<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/NCT03013309</url>
  </required_header>
  <id_info>
    <org_study_id>1U18DP006255-01</org_study_id>
    <nct_id>NCT03013309</nct_id>
  </id_info>
  <brief_title>Raising Healthy Children: A Hybrid Trial of the Family Check-Up 4 Health in Primary Care</brief_title>
  <acronym>FCU4Health</acronym>
  <official_title>An Individually Tailored, Family-Centered Intervention for Childhood Obesity: Connecting Services in Pediatric Primary Healthcare, the Home and the Community</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arizona State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Arizona State University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a hybrid implementation-effectiveness trial of the Family Check-Up 4 Health&#xD;
      (FCU4Health), an adapted version of the Family Check-Up, in pediatric primary care. Patients&#xD;
      will be recruited based on their BMI as documented in the Electronic Health Record (EHR) and&#xD;
      randomized to receive the FCU4Health or Treatment as Usual.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The FCU4Health is an assessment-driven, Motivational Interviewing (MI) based, parent training&#xD;
      program. Parents and children complete a comprehensive assessment, including questionnaire&#xD;
      and observation data. The FCU4Health coordinator reviews the assessment results with the&#xD;
      parents, using MI strategies to create a tailored plan to address family needs. This plan may&#xD;
      include referrals to community resources or parenting modules that focus on family&#xD;
      management.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 9, 2017</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>BMI</measure>
    <time_frame>The investigators will examine trajectories based on 4 assessments over one year</time_frame>
    <description>BMI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body Composition</measure>
    <time_frame>The investigators will examine trajectories based on 4 assessments over one year</time_frame>
    <description>% Body fat</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQol-5D-5Level-Youth (EQ-5D-5L-Y)</measure>
    <time_frame>The investigators will examine trajectories based on 4 assessments over one year</time_frame>
    <description>Quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PedsQL</measure>
    <time_frame>The investigators will examine trajectories based on 4 assessments over one year</time_frame>
    <description>Quality of life</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">240</enrollment>
  <condition>Clinical Trial</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receives the Family Check-Up 4 Health</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receives Treatment as Usual</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Family Check-Up 4 Health</intervention_name>
    <description>A parent-training intervention to improve child health and prevent/manage obesity</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>FCU4Health</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment as usual</intervention_name>
    <description>Treatment as usual</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI at or above 85% tile for age and gender&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cady Berkel, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Arizona State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Terros Health</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valle del Sol</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Phoenix Children's Hospital</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>May 31, 2023</last_update_submitted>
  <last_update_submitted_qc>May 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hybrid</keyword>
  <keyword>Implementation</keyword>
  <keyword>Effectiveness</keyword>
  <keyword>Parent training</keyword>
  <keyword>Fidelity</keyword>
  <keyword>Cost-Effectiveness</keyword>
  <keyword>Primary Care</keyword>
  <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/NCT03013309
org study id: 1U18DP006255-01
nct id: NCT03013309
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is a hybrid implementation-effectiveness trial of the Family Check-Up 4 Health
      (FCU4Health), an adapted version of the Family Check-Up, in pediatric primary care. Patients
      will be recruited based on their BMI as documented in the Electronic Health Record (EHR) and
      randomized to receive the FCU4Health or Treatment as Usual.
The FCU4Health is an assessment-driven, Motivational Interviewing (MI) based, parent training
      program. Parents and children complete a comprehensive assessment, including questionnaire
      and observation data. The FCU4Health coordinator reviews the assessment results with the
      parents, using MI strategies to create a tailored plan to address family needs. This plan may
      include referrals to community resources or parenting modules that focus on family
      management.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: BMI
time frame: The investigators will examine trajectories based on 4 assessments over one year
description: BMI
measure: Body Composition
time frame: The investigators will examine trajectories based on 4 assessments over one year
description: % Body fat
measure: EuroQol-5D-5Level-Youth (EQ-5D-5L-Y)
time frame: The investigators will examine trajectories based on 4 assessments over one year
description: Quality of life
measure: PedsQL
time frame: The investigators will examine trajectories based on 4 assessments over one year
description: Quality of life
arm group label: Intervention
arm group type: Experimental
description: Receives the Family Check-Up 4 Health
arm group label: Control
arm group type: Experimental
description: Receives Treatment as Usual
intervention type: Behavioral
intervention name: Family Check-Up 4 Health
description: A parent-training intervention to improve child health and prevent/manage obesity
arm group label: Intervention
other name: FCU4Health
intervention type: Other
intervention name: Treatment as usual
description: Treatment as usual
arm group label: Control
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: No
last name: Cady Berkel, Ph.D.
role: Principal Investigator
affiliation: Arizona State University
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No