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Hypnosis, Self-hypnosis and Weight Loss in Obese Patients (HYPNODIET)

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ClinicalTrials.gov Identifier: NCT02292108
Recruitment Status : Completed
First Posted : November 17, 2014
Last Update Posted : January 25, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:

High food impulsiveness, impaired food reward and stress response are involved in the phenomena of weight gain and resistance at weight loss. Henceforth, hypnosis is a complementary medicine which is recognized as effective for defined indications. Complexity and diversity of methodological studies with hypnosis does not allow to conclude on its efficacy in treating this disease.

In obese subjects with high food impulsiveness, it is expected that Erickson's hypnosis and self-hypnosis practice would improve food disinhibition assessed by an adapted questionary (TFEQ 51).


Condition or disease Intervention/treatment Phase
Obesity Behavioral: dietetic counselling Behavioral: Hypnosis and self-hypnosis Not Applicable

Detailed Description:

Obese failing patients are recruited in an university hospital. Half of the subjects will be randomised to practice hypnosis and will learn to practice self-hypnosis to reduce food impulsivity and specially disinhibition. In the same time, all the included patients will follow therapeutic workshops based on current recommendations of the High Health Authority of France (HAS) for physical activity and the dietetic.

In the hypnosis group, eight workshops are planned during six months. Furthermore, patients have to practice daily self-hypnosis. In the same time, all the patients included will participate in eight dietetic workshops.

It is expected an improvement in patient involvement in personalized care plan, that eating behavior is more suited and consequently a significant decrease in weight.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of the Influence of Erickson's Hypnosis and Self-hypnosis Practice on Food Impulsivity and Weight Loss in Obese Patients: a Pilot Project
Actual Study Start Date : September 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Hypnosis and dietetic counselling
Patient will benefit of usual dietetic counselling and experimental hypnosis
 Behavioral: dietetic counselling
Behavioral: Hypnosis and self-hypnosis
Erickson's hypnosis and self-hypnosis
dietetic counselling
Patient will only benefit of usual dietetic counselling
 Behavioral: dietetic counselling


Outcome Measures
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Primary Outcome Measures :
  1. Evolution of disinhibition score estimated by the TFEQ 51 at the beginning and at the end of the study [ Time Frame: 8 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • subjects adult volunteers under 70 years old
  • high score of disinhibition (D> 8)
  • obesity grade 1 and 2 (BMI between 30 and 40 kg m ²)
  • no previous practice of hypnosis

Exclusion criteria :

  • weight change of more than 3 kg peak to peak in the last 6 months
  • psychiatric illness known
  • craniopharyngioma
  • treatment with a significant influence on the weight and / or eating behavior: steroids, hyperthyroidism, uncontrolled hypothyroidism,
  • bariatric Surgery
  • major TCA according to DSM IV
  • sensory impairments (hearing, visual skills) and cognitive impairing its award of rating scales
  • planned or ongoing pregnancy
  • refusal of hypnosis.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02292108


Locations
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France
Pitié Salpetriere Hospital
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Philippe Giral, MD, PhD Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02292108    
Other Study ID Numbers: P131202
First Posted: November 17, 2014    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Hypnosis
self-hypnosis
obesity
high food impulsiveness
Additional relevant MeSH terms:
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Weight Loss
Body Weight
Body Weight Changes