<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/NCT02239653</url>
  </required_header>
  <id_info>
    <org_study_id>201403027</org_study_id>
    <nct_id>NCT02239653</nct_id>
  </id_info>
  <brief_title>Reduction of Excessive Calories From Beverages in Children</brief_title>
  <acronym>MWP</acronym>
  <official_title>Randomized Controlled Trial to Reduce Calorie Intake From Sugar-sweetened Beverages by Children 1 - 12 Years of Age</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective: to test the hypothesis that an intervention comprised of targeted physician and&#xD;
      print messages can influence parents to reduce the amount of sugar-sweetened beverages (SSB)&#xD;
      and fruit juice they give to their children 1 - 12 years of age.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be conducted through a practice-based research network of community pediatric&#xD;
      practices. Participating sites will be randomized to the intervention or control condition&#xD;
      (usual care) using a pre-specified randomization scheme derived using computer generated&#xD;
      random numbers. The intervention sites will participate in a 30-minute training for using the&#xD;
      &quot;Milk. Water. Period&quot; intervention (brochures, posters, key talking points and phone&#xD;
      messages) in their office. The goal is for them to discuss beverage consumption and encourage&#xD;
      &quot;Milk. Water. Period&quot; for all children 12 months to 12 years old (not yet reached their 13th&#xD;
      birthday) at their checkup visit. The primary care provider (PCP) will use the talking points&#xD;
      to facilitate the discussion about drink milk and water only and will give a brochure to each&#xD;
      family. Assessments will be by telephone interview of the parent 2 to 4 weeks after a&#xD;
      check-up visit for the index child.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2014</start_date>
  <completion_date type="Actual">November 21, 2014</completion_date>
  <primary_completion_date type="Actual">November 21, 2014</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Excessive calories from beverages</measure>
    <time_frame>2-4 weeks after check-up visit</time_frame>
    <description>percent of children consuming &gt;200 calories/day from soda, SSBs, and fruit juice beverages</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">443</enrollment>
  <condition>Unhealthy Diet</condition>
  <arm_group>
    <arm_group_label>Physician communication</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The &quot;Milk. Water. Period&quot; intervention comprises brochures, posters, and key talking points for use by primary pediatricians to use in discussion with the parent about the child's beverages consumption.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physician communication</intervention_name>
    <arm_group_label>Physician communication</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parent of child age 12 months to 12 years attending for a check-up visit during the&#xD;
             study period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cannot speak English&#xD;
&#xD;
          -  No phone access&#xD;
&#xD;
          -  Already completed the survey for another child.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <last_update_submitted>October 1, 2018</last_update_submitted>
  <last_update_submitted_qc>October 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02239653
org study id: 201403027
nct id: NCT02239653
lead sponsor: 
has dmc: No
Objective: to test the hypothesis that an intervention comprised of targeted physician and
      print messages can influence parents to reduce the amount of sugar-sweetened beverages (SSB)
      and fruit juice they give to their children 1 - 12 years of age.
The study will be conducted through a practice-based research network of community pediatric
      practices. Participating sites will be randomized to the intervention or control condition
      (usual care) using a pre-specified randomization scheme derived using computer generated
      random numbers. The intervention sites will participate in a 30-minute training for using the
      "Milk. Water. Period" intervention (brochures, posters, key talking points and phone
      messages) in their office. The goal is for them to discuss beverage consumption and encourage
      "Milk. Water. Period" for all children 12 months to 12 years old (not yet reached their 13th
      birthday) at their checkup visit. The primary care provider (PCP) will use the talking points
      to facilitate the discussion about drink milk and water only and will give a brochure to each
      family. Assessments will be by telephone interview of the parent 2 to 4 weeks after a
      check-up visit for the index child.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Excessive calories from beverages
time frame: 2-4 weeks after check-up visit
description: percent of children consuming >200 calories/day from soda, SSBs, and fruit juice beverages
arm group label: Physician communication
arm group type: Experimental
description: The "Milk. Water. Period" intervention comprises brochures, posters, and key talking points for use by primary pediatricians to use in discussion with the parent about the child's beverages consumption.
arm group label: Usual care
arm group type: No Intervention
intervention type: Behavioral
intervention name: Physician communication
arm group label: Physician communication
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No