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Trial record 3 of 4 for:    self hypnosis and weight loss

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

Tracking Information
First Submitted Date  ICMJE November 26, 2016
First Posted Date  ICMJE November 30, 2016
Last Update Posted Date January 24, 2018
Actual Study Start Date  ICMJE February 2015
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2016)
weight loss [ Time Frame: 12 months after randomization ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2016)
  • Change in body fat percentage [ Time Frame: 12 months after randomization ]
    Dual Energy X-Ray Absorptiometry (DEXA)
  • Change in fasting glucose [ Time Frame: 12 months after randomization ]
  • Change in insulin circulating values [ Time Frame: 12 months after randomization ]
  • Change in quality of life [ Time Frame: 12 months after randomization ]
    EuroQol (EQ)-5D [Index and Visual Analog Scale (VAS)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Self-conditioning Techniques in Promoting Weight Loss in Patients With Obesity. A Randomized Controlled Trial
Official Title  ICMJE Effects of Self-conditioning Techniques in Promoting Weight Loss in Patients With Severe Obesity. A Randomized Controlled Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Experimental
    self-conditioning techniques plus standard care
    Interventions:
    • Other: self-conditioning techniques
    • Other: standard care (diet, exercise and behavioral therapy)
  • Active Comparator: Control
    Standard care: dietary recommendations, exercise recommendations, and behavioral recommendations
    Intervention: Other: standard care (diet, exercise and behavioral therapy)
Publications * Bo S, Rahimi F, Goitre I, Properzi B, Ponzo V, Regaldo G, Boschetti S, Fadda M, Ciccone G, Abbate Daga G, Mengozzi G, Evangelista A, De Francesco A, Belcastro S, Broglio F. Effects of Self-Conditioning Techniques (Self-Hypnosis) in Promoting Weight Loss in Patients with Severe Obesity: A Randomized Controlled Trial. Obesity (Silver Spring). 2018 Sep;26(9):1422-1429. doi: 10.1002/oby.22262.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 29, 2016)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02978105
Other Study ID Numbers  ICMJE sbo2015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Simona Bo, University of Turin, Italy
Study Sponsor  ICMJE University of Turin, Italy
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Simona Bo, MD University of Turin, Italy
PRS Account University of Turin, Italy
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP