<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/NCT01729273</url>
  </required_header>
  <id_info>
    <org_study_id>CHRI-23724</org_study_id>
    <nct_id>NCT01729273</nct_id>
  </id_info>
  <brief_title>Vascular Health and Exercise Performance of Overweight Children</brief_title>
  <acronym>VHEPOC</acronym>
  <official_title>Vascular Health and Exercise Performance of Overweight Children in 12 Weeks Using Skype</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess exercise performance in 20 healthy children 10-19&#xD;
      years of age with a body mass index greater than 85th percentile and to evaluate the effect&#xD;
      of dietary and exercise intervention over 12 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Our hypothesis is that the vascular health in these children will improve at the end of&#xD;
      intervention. The results of this study will help us in our long-term objective of improving&#xD;
      vascular health of children with congenital/acquired heart disease, a group particularly at&#xD;
      risk for premature atherosclerosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vascular Health</measure>
    <time_frame>Beginning of 12th week and end of 12th week</time_frame>
    <description>Tests will include: EndoPAT analysis to assess endothelial function, applanation tonometry to assess arterial stiffness, carotid artery imaging to assess the wall thickness of the carotid arteries, exercise testing to assess the physical exercise capacity of these children and blood work to evaluate the lipid profile and inflammation status (CRP). The participant will be asked to come in after an overnight fast. They will receive a snack bag before the exercise test.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Patient Compliance</condition>
  <arm_group>
    <arm_group_label>Diet and Exercise Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tests will include EndoPAT analysis to assess endothelial function, applanation tonometry to assess arterial stiffness, carotid artery imaging to assess the wall thickness of the carotid arteries, exercise testing to assess the physical exercise capacity of these children and blood work to evaluate the lipid profile and inflammation status (CRP).&#xD;
The Home Exercise Program will be 3 days a week for 12 weeks and participants will connect with the trainer to perform 45-60 minutes of a combination of strength training and aerobic activity via Skype. The Dietary Approaches to Stop Hypertension(DASH) eating pattern will be prescribed to all participants in the treatment group and specific strategies to achieve goals will be discussed weekly by the participant over the phone.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diet and Exercise Intervention</intervention_name>
    <description>Remote Dietary and Exercise Intervention Program</description>
    <arm_group_label>Diet and Exercise Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  10-19 years old&#xD;
&#xD;
          -  Overweight (BMI &gt; 85 percentile)&#xD;
&#xD;
          -  Interested in a 12 week ¬home exercise &amp; nutrition program&#xD;
&#xD;
          -  Have computer &amp; internet access&#xD;
&#xD;
          -  Can come to Lucile Packard Children's Hospital at Stanford for a 3-hour test at the&#xD;
             start &amp; end of the study (so only twice!)&#xD;
&#xD;
          -  Are able to come to testing after fasting overnight&#xD;
&#xD;
          -  Do not smoke&#xD;
&#xD;
          -  Do not take any medications&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non-overweight adolescents&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Seda Tierney, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lucile Packard Children's Hospital - Pediatric Cardiology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chau N Vu, BS</last_name>
    <role>Study Director</role>
    <affiliation>Lucile Packard Children's Hospital - Pediatric Cardiology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Katie Jo Buccola</last_name>
    <role>Study Chair</role>
    <affiliation>Lucile Packard Children's Hospital - Pediatric Cardiology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jeffrey Kazmucha</last_name>
    <role>Study Chair</role>
    <affiliation>Lucile Packard Children's Hospital - Pediatric Cardiology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Laurie Steinberg</last_name>
    <role>Study Chair</role>
    <affiliation>Stanford Prevention Research Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Olga Ogareva</last_name>
    <role>Study Chair</role>
    <affiliation>Lucile Packard Children's Hospital - Pediatric Cardiology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Inger Olson, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Lucile Packard Children's Hospital - Pediatric Cardiology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chinyelu Nwobu, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Lucile Packard Children's Hospital - Pediatric Cardiology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lucile Packard Children's Hospital at Stanford</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>October 2, 2014</last_update_submitted>
  <last_update_submitted_qc>October 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 6, 2014</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>Overweight</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/NCT01729273
org study id: CHRI-23724
nct id: NCT01729273
lead sponsor: 
has dmc: Yes
The purpose of this study is to assess exercise performance in 20 healthy children 10-19
      years of age with a body mass index greater than 85th percentile and to evaluate the effect
      of dietary and exercise intervention over 12 weeks.
Our hypothesis is that the vascular health in these children will improve at the end of
      intervention. The results of this study will help us in our long-term objective of improving
      vascular health of children with congenital/acquired heart disease, a group particularly at
      risk for premature atherosclerosis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Vascular Health
time frame: Beginning of 12th week and end of 12th week
description: Tests will include: EndoPAT analysis to assess endothelial function, applanation tonometry to assess arterial stiffness, carotid artery imaging to assess the wall thickness of the carotid arteries, exercise testing to assess the physical exercise capacity of these children and blood work to evaluate the lipid profile and inflammation status (CRP). The participant will be asked to come in after an overnight fast. They will receive a snack bag before the exercise test.
arm group label: Diet and Exercise Intervention
arm group type: Experimental
description: Tests will include EndoPAT analysis to assess endothelial function, applanation tonometry to assess arterial stiffness, carotid artery imaging to assess the wall thickness of the carotid arteries, exercise testing to assess the physical exercise capacity of these children and blood work to evaluate the lipid profile and inflammation status (CRP).
The Home Exercise Program will be 3 days a week for 12 weeks and participants will connect with the trainer to perform 45-60 minutes of a combination of strength training and aerobic activity via Skype. The Dietary Approaches to Stop Hypertension(DASH) eating pattern will be prescribed to all participants in the treatment group and specific strategies to achieve goals will be discussed weekly by the participant over the phone.
intervention type: Other
intervention name: Diet and Exercise Intervention
description: Remote Dietary and Exercise Intervention Program
arm group label: Diet and Exercise Intervention
criteria: 
gender: All
minimum age: 10 Years
maximum age: 19 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Seda Tierney, MD
role: Principal Investigator
affiliation: Lucile Packard Children's Hospital - Pediatric Cardiology
last name: Chau N Vu, BS
role: Study Director
affiliation: Lucile Packard Children's Hospital - Pediatric Cardiology
last name: Katie Jo Buccola
role: Study Chair
affiliation: Lucile Packard Children's Hospital - Pediatric Cardiology
last name: Jeffrey Kazmucha
role: Study Chair
affiliation: Lucile Packard Children's Hospital - Pediatric Cardiology
last name: Laurie Steinberg
role: Study Chair
affiliation: Stanford Prevention Research Center
last name: Olga Ogareva
role: Study Chair
affiliation: Lucile Packard Children's Hospital - Pediatric Cardiology
last name: Inger Olson, MD
role: Study Chair
affiliation: Lucile Packard Children's Hospital - Pediatric Cardiology
last name: Chinyelu Nwobu, MD
role: Study Chair
affiliation: Lucile Packard Children's Hospital - Pediatric Cardiology
facility: 
country: United States
responsible party type: Sponsor
mesh term: Overweight