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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02978105
• Other study ID #: sbo2015
• Status: Completed
• Phase: Phase 3
• First received: November 26, 2016
• Last updated: January 22, 2018
• Start date: February 2015
• Est. completion date: September 2017

Study information

• Verified date: January 2018
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Other:
• self-conditioning techniques
Self-hypnosis to increase self-control before meals and every food compulsion episode
• standard care (diet, exercise and behavioral therapy)
dietary recommendations, exercise recommendations, and behavioral recommendations

Locations

Country	Name	City	State
Italy	Città della Salute e della Scienza di Torino	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight loss		12 months after randomization
Secondary	Change in body fat percentage	Dual Energy X-Ray Absorptiometry (DEXA)	12 months after randomization
Secondary	Change in fasting glucose		12 months after randomization
Secondary	Change in insulin circulating values		12 months after randomization
Secondary	Change in quality of life	EuroQol (EQ)-5D [Index and Visual Analog Scale (VAS)	12 months after randomization