<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/NCT04435145</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00153805</org_study_id>
    <nct_id>NCT04435145</nct_id>
  </id_info>
  <brief_title>Warning Labels and College Students' Sugar-Sweetened Beverage Intake</brief_title>
  <official_title>The Impact of Warning Labels on Reducing College Students' Sugar-Sweetened Beverage Intake</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sugar-sweetened beverages (SSBs) are one of the few dietary items causally linked to the&#xD;
      development of obesity and chronic disease. SSB consumption among young adults are&#xD;
      particularly concerning, because of the high levels of consumption and the influence of&#xD;
      disease risk in later life. College students, particularly freshmen, are a captive audience&#xD;
      when it comes to dietary consumption because many of them consume their meals in residential&#xD;
      dining halls. We are currently working with Michigan Dining to implement warning labels on&#xD;
      SSB fountain dispensers to examine whether carefully tailored signage could alter beverage&#xD;
      choices of college students. The current study aims to assess changes in dietary intake&#xD;
      before and after the labels are posted, in a representative sample of University of Michigan&#xD;
      students who eat at residential dining halls.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 6, 2018</start_date>
  <completion_date type="Actual">March 31, 2019</completion_date>
  <primary_completion_date type="Actual">March 31, 2019</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Beverage Intake Questionnaire-15</measure>
    <time_frame>Four months</time_frame>
    <description>The primary outcome is the mean servings of sugar-sweetened and non-sugar-sweetened beverages consumed in the past 30 days, as measured by a validated questionnaire</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1067</enrollment>
  <condition>Diet, Healthy</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sugar-sweetened beverage warning label</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No label</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sugar-sweetened beverage warning label</intervention_name>
    <description>A sugar-sweetened beverage warning label appropriate for the college-aged population was developed and applied to beverage stations at one large campus dining hall</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Currently enrolled student at the University&#xD;
&#xD;
          -  Visited one of three large dining halls at least 100 times in the first 1.5 months of&#xD;
             the academic year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Cindy Leung</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </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/NCT04435145
org study id: HUM00153805
nct id: NCT04435145
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Sugar-sweetened beverages (SSBs) are one of the few dietary items causally linked to the
      development of obesity and chronic disease. SSB consumption among young adults are
      particularly concerning, because of the high levels of consumption and the influence of
      disease risk in later life. College students, particularly freshmen, are a captive audience
      when it comes to dietary consumption because many of them consume their meals in residential
      dining halls. We are currently working with Michigan Dining to implement warning labels on
      SSB fountain dispensers to examine whether carefully tailored signage could alter beverage
      choices of college students. The current study aims to assess changes in dietary intake
      before and after the labels are posted, in a representative sample of University of Michigan
      students who eat at residential dining halls.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Beverage Intake Questionnaire-15
time frame: Four months
description: The primary outcome is the mean servings of sugar-sweetened and non-sugar-sweetened beverages consumed in the past 30 days, as measured by a validated questionnaire
arm group label: Intervention
arm group type: Experimental
description: Sugar-sweetened beverage warning label
arm group label: Control
arm group type: No Intervention
description: No label
intervention type: Behavioral
intervention name: Sugar-sweetened beverage warning label
description: A sugar-sweetened beverage warning label appropriate for the college-aged population was developed and applied to beverage stations at one large campus dining hall
arm group label: Intervention
criteria: 
gender: All
minimum age: 17 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Cindy Leung
investigator title: Assistant Professor
sharing ipd: No