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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental

self-conditioning techniques plus standard care

Group Type EXPERIMENTAL

self-conditioning techniques

Intervention Type OTHER

Self-hypnosis to increase self-control before meals and every food compulsion episode

standard care (diet, exercise and behavioral therapy)

Intervention Type OTHER

dietary recommendations, exercise recommendations, and behavioral recommendations

Control

Standard care: dietary recommendations, exercise recommendations, and behavioral recommendations

Group Type ACTIVE_COMPARATOR

standard care (diet, exercise and behavioral therapy)

Intervention Type OTHER

dietary recommendations, exercise recommendations, and behavioral recommendations

Interventions

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self-conditioning techniques

Self-hypnosis to increase self-control before meals and every food compulsion episode

Intervention Type OTHER

standard care (diet, exercise and behavioral therapy)

dietary recommendations, exercise recommendations, and behavioral recommendations

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No