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Completed

NCT Number: NCT02978105

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

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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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Città della Salute e della Scienza di Torino

Turin, 10126, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

self-conditioning techniques

Other

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

standard care (diet, exercise and behavioral therapy)

Other

dietary recommendations, exercise recommendations, and behavioral recommendations

Primary outcomes

  1. weight loss

    Time frame: 12 months after randomization

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 30, 2016
Registry last updated
Jan 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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