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

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ClinicalTrials.gov Identifier: NCT02978105
Recruitment Status : Completed
First Posted : November 30, 2016
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
Simona Bo, University of Turin, Italy

Study Description
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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.


Condition or disease Intervention/treatment Phase
Obesity Other: self-conditioning techniques Other: standard care (diet, exercise and behavioral therapy) Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Self-conditioning Techniques in Promoting Weight Loss in Patients With Severe Obesity. A Randomized Controlled Trial
Actual Study Start Date : February 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : September 2017

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. weight loss [ Time Frame: 12 months after randomization ]

Secondary Outcome Measures :
  1. Change in body fat percentage [ Time Frame: 12 months after randomization ]
    Dual Energy X-Ray Absorptiometry (DEXA)

  2. Change in fasting glucose [ Time Frame: 12 months after randomization ]
  3. Change in insulin circulating values [ Time Frame: 12 months after randomization ]
  4. Change in quality of life [ Time Frame: 12 months after randomization ]
    EuroQol (EQ)-5D [Index and Visual Analog Scale (VAS)


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02978105


Locations
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Italy
Città della Salute e della Scienza di Torino
Turin, Italy, 10126
Sponsors and Collaborators
University of Turin, Italy
Investigators
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Principal Investigator: Simona Bo, MD University of Turin, Italy
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Simona Bo, Associate Professor, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT02978105    
Other Study ID Numbers: sbo2015
First Posted: November 30, 2016    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Obesity
Weight Loss
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Body Weight Changes