<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/NCT03778021</url>
  </required_header>
  <id_info>
    <org_study_id>RG1001953</org_study_id>
    <secondary_id>8716</secondary_id>
    <secondary_id>NCI-2018-03752</secondary_id>
    <secondary_id>U54CA132381-11</secondary_id>
    <secondary_id>P30CA015704</secondary_id>
    <nct_id>NCT03778021</nct_id>
  </id_info>
  <brief_title>Yeego! Healthy Eating &amp; Gardening School-Based Randomized Controlled Trial</brief_title>
  <acronym>Yeego!</acronym>
  <official_title>Engaging Navajo Elementary Schools in Randomized Controlled Trial of Yeego! Healthy Eating &amp; Gardening</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fred Hutchinson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </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>
      In this study, one year changes in healthy eating and gardening behaviors associated with the&#xD;
      intervention were estimated using a group randomized controlled trial design, with the&#xD;
      comparison arm receiving a delayed intervention in the following school year.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The small randomized controlled trial of an intensive curriculum and school garden&#xD;
      intervention was implemented in elementary schools in two communities (Shiprock and Tsaile).&#xD;
      The study began in year 1 with a period of engagement and recruitment of schools in each&#xD;
      community; with the goal of recruiting three schools in each community to complete the run-in&#xD;
      phase. The run-in period included time for greater engagement with the school community, an&#xD;
      assessment of the potential garden site and an assessment of evaluation readiness. Depending&#xD;
      on whether three schools in the community qualify for the study at the end of run-in, or only&#xD;
      two schools per community, it was planned to randomize three or two schools to intervention&#xD;
      or delayed intervention status in each community. Six schools were randomized, two&#xD;
      intervention schools and 4 comparison (delayed intervention) schools. Baseline data&#xD;
      collection was conducted at the beginning of the school year 2019-2020 in Year 2 with 3rd and&#xD;
      4th grade children. Students in the intervention schools received the curriculum and school&#xD;
      garden during that academic school year (Study Year 2). At the end of the school year,&#xD;
      8-month follow-up assessment was conducted. The main evaluation period is between baseline&#xD;
      and 8-month follow-up, and the statistical analysis methods estimate the differential change&#xD;
      in outcome measures (healthy eating and gardening).&#xD;
&#xD;
      Not part of the clinical trial, the study continued in the next school year (2020-2021). At&#xD;
      the beginning of Study Year 3, the comparison schools were scheduled to receive the delayed&#xD;
      intervention. During Study Year 3, it was planned to conduct quarterly community gardening&#xD;
      workshops for adult family members in all schools. Due to the COVID-19 pandemic, a series of&#xD;
      10 video workshops were produced and made available via YouTube. Attendance/Views were&#xD;
      tracked. A final assessment survey was conducted at the end of that school year (in 2021) in&#xD;
      all 6 schools to allow additional descriptive analyses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 5, 2019</start_date>
  <completion_date type="Actual">August 31, 2021</completion_date>
  <primary_completion_date type="Actual">August 31, 2021</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>
    <intervention_model_description>Group Randomized Trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Interviewers were not informed of school or school assignment at follow-up</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Estimated Change in Child Fruit &amp; Vegetable Self-efficacy</measure>
    <time_frame>Beginning to end of school year 2019-20 ( Baseline and ~ 8 months)</time_frame>
    <description>Self-efficacy for eating F&amp;V score is average of responses to five 4-point Likert scale questions. Higher score is higher self-efficacy. Score range is 1 to 4.&#xD;
Change in self-efficacy is based on a model that uses all available data (from baseline and 8-month follow-up). The unit of analysis is participant-timepoint. The analysis accounts for nesting within schools.&#xD;
Using a repeated measures linear mixed model analysis, the results are estimated change in self-efficacy score from baseline to 8-month follow-up, contrasting intervention group to comparison group.&#xD;
From the model, the estimated change in scores from baseline to 8-month follow-up ranged from 0.14 to 0.62. The unit of measure is &quot;score on a scale&quot;. The results show the least squares estimate of change in that score.&#xD;
Positive estimated change in score indicates self-efficacy increased from baseline to follow-up.&#xD;
Positive differential change indicates that intervention group change was greater than comparison group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Estimated Change in AHEI Healthy Foods Score</measure>
    <time_frame>Beginning to end of school year 2019-20 ( Baseline and ~ 8 months).</time_frame>
    <description>The Healthy Foods Score is a subscale from the modified Alternative Healthy Eating Index (AHEI). Data were derived from a picture sort frequency tool estimating consumption frequencies of ten major food groups of the Navajo diet. Scoring used the published AHEI-2010.&#xD;
The subscale is the sum of scores for fruits (fresh &amp; dried), vegetables (not salad), whole grains, beans, nuts, only. Values range from 0 to 36. Higher values represent a better outcome.&#xD;
Change in Score is based on a model that uses all available data (from baseline and 8-month follow-up).&#xD;
The model is from a repeated measures linear mixed model analysis. Change in Healthy Foods score is estimated from baseline to 8-mth follow-up, contrasting intervention group to comparison group. The change scores ranged from -0.63 to 3.66.&#xD;
Positive estimated change indicates an increase from baseline to follow-up. Positive differential change indicates that intervention group change was greater than comparison group change.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Estimated Ratio of Full Self-efficacy to Grow F&amp;V at School</measure>
    <time_frame>Beginning to end of school year 2019-20 ( Baseline and ~ 8 months)</time_frame>
    <description>Measure derived from Percent of participants at each time point reporting &quot;I know I can&quot;.&#xD;
Using generalized mixed models, specifying a binomial distribution, accounting for nesting within schools, the Odds ratio of 8-month follow-up to baseline percent reporting &quot;I know I can&quot; was estimated for both intervention and comparison groups. The overall range in these odds ratios was 0.95 to 3.63 .&#xD;
The contrast of intervention group to comparison group was also an odds ratio.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">294</enrollment>
  <condition>Dietary Habits</condition>
  <condition>Health Behavior</condition>
  <condition>Eating Behavior</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention schools receive a raised bed school garden and a curriculum of healthy eating and gardening lessons.&#xD;
3rd and 4th grade students in the intervention group received the curriculum and exposure to the school garden during the academic school year (2019-20)&#xD;
Behavioral Gardening Exposure: Assistance provided with planting and maintaining the school garden&#xD;
Healthy Eating and Gardening Curriculum: 14 to 17 lessons (about 45 minutes each) throughout the school year, during the normal school day, that are focused on healthy eating and gardening, coordinated with the growing season.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparison Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>For the comparison group schools, no program was provided in school year (2019-2020).&#xD;
After the trial, and the follow-up evaluation, in school year 2020-2021 comparison schools received delayed intervention components as follows: School gardens were created during the 2020-2021 school year (subject to delays due to pandemic restrictions). Curriculum materials were supplied to the school for use by teachers as they saw fit, after pandemic restrictions were lifted.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavioral Gardening Exposure</intervention_name>
    <description>Assistance provided with planting and maintaining the school garden</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Healthy Eating and Gardening Curriculum</intervention_name>
    <description>14 to 17 lessons (about 45 minutes each) throughout the school year, during the normal school day, that are focused on healthy eating and gardening, coordinated with the growing season</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elementary schools in Tsaile and Shiprock will have been in existence for at least&#xD;
             three years, school size (have between 40 to 100 students in grades 3 and 4 combined),&#xD;
             have more than two-thirds Navajo students and satisfy a garden site checklist that can&#xD;
             overcome garden barriers (e.g. have access to water)&#xD;
&#xD;
          -  Assessment is restricted to Male/female students in grades 3 and 4 attending school in&#xD;
             either Tsaile or Shiprock&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Students in grades other than 3rd or 4th are not eligible for assessment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shirley Beresford</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fred Hutch/University of Washington Cancer Consortium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Agricultural Science Center at Farmington, College of Agricultural, Consumer, and Environmental Sciences, New Mexico State University</name>
      <address>
        <city>Farmington</city>
        <state>New Mexico</state>
        <zip>87401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <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>
  <link>
    <url>https://www.dinecollege.edu/wp-content/uploads/2018/04/dpi-food-sovereignty-report.pdf</url>
    <description>Dine Food Sovereignty</description>
  </link>
  <reference>
    <citation>Lombard KA, Beresford SAA, Ornelas IJ, Jim J, Bauer M, Nez F. Where health and horticulture intersect: A Navajo wellness collaboration. HortScience. 2015;50(9):S360.</citation>
  </reference>
  <reference>
    <citation>Lombard KA, Beresford SA, Ornelas IJ, Topaha C, Becenti T, Thomas D, Vela JG. Healthy gardens/healthy lives: Navajo perceptions of growing food locally to prevent diabetes and cancer. Health Promot Pract. 2014 Mar;15(2):223-31. doi: 10.1177/1524839913492328. Epub 2013 Jul 12.</citation>
    <PMID>23855020</PMID>
  </reference>
  <reference>
    <citation>Lombard KA, Forster-Cox S, Smeal D, O'Neill MK. Diabetes on the Navajo nation: what role can gardening and agriculture extension play to reduce it? Rural Remote Health. 2006 Oct-Dec;6(4):640. Epub 2006 Oct 16.</citation>
    <PMID>17044752</PMID>
  </reference>
  <reference>
    <citation>Ornelas IJ, Deschenie D, Jim J, Bishop S, Lombard K, Beresford SA. Yeego Gardening! A Community Garden Intervention to Promote Health on the Navajo Nation. Prog Community Health Partnersh. 2017;11(4):417-425. doi: 10.1353/cpr.2017.0049.</citation>
    <PMID>29332855</PMID>
  </reference>
  <reference>
    <citation>Ornelas IJ, Rudd K, Bishop S, Deschenie D, Brown E, Lombard K, Beresford SAA. Engaging School and Family in Navajo Gardening for Health: Development of the Yeego Intervention to Promote Healthy Eating among Navajo Children. Health Behav Policy Rev. 2021 May;8(3):212-222. doi: 10.14485/HBPR.8.3.3. Epub 2021 May 1.</citation>
    <PMID>34901297</PMID>
  </reference>
  <results_reference>
    <citation>Beresford SAA, Ornelas IJ, Bauer MC, Garrity G, Bishop SK, Francis B, Rillamus-Sun E, Garcia L, Vecenti F, Lombard KA. Group Randomized Trial of Healthy Eating and Gardening Intervention in Navajo Elementary Schools (Yeego!).AJPM Focus (2022), doi: https://doi.org/10.1016/j.focus.2022.100033 ´</citation>
  </results_reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <results_first_submitted>August 30, 2022</results_first_submitted>
  <results_first_submitted_qc>November 29, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 23, 2022</results_first_posted>
  <last_update_submitted>November 29, 2022</last_update_submitted>
  <last_update_submitted_qc>November 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fred Hutchinson Cancer Center</investigator_affiliation>
    <investigator_full_name>Shirley Beresford</investigator_full_name>
    <investigator_title>Professor, Cancer Prevention Program</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 27, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/21/NCT03778021/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Two areas of the Navajo Nation were selected. Elementary schools within 70 miles of the closest Diné College campus were identified.&#xD;
Eligibility criteria for schools included within 30 miles of one of the two campuses; number of 3rd and 4th grade students between 40 and 140.&#xD;
Ten schools were eligible for recruitment. 6 schools completed run-in.</recruitment_details>
      <pre_assignment_details>Recruitment-eligible schools were 5 in each area. These schools were listed in random order within area. 9 schools started run-in, one school was not contacted. Two schools failed run-in, one in each area, leaving 6 schools eligible to be randomized.&#xD;
In 2019, six schools completed run-in and were randomized to intervention (2) or delayed intervention (4).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Intervention Group</title>
          <description>Intervention schools receive a raised bed school garden and a curriculum of healthy eating and gardening lessons.&#xD;
3rd and 4th grade students in the intervention group received the curriculum and exposure to school garden during the academic school year (2019-20)&#xD;
Behavioral Gardening Exposure: Assistance provided with planting and maintaining the school garden&#xD;
Healthy Eating and Gardening Curriculum: 14 to 17 lessons (about 45 minutes each) throughout the school year, during the normal school day, that are focused on healthy eating and gardening, coordinated with the growing season.</description>
        </group>
        <group group_id="P2">
          <title>Comparison Group</title>
          <description>For the comparison group schools, no program was provided in school year (2019-2020).&#xD;
After the trial, and the follow-up evaluation, comparison schools received delayed intervention components as follows: School gardens were created during the 2020-2021 school year (subject to delays due to pandemic restrictions). Curriculum materials were supplied to the school for use by teachers as they saw fit, after pandemic restrictions were lifted.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
                <participants group_id="P2" count="194"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="72"/>
                <participants group_id="P2" count="141"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="53"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Student failed to respond to follow-up survey</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="53"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>School was unit of randomization, and unit of intervention delivery to 3rd and 4th grade students.&#xD;
3rd and 4th grade student participants completed baseline. Participant was the unit analyzed.</population>
      <group_list>
        <group group_id="B1">
          <title>Intervention Group</title>
          <description>Intervention schools receive a raised bed school garden and a curriculum of healthy eating and gardening lessons.&#xD;
3rd and 4th grade students in the intervention group received the curriculum and exposure to the school garden during the academic school year (2019-20)&#xD;
Behavioral Gardening Exposure: Assistance provided with planting and maintaining the school garden&#xD;
Healthy Eating and Gardening Curriculum: 14 to 17 lessons (about 45 minutes each) throughout the school year, during the normal school day, that are focused on healthy eating and gardening, coordinated with the growing season.</description>
        </group>
        <group group_id="B2">
          <title>Comparison Group</title>
          <description>For the comparison group schools, no program was provided in school year (2019-2020).&#xD;
After the trial, and the follow-up evaluation, comparison schools received delayed intervention components as follows: School gardens were created during the 2020-2021 school year (subject to delays due to pandemic restrictions). Curriculum materials were supplied to the school for use by teachers as they saw fit, after pandemic restrictions were lifted.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="100"/>
            <count group_id="B2" value="194"/>
            <count group_id="B3" value="294"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.6" spread="0.7"/>
                    <measurement group_id="B2" value="8.7" spread="0.9"/>
                    <measurement group_id="B3" value="8.7" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="109"/>
                    <measurement group_id="B3" value="151"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="85"/>
                    <measurement group_id="B3" value="143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="91"/>
                    <measurement group_id="B2" value="175"/>
                    <measurement group_id="B3" value="266"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                    <measurement group_id="B2" value="194"/>
                    <measurement group_id="B3" value="294"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Understands Navajo</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="119"/>
                    <measurement group_id="B3" value="168"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI for age percentile</title>
          <units>percentile</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="73.1" spread="31.2"/>
                    <measurement group_id="B2" value="69.7" spread="29.8"/>
                    <measurement group_id="B3" value="70.9" spread="30.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Overweight or Obese</title>
          <description>Percent overweight or obese (%)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="83"/>
                    <measurement group_id="B3" value="133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Self-efficacy to eat F&amp;V</title>
          <description>Self-efficacy to eat Fruits and Vegetables (F&amp;V) is a scale made up of the average of five items each with four-point Likert scale responses (I know I can, I think I can, I'm not sure I can, and I know I can't). Score range is 1 to 4. Higher scores represents higher self-efficacy.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.2" spread="0.65"/>
                    <measurement group_id="B2" value="3.4" spread="0.57"/>
                    <measurement group_id="B3" value="3.3" spread="0.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>AHEI Healthy Foods Score</title>
          <description>The Healthy Foods Score is a subscale from the modified Alternative Healthy Eating Index (AHEI). Data for the modified AHEI were derived from a picture sort frequency tool, estimating frequencies of consumption of ten major food groups of the Navajo diet. Scoring published as AHEI-2010 was applied.&#xD;
The subscale, the Healthy Foods Score, is the sum of scores for fruits (fresh &amp; dried), vegetables (not salad), whole grains, beans, nuts, only. The minimum value is 0 and the maximum is 36. Higher values represent a better outcome.&#xD;
.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.9" spread="5.8"/>
                    <measurement group_id="B2" value="17.8" spread="6.4"/>
                    <measurement group_id="B3" value="17.5" spread="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Full self-efficacy to grow F&amp;V at school</title>
          <description>Percent of participants reporting &quot;I know I can&quot;. This binary variable was derived from a question about student's confidence to grow F&amp;V at school. The question had responses on a 4-point Likert scale. Only the &quot;I know I can&quot; point was used to create the binary variable for full self-efficacy to grow F&amp;V at school.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49.0"/>
                    <measurement group_id="B2" value="40.0"/>
                    <measurement group_id="B3" value="43.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Estimated Change in Child Fruit &amp; Vegetable Self-efficacy</title>
        <description>Self-efficacy for eating F&amp;V score is average of responses to five 4-point Likert scale questions. Higher score is higher self-efficacy. Score range is 1 to 4.&#xD;
Change in self-efficacy is based on a model that uses all available data (from baseline and 8-month follow-up). The unit of analysis is participant-timepoint. The analysis accounts for nesting within schools.&#xD;
Using a repeated measures linear mixed model analysis, the results are estimated change in self-efficacy score from baseline to 8-month follow-up, contrasting intervention group to comparison group.&#xD;
From the model, the estimated change in scores from baseline to 8-month follow-up ranged from 0.14 to 0.62. The unit of measure is &quot;score on a scale&quot;. The results show the least squares estimate of change in that score.&#xD;
Positive estimated change in score indicates self-efficacy increased from baseline to follow-up.&#xD;
Positive differential change indicates that intervention group change was greater than comparison group.</description>
        <time_frame>Beginning to end of school year 2019-20 ( Baseline and ~ 8 months)</time_frame>
        <population>Participants were 3rd and 4th grade students responding to baseline and/or 8-month follow-up. The participant at specified time point was the unit of analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>Intervention schools receive a raised bed school garden and a curriculum of healthy eating and gardening lessons.&#xD;
3rd and 4th grade students in the intervention group received the curriculum and exposure to the school garden during the academic school year (2019-20)&#xD;
Behavioral Gardening Exposure: Assistance provided with planting and maintaining the school garden&#xD;
Healthy Eating and Gardening Curriculum: 14 to 17 lessons (about 45 minutes each) throughout the school year, during the normal school day, that are focused on healthy eating and gardening, coordinated with the growing season.</description>
          </group>
          <group group_id="O2">
            <title>Comparison Group</title>
            <description>For the comparison group schools, no program was provided in school year (2019-2020).&#xD;
After the trial, and the follow-up evaluation, comparison schools received delayed intervention components as follows: School gardens were created during the 2020-2021 school year (subject to delays due to pandemic restrictions). Curriculum materials were supplied to the school for use by teachers as they saw fit, after pandemic restrictions were lifted.</description>
          </group>
        </group_list>
        <measure>
          <title>Estimated Change in Child Fruit &amp; Vegetable Self-efficacy</title>
          <description>Self-efficacy for eating F&amp;V score is average of responses to five 4-point Likert scale questions. Higher score is higher self-efficacy. Score range is 1 to 4.&#xD;
Change in self-efficacy is based on a model that uses all available data (from baseline and 8-month follow-up). The unit of analysis is participant-timepoint. The analysis accounts for nesting within schools.&#xD;
Using a repeated measures linear mixed model analysis, the results are estimated change in self-efficacy score from baseline to 8-month follow-up, contrasting intervention group to comparison group.&#xD;
From the model, the estimated change in scores from baseline to 8-month follow-up ranged from 0.14 to 0.62. The unit of measure is &quot;score on a scale&quot;. The results show the least squares estimate of change in that score.&#xD;
Positive estimated change in score indicates self-efficacy increased from baseline to follow-up.&#xD;
Positive differential change indicates that intervention group change was greater than comparison group.</description>
          <population>Participants were 3rd and 4th grade students responding to baseline and/or 8-month follow-up. The participant at specified time point was the unit of analysis.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <units_analyzed>participant-time point</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="194"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>participant-time point</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="172"/>
                <count group_id="O2" value="335"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.47" spread="0.08"/>
                    <measurement group_id="O2" value="0.24" spread="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The unit of measure is &quot;score on a scale&quot;. The results show the least squares estimate of change in that score, from baseline to 8-month follow-up in each group from model.&#xD;
Values from the 100 and 194 baseline respondents and from the 72 and 141 follow-up respondents of intervention and comparison groups respectively contributed to the repeated measures linear mixed model, where the units of analysis were participant-time. The nesting within schools was accounted for in the model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.017</p_value>
            <p_value_desc>Estimated differential change in score between intervention and comparison group from repeated measures linear mixed model.&#xD;
All the reported analyses conservatively specified covariance structure as general covariance (unstructured). alpha = 0.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Repeated measures linear mixed model analysis. Student nested within school. Model fit time, intervention and time by intervention interaction.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.22</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.093</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.04</ci_lower_limit>
            <ci_upper_limit>0.41</ci_upper_limit>
            <estimate_desc>Estimated differential change (intervention minus control) from repeated measures linear mixed model</estimate_desc>
            <other_analysis_desc>In the repeated measures linear mixed model, time was treated as a fixed effect. In the specification of the repeated measures linear mixed model, students were nested within schools.&#xD;
All the reported analyses conservatively specified covariance structure as general covariance (unstructured).</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Estimated Change in AHEI Healthy Foods Score</title>
        <description>The Healthy Foods Score is a subscale from the modified Alternative Healthy Eating Index (AHEI). Data were derived from a picture sort frequency tool estimating consumption frequencies of ten major food groups of the Navajo diet. Scoring used the published AHEI-2010.&#xD;
The subscale is the sum of scores for fruits (fresh &amp; dried), vegetables (not salad), whole grains, beans, nuts, only. Values range from 0 to 36. Higher values represent a better outcome.&#xD;
Change in Score is based on a model that uses all available data (from baseline and 8-month follow-up).&#xD;
The model is from a repeated measures linear mixed model analysis. Change in Healthy Foods score is estimated from baseline to 8-mth follow-up, contrasting intervention group to comparison group. The change scores ranged from -0.63 to 3.66.&#xD;
Positive estimated change indicates an increase from baseline to follow-up. Positive differential change indicates that intervention group change was greater than comparison group change.</description>
        <time_frame>Beginning to end of school year 2019-20 ( Baseline and ~ 8 months).</time_frame>
        <population>Participants were 3rd and 4th grade students responding to baseline and/or 8-month follow-up. The participant at specified time point was the unit of analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>Intervention schools receive a raised bed school garden and a curriculum of healthy eating and gardening lessons.&#xD;
3rd and 4th grade students in the intervention group received the curriculum and exposure to the school garden during the academic school year (2019-20)&#xD;
Behavioral Gardening Exposure: Assistance provided with planting and maintaining the school garden&#xD;
Healthy Eating and Gardening Curriculum: 14 to 17 lessons (about 45 minutes each) throughout the school year, during the normal school day, that are focused on healthy eating and gardening, coordinated with the growing season.</description>
          </group>
          <group group_id="O2">
            <title>Comparison Group</title>
            <description>For the comparison group schools, no program was provided in school year (2019-2020).&#xD;
After the trial, and the follow-up evaluation, comparison schools received delayed intervention components as follows: School gardens were created during the 2020-2021 school year (subject to delays due to pandemic restrictions). Curriculum materials were supplied to the school for use by teachers as they saw fit, after pandemic restrictions were lifted.</description>
          </group>
        </group_list>
        <measure>
          <title>Estimated Change in AHEI Healthy Foods Score</title>
          <description>The Healthy Foods Score is a subscale from the modified Alternative Healthy Eating Index (AHEI). Data were derived from a picture sort frequency tool estimating consumption frequencies of ten major food groups of the Navajo diet. Scoring used the published AHEI-2010.&#xD;
The subscale is the sum of scores for fruits (fresh &amp; dried), vegetables (not salad), whole grains, beans, nuts, only. Values range from 0 to 36. Higher values represent a better outcome.&#xD;
Change in Score is based on a model that uses all available data (from baseline and 8-month follow-up).&#xD;
The model is from a repeated measures linear mixed model analysis. Change in Healthy Foods score is estimated from baseline to 8-mth follow-up, contrasting intervention group to comparison group. The change scores ranged from -0.63 to 3.66.&#xD;
Positive estimated change indicates an increase from baseline to follow-up. Positive differential change indicates that intervention group change was greater than comparison group change.</description>
          <population>Participants were 3rd and 4th grade students responding to baseline and/or 8-month follow-up. The participant at specified time point was the unit of analysis.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <units_analyzed>participant-time point</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="194"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>participant-time point</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="172"/>
                <count group_id="O2" value="335"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.98" spread="0.85"/>
                    <measurement group_id="O2" value="0.58" spread="0.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Results present estimated change in score from baseline to 8-month follow-up in each group from model.&#xD;
Values from the 100 and 194 baseline respondents and from the 72 and 141 follow-up respondents of intervention and comparison groups respectively contributed to the repeated measures linear mixed model, where the units of analysis were participant-time. The nesting within schools was accounted for in the model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.18</p_value>
            <p_value_desc>Estimated differential change in score between intervention and comparison group from repeated measures linear mixed model.&#xD;
All the reported analyses conservatively specified covariance structure as general covariance (unstructured). alpha = 0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Repeated measures linear mixed model analysis. Student nested within school. Model fit time, intervention and time by intervention interaction.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.41</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.66</ci_lower_limit>
            <ci_upper_limit>3.49</ci_upper_limit>
            <estimate_desc>Estimated differential change from baseline to follow-up from model (intervention minus control)</estimate_desc>
            <other_analysis_desc>In the repeated measures linear mixed model, time was treated as a fixed effect. In the specification of the repeated measures linear mixed model, students were nested within schools</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Estimated Ratio of Full Self-efficacy to Grow F&amp;V at School</title>
        <description>Measure derived from Percent of participants at each time point reporting &quot;I know I can&quot;.&#xD;
Using generalized mixed models, specifying a binomial distribution, accounting for nesting within schools, the Odds ratio of 8-month follow-up to baseline percent reporting &quot;I know I can&quot; was estimated for both intervention and comparison groups. The overall range in these odds ratios was 0.95 to 3.63 .&#xD;
The contrast of intervention group to comparison group was also an odds ratio.</description>
        <time_frame>Beginning to end of school year 2019-20 ( Baseline and ~ 8 months)</time_frame>
        <population>Participants were 3rd and 4th grade students responding to baseline and/or 8-month follow-up. The participant at specified time point was the unit of analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>Intervention schools receive a raised bed school garden and a curriculum of healthy eating and gardening lessons.&#xD;
3rd and 4th grade students in the intervention group received the curriculum and exposure to the school garden during the academic school year (2019-20)&#xD;
Behavioral Gardening Exposure: Assistance provided with planting and maintaining the school garden&#xD;
Healthy Eating and Gardening Curriculum: 14 to 17 lessons (about 45 minutes each) throughout the school year, during the normal school day, that are focused on healthy eating and gardening, coordinated with the growing season.</description>
          </group>
          <group group_id="O2">
            <title>Comparison Group</title>
            <description>.For the comparison group schools, no program was provided in school year (2019-2020).&#xD;
After the trial, and the follow-up evaluation, comparison schools received delayed intervention components as follows: School gardens were created during the 2020-2021 school year (subject to delays due to pandemic restrictions). Curriculum materials were supplied to the school for use by teachers as they saw fit, after pandemic restrictions were lifted.</description>
          </group>
        </group_list>
        <measure>
          <title>Estimated Ratio of Full Self-efficacy to Grow F&amp;V at School</title>
          <description>Measure derived from Percent of participants at each time point reporting &quot;I know I can&quot;.&#xD;
Using generalized mixed models, specifying a binomial distribution, accounting for nesting within schools, the Odds ratio of 8-month follow-up to baseline percent reporting &quot;I know I can&quot; was estimated for both intervention and comparison groups. The overall range in these odds ratios was 0.95 to 3.63 .&#xD;
The contrast of intervention group to comparison group was also an odds ratio.</description>
          <population>Participants were 3rd and 4th grade students responding to baseline and/or 8-month follow-up. The participant at specified time point was the unit of analysis.</population>
          <units>odds ratio</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>participant-time point</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="194"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>participant-time point</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="172"/>
                <count group_id="O2" value="335"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.92" lower_limit="1.02" upper_limit="3.63"/>
                    <measurement group_id="O2" value="1.48" lower_limit="0.95" upper_limit="2.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Odds ratio of 8-month follow-up to baseline percent reporting &quot; I know I can&quot; was estimated from repeated measures generalized linear mixed model with binomial distribution.&#xD;
Values included from the 100 and 194 baseline respondents and from the 72 and 141 8-month follow-up respondents of intervention and comparison groups respectively. The person-timepoint is the unit of analysis.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.51</p_value>
            <p_value_desc>Repeated measures generalized linear mixed model with binomial distribution (variable was &quot;I know I can&quot; - yes versus no).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>The odds of the odds ratio is reported as the intervention effect.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.29</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.60</ci_lower_limit>
            <ci_upper_limit>2.81</ci_upper_limit>
            <estimate_desc>Odds ratio from estimated least squares from generalized mixed model with binomial distribution specified. Intervention odds of change compared to comparison group odds of change via odds ratio..</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 1 year 8 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Intervention Group</title>
          <description>Intervention schools receive a raised bed school garden and a curriculum of healthy eating and gardening lessons.&#xD;
3rd and 4th grade students in the intervention group received the curriculum and exposure to the school garden during the academic school year (2019-20)&#xD;
Behavioral Gardening Exposure: Assistance provided with planting and maintaining the school garden&#xD;
Healthy Eating and Gardening Curriculum: 14 to 17 lessons (about 45 minutes each) throughout the school year, during the normal school day, that are focused on healthy eating and gardening, coordinated with the growing season.</description>
        </group>
        <group group_id="E2">
          <title>Comparison Group</title>
          <description>For the comparison group schools, no program was provided in school year (2019-2020).&#xD;
After the trial, and the follow-up evaluation, comparison schools received delayed intervention components as follows: School gardens were created during the 2020-2021 school year (subject to delays due to pandemic restrictions). Curriculum materials were supplied to the school for use by teachers as they saw fit, after pandemic restrictions were lifted.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="194"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="194"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="194"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The group randomized trial was small, in that only six schools were enrolled and randomized. Not all 3rd and 4th graders participated in the baseline assessment.&#xD;
Not all students completing baseline also completed follow-up. Only six of the 11 standard components of AHEI could be estimated. Dietary behaviors were assessed using self-efficacy for F&amp;V, and metrics based on the picture sort tool. Neither of these methods is considered as reliable as the 24 hour recall.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Shirley A.A. Beresford, Principal Investigator</name_or_title>
      <organization>University of Washington, Department of Epidemiology</organization>
      <phone>206 543 9512</phone>
      <email>beresfrd@uw.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03778021
org study id: RG1001953
secondary id: 8716
secondary id: NCI-2018-03752
secondary id: U54CA132381-11
secondary id: P30CA015704
nct id: NCT03778021
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study, one year changes in healthy eating and gardening behaviors associated with the
      intervention were estimated using a group randomized controlled trial design, with the
      comparison arm receiving a delayed intervention in the following school year.
The small randomized controlled trial of an intensive curriculum and school garden
      intervention was implemented in elementary schools in two communities (Shiprock and Tsaile).
      The study began in year 1 with a period of engagement and recruitment of schools in each
      community; with the goal of recruiting three schools in each community to complete the run-in
      phase. The run-in period included time for greater engagement with the school community, an
      assessment of the potential garden site and an assessment of evaluation readiness. Depending
      on whether three schools in the community qualify for the study at the end of run-in, or only
      two schools per community, it was planned to randomize three or two schools to intervention
      or delayed intervention status in each community. Six schools were randomized, two
      intervention schools and 4 comparison (delayed intervention) schools. Baseline data
      collection was conducted at the beginning of the school year 2019-2020 in Year 2 with 3rd and
      4th grade children. Students in the intervention schools received the curriculum and school
      garden during that academic school year (Study Year 2). At the end of the school year,
      8-month follow-up assessment was conducted. The main evaluation period is between baseline
      and 8-month follow-up, and the statistical analysis methods estimate the differential change
      in outcome measures (healthy eating and gardening).

      Not part of the clinical trial, the study continued in the next school year (2020-2021). At
      the beginning of Study Year 3, the comparison schools were scheduled to receive the delayed
      intervention. During Study Year 3, it was planned to conduct quarterly community gardening
      workshops for adult family members in all schools. Due to the COVID-19 pandemic, a series of
      10 video workshops were produced and made available via YouTube. Attendance/Views were
      tracked. A final assessment survey was conducted at the end of that school year (in 2021) in
      all 6 schools to allow additional descriptive analyses.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Group Randomized Trial
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: Interviewers were not informed of school or school assignment at follow-up
measure: Estimated Change in Child Fruit & Vegetable Self-efficacy
time frame: Beginning to end of school year 2019-20 ( Baseline and ~ 8 months)
description: Self-efficacy for eating F&V score is average of responses to five 4-point Likert scale questions. Higher score is higher self-efficacy. Score range is 1 to 4.
Change in self-efficacy is based on a model that uses all available data (from baseline and 8-month follow-up). The unit of analysis is participant-timepoint. The analysis accounts for nesting within schools.
Using a repeated measures linear mixed model analysis, the results are estimated change in self-efficacy score from baseline to 8-month follow-up, contrasting intervention group to comparison group.
From the model, the estimated change in scores from baseline to 8-month follow-up ranged from 0.14 to 0.62. The unit of measure is "score on a scale". The results show the least squares estimate of change in that score.
Positive estimated change in score indicates self-efficacy increased from baseline to follow-up.
Positive differential change indicates that intervention group change was greater than comparison group.
measure: Estimated Change in AHEI Healthy Foods Score
time frame: Beginning to end of school year 2019-20 ( Baseline and ~ 8 months).
description: The Healthy Foods Score is a subscale from the modified Alternative Healthy Eating Index (AHEI). Data were derived from a picture sort frequency tool estimating consumption frequencies of ten major food groups of the Navajo diet. Scoring used the published AHEI-2010.
The subscale is the sum of scores for fruits (fresh & dried), vegetables (not salad), whole grains, beans, nuts, only. Values range from 0 to 36. Higher values represent a better outcome.
Change in Score is based on a model that uses all available data (from baseline and 8-month follow-up).
The model is from a repeated measures linear mixed model analysis. Change in Healthy Foods score is estimated from baseline to 8-mth follow-up, contrasting intervention group to comparison group. The change scores ranged from -0.63 to 3.66.
Positive estimated change indicates an increase from baseline to follow-up. Positive differential change indicates that intervention group change was greater than comparison group change.
measure: Estimated Ratio of Full Self-efficacy to Grow F&V at School
time frame: Beginning to end of school year 2019-20 ( Baseline and ~ 8 months)
description: Measure derived from Percent of participants at each time point reporting "I know I can".
Using generalized mixed models, specifying a binomial distribution, accounting for nesting within schools, the Odds ratio of 8-month follow-up to baseline percent reporting "I know I can" was estimated for both intervention and comparison groups. The overall range in these odds ratios was 0.95 to 3.63 .
The contrast of intervention group to comparison group was also an odds ratio.
arm group label: Intervention Group
arm group type: Experimental
description: Intervention schools receive a raised bed school garden and a curriculum of healthy eating and gardening lessons.
3rd and 4th grade students in the intervention group received the curriculum and exposure to the school garden during the academic school year (2019-20)
Behavioral Gardening Exposure: Assistance provided with planting and maintaining the school garden
Healthy Eating and Gardening Curriculum: 14 to 17 lessons (about 45 minutes each) throughout the school year, during the normal school day, that are focused on healthy eating and gardening, coordinated with the growing season.
arm group label: Comparison Group
arm group type: No Intervention
description: For the comparison group schools, no program was provided in school year (2019-2020).
After the trial, and the follow-up evaluation, in school year 2020-2021 comparison schools received delayed intervention components as follows: School gardens were created during the 2020-2021 school year (subject to delays due to pandemic restrictions). Curriculum materials were supplied to the school for use by teachers as they saw fit, after pandemic restrictions were lifted.
intervention type: Behavioral
intervention name: Behavioral Gardening Exposure
description: Assistance provided with planting and maintaining the school garden
arm group label: Intervention Group
intervention type: Behavioral
intervention name: Healthy Eating and Gardening Curriculum
description: 14 to 17 lessons (about 45 minutes each) throughout the school year, during the normal school day, that are focused on healthy eating and gardening, coordinated with the growing season
arm group label: Intervention Group
criteria: 
gender: All
minimum age: 8 Years
maximum age: 12 Years
healthy volunteers: No
last name: Shirley Beresford
role: Principal Investigator
affiliation: Fred Hutch/University of Washington Cancer Consortium
facility: 
facility: 
country: United States
url: https://www.dinecollege.edu/wp-content/uploads/2018/04/dpi-food-sovereignty-report.pdf
description: Dine Food Sovereignty
citation: Lombard KA, Beresford SAA, Ornelas IJ, Jim J, Bauer M, Nez F. Where health and horticulture intersect: A Navajo wellness collaboration. HortScience. 2015;50(9):S360.
citation: Lombard KA, Beresford SA, Ornelas IJ, Topaha C, Becenti T, Thomas D, Vela JG. Healthy gardens/healthy lives: Navajo perceptions of growing food locally to prevent diabetes and cancer. Health Promot Pract. 2014 Mar;15(2):223-31. doi: 10.1177/1524839913492328. Epub 2013 Jul 12.
PMID: 23855020
citation: Lombard KA, Forster-Cox S, Smeal D, O'Neill MK. Diabetes on the Navajo nation: what role can gardening and agriculture extension play to reduce it? Rural Remote Health. 2006 Oct-Dec;6(4):640. Epub 2006 Oct 16.
PMID: 17044752
citation: Ornelas IJ, Deschenie D, Jim J, Bishop S, Lombard K, Beresford SA. Yeego Gardening! A Community Garden Intervention to Promote Health on the Navajo Nation. Prog Community Health Partnersh. 2017;11(4):417-425. doi: 10.1353/cpr.2017.0049.
PMID: 29332855
citation: Ornelas IJ, Rudd K, Bishop S, Deschenie D, Brown E, Lombard K, Beresford SAA. Engaging School and Family in Navajo Gardening for Health: Development of the Yeego Intervention to Promote Healthy Eating among Navajo Children. Health Behav Policy Rev. 2021 May;8(3):212-222. doi: 10.14485/HBPR.8.3.3. Epub 2021 May 1.
PMID: 34901297
citation: Beresford SAA, Ornelas IJ, Bauer MC, Garrity G, Bishop SK, Francis B, Rillamus-Sun E, Garcia L, Vecenti F, Lombard KA. Group Randomized Trial of Healthy Eating and Gardening Intervention in Navajo Elementary Schools (Yeego!).AJPM Focus (2022), doi: https://doi.org/10.1016/j.focus.2022.100033 ´
responsible party type: Principal Investigator
investigator affiliation: Fred Hutchinson Cancer Center
investigator full name: Shirley Beresford
investigator title: Professor, Cancer Prevention Program
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The group randomized trial was small, in that only six schools were enrolled and randomized. Not all 3rd and 4th graders participated in the baseline assessment.
Not all students completing baseline also completed follow-up. Only six of the 11 standard components of AHEI could be estimated. Dietary behaviors were assessed using self-efficacy for F&V, and metrics based on the picture sort tool. Neither of these methods is considered as reliable as the 24 hour recall.
point of contact: 