NCT03485469

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
3mo left

Started Mar 2019

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Mar 2019Oct 2026

First Submitted

Initial submission to the registry

March 26, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 2, 2018

Completed
12 months until next milestone

Study Start

First participant enrolled

March 29, 2019

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

January 17, 2025

Status Verified

January 1, 2025

Enrollment Period

7.5 years

First QC Date

March 26, 2018

Last Update Submit

January 16, 2025

Conditions

ObesityBariatric Surgery

Keywords

Obesitybariatric surgeryHypnosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Change in weight in 12 months

    12 months

  • Self-esteem

    12 months

  • Evolution of Quality of life

    12 months

  • Anxiety and depressive state

    12 months

  • Feeding behavior

    12 months

  • +1 more secondary outcomes

Study Arms (2)

Usual Care

OTHER

The control group will benefit from a standard care dietary consultation in the service and 9 dietary consultations by phone every 15 days.

Behavioral: Standard Care

Hypnosis

OTHER

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.

Behavioral: Hypnosis

Interventions

HypnosisBEHAVIORAL

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.

Hypnosis
Standard CareBEHAVIORAL

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)

Usual Care

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Obese patient (BMI = 30 kg / m ²)
  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

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

MeSH Terms

Conditions

Obesity

Interventions

HypnosisStandard of Care

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and ActivitiesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • David NOCCA, PU-PH

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cécile GODEL, Dietetician

CONTACT

04.67.33.79.52c-godel@chu-montpellier.fr

Mélanie DELOZE, CRA

CONTACT

m-deloze@chu-montpellier.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2018

First Posted

April 2, 2018

Study Start

March 29, 2019

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

January 17, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(5)