<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/NCT03283033</url>
  </required_header>
  <id_info>
    <org_study_id>R01HL139120</org_study_id>
    <nct_id>NCT03283033</nct_id>
  </id_info>
  <brief_title>School Lunch Salad Bars and Fruit and Vegetable Consumption</brief_title>
  <official_title>Salad Bars and Students' Fruit and Vegetable Consumption: A Group-randomized Trial With Objective Assessments</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arizona State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Arizona State University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The investigators propose an efficacy study (i.e., do salad bars work under controlled&#xD;
      conditions in naturalistic settings) to test whether introducing salad bars in elementary,&#xD;
      middle, and high schools that have never had salad bars affects students' FV consumption and&#xD;
      waste during lunch. A cluster randomized controlled trial will test new salad bars against&#xD;
      controls for 6 wks, with/without an additional 4-wk marketing phase .&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2022</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in grams of fruit and vegetables consumed</measure>
    <time_frame>Baseline (prior to randomization allocation of installation of salad bars), Time 2 (6 weeks after randomization), and Time 3 (10 weeks after randomization)</time_frame>
    <description>The amount (grams) of fresh and canned fruits and vegetables consumed at lunch</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in grams of fruit and vegetables selected</measure>
    <time_frame>Baseline (prior to randomization allocation of installation of salad bars), Time 2 (6 weeks after randomization), and Time 3 (10 weeks after randomization)</time_frame>
    <description>The amount (grams) of fresh and canned fruits and vegetables selected at lunch</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in percent of fruit and vegetables wasted</measure>
    <time_frame>Baseline (prior to randomization allocation of installation of salad bars), Time 2 (6 weeks after randomization), and Time 3 (10 weeks after randomization)</time_frame>
    <description>The percent of fresh and canned fruits and vegetables wasted at lunch</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">6408</enrollment>
  <condition>Children, Only</condition>
  <condition>Behavior, Eating</condition>
  <condition>School</condition>
  <condition>Obesity</condition>
  <condition>Food Selection</condition>
  <condition>Food Habits</condition>
  <condition>Diet Modification</condition>
  <condition>Adolescent Behavior</condition>
  <arm_group>
    <arm_group_label>Experimental 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Introduction of a new salad bar and marketing conditions during second semester of school year</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Introduction of marketing conditions during second semester of school year</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Introduction of a new salad bar during second semester of school year</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No introduction of a new salad bar and no introduction of marketing conditions</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>New salad bar</intervention_name>
    <description>New salad bar placed in school</description>
    <arm_group_label>Experimental 1</arm_group_label>
    <arm_group_label>Experimental 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Marketing</intervention_name>
    <description>Marketing conditions (printed material, displays, verbal announcements, prompts and taste tests)</description>
    <arm_group_label>Experimental 2</arm_group_label>
    <arm_group_label>Experimental 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Students enrolled in any grade between grades one and twelve&#xD;
&#xD;
          -  Student ID number matches that on a list of randomly selected student ID numbers from&#xD;
             the population of student enrolled in school&#xD;
&#xD;
          -  Students who elect to receive a hot entree at lunch&#xD;
&#xD;
          -  Students who assent to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Students in detention&#xD;
&#xD;
          -  Students in special education&#xD;
&#xD;
          -  Students in Kindergarten&#xD;
&#xD;
          -  Students not in school for any reason (e.g. illness, vacation)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Marc A Adams, PhD</last_name>
    <phone>6028272470</phone>
    <email>marc.adams@asu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Meg Bruening, PhD</last_name>
    <email>meg.bruening@asu.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Arizona State University</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85004</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marc A Adams</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>October 26, 2021</last_update_submitted>
  <last_update_submitted_qc>October 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Arizona State University</investigator_affiliation>
    <investigator_full_name>Marc Adams, PhD, MPH</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Children</keyword>
  <keyword>Plate Waste</keyword>
  <keyword>Fruit and vegetable intake</keyword>
  <keyword>School lunch</keyword>
  <keyword>social marketing</keyword>
  <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/NCT03283033
org study id: R01HL139120
nct id: NCT03283033
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators propose an efficacy study (i.e., do salad bars work under controlled
      conditions in naturalistic settings) to test whether introducing salad bars in elementary,
      middle, and high schools that have never had salad bars affects students' FV consumption and
      waste during lunch. A cluster randomized controlled trial will test new salad bars against
      controls for 6 wks, with/without an additional 4-wk marketing phase .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Change in grams of fruit and vegetables consumed
time frame: Baseline (prior to randomization allocation of installation of salad bars), Time 2 (6 weeks after randomization), and Time 3 (10 weeks after randomization)
description: The amount (grams) of fresh and canned fruits and vegetables consumed at lunch
measure: Change in grams of fruit and vegetables selected
time frame: Baseline (prior to randomization allocation of installation of salad bars), Time 2 (6 weeks after randomization), and Time 3 (10 weeks after randomization)
description: The amount (grams) of fresh and canned fruits and vegetables selected at lunch
measure: Change in percent of fruit and vegetables wasted
time frame: Baseline (prior to randomization allocation of installation of salad bars), Time 2 (6 weeks after randomization), and Time 3 (10 weeks after randomization)
description: The percent of fresh and canned fruits and vegetables wasted at lunch
arm group label: Experimental 3
arm group type: Experimental
description: Introduction of a new salad bar and marketing conditions during second semester of school year
arm group label: Experimental 2
arm group type: Experimental
description: Introduction of marketing conditions during second semester of school year
arm group label: Experimental 1
arm group type: Experimental
description: Introduction of a new salad bar during second semester of school year
arm group label: Control
arm group type: No Intervention
description: No introduction of a new salad bar and no introduction of marketing conditions
intervention type: Behavioral
intervention name: New salad bar
description: New salad bar placed in school
arm group label: Experimental 1
arm group label: Experimental 3
intervention type: Behavioral
intervention name: Marketing
description: Marketing conditions (printed material, displays, verbal announcements, prompts and taste tests)
arm group label: Experimental 2
arm group label: Experimental 3
criteria: 
gender: All
minimum age: 6 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marc A Adams, PhD
phone: 6028272470
email: marc.adams@asu.edu
last name: Meg Bruening, PhD
email: meg.bruening@asu.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Arizona State University
investigator full name: Marc Adams, PhD, MPH
investigator title: Assistant Professor
sharing ipd: No