Effects of Self-conditioning Techniques in Promoting Weight Loss in Patients With Obesity. A Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesized that hypnosis is an alternative technique that could be applied to help patients with obesity to lose weight. The possibility that a self-conditioning technique (self-hypnosis) added to traditional approach (diet, exercise and behavioral recommendations) will be effective in determining weight loss with respect to the traditional approach in subjects with a body mass index (BMI) between 35 and 50 kg/m2 will be studied.

Detailed Description
-----------------
Obesity is a serious health concern. Most lifestyle interventions fail over time; indeed, overeating often involves loss of control and compulsive behaviors. Hypnosis could increase the ability to control emotional impulses. Self-conditioning techniques borrowed from hypnosis (self-hypnosis) increase self-control and self-management of emotions. Recent hypnosis techniques with a rapid-induction phase allow the trained patients to go into self-hypnosis in a few minutes and to repeat the experience in complete autonomy, employing a short time of the day only.

Official Title
-----------------
Effects of Self-conditioning Techniques in Promoting Weight Loss in Patients With Severe Obesity. A Randomized Controlled Trial

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

Intervention / Treatment
-----------------
* Other: self-conditioning techniques
* Other: standard care (diet, exercise and behavioral therapy)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to give written informed consent BMI between 35 and 50 kg/m2 Age 20-70 years Exclusion Criteria: Current or previous mental disorders and/or on any psychotropic drug Insulin treatment Candidates for bariatric surgery Current (or discontinued for less than 6 months) treatment with anti-obesity drugs Patients at risk of heart failure, edema, ascites (heart diseases, chronic liver diseases, nephrotic syndrome, renal failure) Patients with untreated or uncompensated thyroid diseases

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>self-conditioning techniques plus standard care | Other: self-conditioning techniques<br>* Self-hypnosis to increase self-control before meals and every food compulsion episode<br>Other: standard care (diet, exercise and behavioral therapy)<br>* dietary recommendations, exercise recommendations, and behavioral recommendations<br>|
| Active Comparator: Control<br>Standard care: dietary recommendations, exercise recommendations, and behavioral recommendations | Other: standard care (diet, exercise and behavioral therapy)<br>* dietary recommendations, exercise recommendations, and behavioral recommendations<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss |  | 12 months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body fat percentage | Dual Energy X-Ray Absorptiometry (DEXA) | 12 months after randomization | 
| Change in fasting glucose |  | 12 months after randomization | 
| Change in insulin circulating values |  | 12 months after randomization | 
| Change in quality of life | EuroQol (EQ)-5D [Index and Visual Analog Scale (VAS) | 12 months after randomization |