<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/NCT03775889</url>
  </required_header>
  <id_info>
    <org_study_id>RG1001447</org_study_id>
    <secondary_id>8452</secondary_id>
    <nct_id>NCT03775889</nct_id>
  </id_info>
  <brief_title>Engaging School and Family in Navajo Gardening for Health</brief_title>
  <official_title>Engaging School and Family in Navajo Gardening for Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fred Hutchinson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fred Hutchinson Cancer Center</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>
      This study builds on several years of working with Navajo communities to increase gardening&#xD;
      and healthy eating. In collaboration with the Dream Diné Charter School in Shiprock, NM, the&#xD;
      investigators propose to develop a school garden intervention to increase fruit and vegetable&#xD;
      consumption and reduce risk for obesity among Navajo families. The intervention will&#xD;
      integrate: an enhanced school garden plot; a curriculum for elementary school children on&#xD;
      gardening and healthy eating; and family engagement in the curriculum and at community&#xD;
      gardening fairs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 21, 2016</start_date>
  <completion_date type="Actual">June 13, 2018</completion_date>
  <primary_completion_date type="Actual">June 13, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Child healthy eating behaviors assessment</measure>
    <time_frame>1 year</time_frame>
    <description>Assess servings of vegetables and fruits eaten per week from the picture sort frequency method using the 5 a Day questions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Child Gardening Participation Survey</measure>
    <time_frame>1 year</time_frame>
    <description>Survey children to see if they have a garden at home, and if so how often they do gardening activities there</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Gardening Self-efficacy Survey</measure>
    <time_frame>1 year</time_frame>
    <description>Survey children to identify how confident they are in their abilities to perform gardening behaviors, utilizing six-item likert scale</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Dietary Habits</condition>
  <condition>Eating Behavior</condition>
  <condition>Health Behavior</condition>
  <arm_group>
    <arm_group_label>Behavioral</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Behavioral Gardening Exposure</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Gardening</intervention_name>
    <description>Assist with planting and maintaining the school garden, as well as observe the school garden curriculum and dietary assessment protocols</description>
    <arm_group_label>Behavioral</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Attending School Participating in Trial&#xD;
&#xD;
          -  Parent able to Participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shirley Beresford</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fred Hutchinson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fred Hutch/University of Washington Cancer Consortium</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>April 11, 2019</last_update_submitted>
  <last_update_submitted_qc>April 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT03775889
org study id: RG1001447
secondary id: 8452
nct id: NCT03775889
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study builds on several years of working with Navajo communities to increase gardening
      and healthy eating. In collaboration with the Dream Diné Charter School in Shiprock, NM, the
      investigators propose to develop a school garden intervention to increase fruit and vegetable
      consumption and reduce risk for obesity among Navajo families. The intervention will
      integrate: an enhanced school garden plot; a curriculum for elementary school children on
      gardening and healthy eating; and family engagement in the curriculum and at community
      gardening fairs.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Child healthy eating behaviors assessment
time frame: 1 year
description: Assess servings of vegetables and fruits eaten per week from the picture sort frequency method using the 5 a Day questions
measure: Child Gardening Participation Survey
time frame: 1 year
description: Survey children to see if they have a garden at home, and if so how often they do gardening activities there
measure: Child Gardening Self-efficacy Survey
time frame: 1 year
description: Survey children to identify how confident they are in their abilities to perform gardening behaviors, utilizing six-item likert scale
arm group label: Behavioral
arm group type: Experimental
description: Behavioral Gardening Exposure
intervention type: Behavioral
intervention name: Gardening
description: Assist with planting and maintaining the school garden, as well as observe the school garden curriculum and dietary assessment protocols
arm group label: Behavioral
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Shirley Beresford
role: Principal Investigator
affiliation: Fred Hutchinson Cancer Center
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No