<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/NCT01697124</url>
  </required_header>
  <id_info>
    <org_study_id>H-20952</org_study_id>
    <secondary_id>R21HD054836-02</secondary_id>
    <nct_id>NCT01697124</nct_id>
  </id_info>
  <brief_title>The Children in Action Feasibility Study</brief_title>
  <acronym>CIA</acronym>
  <official_title>The Children in Action Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Baylor College of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Children in Action (CIA) program was a five month physical activity intervention. This&#xD;
      intervention was a feasibility study with 3- to 5-year-olds enrolled in four Head Start&#xD;
      centers. After baseline assessment, centers were matched by ethnicity and for number of&#xD;
      participants and randomly assigned to either the intervention or the control condition. A&#xD;
      total of 224 preschool children were randomly selected across the four centers. To evaluate&#xD;
      the efficacy of the CIA intervention, the change in physical activity, gross motor skills and&#xD;
      weight during the awake time and used mixed effect time-series regression models was&#xD;
      compared. Observations did not show a statistical difference between intervention and control&#xD;
      groups in physical activity level during the awake time, gross motor development or weight&#xD;
      status. It was demonstrated that it is feasible to conduct the SPARK-EC curriculum among&#xD;
      preschool children attending Head Start Centers but that an increased dose and/or longer&#xD;
      intervention duration will be required to impact gross motor skills, weight status and&#xD;
      physical activity levels during this critical early childhood development stage.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2007</start_date>
  <completion_date type="Actual">August 2009</completion_date>
  <primary_completion_date type="Actual">August 2009</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in physical activity at post-intervention.</measure>
    <time_frame>8 months</time_frame>
    <description>Mini-Mitter Actical, an accelerometer-based activity monitor, was used to assess physical activity of the preschool children. Unit of measurement was mean percentage of time spent in sedentary, light and moderate-vigorous physical activity each day.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in gross motor skills at post intervention.</measure>
    <time_frame>8 months</time_frame>
    <description>Gross motor skills were measured using the Test of Gross Motor Development. Unit of measurement was the Total Gross Motor Development percentile rank.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index</measure>
    <time_frame>8 months</time_frame>
    <description>Body Mass Index was calculated using height and weight measures collected on the preschool children. Unit of measurement was kilograms (wt.)/meters squared (ht.).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">274</enrollment>
  <condition>Obesity</condition>
  <condition>Motor Activity</condition>
  <arm_group>
    <arm_group_label>SPARK-EC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SPARK-EC curriculum for preschoolers offered instruction and practice in a comprehensive program designed to promote motor development through increased physical activity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SPARK-EC</intervention_name>
    <description>The CIA study was a 5 month physical activity change intervention that utilized the SPARK-EC curriculum as the intervention. The SPARK-EC curriculum was designed to be a quality, comprehensive physical activity program for the preschool setting. Pre-and Post-intervention assessments were conducted</description>
    <arm_group_label>SPARK-EC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  3-5 years old&#xD;
&#xD;
          -  attends Head Start&#xD;
&#xD;
          -  African-American&#xD;
&#xD;
          -  Hispanic-American&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  older than 5 years old&#xD;
&#xD;
          -  does not attend Head Start&#xD;
&#xD;
          -  race/ethnicity other than African-American or Hispanic-American&#xD;
&#xD;
          -  has a disability or handicap that would prevent them from participating in physical&#xD;
             activities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Theresa A Nicklas, DrPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baylor College of Medicine</affiliation>
  </overall_official>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>September 28, 2012</last_update_submitted>
  <last_update_submitted_qc>September 28, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
    <investigator_full_name>Theresa A Nicklas</investigator_full_name>
    <investigator_title>Professor of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Physical activity</keyword>
  <keyword>children</keyword>
  <keyword>Head Start</keyword>
  <keyword>SPARK-EC</keyword>
  <!-- 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/NCT01697124
org study id: H-20952
secondary id: R21HD054836-02
nct id: NCT01697124
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The Children in Action (CIA) program was a five month physical activity intervention. This
      intervention was a feasibility study with 3- to 5-year-olds enrolled in four Head Start
      centers. After baseline assessment, centers were matched by ethnicity and for number of
      participants and randomly assigned to either the intervention or the control condition. A
      total of 224 preschool children were randomly selected across the four centers. To evaluate
      the efficacy of the CIA intervention, the change in physical activity, gross motor skills and
      weight during the awake time and used mixed effect time-series regression models was
      compared. Observations did not show a statistical difference between intervention and control
      groups in physical activity level during the awake time, gross motor development or weight
      status. It was demonstrated that it is feasible to conduct the SPARK-EC curriculum among
      preschool children attending Head Start Centers but that an increased dose and/or longer
      intervention duration will be required to impact gross motor skills, weight status and
      physical activity levels during this critical early childhood development stage.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Change from baseline in physical activity at post-intervention.
time frame: 8 months
description: Mini-Mitter Actical, an accelerometer-based activity monitor, was used to assess physical activity of the preschool children. Unit of measurement was mean percentage of time spent in sedentary, light and moderate-vigorous physical activity each day.
measure: Change from baseline in gross motor skills at post intervention.
time frame: 8 months
description: Gross motor skills were measured using the Test of Gross Motor Development. Unit of measurement was the Total Gross Motor Development percentile rank.
measure: Body Mass Index
time frame: 8 months
description: Body Mass Index was calculated using height and weight measures collected on the preschool children. Unit of measurement was kilograms (wt.)/meters squared (ht.).
arm group label: SPARK-EC
arm group type: Experimental
description: SPARK-EC curriculum for preschoolers offered instruction and practice in a comprehensive program designed to promote motor development through increased physical activity.
intervention type: Behavioral
intervention name: SPARK-EC
description: The CIA study was a 5 month physical activity change intervention that utilized the SPARK-EC curriculum as the intervention. The SPARK-EC curriculum was designed to be a quality, comprehensive physical activity program for the preschool setting. Pre-and Post-intervention assessments were conducted
arm group label: SPARK-EC
criteria: 
gender: All
minimum age: 3 Years
maximum age: 5 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Theresa A Nicklas, DrPH
role: Principal Investigator
affiliation: Baylor College of Medicine
responsible party type: Principal Investigator
investigator affiliation: Baylor College of Medicine
investigator full name: Theresa A Nicklas
investigator title: Professor of Pediatrics