<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/NCT03297541</url>
  </required_header>
  <id_info>
    <org_study_id>2016-009-PBRC</org_study_id>
    <nct_id>NCT03297541</nct_id>
  </id_info>
  <brief_title>Healthy Kids I-PAL</brief_title>
  <official_title>Healthy Kids at I-PAL (Interactive Physical Activity Lab)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pennington Biomedical Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Southeastern Louisiana University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Pennington Biomedical Research Center</source>
  <oversight_info>
    <has_dmc>No</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>
      Up to 30 parent/child dyads will be recruited to participate in an m-Health intervention&#xD;
      (delivered over smartphone, iPad/Tablet, or desktop/laptop) to promote healthy behaviors and&#xD;
      healthy weight among children and their parents.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 5, 2017</start_date>
  <completion_date type="Actual">December 12, 2017</completion_date>
  <primary_completion_date type="Actual">December 12, 2017</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>Acceptability/feasibility of the mHealth approach</measure>
    <time_frame>Week 0 to Week 14-16</time_frame>
    <description>Acceptability/feasibility of the mHealth approach will be evaluated by a survey.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Childhood Obesity</condition>
  <arm_group>
    <arm_group_label>m-health approach</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All dyads will receive the m-health approach.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>m-health approach</intervention_name>
    <description>Parent/child dyads attend remote counseling sessions delivered over Internet-connected device (e.g. smartphone, iPad/tablet, laptop, or desktop computer). A counselor will deliver the lesson, review progress based on the objectively measured data, and provide individualized advice and problem-solving strategies for parent and child. Families will receive weekly contact via smartphone. Each lesson will include an interactive component for parent and child related to healthy eating and active play, as well as an interactive parenting training component. Lessons are based on the family treatment methods that effectively promote child and parent weight loss that is sustained for 10 years (Epstein et al., 1990; Epstein et al., 1981).</description>
    <arm_group_label>m-health approach</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for Child:&#xD;
&#xD;
          -  Have at least one participating parent&#xD;
&#xD;
          -  Be physically capable of exercise&#xD;
&#xD;
          -  Be free of diseases that affect metabolism, body weight, and food intake, including&#xD;
             type 1 or type 2 diabetes, HIV/AIDS, and cancer&#xD;
&#xD;
        Inclusion Criteria for Parent:&#xD;
&#xD;
          -  Have a smart phone&#xD;
&#xD;
          -  Be willing to use the smartphone for the mHealth intervention&#xD;
&#xD;
        Exclusion Criteria for Child:&#xD;
&#xD;
          -  Significant cardiovascular disease or disorders via self-report from parent&#xD;
&#xD;
          -  Other significant medical problems that would prevent them from engaging in regular&#xD;
             physical activity.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amanda Staiano, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pennington Biomedical Research Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Corby Martin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pennington Biomedical Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Southeastern Louisiana University</name>
      <address>
        <city>Hammond</city>
        <state>Louisiana</state>
        <zip>70402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>August 25, 2022</last_update_submitted>
  <last_update_submitted_qc>August 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pennington Biomedical Research Center</investigator_affiliation>
    <investigator_full_name>Amanda Staiano</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pediatric Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>June 19, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03297541
org study id: 2016-009-PBRC
nct id: NCT03297541
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Up to 30 parent/child dyads will be recruited to participate in an m-Health intervention
      (delivered over smartphone, iPad/Tablet, or desktop/laptop) to promote healthy behaviors and
      healthy weight among children and their parents.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Acceptability/feasibility of the mHealth approach
time frame: Week 0 to Week 14-16
description: Acceptability/feasibility of the mHealth approach will be evaluated by a survey.
arm group label: m-health approach
arm group type: Experimental
description: All dyads will receive the m-health approach.
intervention type: Behavioral
intervention name: m-health approach
description: Parent/child dyads attend remote counseling sessions delivered over Internet-connected device (e.g. smartphone, iPad/tablet, laptop, or desktop computer). A counselor will deliver the lesson, review progress based on the objectively measured data, and provide individualized advice and problem-solving strategies for parent and child. Families will receive weekly contact via smartphone. Each lesson will include an interactive component for parent and child related to healthy eating and active play, as well as an interactive parenting training component. Lessons are based on the family treatment methods that effectively promote child and parent weight loss that is sustained for 10 years (Epstein et al., 1990; Epstein et al., 1981).
arm group label: m-health approach
criteria: 
gender: All
minimum age: 5 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Amanda Staiano, PhD
role: Principal Investigator
affiliation: Pennington Biomedical Research Center
last name: Corby Martin, PhD
role: Principal Investigator
affiliation: Pennington Biomedical Research Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Pennington Biomedical Research Center
investigator full name: Amanda Staiano
investigator title: Principal Investigator
mesh term: Pediatric Obesity
sharing ipd: No
submitted: June 19, 2023