Clinical trial NCT02978105: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: weight loss
timeFrame: 12 months after randomization
Secondary outcomes:
measure: Change in body fat percentage
timeFrame: 12 months after randomization
measure: Change in fasting glucose
timeFrame: 12 months after randomization
measure: Change in insulin circulating values
timeFrame: 12 months after randomization
measure: Change in quality of life
timeFrame: 12 months after randomization
Other outcomes:
Locations:
city: Turin
country: Italy
facility: Città della Salute e della Scienza di Torino
Study officials:
affiliation: University of Turin, Italy
name: Simona Bo, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.