Hypnosis, Self-hypnosis and Weight Loss in Obese Patients

Obesity Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02292108
• Other study ID #: P131202
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: April 2016

Study information

• Verified date: January 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• dietetic counselling

• Hypnosis and self-hypnosis
Erickson's hypnosis and self-hypnosis

Locations

Country	Name	City	State
France	Pitié Salpetriere Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of disinhibition score estimated by the TFEQ 51 at the beginning and at the end of the study		8 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Evolution of weight at the beginning and at the end of study	Weight will be measured in Kg	8 months
Secondary	Evolution of waist circumference at the beginning and at the end of study	Waist circumference will be measured in Cm	8 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Evolution of Total cholesterol at the beginning and the end of the study	Total cholesterol will be measured in g/L	8 months
Secondary	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
Secondary	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
Secondary	Evolution of Triglyceride at the beginning and the end of the study	Triglyceride will be measured in g/L	8 months
Secondary	Evolution of fasting glucose at the beginning and the end of the study	Fasting glucose will be measured in mmol/L	8 months
Secondary	Evolution of HbA1c at the beginning and the end of the study	HbA1c will be measured in %	8 months
Secondary	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
Secondary	Evolution of stress measured at beginning and the end of study.	stress will be measured by General Health Questionnaire (GHQ28)	8 months
Secondary	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
Secondary	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
Secondary	: 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
Secondary	: 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
Secondary	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
Secondary	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
Secondary	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
Secondary	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