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

January 22, 2018 updated by: Simona Bo, University of Turin, Italy

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Turin, Italy, 10126
        • Citta della Salute e della Scienza di Torino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
weight loss
Time Frame: 12 months after randomization
12 months after randomization

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turin, Italy

Investigators

  • Principal Investigator: Simona Bo, MD, University of Turin, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

November 26, 2016

First Submitted That Met QC Criteria

November 29, 2016

First Posted (Estimate)

November 30, 2016

Study Record Updates

Last Update Posted (Actual)

January 24, 2018

Last Update Submitted That Met QC Criteria

January 22, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sbo2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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