<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/NCT01716325</url>
  </required_header>
  <id_info>
    <org_study_id>EHOW</org_study_id>
    <nct_id>NCT01716325</nct_id>
  </id_info>
  <brief_title>E-support for Healthcare Processes - WEIGHT LOSS</brief_title>
  <official_title>E-support for Healthcare Processes - WEIGHT LOSS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Primorska</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Public Health, Slovenia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Primorska</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to establish and clinically evaluate a new approach to treating&#xD;
      obesity by using information and communication technologies (ICT). A mobile environment and&#xD;
      organizational interventions to improve the process of an integrated treatment of people with&#xD;
      obesity will be identified, developed, introduced and clinically evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A mobile environment to improve the process of an integrated treatment of obese people will&#xD;
      be identified, developed, introduced and clinically evaluated. The study will include 150&#xD;
      patients aged between 25 to 65 for men and 25 to 70 for women, diagnosed with obesity (BMI≥30&#xD;
      or BMI&gt;27,5 and 20% risk or more for developing a cardiovascular diseases). One group of&#xD;
      patients will visit conventional live workshops for weight loss and the other group will use&#xD;
      ICT. At the initial examination by the doctor all survey participants will have measured&#xD;
      blood pressure, body mass, waist circumference, percentage of body fat, percentage of&#xD;
      skeletal muscle, resting metabolic rate, estimated risk of developing cardiovascular disease&#xD;
      and will be directed to laboratory examination (blood lipids and cholesterol, blood sugar).&#xD;
      Both groups will go through 16 workshops for weight loss. Each week they will monitor their&#xD;
      body mass, waist circumference, physical activity (type, duration, intensity) and food intake&#xD;
      (type, quantity). After six months all survey participants will be examined again. We will&#xD;
      compare effectiveness of ICT weight loss group with conventional weight loss group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2012</start_date>
  <completion_date type="Anticipated">April 2013</completion_date>
  <primary_completion_date type="Anticipated">December 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight loss</measure>
    <time_frame>16 weeks</time_frame>
    <description>Weight loss of 5 to 10 % of the body mass at the beginning of the study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Successful maintenance or improvement of the following measured parameter: Body mass index.</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Successful maintenance or improvement of the following measured parameter: waist circumference</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Weight loss - ICT support</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Weight loss - ICT support</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Weight loss, comparator - no ICT support; conventional live workshops for weight loss</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Self-management weight loss plan endorsement.</intervention_name>
    <description>Self-management weight loss plan endorsement.</description>
    <arm_group_label>Weight loss - ICT support</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional</intervention_name>
    <description>Weight loss, comparator - no ICT support; conventional live workshops for weight loss</description>
    <arm_group_label>Conventional</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI≥30 or BMI&gt;27,5 and 20% or more risk for developing a cardiovascular diseases&#xD;
&#xD;
          -  Age between 25 - 65 years for men and 25 - 70 years for women&#xD;
&#xD;
          -  Own a mobile phone&#xD;
&#xD;
          -  Internet&#xD;
&#xD;
          -  Know how to use a computer&#xD;
&#xD;
          -  Know how to use an e-mail&#xD;
&#xD;
          -  Signed voluntary consent to participate in the survey&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  People with movement disorders&#xD;
&#xD;
          -  Age&lt;18 years or age&gt;70 years for women and 65 years for men&#xD;
&#xD;
          -  Pregnancy, breast feeding, intention of getting pregnant during the study, period&#xD;
             after childbirth (9 months)&#xD;
&#xD;
          -  Does not own or know how to handle a mobile phone&#xD;
&#xD;
          -  No internet access&#xD;
&#xD;
          -  Known hospitalization for severe psychiatric disorders (schizophrenia, psychosis)&#xD;
&#xD;
          -  Known history of eating disorders (anorexia, bulimia nervosa and others)&#xD;
&#xD;
          -  Cancer incidence in the last 5 years&#xD;
&#xD;
          -  Heart problems, chest pain, nausea, dizziness&#xD;
&#xD;
          -  Chronic inflammatory diseases&#xD;
&#xD;
          -  Other unregulated chronic diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cirila Hlastan Ribič, PhD, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institute of public Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cirila Hlastan Ribič, PhD, Prof.</last_name>
    <phone>+386 1 5477372</phone>
    <email>cirila.hlastan@ivz-rs.si</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Iztok Cukjati</last_name>
    <phone>+386 40 186 268</phone>
    <email>iztok.cukjati@upr.si</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CINDI Slovenia, National Institute of Public Health</name>
      <address>
        <city>Ljubljana</city>
        <zip>00386</zip>
        <country>Slovenia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cirila Hlastan Ribič, PhD, Prof.</last_name>
      <phone>+386 1 5477372</phone>
      <email>cirila.hlastan@ivz-rs.si</email>
    </contact>
    <contact_backup>
      <last_name>Breda Cus</last_name>
      <phone>+386 1 5477368</phone>
      <email>breda.cus@ivz-rs.si</email>
    </contact_backup>
    <investigator>
      <last_name>Ana Šerona</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Slovenia</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>October 24, 2012</last_update_submitted>
  <last_update_submitted_qc>October 24, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 29, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <!-- 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/NCT01716325
org study id: EHOW
nct id: NCT01716325
lead sponsor: 
collaborator: 
has dmc: No
The purpose of the study is to establish and clinically evaluate a new approach to treating
      obesity by using information and communication technologies (ICT). A mobile environment and
      organizational interventions to improve the process of an integrated treatment of people with
      obesity will be identified, developed, introduced and clinically evaluated.
A mobile environment to improve the process of an integrated treatment of obese people will
      be identified, developed, introduced and clinically evaluated. The study will include 150
      patients aged between 25 to 65 for men and 25 to 70 for women, diagnosed with obesity (BMI≥30
      or BMI>27,5 and 20% risk or more for developing a cardiovascular diseases). One group of
      patients will visit conventional live workshops for weight loss and the other group will use
      ICT. At the initial examination by the doctor all survey participants will have measured
      blood pressure, body mass, waist circumference, percentage of body fat, percentage of
      skeletal muscle, resting metabolic rate, estimated risk of developing cardiovascular disease
      and will be directed to laboratory examination (blood lipids and cholesterol, blood sugar).
      Both groups will go through 16 workshops for weight loss. Each week they will monitor their
      body mass, waist circumference, physical activity (type, duration, intensity) and food intake
      (type, quantity). After six months all survey participants will be examined again. We will
      compare effectiveness of ICT weight loss group with conventional weight loss group.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Weight loss
time frame: 16 weeks
description: Weight loss of 5 to 10 % of the body mass at the beginning of the study
measure: Successful maintenance or improvement of the following measured parameter: Body mass index.
time frame: 16 weeks
measure: Successful maintenance or improvement of the following measured parameter: waist circumference
time frame: 16 weeks
arm group label: Weight loss - ICT support
arm group type: Experimental
description: Weight loss - ICT support
arm group label: Conventional
arm group type: Other
description: Weight loss, comparator - no ICT support; conventional live workshops for weight loss
intervention type: Other
intervention name: Self-management weight loss plan endorsement.
description: Self-management weight loss plan endorsement.
arm group label: Weight loss - ICT support
intervention type: Other
intervention name: Conventional
description: Weight loss, comparator - no ICT support; conventional live workshops for weight loss
arm group label: Conventional
criteria: 
gender: All
minimum age: 25 Years
maximum age: 70 Years
healthy volunteers: No
last name: Cirila Hlastan Ribič, PhD, Prof.
role: Principal Investigator
affiliation: National Institute of public Health
last name: Cirila Hlastan Ribič, PhD, Prof.
phone: +386 1 5477372
email: cirila.hlastan@ivz-rs.si
last name: Iztok Cukjati
phone: +386 40 186 268
email: iztok.cukjati@upr.si
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Slovenia
responsible party type: Sponsor
mesh term: Weight Loss