<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02978105</url>
  </required_header>
  <id_info>
    <org_study_id>sbo2015</org_study_id>
    <nct_id>NCT02978105</nct_id>
  </id_info>
  <brief_title>Effects of Self-conditioning Techniques in Promoting Weight Loss in Patients With Obesity. A Randomized Controlled Trial</brief_title>
  <official_title>Effects of Self-conditioning Techniques in Promoting Weight Loss in Patients With Severe Obesity. A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Turin, Italy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Turin, Italy</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesized that hypnosis is an alternative technique that could be&#xD;
      applied to help patients with obesity to lose weight.&#xD;
&#xD;
      The possibility that a self-conditioning technique (self-hypnosis) added to traditional&#xD;
      approach (diet, exercise and behavioral recommendations) will be effective in determining&#xD;
      weight loss with respect to the traditional approach in subjects with a body mass index (BMI)&#xD;
      between 35 and 50 kg/m2 will be studied.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obesity is a serious health concern. Most lifestyle interventions fail over time; indeed,&#xD;
      overeating often involves loss of control and compulsive behaviors.&#xD;
&#xD;
      Hypnosis could increase the ability to control emotional impulses. Self-conditioning&#xD;
      techniques borrowed from hypnosis (self-hypnosis) increase self-control and self-management&#xD;
      of emotions. Recent hypnosis techniques with a rapid-induction phase allow the trained&#xD;
      patients to go into self-hypnosis in a few minutes and to repeat the experience in complete&#xD;
      autonomy, employing a short time of the day only.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2015</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>weight loss</measure>
    <time_frame>12 months after randomization</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in body fat percentage</measure>
    <time_frame>12 months after randomization</time_frame>
    <description>Dual Energy X-Ray Absorptiometry (DEXA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting glucose</measure>
    <time_frame>12 months after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in insulin circulating values</measure>
    <time_frame>12 months after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>12 months after randomization</time_frame>
    <description>EuroQol (EQ)-5D [Index and Visual Analog Scale (VAS)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>self-conditioning techniques plus standard care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard care: dietary recommendations, exercise recommendations, and behavioral recommendations</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>self-conditioning techniques</intervention_name>
    <description>Self-hypnosis to increase self-control before meals and every food compulsion episode</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>standard care (diet, exercise and behavioral therapy)</intervention_name>
    <description>dietary recommendations, exercise recommendations, and behavioral recommendations</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to give written informed consent&#xD;
&#xD;
          -  BMI between 35 and 50 kg/m2&#xD;
&#xD;
          -  Age 20-70 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or previous mental disorders and/or on any psychotropic drug&#xD;
&#xD;
          -  Insulin treatment&#xD;
&#xD;
          -  Candidates for bariatric surgery&#xD;
&#xD;
          -  Current (or discontinued for less than 6 months) treatment with anti-obesity drugs&#xD;
&#xD;
          -  Patients at risk of heart failure, edema, ascites (heart diseases, chronic liver&#xD;
             diseases, nephrotic syndrome, renal failure)&#xD;
&#xD;
          -  Patients with untreated or uncompensated thyroid diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Simona Bo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Turin, Italy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Città della Salute e della Scienza di Torino</name>
      <address>
        <city>Turin</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>November 26, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>January 22, 2018</last_update_submitted>
  <last_update_submitted_qc>January 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Turin, Italy</investigator_affiliation>
    <investigator_full_name>Simona Bo</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02978105
org study id: sbo2015
nct id: NCT02978105
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: weight loss
time frame: 12 months after randomization
measure: Change in body fat percentage
time frame: 12 months after randomization
description: Dual Energy X-Ray Absorptiometry (DEXA)
measure: Change in fasting glucose
time frame: 12 months after randomization
measure: Change in insulin circulating values
time frame: 12 months after randomization
measure: Change in quality of life
time frame: 12 months after randomization
description: EuroQol (EQ)-5D [Index and Visual Analog Scale (VAS)
arm group label: Experimental
arm group type: Experimental
description: self-conditioning techniques plus standard care
arm group label: Control
arm group type: Active Comparator
description: Standard care: dietary recommendations, exercise recommendations, and behavioral recommendations
intervention type: Other
intervention name: self-conditioning techniques
description: Self-hypnosis to increase self-control before meals and every food compulsion episode
arm group label: Experimental
intervention type: Other
intervention name: standard care (diet, exercise and behavioral therapy)
description: dietary recommendations, exercise recommendations, and behavioral recommendations
arm group label: Control
arm group label: Experimental
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Simona Bo, MD
role: Principal Investigator
affiliation: University of Turin, Italy
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Turin, Italy
investigator full name: Simona Bo
investigator title: Associate Professor
mesh term: Obesity
mesh term: Weight Loss
sharing ipd: No