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

Study of the Influence of Erickson's Hypnosis and Self-hypnosis Practice on Food Impulsivity and Weight Loss in Obese Patients: a Pilot Project

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).

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: dietetic counselling; Behavioral: Hypnosis and self-hypnosis

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 Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Pitié Salpétrière Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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
Other: dietetic counselling; Patient will only benefit of usual dietetic counselling	Behavioral: dietetic counselling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evolution of disinhibition score estimated by the TFEQ 51 at the beginning and at the end of the study	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	8 months
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)	8 months
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)	8 months
Evolution of weight at the beginning and at the end of study	Weight will be measured in Kg	8 months
Evolution of waist circumference at the beginning and at the end of study	Waist circumference will be measured in Cm	8 months
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)	8 months
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)	8 months
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)	8 months
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	8 months
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.	8 months
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	8 months
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	8 months
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	8 months
Evolution of Total cholesterol at the beginning and the end of the study	Total cholesterol will be measured in g/L	8 months
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	8 months
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	8 months
Evolution of Triglyceride at the beginning and the end of the study	Triglyceride will be measured in g/L	8 months
Evolution of fasting glucose at the beginning and the end of the study	Fasting glucose will be measured in mmol/L	8 months
Evolution of HbA1c at the beginning and the end of the study	HbA1c will be measured in %	8 months
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.	8 months
Evolution of stress measured at beginning and the end of study.	stress will be measured by General Health Questionnaire (GHQ28)	8 months
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.	8 months
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..	8 months
: 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	8 months
: 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	8 months
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	8 months
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	8 months
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	8 months
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	8 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Philippe Giral, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• Delestre F, Lehéricey 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: November 12, 2014
• First Submitted That Met QC Criteria: November 12, 2014
• First Posted (Estimate): November 17, 2014

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2021
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: obesity; Hypnosis; self-hypnosis; high food impulsiveness
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: P131202