Hypnosis, Self-hypnosis and Weight Loss in Obese Patients

Study Overview
=================
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.

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

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: dietetic counselling
* Behavioral: Hypnosis and self-hypnosis


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypnosis and dietetic counselling<br>Patient will benefit of usual dietetic counselling and experimental hypnosis | Behavioral: dietetic counselling<br> <br> Behavioral: Hypnosis and self-hypnosis<br>* Erickson's hypnosis and self-hypnosis<br>|
| Other: dietetic counselling<br>Patient will only benefit of usual dietetic counselling | Behavioral: dietetic counselling<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypnosis, self-hypnosis, obesity, high food impulsiveness