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

Phase 3

Completed

• Conditions: Obesity
• Interventions: Other: standard care (diet, exercise and behavioral therapy); Other: self-conditioning techniques

• Registration Number: NCT02978105
• Lead Sponsor: University of Turin, Italy

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2016-11-26
• Study First Submitted QC: 2016-11-29
• Study First Posted: 2016-11-30
• Primary Completion: 2017-07
• Study Completion: 2017-09
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-22
• Last Update Posted: 2018-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	standard care (diet, exercise and behavioral therapy)	Standard care: dietary recommendations, exercise recommendations, and behavioral recommendations
Experimental	standard care (diet, exercise and behavioral therapy)	self-conditioning techniques plus standard care
Experimental	self-conditioning techniques	self-conditioning techniques plus standard care

Primary Outcome Measures

Name	Time	Method
weight loss	12 months after randomization

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Città della Salute e della Scienza di Torino; 🇮🇹 Turin, Italy