<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/NCT02257203</url>
  </required_header>
  <id_info>
    <org_study_id>PC-Based Beverage</org_study_id>
    <nct_id>NCT02257203</nct_id>
  </id_info>
  <brief_title>Primary Care Beverage Study</brief_title>
  <official_title>Evaluation of a Primary Care-Based Intervention to Reduce Consumption of Sugar-sweetened Beverages and 100% Fruit Juice Among Latino Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Academic Pediatric Association</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot randomized clinical trial of a brief educational intervention offered in&#xD;
      primary care for Latino parents that promotes healthy beverage consumption by infants and&#xD;
      toddlers. The control group will receive an educational intervention that promotes parents&#xD;
      reading to children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To use a randomized controlled trial (RCT) design to test the efficacy of a primary&#xD;
      care-based intervention to promote Bright Futures recommendations for consumption of&#xD;
      sugar-sweetened beverages and 100% fruit juice among Latino children ages 6 months to 5&#xD;
      years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)</measure>
    <time_frame>Baseline</time_frame>
    <description>24-hour recall</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)</measure>
    <time_frame>2 weeks</time_frame>
    <description>24-hour recall</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)</measure>
    <time_frame>2 months</time_frame>
    <description>24-hour recall</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)</measure>
    <time_frame>3 months</time_frame>
    <description>24-hour recall</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines</measure>
    <time_frame>Baseline</time_frame>
    <description>24-hour recall</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines</measure>
    <time_frame>2 weeks</time_frame>
    <description>24-hour recall</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines</measure>
    <time_frame>2 months</time_frame>
    <description>24-hour recall</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines</measure>
    <time_frame>3 months</time_frame>
    <description>24-hour recall</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Servings of SSB and 100% fruit juice in the past 7 days</measure>
    <time_frame>Baseline</time_frame>
    <description>From the 7-day structured beverage frequency questionnaire we will determine the total servings of SSBs and 100% fruit juice consumed over a 7-day period at each time point</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Servings of SSB and 100% fruit juice in the past 7 days</measure>
    <time_frame>2 weeks</time_frame>
    <description>From the 7-day structured beverage frequency questionnaire we will determine the total servings of SSBs and 100% fruit juice consumed over a 7-day period at each time point</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Servings of SSB and 100% fruit juice in the past 7 days</measure>
    <time_frame>2 months</time_frame>
    <description>From the 7-day structured beverage frequency questionnaire we will determine the total servings of SSBs and 100% fruit juice consumed over a 7-day period at each time point</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Servings of SSB and 100% fruit juice in the past 7 days</measure>
    <time_frame>3 months</time_frame>
    <description>From the 7-day structured beverage frequency questionnaire we will determine the total servings of SSBs and 100% fruit juice consumed over a 7-day period at each time point</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Obesity</condition>
  <condition>Dental Caries</condition>
  <arm_group>
    <arm_group_label>Sugar Sweetened Beverage Education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Parents will receive an educational module on beverage just after the conclusion of their child's well visit in a private room adjacent to the clinic</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reading Education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Parents will receive an educational module on the importance of reading to children with instruction in interactive reading techniques that are appropriate to the child's age</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sugar Sweetened Beverage Education</intervention_name>
    <description>Parents will receive an educational module on beverage just after the conclusion of their child's well visit in a private room adjacent to the clinic</description>
    <arm_group_label>Sugar Sweetened Beverage Education</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Reading Education</intervention_name>
    <description>Parents randomized to control will receive a 25-minute educational module on the importance of reading to children with instruction in interactive reading techniques that are appropriate to the child's age</description>
    <arm_group_label>Reading Education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parents self-identify as Latino&#xD;
&#xD;
          -  Parents speak English or Spanish&#xD;
&#xD;
          -  Parents have a child between the ages of 6 months and 5 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parents who have participated in group educational sessions on nutrition offered&#xD;
             through our obesity clinic or who have been newly referred to obesity clinic&#xD;
&#xD;
          -  Parents whose child has a chronic condition which affects feeding (such as requiring&#xD;
             tube feeds or being on a specialized diet for poor weight gain)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amy L Beck, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Health Center at San Francisco General Hospital</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>September 16, 2016</last_update_submitted>
  <last_update_submitted_qc>September 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dietary sucrose</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
  </condition_browse>
  <!-- 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/NCT02257203
org study id: PC-Based Beverage
nct id: NCT02257203
lead sponsor: 
collaborator: 
has dmc: No
This is a pilot randomized clinical trial of a brief educational intervention offered in
      primary care for Latino parents that promotes healthy beverage consumption by infants and
      toddlers. The control group will receive an educational intervention that promotes parents
      reading to children.
To use a randomized controlled trial (RCT) design to test the efficacy of a primary
      care-based intervention to promote Bright Futures recommendations for consumption of
      sugar-sweetened beverages and 100% fruit juice among Latino children ages 6 months to 5
      years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)
time frame: Baseline
description: 24-hour recall
measure: Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)
time frame: 2 weeks
description: 24-hour recall
measure: Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)
time frame: 2 months
description: 24-hour recall
measure: Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)
time frame: 3 months
description: 24-hour recall
measure: Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines
time frame: Baseline
description: 24-hour recall
measure: Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines
time frame: 2 weeks
description: 24-hour recall
measure: Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines
time frame: 2 months
description: 24-hour recall
measure: Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines
time frame: 3 months
description: 24-hour recall
measure: Servings of SSB and 100% fruit juice in the past 7 days
time frame: Baseline
description: From the 7-day structured beverage frequency questionnaire we will determine the total servings of SSBs and 100% fruit juice consumed over a 7-day period at each time point
measure: Servings of SSB and 100% fruit juice in the past 7 days
time frame: 2 weeks
description: From the 7-day structured beverage frequency questionnaire we will determine the total servings of SSBs and 100% fruit juice consumed over a 7-day period at each time point
measure: Servings of SSB and 100% fruit juice in the past 7 days
time frame: 2 months
description: From the 7-day structured beverage frequency questionnaire we will determine the total servings of SSBs and 100% fruit juice consumed over a 7-day period at each time point
measure: Servings of SSB and 100% fruit juice in the past 7 days
time frame: 3 months
description: From the 7-day structured beverage frequency questionnaire we will determine the total servings of SSBs and 100% fruit juice consumed over a 7-day period at each time point
arm group label: Sugar Sweetened Beverage Education
arm group type: Experimental
description: Parents will receive an educational module on beverage just after the conclusion of their child's well visit in a private room adjacent to the clinic
arm group label: Reading Education
arm group type: Active Comparator
description: Parents will receive an educational module on the importance of reading to children with instruction in interactive reading techniques that are appropriate to the child's age
intervention type: Behavioral
intervention name: Sugar Sweetened Beverage Education
description: Parents will receive an educational module on beverage just after the conclusion of their child's well visit in a private room adjacent to the clinic
arm group label: Sugar Sweetened Beverage Education
intervention type: Behavioral
intervention name: Reading Education
description: Parents randomized to control will receive a 25-minute educational module on the importance of reading to children with instruction in interactive reading techniques that are appropriate to the child's age
arm group label: Reading Education
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Amy L Beck, MD, MPH
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dental Caries