<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/NCT02996422</url>
  </required_header>
  <id_info>
    <org_study_id>16-0245-P3H</org_study_id>
    <secondary_id>U01MD010556</secondary_id>
    <nct_id>NCT02996422</nct_id>
  </id_info>
  <brief_title>Appalachians Together Restoring the Eating Environment: Improving Healthy Diet in Rural Appalachian Kentucky</brief_title>
  <official_title>Appalachians Together Restoring the Eating Environment (Appal-TREE): Advancing Sustainable CBPR Interventions to Improve Healthy Diet in Rural Appalachian Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mark Swanson, PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Minority Health and Health Disparities (NIMHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Community Farm Alliance</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Kentucky</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>
      Most of the nation's serious chronic health challenges and causes of death, including&#xD;
      diabetes, heart disease, cancer, and obesity, are directly linked to sub-optimal diet. Both&#xD;
      poor diets and associated disease are disproportionately common in the Appalachian counties&#xD;
      of eastern Kentucky, a region with stark health inequities, including elevated rates of&#xD;
      obesity, overweight, and premature mortality. The purpose of this study is to evaluate a&#xD;
      multi-component intervention developed through community-based participatory research methods&#xD;
      for improving access to healthy foods and enhancing dietary intake in eastern Kentucky. The&#xD;
      intervention components evaluated in this study consist of: 1) a school-based campaign to&#xD;
      promote water consumption in middle and high schools and 2) a series of group cooking classes&#xD;
      for adults.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">July 31, 2020</completion_date>
  <primary_completion_date type="Actual">July 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-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 in beverage consumption (students)</measure>
    <time_frame>Baseline, 6 months, 12 months, 18 months, 24 months, 30 months</time_frame>
    <description>Survey items address frequency and quantity of beverages consumed in past month. Includes water, pop/soda, diet pop/soda, sports drinks, energy drinks, sweetened tea, 100% fruit juice, and milk.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in fruit and vegetable consumption (adults)</measure>
    <time_frame>Baseline to 8 weeks</time_frame>
    <description>Survey items address frequency and quantity of consumption of fruits and vegetables in the past month.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in attitudes and preferences about beverages (students)</measure>
    <time_frame>Baseline, 6 months, 12 months, 18 months, 24 months, 30 months</time_frame>
    <description>Survey items address taste preferences, attitudes about eating/drinking behavior and body image, and self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in purchasing of drinks (students)</measure>
    <time_frame>Baseline, 6 months, 12 months, 18 months, 24 months, 30 months</time_frame>
    <description>Survey items will address frequency of purchasing beverages at fast food restaurants, convenience stores, and school venues and events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in food preparation habits (adults)</measure>
    <time_frame>Baseline to 8 weeks</time_frame>
    <description>Survey items address meal planning and preparation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in food purchasing habits (adults)</measure>
    <time_frame>Baseline to 8 weeks</time_frame>
    <description>Survey items address frequency of purchasing food at work, grocery/convenience stores, restaurants and produce stands</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in perceptions of availability of health foods (adults)</measure>
    <time_frame>Baseline to 8 weeks</time_frame>
    <description>Survey items address availability of high quality fruits and vegetables and low-fat foods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in barriers to health eating (adults)</measure>
    <time_frame>Baseline to 8 weeks</time_frame>
    <description>Survey items address physical, psychosocial, emotional, and financial barriers to healthy eating</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">1657</enrollment>
  <condition>Feeding Behavior</condition>
  <condition>Drinking Behavior</condition>
  <arm_group>
    <arm_group_label>School-based water campaign</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Students who attend middle and high schools in the intervention counties will receive a school-based water campaign. A sample of students from each school will complete surveys before and after the installation of the water refilling stations to measure beverage consumption, knowledge, attitudes, and self-efficacy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparison schools</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>A sample of students who attend middle and high schools in the comparison county, which does not receive any intervention components, will complete surveys to measure beverage consumption, knowledge, attitudes, and self-efficacy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Community cooking classes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adults in the same intervention counties as the school-based water campaign will enroll in group cooking classes. They will complete a baseline and two follow-up surveys to measure changes in fruit and vegetable consumption, attitudes, and self-efficacy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>School-based water campaign</intervention_name>
    <description>Includes: 1) the installation of filtered water bottle refilling stations, 2) the distribution of reusable water bottles to all students and teachers, and 3) a social marketing campaign to support the increase of water consumption among students.</description>
    <arm_group_label>School-based water campaign</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Community cooking classes</intervention_name>
    <description>Cooking classes will be delivered to groups of 8-12 adult participants as a series of 8 weekly classes in community venues. The content of each class is driven by topics and themes identified and prioritized by community members, namely cooking healthy on tight budget.</description>
    <arm_group_label>Community cooking classes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  For school-based component: Student in selected middle or high school classroom in a&#xD;
             participating school in intervention or comparison counties (6th to 12th grades)&#xD;
&#xD;
          -  For cooking classes: adult aged 18 years or older and residing in intervention county&#xD;
             who have at least one dependent child attending middle or high school in the&#xD;
             participating school districts&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to speak or read English, as all materials will be presented in English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Swanson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kentucky</affiliation>
  </overall_official>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>June 11, 2021</last_update_submitted>
  <last_update_submitted_qc>June 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Kentucky</investigator_affiliation>
    <investigator_full_name>Mark Swanson, PhD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Drinking Behavior</mesh_term>
  </condition_browse>
  <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/NCT02996422
org study id: 16-0245-P3H
secondary id: U01MD010556
nct id: NCT02996422
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Most of the nation's serious chronic health challenges and causes of death, including
      diabetes, heart disease, cancer, and obesity, are directly linked to sub-optimal diet. Both
      poor diets and associated disease are disproportionately common in the Appalachian counties
      of eastern Kentucky, a region with stark health inequities, including elevated rates of
      obesity, overweight, and premature mortality. The purpose of this study is to evaluate a
      multi-component intervention developed through community-based participatory research methods
      for improving access to healthy foods and enhancing dietary intake in eastern Kentucky. The
      intervention components evaluated in this study consist of: 1) a school-based campaign to
      promote water consumption in middle and high schools and 2) a series of group cooking classes
      for adults.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in beverage consumption (students)
time frame: Baseline, 6 months, 12 months, 18 months, 24 months, 30 months
description: Survey items address frequency and quantity of beverages consumed in past month. Includes water, pop/soda, diet pop/soda, sports drinks, energy drinks, sweetened tea, 100% fruit juice, and milk.
measure: Change in fruit and vegetable consumption (adults)
time frame: Baseline to 8 weeks
description: Survey items address frequency and quantity of consumption of fruits and vegetables in the past month.
measure: Change in attitudes and preferences about beverages (students)
time frame: Baseline, 6 months, 12 months, 18 months, 24 months, 30 months
description: Survey items address taste preferences, attitudes about eating/drinking behavior and body image, and self-efficacy.
measure: Change in purchasing of drinks (students)
time frame: Baseline, 6 months, 12 months, 18 months, 24 months, 30 months
description: Survey items will address frequency of purchasing beverages at fast food restaurants, convenience stores, and school venues and events.
measure: Change in food preparation habits (adults)
time frame: Baseline to 8 weeks
description: Survey items address meal planning and preparation
measure: Change in food purchasing habits (adults)
time frame: Baseline to 8 weeks
description: Survey items address frequency of purchasing food at work, grocery/convenience stores, restaurants and produce stands
measure: Change in perceptions of availability of health foods (adults)
time frame: Baseline to 8 weeks
description: Survey items address availability of high quality fruits and vegetables and low-fat foods
measure: Change in barriers to health eating (adults)
time frame: Baseline to 8 weeks
description: Survey items address physical, psychosocial, emotional, and financial barriers to healthy eating
arm group label: School-based water campaign
arm group type: Experimental
description: Students who attend middle and high schools in the intervention counties will receive a school-based water campaign. A sample of students from each school will complete surveys before and after the installation of the water refilling stations to measure beverage consumption, knowledge, attitudes, and self-efficacy.
arm group label: Comparison schools
arm group type: No Intervention
description: A sample of students who attend middle and high schools in the comparison county, which does not receive any intervention components, will complete surveys to measure beverage consumption, knowledge, attitudes, and self-efficacy.
arm group label: Community cooking classes
arm group type: Experimental
description: Adults in the same intervention counties as the school-based water campaign will enroll in group cooking classes. They will complete a baseline and two follow-up surveys to measure changes in fruit and vegetable consumption, attitudes, and self-efficacy.
intervention type: Behavioral
intervention name: School-based water campaign
description: Includes: 1) the installation of filtered water bottle refilling stations, 2) the distribution of reusable water bottles to all students and teachers, and 3) a social marketing campaign to support the increase of water consumption among students.
arm group label: School-based water campaign
intervention type: Behavioral
intervention name: Community cooking classes
description: Cooking classes will be delivered to groups of 8-12 adult participants as a series of 8 weekly classes in community venues. The content of each class is driven by topics and themes identified and prioritized by community members, namely cooking healthy on tight budget.
arm group label: Community cooking classes
criteria: 
gender: All
minimum age: 10 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mark Swanson, PhD
role: Principal Investigator
affiliation: University of Kentucky
responsible party type: Sponsor-Investigator
investigator affiliation: University of Kentucky
investigator full name: Mark Swanson, PhD
investigator title: Associate Professor
mesh term: Drinking Behavior
sharing ipd: No