Clinical trial NCT02292108: Hypnosis, Self-hypnosis and Weight Loss in Obese Patients
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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Hypnosis
self-hypnosis
obesity
high food impulsiveness
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-11-17
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Evolution of disinhibition score estimated by the TFEQ 51 at the beginning and at the end of the study
timeFrame: 8 months
Secondary outcomes:
measure: Evolution of cognitive restraint at the beginning and at the end of the study
timeFrame: 8 months
measure: Evolution of flexible cognitive restraint at the beginning and at the end of the study
timeFrame: 8 months
measure: Evolution of rigid cognitive restraint at the beginning and at the end of the study
timeFrame: 8 months
measure: Evolution of weight at the beginning and at the end of study
timeFrame: 8 months
measure: Evolution of waist circumference at the beginning and at the end of study
timeFrame: 8 months
measure: Evolution of body fat at the beginning and at the end of the study
timeFrame: 8 months
measure: Evolution of lean mass at the beginning and at the end of the study
timeFrame: 8 months
measure: Evolution of water mass at the beginning and at the end of the study
timeFrame: 8 months
measure: Evolution of calories intakes. at the beginning and at the end of the study
timeFrame: 8 months
measure: Evolution of protein intakes.at the beginning and at the end of the study
timeFrame: 8 months
measure: Evolution of carbohydrate intakes
timeFrame: 8 months
measure: Evolution of total fat intakes at the beginning and at the end of the study.
timeFrame: 8 months
measure: Evolution of saturated fatty acids intakes at the beginning and at the end of the study.
timeFrame: 8 months
measure: Evolution of Total cholesterol at the beginning and the end of the study
timeFrame: 8 months
measure: Evolution of High-density lipoprotein-cholesterol (HDL-C) at the beginning and the end of the study
timeFrame: 8 months
measure: Evolution of Low-density lipoprotein (LDL-C) at the beginning and the end of the study
timeFrame: 8 months
measure: Evolution of Triglyceride at the beginning and the end of the study
timeFrame: 8 months
measure: Evolution of fasting glucose at the beginning and the end of the study
timeFrame: 8 months
measure: Evolution of HbA1c at the beginning and the end of the study
timeFrame: 8 months
measure: 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
timeFrame: 8 months
measure: Evolution of stress measured at beginning and the end of study.
timeFrame: 8 months
measure: Evolution of coping strategies measured by The Coping Inventory for Stressful Situations (CISS) at beginning and the end of study
timeFrame: 8 months
measure: Evolution of the Self-esteem measured by The Self-esteem Inventory (SEI of Coopersmith) at beginning and the end of study
timeFrame: 8 months
measure: : 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
timeFrame: 8 months
measure: : Evolution of the patient's emotional state evaluated by content analysis of a psychological interview at beginning and the end of study
timeFrame: 8 months
measure: Evolution of the food reward evaluated by content analysis of a psychological interview at beginning and the end of study
timeFrame: 8 months
measure: Evolution of the self-perception of self-care competence evaluated by content analysis of a psychological interview at beginning and the end of study
timeFrame: 8 months
measure: 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
timeFrame: 8 months
measure: Evolution of the physical activity assessed with a pedometer for a week prior to the second and final visits.
timeFrame: 8 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Pitié Salpetriere Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Philippe Giral, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.