Hypnosis, Self-hypnosis and Weight Loss in Obese Patients
- Conditions
- Obesity
- Interventions
- Behavioral: dietetic counsellingBehavioral: Hypnosis and self-hypnosis
- Registration Number
- NCT02292108
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 82
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hypnosis and dietetic counselling Hypnosis and self-hypnosis Patient will benefit of usual dietetic counselling and experimental hypnosis dietetic counselling dietetic counselling Patient will only benefit of usual dietetic counselling Hypnosis and dietetic counselling dietetic counselling Patient will benefit of usual dietetic counselling and experimental hypnosis
- Primary Outcome Measures
Name Time Method Evolution of disinhibition score estimated by the TFEQ 51 at the beginning and at the end of the study 8 months
- Secondary Outcome Measures
Name Time Method Evolution of lean mass at the beginning and at the end of the study 8 months Lean mass will be measured in Kg using dual-energy X-ray absorptiometry (DXA)
Evolution of waist circumference at the beginning and at the end of study 8 months Waist circumference will be measured in Cm
Evolution of carbohydrate intakes 8 months 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 saturated fatty acids intakes at the beginning and at the end of the study. 8 months 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 HbA1c at the beginning and the end of the study 8 months HbA1c will be measured in %
Evolution of the physical activity assessed with a pedometer for a week prior to the second and final visits. 8 months Walking will be measure in number of steps/day
Evolution of body fat at the beginning and at the end of the study 8 months Body fat will be measured in Kg using dual-energy X-ray absorptiometry (DXA)
Evolution of flexible cognitive restraint at the beginning and at the end of the study 8 months Flexible cognitive restraint estimated by the Three Factor Eating Questionnaire (TFEQ 51)
Evolution of weight at the beginning and at the end of study 8 months Weight will be measured in Kg
Evolution of water mass at the beginning and at the end of the study 8 months 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 8 months 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 cognitive restraint at the beginning and at the end of the study 8 months 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 8 months Rigid cognitive restraint estimated by the Three Factor Eating Questionnaire (TFEQ 51)
Evolution of protein intakes.at the beginning and at the end of the study 8 months 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 total fat intakes at the beginning and at the end of the study. 8 months 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 Total cholesterol at the beginning and the end of the study 8 months Total cholesterol will be measured in g/L
Evolution of Low-density lipoprotein (LDL-C) at the beginning and the end of the study 8 months Low-density lipoprotein (LDL-C) will be measured in g/L
Evolution of Triglyceride at the beginning and the end of the study 8 months Triglyceride will be measured in g/L
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 8 months Scores range from 0 to 100 with a higher score indicating a greater QoL.
Evolution of the food reward evaluated by content analysis of a psychological interview at beginning and the end of study 8 months Analysis of speech content using Sphinx software
Evolution of fasting glucose at the beginning and the end of the study 8 months Fasting glucose will be measured in mmol/L
Evolution of the Self-esteem measured by The Self-esteem Inventory (SEI of Coopersmith) at beginning and the end of study 8 months 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 emotional state evaluated by content analysis of a psychological interview at beginning and the end of study 8 months 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 8 months 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 High-density lipoprotein-cholesterol (HDL-C) at the beginning and the end of the study 8 months High-density lipoprotein-cholesterol (HDL-C) will be measured in g/L
Evolution of stress measured at beginning and the end of study. 8 months 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 8 months 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 patient's involvement in the personalized care project evaluated by content analysis of a psychological interview at beginning and the end of study 8 months 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 8 months Analysis of speech content using Sphinx software
Trial Locations
- Locations (1)
Pitié Salpetriere Hospital
🇫🇷Paris, France