<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/NCT01660789</url>
  </required_header>
  <id_info>
    <org_study_id>H-2-2011-132</org_study_id>
    <nct_id>NCT01660789</nct_id>
  </id_info>
  <brief_title>&quot;Fit For Kids&quot;-Copenhagen</brief_title>
  <acronym>FFK</acronym>
  <official_title>&quot;Fit For Kids&quot; Copenhagen - an Interventions Study on Obesity and Physical Inactivity in Children.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to evaluate the effect of a 40- week multifactorial intervention against&#xD;
      overweight, obesity and physical inactivity in Danish children.&#xD;
&#xD;
      The investigators wish to examine 40 children before and after the &quot;Fit for Kids&quot;&#xD;
      intervention with basic anthropometric measures such as body mass indexi (BMI), waist/hip&#xD;
      ratio, systolic- and diastolic blood pressure, level of physical fitness and Total Body fat&#xD;
      mass.&#xD;
&#xD;
      Furthermore the investigators wish to examine the more specific inflammatory, metabolic and&#xD;
      hormonal effect of the intervention with a more extensive examination programme.&#xD;
&#xD;
      The tests include a DXA-scan, cardio-respiratory fitness, accelerometer monitoring, pedometer&#xD;
      monitoring, cognitive testing, Continuous Glucose Monitoring System, different metabolic and&#xD;
      inflammatory markers and an oral glucose tolerance test. The study will take place at Centre&#xD;
      of Inflammation and Metabolism, Rigshospitalet, Copenhagen.&#xD;
&#xD;
      The study is a randomised controlled trial with a gradual rollout. The 40 children will be&#xD;
      randomised. Twenty children will start the intervention at baseline and 20 children will&#xD;
      start after the first 20 weeks of intervention, thus providing a control group.&#xD;
&#xD;
      The investigators expect to find a significant reduction in BMI, total body fat mass and&#xD;
      systolic blood pressure after the intervention. As for the more extensive tests, the data&#xD;
      approach is explorative, as the investigators look at more statistical dependent variables.&#xD;
      The contribution of this project is a further description on the effect of intervention&#xD;
      against overweight and physical inactivity on the metabolic and inflammatory response.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">August 2012</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>BMI</measure>
    <time_frame>One year</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Lifestyle intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Lifestyle intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical activity, dietary counseling, coaching</intervention_name>
    <description>Physical activity, dietary counseling, coaching</description>
    <arm_group_label>Lifestyle intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Obese children&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other chronic medical conditions&#xD;
&#xD;
          -  Medical intake&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nina Marie Birk Eriksen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre of Inflammation and Metabolism</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre of Inflammation and Metabolism, Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>April 2, 2012</study_first_submitted>
  <study_first_submitted_qc>August 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>August 30, 2012</last_update_submitted>
  <last_update_submitted_qc>August 30, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 31, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Inge Holm</investigator_full_name>
    <investigator_title>Administrator</investigator_title>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Diabetes</keyword>
  <keyword>Physical activity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</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/NCT01660789
org study id: H-2-2011-132
nct id: NCT01660789
lead sponsor: 
has dmc: Yes
This study aims to evaluate the effect of a 40- week multifactorial intervention against
      overweight, obesity and physical inactivity in Danish children.

      The investigators wish to examine 40 children before and after the "Fit for Kids"
      intervention with basic anthropometric measures such as body mass indexi (BMI), waist/hip
      ratio, systolic- and diastolic blood pressure, level of physical fitness and Total Body fat
      mass.

      Furthermore the investigators wish to examine the more specific inflammatory, metabolic and
      hormonal effect of the intervention with a more extensive examination programme.

      The tests include a DXA-scan, cardio-respiratory fitness, accelerometer monitoring, pedometer
      monitoring, cognitive testing, Continuous Glucose Monitoring System, different metabolic and
      inflammatory markers and an oral glucose tolerance test. The study will take place at Centre
      of Inflammation and Metabolism, Rigshospitalet, Copenhagen.

      The study is a randomised controlled trial with a gradual rollout. The 40 children will be
      randomised. Twenty children will start the intervention at baseline and 20 children will
      start after the first 20 weeks of intervention, thus providing a control group.

      The investigators expect to find a significant reduction in BMI, total body fat mass and
      systolic blood pressure after the intervention. As for the more extensive tests, the data
      approach is explorative, as the investigators look at more statistical dependent variables.
      The contribution of this project is a further description on the effect of intervention
      against overweight and physical inactivity on the metabolic and inflammatory response.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: BMI
time frame: One year
arm group label: Lifestyle intervention
arm group type: Other
description: Lifestyle intervention.
intervention type: Behavioral
intervention name: Physical activity, dietary counseling, coaching
description: Physical activity, dietary counseling, coaching
arm group label: Lifestyle intervention
criteria: 
gender: All
minimum age: 7 Years
maximum age: 10 Years
healthy volunteers: No
last name: Nina Marie Birk Eriksen, MD
role: Principal Investigator
affiliation: Centre of Inflammation and Metabolism
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Inge Holm
investigator title: Administrator
mesh term: Obesity