<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/NCT03300271</url>
  </required_header>
  <id_info>
    <org_study_id>4-2017-0666</org_study_id>
    <nct_id>NCT03300271</nct_id>
  </id_info>
  <brief_title>Effects of a Supportive Mobile Health for Life Style Modification on Blood Pressure and Insulin Resistance Improvement in People With Metabolic Abnormalities</brief_title>
  <official_title>Effects of a Supportive Mobile Health for Life Style Modification on Blood Pressure and Insulin Resistance Improvement in People With Metabolic Abnormalities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this randomized study is to assess the efficacy of a mobile application for&#xD;
      the improvement of blood pressure and insulin resistance in people with metabolic&#xD;
      abnormalities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this randomized study is to assess the efficacy of a mobile application for&#xD;
      the improvement of blood pressure and insulin resistance in people with metabolic syndrome.&#xD;
&#xD;
      This study is a 24 week follow up randomized prevention trial. Participants visit for a&#xD;
      screening test, then eligible participants are randomly assigned for one of the following&#xD;
      arms; 1 intervention group using a mobile application to monitor their life style behaviors,&#xD;
      1 intervention group using a mobile application for personal coaching on purpose of improving&#xD;
      their life style behavior, and 1 control group providing education about managing life style&#xD;
      behaviors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 28, 2017</start_date>
  <completion_date type="Actual">August 2, 2018</completion_date>
  <primary_completion_date type="Actual">August 2, 2018</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>Participants will be randomly assigned to either the experimental conditions (mobile application), or the usual condition (education).</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>A designated researcher will be responsible for the random allocation and mask the results, so the investigators and the outcomes assessor do know the which group the participants are been allocated in.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in systolic/diastolic blood pressures</measure>
    <time_frame>24 weeks</time_frame>
    <description>Change of systolic/diastolic blood pressures and insulin resistance are the differences between the last visit and baseline (screening visit).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the eligibility criteria for metabolic syndrome</measure>
    <time_frame>24 weeks</time_frame>
    <description>Change of metabolic profiles are the differences between the last visit and baseline (screening visit).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">129</enrollment>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>No intervention (Education)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants in this group is provided education. Education includes information of metabolic syndrome, methods to manage lifestyle (diet, physical activity).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mobile Application (Self monitoring)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will be introduced to use a mobile application to self record and monitor their life style behaviors. They will be also be provided education same as the control group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mobile Application (Personal coaching)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will be introduced to use a mobile application. Personal coaches such as dietitian, sports manager encourage to improve their life style behaviors. They will be also be provided education same as the control group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mobile application for self monitoring</intervention_name>
    <description>Participants in this group will be introduced to use a mobile application to self record and monitor their life style behaviors. They will be also be provided education same as the control group.</description>
    <arm_group_label>Mobile Application (Self monitoring)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Education</intervention_name>
    <description>Participants in this group is provided education. Education includes information of metabolic syndrome, methods to manage lifestyle (diet, physical activity).</description>
    <arm_group_label>No intervention (Education)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mobile application for personal coaching</intervention_name>
    <description>Participants in this group will be introduced to use a mobile application. Personal coaches such as dietitian, sports manager encourage to improve their life style behaviors. They will be also be provided education same as the control group.</description>
    <arm_group_label>Mobile Application (Personal coaching)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &quot;Etiologic study on cardiovascular and metabolic diseases: prospective cohort study&#xD;
             (Severance Hospital IRB No. 4-2013-0661)&quot; participants&#xD;
&#xD;
          -  Smartphone user&#xD;
&#xD;
          -  Metabolic abnormality. Having 2 or more components of metabolic syndrome described&#xD;
             below:&#xD;
&#xD;
               1. Central obesity : waist circumference ≥ 90cm in male, ≥ 80cm in female&#xD;
&#xD;
               2. Systolic/diastolic blood pressure ≥ 130/85 mmHg&#xD;
&#xD;
               3. Serum triglyceride ≥ 150 mg/dL&#xD;
&#xD;
               4. Serum high density lipoprotein cholesterol &lt; 40 mg/dL in male, 50 mg/dL in female&#xD;
&#xD;
               5. Fasting glucose ≥ 100mg/dL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presently or planning for pregnant/breastfeeding during the study. Or confirmed&#xD;
             pregnancy by a urine test.&#xD;
&#xD;
          -  Currently taking medication (including insulin injection) for hypertension,&#xD;
             dyslipidemia, or diabetes.&#xD;
&#xD;
          -  Presently using a mobile application for lifestyle modification&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Yonsei University College of Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 24, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>January 9, 2019</last_update_submitted>
  <last_update_submitted_qc>January 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2019</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>Metabolic Syndrome</mesh_term>
    <mesh_term>Insulin Resistance</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/NCT03300271
org study id: 4-2017-0666
nct id: NCT03300271
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this randomized study is to assess the efficacy of a mobile application for
      the improvement of blood pressure and insulin resistance in people with metabolic
      abnormalities.
The purpose of this randomized study is to assess the efficacy of a mobile application for
      the improvement of blood pressure and insulin resistance in people with metabolic syndrome.

      This study is a 24 week follow up randomized prevention trial. Participants visit for a
      screening test, then eligible participants are randomly assigned for one of the following
      arms; 1 intervention group using a mobile application to monitor their life style behaviors,
      1 intervention group using a mobile application for personal coaching on purpose of improving
      their life style behavior, and 1 control group providing education about managing life style
      behaviors.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomly assigned to either the experimental conditions (mobile application), or the usual condition (education).
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
masking description: A designated researcher will be responsible for the random allocation and mask the results, so the investigators and the outcomes assessor do know the which group the participants are been allocated in.
measure: Change in systolic/diastolic blood pressures
time frame: 24 weeks
description: Change of systolic/diastolic blood pressures and insulin resistance are the differences between the last visit and baseline (screening visit).
measure: Change in the eligibility criteria for metabolic syndrome
time frame: 24 weeks
description: Change of metabolic profiles are the differences between the last visit and baseline (screening visit).
arm group label: No intervention (Education)
arm group type: Other
description: Participants in this group is provided education. Education includes information of metabolic syndrome, methods to manage lifestyle (diet, physical activity).
arm group label: Mobile Application (Self monitoring)
arm group type: Experimental
description: Participants in this group will be introduced to use a mobile application to self record and monitor their life style behaviors. They will be also be provided education same as the control group.
arm group label: Mobile Application (Personal coaching)
arm group type: Experimental
description: Participants in this group will be introduced to use a mobile application. Personal coaches such as dietitian, sports manager encourage to improve their life style behaviors. They will be also be provided education same as the control group.
intervention type: Other
intervention name: Mobile application for self monitoring
description: Participants in this group will be introduced to use a mobile application to self record and monitor their life style behaviors. They will be also be provided education same as the control group.
arm group label: Mobile Application (Self monitoring)
intervention type: Other
intervention name: Education
description: Participants in this group is provided education. Education includes information of metabolic syndrome, methods to manage lifestyle (diet, physical activity).
arm group label: No intervention (Education)
intervention type: Other
intervention name: Mobile application for personal coaching
description: Participants in this group will be introduced to use a mobile application. Personal coaches such as dietitian, sports manager encourage to improve their life style behaviors. They will be also be provided education same as the control group.
arm group label: Mobile Application (Personal coaching)
criteria: 
gender: All
minimum age: 30 Years
maximum age: 59 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Metabolic Syndrome
mesh term: Insulin Resistance
sharing ipd: No