancy, or breastfeeding
  • Presence of craniopharyngioma, other active cancers, or chronic illness in decompensation
  • High likelihood of poor compliance or dropping out
  • Diagnosed dissociative psychiatric disorders (schizophrenia, psychosis, bipolar disorder)
  • Sensory or cognitive impairments that may interfere with sessions
  • Unable to understand the study or communicate with the investigator
  • Previous hypnotherapy for weight loss
  • Taking medications affecting weight loss (e.g., corticosteroids, antithyroid drugs)
  • Legally protected adults or considered vulnerable (under guardianship)

AI-Screening

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Trial Site Locations

Total: 5 locations

1

CHR Saint Pierre - maladies métaboliques

La Réunion, France

Actively Recruiting

2

Cécile GODEL

Montpellier, France

Actively Recruiting

3

Orléans University Hospital

Orléans, France

Actively Recruiting

4

Reims University Hospital

Reims, France

Actively Recruiting

5

Toulouse University Hospital

Toulouse, France

Actively Recruiting

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Research Team

C

Cécile GODEL, Dietetician

M

Mélanie DELOZE, CRA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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