NCT02292108

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

September 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 17, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2017

Enrollment Period

1.6 years

First QC Date

November 12, 2014

Last Update Submit

December 20, 2021

Conditions

Obesity

Keywords

Hypnosisself-hypnosisobesityhigh food impulsiveness

Outcome Measures

Primary Outcomes (1)

  • Evolution of disinhibition score estimated by the TFEQ 51 at the beginning and at the end of the study

    8 months

Secondary Outcomes (29)

  • Evolution of cognitive restraint at the beginning and at the end of the study

    8 months

  • Evolution of flexible cognitive restraint at the beginning and at the end of the study

    8 months

  • Evolution of rigid cognitive restraint at the beginning and at the end of the study

    8 months

  • Evolution of weight at the beginning and at the end of study

    8 months

  • Evolution of waist circumference at the beginning and at the end of study

    8 months

  • +24 more secondary outcomes

Study Arms (2)

Hypnosis and dietetic counselling

EXPERIMENTAL

Patient will benefit of usual dietetic counselling and experimental hypnosis

Behavioral: dietetic counsellingBehavioral: Hypnosis and self-hypnosis

dietetic counselling

OTHER

Patient will only benefit of usual dietetic counselling

Behavioral: dietetic counselling

Interventions

dietetic counsellingBEHAVIORAL
Hypnosis and dietetic counsellingdietetic counselling
Hypnosis and self-hypnosisBEHAVIORAL

Erickson's hypnosis and self-hypnosis

Hypnosis and dietetic counselling

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pitié Salpetriere Hospital

Paris, 75013, France

Location

Related Publications (1)

  • Delestre F, Lehericey G, Estellat C, Diallo MH, Hansel B, Giral P. Hypnosis reduces food impulsivity in patients with obesity and high levels of disinhibition: HYPNODIET randomized controlled clinical trial. Am J Clin Nutr. 2022 Jun 7;115(6):1637-1645. doi: 10.1093/ajcn/nqac046.

    PMID: 35170724DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Philippe Giral, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2014

First Posted

November 17, 2014

Study Start

September 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

January 11, 2022

Record last verified: 2017-01

Locations

FR(1)