<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/NCT03021980</url>
  </required_header>
  <id_info>
    <org_study_id>NL58061.068.16</org_study_id>
    <nct_id>NCT03021980</nct_id>
  </id_info>
  <brief_title>Systems of Underprivileged Preschoolers in Their Home and Preschool EnviRonment: Family Intervention Trial</brief_title>
  <acronym>SuperFIT</acronym>
  <official_title>Development and Evaluation of SuperFIT: Systems of Underprivileged Preschoolers in Their Home and Preschool EnviRonment: Family Intervention Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fonds NutsOhra</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>ZonMw: The Netherlands Organisation for Health Research and Development</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Maastricht University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the effectiveness of SuperFIT, an integrative lifestyle intervention&#xD;
      for preschool children. It will consist of both an preschool component and a family component&#xD;
      and is aimed at increasing healthy nutrition and physical activity. Half of the participating&#xD;
      preschools will implement SuperFIT, while the other half of the preschools will continue as&#xD;
      usual.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">July 2019</completion_date>
  <primary_completion_date type="Actual">July 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in BMI</measure>
    <time_frame>from baseline to one year and 1.5 years after baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in physical activity by an Actigraph accelerometer</measure>
    <time_frame>from baseline to one year and 1.5 years after baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Diet, Food and Nutrition by a 24HR recall</measure>
    <time_frame>from baseline to one year and 1.5 years after baseline</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">212</enrollment>
  <condition>Child Obesity</condition>
  <arm_group>
    <arm_group_label>SuperFIT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is the intervention group. They will receive the intervention SuperFIT.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This is the control group. Participants will receive 'care as usual' in this arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SuperFIT</intervention_name>
    <description>Behavioural intervention with two components. One component will consist of social and physical environmental changes at the preschools and the other component consists of a family educational program.</description>
    <arm_group_label>SuperFIT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children attending the participating preschools&#xD;
&#xD;
          -  at least one parent has to be able to understand the Dutch language&#xD;
&#xD;
          -  Both caregivers (if applicable) of the child give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  There are no exclusion criteria for this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>4 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sanne Gerards, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Health Promotion, Maastricht University</affiliation>
  </overall_official>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>August 22, 2019</last_update_submitted>
  <last_update_submitted_qc>August 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>Undecided</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/NCT03021980
org study id: NL58061.068.16
nct id: NCT03021980
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This study will evaluate the effectiveness of SuperFIT, an integrative lifestyle intervention
      for preschool children. It will consist of both an preschool component and a family component
      and is aimed at increasing healthy nutrition and physical activity. Half of the participating
      preschools will implement SuperFIT, while the other half of the preschools will continue as
      usual.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in BMI
time frame: from baseline to one year and 1.5 years after baseline
measure: Change in physical activity by an Actigraph accelerometer
time frame: from baseline to one year and 1.5 years after baseline
measure: Change in Diet, Food and Nutrition by a 24HR recall
time frame: from baseline to one year and 1.5 years after baseline
arm group label: SuperFIT
arm group type: Experimental
description: This is the intervention group. They will receive the intervention SuperFIT.
arm group label: Control
arm group type: No Intervention
description: This is the control group. Participants will receive 'care as usual' in this arm.
intervention type: Behavioral
intervention name: SuperFIT
description: Behavioural intervention with two components. One component will consist of social and physical environmental changes at the preschools and the other component consists of a family educational program.
arm group label: SuperFIT
criteria: 
gender: All
minimum age: 2 Years
maximum age: 4 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sanne Gerards, Dr.
role: Principal Investigator
affiliation: Department of Health Promotion, Maastricht University
responsible party type: Sponsor
mesh term: Pediatric Obesity
sharing ipd: Undecided