<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/NCT01713465</url>
  </required_header>
  <id_info>
    <org_study_id>GIA22012</org_study_id>
    <nct_id>NCT01713465</nct_id>
  </id_info>
  <brief_title>Use of Computers to Prevent Metabolic Syndrome</brief_title>
  <official_title>An Innovative Informatics Platform to Deliver a Multidimensional Intervention to Prevent and Manage Metabolic Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asian Institute of Public Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asian Institute of Public Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the proposed study is to design and evaluate a touch screen computer based&#xD;
      multi-factorial intervention to educate individuals at risk of Metabolic syndrome in diverse&#xD;
      Indian settings including urban, rural and slum in the State of Bhubaneshwar. The study&#xD;
      objective is to improve metabolic syndrome related knowledge, attitude and practices among&#xD;
      individuals using the proposed interactive, bilingual computer based educational program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The rising prevalence of overweight and obesity has a direct correlation with increasing&#xD;
      prevalence of hypertension, dyslipidemia, type2 diabetes mellitus (T2DM), Metabolic Syndrome&#xD;
      (MetS), and Cardiovascular diseases (CVD). Most of the previous studies in India have been&#xD;
      cross sectional nature and have looked at prevalence of Metabolic Syndrome (MetS. Despite the&#xD;
      clinical and public health importance of this phenomenon, not enough work has been carried&#xD;
      out so far to study and remedy this situation. A computer based interactive and bilingual&#xD;
      system is proposed to improve Metabolic syndrome related knowledge, attitudes and practices&#xD;
      among individuals living in urban, rural and slum settings of Bhubaneswar, India. We propose&#xD;
      to enroll 750 individuals and the eligible study participants will be randomly assigned to&#xD;
      either the intervention (computer based MetS Program CBMP) or control (Printed Educational&#xD;
      Material, PEM) groups. The study participants will be followed at days 30, 60 and 90 days&#xD;
      following the baseline visit. The primary outcomes include change in knowledge, attitudes and&#xD;
      practices and secondary outcomes include improvement in quality of life and increase&#xD;
      satisfaction to medical care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2012</start_date>
  <completion_date type="Anticipated">April 2013</completion_date>
  <primary_completion_date type="Anticipated">January 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of participants with increase in Knowledge, Attitude and Practice scores</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of participants with increase in treatment adherence scores</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of participants with increase in Satisfaction to Medical Care</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">750</enrollment>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>1 CBMP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CBMP: Computer based Metabolic syndrome program</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Computer based Metabolic Syndrome educational program</intervention_name>
    <description>Individuals in the intervention group will receive metabolic syndrome related education using a touch screen interactive and bilingual multimedia enabled educational program</description>
    <arm_group_label>1 CBMP</arm_group_label>
    <other_name>CBMP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adults age 30 years and above, agreeing to participate in the study available for&#xD;
             follow-up interview.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  mental and physical challenge that makes it difficult to use the touch based computer&#xD;
             program nonavailability for telephone follow-up involvement in other clinical trials&#xD;
             or protocols related to Metabolic Syndrome.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ashish Joshi, MD,PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNMC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ashish Joshi, MD,PhD, MPH</last_name>
    <phone>4435706018</phone>
    <email>ashish1875@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Shruti Mehta, PGDHHM</last_name>
    <phone>8763717844</phone>
    <email>drshruti.mehta1@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Center for Public Health informatics, AIPH</name>
      <address>
        <city>Bhubaneshwar</city>
        <state>Orissa</state>
        <zip>751002</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shruti Mehta, PGDHHM</last_name>
      <phone>8763717844</phone>
      <email>drshruti.mehta1@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <reference>
    <citation>Finkelstein J, Joshi A, Hise MK. Association of physical activity and renal function in subjects with and without metabolic syndrome: a review of the Third National Health and Nutrition Examination Survey (NHANES III). Am J Kidney Dis. 2006 Sep;48(3):372-82. doi: 10.1053/j.ajkd.2006.05.013.</citation>
    <PMID>16931210</PMID>
  </reference>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <last_update_submitted>October 23, 2012</last_update_submitted>
  <last_update_submitted_qc>October 23, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 24, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asian Institute of Public Health</investigator_affiliation>
    <investigator_full_name>Ashish Joshi</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Diabetes</keyword>
  <keyword>Hypertension</keyword>
  <keyword>Hypercholesterolemia</keyword>
  <keyword>Obesity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT01713465
org study id: GIA22012
nct id: NCT01713465
lead sponsor: 
has dmc: Yes
The objective of the proposed study is to design and evaluate a touch screen computer based
      multi-factorial intervention to educate individuals at risk of Metabolic syndrome in diverse
      Indian settings including urban, rural and slum in the State of Bhubaneshwar. The study
      objective is to improve metabolic syndrome related knowledge, attitude and practices among
      individuals using the proposed interactive, bilingual computer based educational program.
The rising prevalence of overweight and obesity has a direct correlation with increasing
      prevalence of hypertension, dyslipidemia, type2 diabetes mellitus (T2DM), Metabolic Syndrome
      (MetS), and Cardiovascular diseases (CVD). Most of the previous studies in India have been
      cross sectional nature and have looked at prevalence of Metabolic Syndrome (MetS. Despite the
      clinical and public health importance of this phenomenon, not enough work has been carried
      out so far to study and remedy this situation. A computer based interactive and bilingual
      system is proposed to improve Metabolic syndrome related knowledge, attitudes and practices
      among individuals living in urban, rural and slum settings of Bhubaneswar, India. We propose
      to enroll 750 individuals and the eligible study participants will be randomly assigned to
      either the intervention (computer based MetS Program CBMP) or control (Printed Educational
      Material, PEM) groups. The study participants will be followed at days 30, 60 and 90 days
      following the baseline visit. The primary outcomes include change in knowledge, attitudes and
      practices and secondary outcomes include improvement in quality of life and increase
      satisfaction to medical care.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Frequency of participants with increase in Knowledge, Attitude and Practice scores
time frame: 3 months
measure: Frequency of participants with increase in treatment adherence scores
time frame: 3 months
measure: Frequency of participants with increase in Satisfaction to Medical Care
time frame: 3 months
arm group label: 1 CBMP
arm group type: Experimental
description: CBMP: Computer based Metabolic syndrome program
intervention type: Other
intervention name: Computer based Metabolic Syndrome educational program
description: Individuals in the intervention group will receive metabolic syndrome related education using a touch screen interactive and bilingual multimedia enabled educational program
arm group label: 1 CBMP
other name: CBMP
criteria: 
gender: All
minimum age: 30 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ashish Joshi, MD,PhD, MPH
role: Principal Investigator
affiliation: UNMC
last name: Ashish Joshi, MD,PhD, MPH
phone: 4435706018
email: ashish1875@gmail.com
last name: Shruti Mehta, PGDHHM
phone: 8763717844
email: drshruti.mehta1@gmail.com
facility: 
status: Recruiting
contact: 
country: India
citation: Finkelstein J, Joshi A, Hise MK. Association of physical activity and renal function in subjects with and without metabolic syndrome: a review of the Third National Health and Nutrition Examination Survey (NHANES III). Am J Kidney Dis. 2006 Sep;48(3):372-82. doi: 10.1053/j.ajkd.2006.05.013.
PMID: 16931210
responsible party type: Principal Investigator
investigator affiliation: Asian Institute of Public Health
investigator full name: Ashish Joshi
investigator title: Assistant Professor
mesh term: Metabolic Syndrome
mesh term: Syndrome