<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/NCT02206191</url>
  </required_header>
  <id_info>
    <org_study_id>IRB13-00262</org_study_id>
    <secondary_id>Food Innovation Center</secondary_id>
    <nct_id>NCT02206191</nct_id>
  </id_info>
  <brief_title>The Primary Care Obesity Network (PCON): Incorporating Principles of Self-regulation of Intake</brief_title>
  <acronym>PCON</acronym>
  <official_title>The Primary Care Obesity Network (PCON): Incorporating Principles of Self-regulation of Intake</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nationwide Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nationwide Children's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In response to the high prevalence rates of childhood obesity in central Ohio, the Center for&#xD;
      Healthy Weight and Nutrition (CHWN) established the Primary Care Obesity Network (PCON); a&#xD;
      partnership between primary care physicians and Nationwide Children's Hospital's Center for&#xD;
      Healthy Weight and Nutrition, a tertiary care obesity center, the first of its kind in Ohio.&#xD;
      The overall goal of PCON is to bring an effective and user friendly obesity management&#xD;
      program to the community physician's office to prevent and treat the growing number of obese&#xD;
      children in the setting of the private office. The predominant nutrition messaging approach&#xD;
      to tackling childhood obesity has revolved around the food choices and portion sizes. While&#xD;
      this is relevant, an area with significant potential for impact for maintaining optimal&#xD;
      growth and a healthy weight for young children is addressing feeding behaviors and&#xD;
      self-regulation of intake;. - the &quot;how&quot; of eating. The investigators objective it to&#xD;
      investigate whether this self-regulation approach can be employed for an older age group of&#xD;
      6-11 years old.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Actual">January 30, 2017</completion_date>
  <primary_completion_date type="Actual">January 30, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Examining use of disordered self-regulatory feeding behaviors, at survey completion</measure>
    <time_frame>At survey completion, which will occur about 30 minutes after the survey is administered</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">120</enrollment>
  <condition>Self-regulation</condition>
  <arm_group>
    <arm_group_label>Mothers of 6-11 year olds</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Mothers of 6-11 year olds being seen in primary care offices throughout Columbus, OH.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mother of a 6-11 year old child&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to speak and read English&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ihuoma Eneli, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nationwide Childrens Hospital, Columbus, Ohio</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>March 29, 2018</last_update_submitted>
  <last_update_submitted_qc>March 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nationwide Children's Hospital</investigator_affiliation>
    <investigator_full_name>Ihuoma Eneli</investigator_full_name>
    <investigator_title>Director, Center for Healthy Weight and Nutrition; Professor of Pediatrics, The Ohio State University</investigator_title>
  </responsible_party>
  <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/NCT02206191
org study id: IRB13-00262
secondary id: Food Innovation Center
nct id: NCT02206191
lead sponsor: 
collaborator: 
has dmc: Yes
In response to the high prevalence rates of childhood obesity in central Ohio, the Center for
      Healthy Weight and Nutrition (CHWN) established the Primary Care Obesity Network (PCON); a
      partnership between primary care physicians and Nationwide Children's Hospital's Center for
      Healthy Weight and Nutrition, a tertiary care obesity center, the first of its kind in Ohio.
      The overall goal of PCON is to bring an effective and user friendly obesity management
      program to the community physician's office to prevent and treat the growing number of obese
      children in the setting of the private office. The predominant nutrition messaging approach
      to tackling childhood obesity has revolved around the food choices and portion sizes. While
      this is relevant, an area with significant potential for impact for maintaining optimal
      growth and a healthy weight for young children is addressing feeding behaviors and
      self-regulation of intake;. - the "how" of eating. The investigators objective it to
      investigate whether this self-regulation approach can be employed for an older age group of
      6-11 years old.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Examining use of disordered self-regulatory feeding behaviors, at survey completion
time frame: At survey completion, which will occur about 30 minutes after the survey is administered
arm group label: Mothers of 6-11 year olds
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: ihuoma Eneli, MD
role: Principal Investigator
affiliation: Nationwide Childrens Hospital, Columbus, Ohio
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Nationwide Children's Hospital
investigator full name: Ihuoma Eneli
investigator title: Director, Center for Healthy Weight and Nutrition; Professor of Pediatrics, The Ohio State University
mesh term: Obesity