<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/NCT02193009</url>
  </required_header>
  <id_info>
    <org_study_id>R01CA154364</org_study_id>
    <nct_id>NCT02193009</nct_id>
  </id_info>
  <brief_title>SipSmarter: A Nutrition Literacy Approach to Reducing Sugary Beverages</brief_title>
  <official_title>SipSmarter: A Nutrition Literacy Approach to Reducing Sugary Beverages</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Virginia Polytechnic Institute and State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Kansas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Hawaii</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Virginia Polytechnic Institute and State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim of this pragmatic randomized-controlled trial was to determine the&#xD;
      effectiveness of a scalable 6-month intervention aimed at decreasing SSB consumption&#xD;
      (SIPsmartER) when compared to a matched contact physical activity promotion control group&#xD;
      (MoveMore).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary aim of this application targeting at-risk residents from rural southwest Virginia&#xD;
      counties is to:&#xD;
&#xD;
      1. Determine the effectiveness of SIPsmart and SIPsmartER at decreasing SSB consumption when&#xD;
      compared to a matched contact control group targeting walking behaviors.&#xD;
&#xD;
      The secondary aims are to:&#xD;
&#xD;
        1. Explore causal pathways through which changes in SSB attitudes, subjective norms, and&#xD;
           perceived behavioral control influence behavioral intentions and SSB consumption, and&#xD;
           the extent to which changes in SSB consumption are mediated by changes in nutrition&#xD;
           numeracy and nutrition-related media literacy.&#xD;
&#xD;
        2. Determine the reach and representativeness, adoption feasibility, degree to which the&#xD;
           intervention was implemented as intended (and associated costs), and the maintenance of&#xD;
           behavior changes 6 and 12 months post intervention (i.e., 18 months from baseline) when&#xD;
           compared to control.&#xD;
&#xD;
        3. Assess intervention impacts on body weight.&#xD;
&#xD;
      An exploratory aim is to:&#xD;
&#xD;
      1. Assess intervention impacts on a 13C biomarker, a new non-invasive biomarker fingerstick&#xD;
      technique for added sugar intake, and evaluate the changes in this biomarker over time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2011</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in Kilocalories of Sugar-Sweetened Beverages at 6 months</measure>
    <time_frame>baseline, 6-months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Minutes of Physical Activity at 6 months</measure>
    <time_frame>baseline, 6-months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from Baseline in Weight at 6 months</measure>
    <time_frame>baseline, 6-months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline in C13 biomarker at 6 months</measure>
    <time_frame>baseline, 6-months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">304</enrollment>
  <condition>Dietary Habits</condition>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>SIPsmartER, behavioral intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Aimed at decreasing sugar-sweetened beverage consumption</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Move More, behavioral intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Aimed at physical activity promotion</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SipSmarter</intervention_name>
    <description>6-month behavioral trial</description>
    <arm_group_label>SIPsmartER, behavioral intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MoveMore</intervention_name>
    <description>6 month behavioral trial</description>
    <arm_group_label>Move More, behavioral intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion criteria included English-speaking adults &gt;18 years of age, who consume &gt;200&#xD;
             SSB kcals/day, self-report no contraindications for physical activity, and have&#xD;
             regular access to a telephone.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  To minimize potential confounds, only one member per household is eligible to enroll&#xD;
             and individuals cannot be concurrently enrolled in a Cooperative Extension program&#xD;
             because these programs focus on improving nutrition.&#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>Jamie M Zoellner, PhD, RD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Virginia Polytechnic Institute and State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Virginia Tech, Departmen of Human Nutrition, Foods, and Exercise</name>
      <address>
        <city>Blacksburg</city>
        <state>Virginia</state>
        <zip>24060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>April 19, 2022</last_update_submitted>
  <last_update_submitted_qc>April 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02193009
org study id: R01CA154364
nct id: NCT02193009
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The primary aim of this pragmatic randomized-controlled trial was to determine the
      effectiveness of a scalable 6-month intervention aimed at decreasing SSB consumption
      (SIPsmartER) when compared to a matched contact physical activity promotion control group
      (MoveMore).
The primary aim of this application targeting at-risk residents from rural southwest Virginia
      counties is to:

      1. Determine the effectiveness of SIPsmart and SIPsmartER at decreasing SSB consumption when
      compared to a matched contact control group targeting walking behaviors.

      The secondary aims are to:

        1. Explore causal pathways through which changes in SSB attitudes, subjective norms, and
           perceived behavioral control influence behavioral intentions and SSB consumption, and
           the extent to which changes in SSB consumption are mediated by changes in nutrition
           numeracy and nutrition-related media literacy.

        2. Determine the reach and representativeness, adoption feasibility, degree to which the
           intervention was implemented as intended (and associated costs), and the maintenance of
           behavior changes 6 and 12 months post intervention (i.e., 18 months from baseline) when
           compared to control.

        3. Assess intervention impacts on body weight.

      An exploratory aim is to:

      1. Assess intervention impacts on a 13C biomarker, a new non-invasive biomarker fingerstick
      technique for added sugar intake, and evaluate the changes in this biomarker over time.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change from Baseline in Kilocalories of Sugar-Sweetened Beverages at 6 months
time frame: baseline, 6-months
measure: Change from Baseline in Minutes of Physical Activity at 6 months
time frame: baseline, 6-months
measure: Change from Baseline in Weight at 6 months
time frame: baseline, 6-months
measure: Change from Baseline in C13 biomarker at 6 months
time frame: baseline, 6-months
arm group label: SIPsmartER, behavioral intervention
arm group type: Experimental
description: Aimed at decreasing sugar-sweetened beverage consumption
arm group label: Move More, behavioral intervention
arm group type: Active Comparator
description: Aimed at physical activity promotion
intervention type: Behavioral
intervention name: SipSmarter
description: 6-month behavioral trial
arm group label: SIPsmartER, behavioral intervention
intervention type: Behavioral
intervention name: MoveMore
description: 6 month behavioral trial
arm group label: Move More, behavioral intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jamie M Zoellner, PhD, RD
role: Principal Investigator
affiliation: Virginia Polytechnic Institute and State University
facility: 
country: United States
responsible party type: Sponsor