Effects of Self-conditioning Techniques in Promoting Weight Loss in Patients With Obesity. A Randomized Controlled Trial
Primary Purpose
Obesity
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
self-conditioning techniques
standard care (diet, exercise and behavioral therapy)
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility 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
Sites / Locations
- Città della Salute e della Scienza di Torino
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental
Control
Arm Description
self-conditioning techniques plus standard care
Standard care: dietary recommendations, exercise recommendations, and behavioral recommendations
Outcomes
Primary Outcome Measures
weight loss
Secondary Outcome Measures
Change in body fat percentage
Dual Energy X-Ray Absorptiometry (DEXA)
Change in fasting glucose
Change in insulin circulating values
Change in quality of life
EuroQol (EQ)-5D [Index and Visual Analog Scale (VAS)
Full Information
NCT ID
NCT02978105
First Posted
November 26, 2016
Last Updated
January 22, 2018
Sponsor
University of Turin, Italy
1. Study Identification
Unique Protocol Identification Number
NCT02978105
Brief Title
Effects of Self-conditioning Techniques in Promoting Weight Loss in Patients With Obesity. A Randomized Controlled Trial
Official Title
Effects of Self-conditioning Techniques in Promoting Weight Loss in Patients With Severe Obesity. A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turin, Italy
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
self-conditioning techniques plus standard care
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Standard care: dietary recommendations, exercise recommendations, and behavioral recommendations
Intervention Type
Other
Intervention Name(s)
self-conditioning techniques
Intervention Description
Self-hypnosis to increase self-control before meals and every food compulsion episode
Intervention Type
Other
Intervention Name(s)
standard care (diet, exercise and behavioral therapy)
Intervention Description
dietary recommendations, exercise recommendations, and behavioral recommendations
Primary Outcome Measure Information:
Title
weight loss
Time Frame
12 months after randomization
Secondary Outcome Measure Information:
Title
Change in body fat percentage
Description
Dual Energy X-Ray Absorptiometry (DEXA)
Time Frame
12 months after randomization
Title
Change in fasting glucose
Time Frame
12 months after randomization
Title
Change in insulin circulating values
Time Frame
12 months after randomization
Title
Change in quality of life
Description
EuroQol (EQ)-5D [Index and Visual Analog Scale (VAS)
Time Frame
12 months after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simona Bo, MD
Organizational Affiliation
University of Turin, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Città della Salute e della Scienza di Torino
City
Turin
ZIP/Postal Code
10126
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30226009
Citation
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.
Results Reference
derived
Learn more about this trial
Effects of Self-conditioning Techniques in Promoting Weight Loss in Patients With Obesity. A Randomized Controlled Trial
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