<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/NCT02216968</url>
  </required_header>
  <id_info>
    <org_study_id>H-30554</org_study_id>
    <secondary_id>1R21HD073608-01A1</secondary_id>
    <nct_id>NCT02216968</nct_id>
  </id_info>
  <brief_title>Increasing Vegetable Intake in Children</brief_title>
  <official_title>Increasing Vegetable Intake in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <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 purpose of this study is to test the feasibility of an innovative approach to increase&#xD;
      the amount of vegetable's (V) intake consumed by preschool children who are predominately&#xD;
      African-American (AA) and Hispanic-American (HA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to test the feasibility of an innovative approach to increase&#xD;
      the amount of vegetable's (V) intake consumed by preschool children who are predominately&#xD;
      African-American (AA) and Hispanic-American (HA).The primary endpoint will be changes in V&#xD;
      consumption in high school children with the hypothesis that a puppet intervention will&#xD;
      increase their V consumption by preschool children. To achieve the project goal, our specific&#xD;
      aims (SA) are to: SA1: Successfully recruit 6 preschool (PS) centers and 168 AA and 168 HA&#xD;
      children 3 to 5 y enrolled there. SA2: Conduct individual interviews for formative assessment&#xD;
      of the PUPPET shows. SA3: Develop the manual of operation and intervention protocols SA4:&#xD;
      Develop 4 videotaped theatre-based PUPPET shows that are developmentally and cognitively&#xD;
      appropriate for use with 3- to 5-year-old AA and HA children SA5: Pilot-test the feasibility&#xD;
      of the PUPPET intervention with 3 intervention and 3 control HS centers. SA6: Use the data&#xD;
      collected in Aim 5 to estimate parameters required to conduct a group randomized trial for an&#xD;
      evaluation of the efficacy of the intervention. The primary hypothesis (H1) to be tested is&#xD;
      that children who receive the PUPPET intervention will demonstrate increased V consumption in&#xD;
      HS compared to children in the control group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2012</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vegetable Intake in Preschool Children</measure>
    <time_frame>1 year 11 months</time_frame>
    <description>There will be 2 phases to program development: diagnostic and formative. The diagnostic phase will consist of 20 individual interviews with child-care providers and parents (½ AA, ½ HA) and 20 interviews with preschool children (½ AA, ½ HA).In addition the parents will be asked to complete the Cooking Confidence Questionnaire, the Barriers and Facilitators Questionnaire on Vegetables and a list of their child's favorite vegetables before coming to the interview. Implementation will include the showing of the 4 video-taped puppet shows to 10-12 children immediately prior to the lunch meal on 4 consecutive days. These children will be assessed at lunch using the digital diet estimation method.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Obesity</condition>
  <condition>Behavior</condition>
  <condition>Food Habits</condition>
  <arm_group>
    <arm_group_label>AA - Increase vegetable intake</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>60 African-American (AA) preschool children will participate in the Intervention Group. 60 AA children will belong to the Control Group.&#xD;
6-week Intervention: 120 AA and HA children will be shown the Puppet Shows and will be given a bag of ingredients to prepare the vegetable highlighted that week in the Puppet Show. The 6 week intervention includes a baseline assessment (1 week), followed by the intervention (4 weeks), and post assessment (1 week). The primary hypothesis to be tested is children who receive the PUPPET intervention with a parent/teacher component will demonstrate &quot;increase vegetable intake in pre-school children&quot;.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HA - Increase vegetable intake</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>60 Hispanic-American (HA) preschool children will participate in the Intervention Group. 60 HA children will belong to the Control Group.&#xD;
6-week Intervention: 120 AA and HA children will be shown the Puppet Shows and will be given a bag of ingredients to prepare the vegetable highlighted that week in the Puppet Show. The 6 week intervention includes a baseline assessment (1 week), followed by the intervention (4 weeks), and post assessment (1 week). The primary hypothesis to be tested is children who receive the PUPPET intervention with a parent/teacher component will demonstrate &quot;increase vegetable intake in pre-school children&quot;.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Increase vegetable intake in pre-school children</intervention_name>
    <description>6-week Intervention: 120 AA and HA children will be shown the Puppet Shows and will be given a bag of ingredients to prepare the vegetable highlighted that week in the Puppet Show. The 6 week intervention includes a baseline assessment (1 week), followed by the intervention (4 weeks), and post assessment (1 week). The primary hypothesis to be tested is children who receive the PUPPET intervention with a parent/teacher component will demonstrate &quot;increase vegetable intake in pre-school children&quot;.</description>
    <arm_group_label>AA - Increase vegetable intake</arm_group_label>
    <arm_group_label>HA - Increase vegetable intake</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  non-patient&#xD;
&#xD;
          -  normals&#xD;
&#xD;
          -  African-american&#xD;
&#xD;
          -  Hispanic-american&#xD;
&#xD;
          -  3 to 5 y olds&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant woman&#xD;
&#xD;
          -  neonates&#xD;
&#xD;
          -  dietary restrictions&#xD;
&#xD;
          -  chronic disease&#xD;
&#xD;
          -  developmental disabilities&#xD;
&#xD;
          -  special education&#xD;
&#xD;
          -  does not read or write in spanish or english&#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>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>July 11, 2017</last_update_submitted>
  <last_update_submitted_qc>July 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2017</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</investigator_title>
  </responsible_party>
  <keyword>vegetables</keyword>
  <keyword>Head Start</keyword>
  <keyword>preschool</keyword>
  <keyword>children</keyword>
  <keyword>theater</keyword>
  <keyword>puppet</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/NCT02216968
org study id: H-30554
secondary id: 1R21HD073608-01A1
nct id: NCT02216968
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to test the feasibility of an innovative approach to increase
      the amount of vegetable's (V) intake consumed by preschool children who are predominately
      African-American (AA) and Hispanic-American (HA).
The purpose of this study is to test the feasibility of an innovative approach to increase
      the amount of vegetable's (V) intake consumed by preschool children who are predominately
      African-American (AA) and Hispanic-American (HA).The primary endpoint will be changes in V
      consumption in high school children with the hypothesis that a puppet intervention will
      increase their V consumption by preschool children. To achieve the project goal, our specific
      aims (SA) are to: SA1: Successfully recruit 6 preschool (PS) centers and 168 AA and 168 HA
      children 3 to 5 y enrolled there. SA2: Conduct individual interviews for formative assessment
      of the PUPPET shows. SA3: Develop the manual of operation and intervention protocols SA4:
      Develop 4 videotaped theatre-based PUPPET shows that are developmentally and cognitively
      appropriate for use with 3- to 5-year-old AA and HA children SA5: Pilot-test the feasibility
      of the PUPPET intervention with 3 intervention and 3 control HS centers. SA6: Use the data
      collected in Aim 5 to estimate parameters required to conduct a group randomized trial for an
      evaluation of the efficacy of the intervention. The primary hypothesis (H1) to be tested is
      that children who receive the PUPPET intervention will demonstrate increased V consumption in
      HS compared to children in the control group.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Other
masking: Single (Participant)
measure: Vegetable Intake in Preschool Children
time frame: 1 year 11 months
description: There will be 2 phases to program development: diagnostic and formative. The diagnostic phase will consist of 20 individual interviews with child-care providers and parents (½ AA, ½ HA) and 20 interviews with preschool children (½ AA, ½ HA).In addition the parents will be asked to complete the Cooking Confidence Questionnaire, the Barriers and Facilitators Questionnaire on Vegetables and a list of their child's favorite vegetables before coming to the interview. Implementation will include the showing of the 4 video-taped puppet shows to 10-12 children immediately prior to the lunch meal on 4 consecutive days. These children will be assessed at lunch using the digital diet estimation method.
arm group label: AA - Increase vegetable intake
arm group type: Experimental
description: 60 African-American (AA) preschool children will participate in the Intervention Group. 60 AA children will belong to the Control Group.
6-week Intervention: 120 AA and HA children will be shown the Puppet Shows and will be given a bag of ingredients to prepare the vegetable highlighted that week in the Puppet Show. The 6 week intervention includes a baseline assessment (1 week), followed by the intervention (4 weeks), and post assessment (1 week). The primary hypothesis to be tested is children who receive the PUPPET intervention with a parent/teacher component will demonstrate "increase vegetable intake in pre-school children".
arm group label: HA - Increase vegetable intake
arm group type: Experimental
description: 60 Hispanic-American (HA) preschool children will participate in the Intervention Group. 60 HA children will belong to the Control Group.
6-week Intervention: 120 AA and HA children will be shown the Puppet Shows and will be given a bag of ingredients to prepare the vegetable highlighted that week in the Puppet Show. The 6 week intervention includes a baseline assessment (1 week), followed by the intervention (4 weeks), and post assessment (1 week). The primary hypothesis to be tested is children who receive the PUPPET intervention with a parent/teacher component will demonstrate "increase vegetable intake in pre-school children".
intervention type: Behavioral
intervention name: Increase vegetable intake in pre-school children
description: 6-week Intervention: 120 AA and HA children will be shown the Puppet Shows and will be given a bag of ingredients to prepare the vegetable highlighted that week in the Puppet Show. The 6 week intervention includes a baseline assessment (1 week), followed by the intervention (4 weeks), and post assessment (1 week). The primary hypothesis to be tested is children who receive the PUPPET intervention with a parent/teacher component will demonstrate "increase vegetable intake in pre-school children".
arm group label: AA - Increase vegetable intake
arm group label: HA - Increase vegetable intake
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
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Baylor College of Medicine
investigator full name: Theresa A Nicklas
investigator title: Professor