Hypnosis, Self-hypnosis and Weight Loss in Obese Patients (HYPNODIET)
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
dietetic counselling
Hypnosis and self-hypnosis
Sponsored by

About this trial
This is an interventional treatment trial for Obesity focused on measuring Hypnosis, self-hypnosis, obesity, high food impulsiveness
Eligibility 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.
Sites / Locations
- Pitié Salpetriere Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Hypnosis and dietetic counselling
dietetic counselling
Arm Description
Patient will benefit of usual dietetic counselling and experimental hypnosis
Patient will only benefit of usual dietetic counselling
Outcomes
Primary Outcome Measures
Evolution of disinhibition score estimated by the TFEQ 51 at the beginning and at the end of the study
Secondary Outcome Measures
Evolution of cognitive restraint at the beginning and at the end of the study
Cognitive restraint estimated by the Three Factor Eating Questionnaire (TFEQ 51)
Evolution of flexible cognitive restraint at the beginning and at the end of the study
Flexible cognitive restraint estimated by the Three Factor Eating Questionnaire (TFEQ 51)
Evolution of rigid cognitive restraint at the beginning and at the end of the study
Rigid cognitive restraint estimated by the Three Factor Eating Questionnaire (TFEQ 51)
Evolution of weight at the beginning and at the end of study
Weight will be measured in Kg
Evolution of waist circumference at the beginning and at the end of study
Waist circumference will be measured in Cm
Evolution of body fat at the beginning and at the end of the study
Body fat will be measured in Kg using dual-energy X-ray absorptiometry (DXA)
Evolution of lean mass at the beginning and at the end of the study
Lean mass will be measured in Kg using dual-energy X-ray absorptiometry (DXA)
Evolution of water mass at the beginning and at the end of the study
Water mass will be measured in Kg using dual-energy X-ray absorptiometry (DXA)
Evolution of calories intakes. at the beginning and at the end of the study
calories will be measured in Kcal/day, assessed for 3 representative days (two weekdays and one weekend day) and collected using an interactive self-administered food journal from the internet enabled during the week prior to the inclusion visit and the final visit
Evolution of protein intakes.at the beginning and at the end of the study
Protein will be measured in g/day assessed for 3 representative days (two weekdays and one weekend day) and collected using an interactive self-administered food journal frome the internet enabled during the week prior to the inclusion visit and the final visit.
Evolution of carbohydrate intakes
carbohydrates be measured in g/day, assessed for 3 representative days (two weekdays and one weekend day) and collected using an interactive self-administered food journal from the internet enabled during the week prior to the inclusion visit and the final visit
Evolution of total fat intakes at the beginning and at the end of the study.
Total fat will be measured in g/day assessed for 3 representative days (two weekdays and one weekend day) and collected using an interactive self-administered food journal from the internet enabled during the week prior to the inclusion visit and the final visit
Evolution of saturated fatty acids intakes at the beginning and at the end of the study.
Saturated fatty acids will be measured in g/day assessed for 3 representative days (two weekdays and one weekend day) and collected using an interactive self-administered food journal from the internet enabled during the week prior to the inclusion visit and the final visit
Evolution of Total cholesterol at the beginning and the end of the study
Total cholesterol will be measured in g/L
Evolution of High-density lipoprotein-cholesterol (HDL-C) at the beginning and the end of the study
High-density lipoprotein-cholesterol (HDL-C) will be measured in g/L
Evolution of Low-density lipoprotein (LDL-C) at the beginning and the end of the study
Low-density lipoprotein (LDL-C) will be measured in g/L
Evolution of Triglyceride at the beginning and the end of the study
Triglyceride will be measured in g/L
Evolution of fasting glucose at the beginning and the end of the study
Fasting glucose will be measured in mmol/L
Evolution of HbA1c at the beginning and the end of the study
HbA1c will be measured in %
Evolution of quality of Live (QoL) estimated by The Short-Form Health Survey (SF-36) at beginning and the end of study at the beginning and the end of the study
Scores range from 0 to 100 with a higher score indicating a greater QoL.
Evolution of stress measured at beginning and the end of study.
stress will be measured by General Health Questionnaire (GHQ28)
Evolution of coping strategies measured by The Coping Inventory for Stressful Situations (CISS) at beginning and the end of study
In the Coping Inventory for Stressful Situations (CISS) items are scored on a 5-point Likert scale (from 1 not at all to 5 very much). Scores for all items per scale are summed to form scale scores; higher scores indicate a greater use of that coping strategy.
Evolution of the Self-esteem measured by The Self-esteem Inventory (SEI of Coopersmith) at beginning and the end of study
The Self-esteem Inventory (SEI of Coopersmith) consists of 58 items and 4 subscales: general, social, family and professional self-esteem. A lie score is also computed to capture social desirability in participants answers. Higher scores indicate a greater self-esteem..
: Evolution of the patient's involvement in the personalized care project evaluated by content analysis of a psychological interview at beginning and the end of study
Analysis of speech content using Sphinx software
: Evolution of the patient's emotional state evaluated by content analysis of a psychological interview at beginning and the end of study
Analysis of speech content using Sphinx software
Evolution of the food reward evaluated by content analysis of a psychological interview at beginning and the end of study
Analysis of speech content using Sphinx software
Evolution of the self-perception of self-care competence evaluated by content analysis of a psychological interview at beginning and the end of study
Analysis of speech content using Sphinx software
Evolution of the physical activity assessed with the abridged version of the International Physical Activity Questionnaire (IPAQ) completed online before the inclusion visit and before the final visit
In the abridged version of the International Physical Activity Questionnaire (IPAQ) walking, moderate Physical activity and vigorous Physical activity will be measure in min/week, the Sedentary will be measure in min/day
Evolution of the physical activity assessed with a pedometer for a week prior to the second and final visits.
Walking will be measure in number of steps/day
Full Information
NCT ID
NCT02292108
First Posted
November 12, 2014
Last Updated
December 20, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT02292108
Brief Title
Hypnosis, Self-hypnosis and Weight Loss in Obese Patients
Acronym
HYPNODIET
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Hypnosis, self-hypnosis, obesity, high food impulsiveness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hypnosis and dietetic counselling
Arm Type
Experimental
Arm Description
Patient will benefit of usual dietetic counselling and experimental hypnosis
Arm Title
dietetic counselling
Arm Type
Other
Arm Description
Patient will only benefit of usual dietetic counselling
Intervention Type
Behavioral
Intervention Name(s)
dietetic counselling
Intervention Type
Behavioral
Intervention Name(s)
Hypnosis and self-hypnosis
Intervention Description
Erickson's hypnosis and self-hypnosis
Primary Outcome Measure Information:
Title
Evolution of disinhibition score estimated by the TFEQ 51 at the beginning and at the end of the study
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Evolution of cognitive restraint at the beginning and at the end of the study
Description
Cognitive restraint estimated by the Three Factor Eating Questionnaire (TFEQ 51)
Time Frame
8 months
Title
Evolution of flexible cognitive restraint at the beginning and at the end of the study
Description
Flexible cognitive restraint estimated by the Three Factor Eating Questionnaire (TFEQ 51)
Time Frame
8 months
Title
Evolution of rigid cognitive restraint at the beginning and at the end of the study
Description
Rigid cognitive restraint estimated by the Three Factor Eating Questionnaire (TFEQ 51)
Time Frame
8 months
Title
Evolution of weight at the beginning and at the end of study
Description
Weight will be measured in Kg
Time Frame
8 months
Title
Evolution of waist circumference at the beginning and at the end of study
Description
Waist circumference will be measured in Cm
Time Frame
8 months
Title
Evolution of body fat at the beginning and at the end of the study
Description
Body fat will be measured in Kg using dual-energy X-ray absorptiometry (DXA)
Time Frame
8 months
Title
Evolution of lean mass at the beginning and at the end of the study
Description
Lean mass will be measured in Kg using dual-energy X-ray absorptiometry (DXA)
Time Frame
8 months
Title
Evolution of water mass at the beginning and at the end of the study
Description
Water mass will be measured in Kg using dual-energy X-ray absorptiometry (DXA)
Time Frame
8 months
Title
Evolution of calories intakes. at the beginning and at the end of the study
Description
calories will be measured in Kcal/day, assessed for 3 representative days (two weekdays and one weekend day) and collected using an interactive self-administered food journal from the internet enabled during the week prior to the inclusion visit and the final visit
Time Frame
8 months
Title
Evolution of protein intakes.at the beginning and at the end of the study
Description
Protein will be measured in g/day assessed for 3 representative days (two weekdays and one weekend day) and collected using an interactive self-administered food journal frome the internet enabled during the week prior to the inclusion visit and the final visit.
Time Frame
8 months
Title
Evolution of carbohydrate intakes
Description
carbohydrates be measured in g/day, assessed for 3 representative days (two weekdays and one weekend day) and collected using an interactive self-administered food journal from the internet enabled during the week prior to the inclusion visit and the final visit
Time Frame
8 months
Title
Evolution of total fat intakes at the beginning and at the end of the study.
Description
Total fat will be measured in g/day assessed for 3 representative days (two weekdays and one weekend day) and collected using an interactive self-administered food journal from the internet enabled during the week prior to the inclusion visit and the final visit
Time Frame
8 months
Title
Evolution of saturated fatty acids intakes at the beginning and at the end of the study.
Description
Saturated fatty acids will be measured in g/day assessed for 3 representative days (two weekdays and one weekend day) and collected using an interactive self-administered food journal from the internet enabled during the week prior to the inclusion visit and the final visit
Time Frame
8 months
Title
Evolution of Total cholesterol at the beginning and the end of the study
Description
Total cholesterol will be measured in g/L
Time Frame
8 months
Title
Evolution of High-density lipoprotein-cholesterol (HDL-C) at the beginning and the end of the study
Description
High-density lipoprotein-cholesterol (HDL-C) will be measured in g/L
Time Frame
8 months
Title
Evolution of Low-density lipoprotein (LDL-C) at the beginning and the end of the study
Description
Low-density lipoprotein (LDL-C) will be measured in g/L
Time Frame
8 months
Title
Evolution of Triglyceride at the beginning and the end of the study
Description
Triglyceride will be measured in g/L
Time Frame
8 months
Title
Evolution of fasting glucose at the beginning and the end of the study
Description
Fasting glucose will be measured in mmol/L
Time Frame
8 months
Title
Evolution of HbA1c at the beginning and the end of the study
Description
HbA1c will be measured in %
Time Frame
8 months
Title
Evolution of quality of Live (QoL) estimated by The Short-Form Health Survey (SF-36) at beginning and the end of study at the beginning and the end of the study
Description
Scores range from 0 to 100 with a higher score indicating a greater QoL.
Time Frame
8 months
Title
Evolution of stress measured at beginning and the end of study.
Description
stress will be measured by General Health Questionnaire (GHQ28)
Time Frame
8 months
Title
Evolution of coping strategies measured by The Coping Inventory for Stressful Situations (CISS) at beginning and the end of study
Description
In the Coping Inventory for Stressful Situations (CISS) items are scored on a 5-point Likert scale (from 1 not at all to 5 very much). Scores for all items per scale are summed to form scale scores; higher scores indicate a greater use of that coping strategy.
Time Frame
8 months
Title
Evolution of the Self-esteem measured by The Self-esteem Inventory (SEI of Coopersmith) at beginning and the end of study
Description
The Self-esteem Inventory (SEI of Coopersmith) consists of 58 items and 4 subscales: general, social, family and professional self-esteem. A lie score is also computed to capture social desirability in participants answers. Higher scores indicate a greater self-esteem..
Time Frame
8 months
Title
: Evolution of the patient's involvement in the personalized care project evaluated by content analysis of a psychological interview at beginning and the end of study
Description
Analysis of speech content using Sphinx software
Time Frame
8 months
Title
: Evolution of the patient's emotional state evaluated by content analysis of a psychological interview at beginning and the end of study
Description
Analysis of speech content using Sphinx software
Time Frame
8 months
Title
Evolution of the food reward evaluated by content analysis of a psychological interview at beginning and the end of study
Description
Analysis of speech content using Sphinx software
Time Frame
8 months
Title
Evolution of the self-perception of self-care competence evaluated by content analysis of a psychological interview at beginning and the end of study
Description
Analysis of speech content using Sphinx software
Time Frame
8 months
Title
Evolution of the physical activity assessed with the abridged version of the International Physical Activity Questionnaire (IPAQ) completed online before the inclusion visit and before the final visit
Description
In the abridged version of the International Physical Activity Questionnaire (IPAQ) walking, moderate Physical activity and vigorous Physical activity will be measure in min/week, the Sedentary will be measure in min/day
Time Frame
8 months
Title
Evolution of the physical activity assessed with a pedometer for a week prior to the second and final visits.
Description
Walking will be measure in number of steps/day
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Giral, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pitié Salpetriere Hospital
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
35170724
Citation
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. Erratum In: Am J Clin Nutr. 2022 Oct 6;116(4):1187.
Results Reference
derived
Learn more about this trial
Hypnosis, Self-hypnosis and Weight Loss in Obese Patients
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