<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/NCT03251950</url>
  </required_header>
  <id_info>
    <org_study_id>R01MD011266</org_study_id>
    <secondary_id>R01MD011266</secondary_id>
    <nct_id>NCT03251950</nct_id>
  </id_info>
  <brief_title>Food Resource Equity and Sustainability for Health</brief_title>
  <acronym>FRESH</acronym>
  <official_title>Food Resource Equity and Sustainability for Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oklahoma State University Center for Health Sciences</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>
  </sponsors>
  <source>Oklahoma State University Center for Health Sciences</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>
      Food insecurity increases the risk of obesity, diabetes, hypertension, and cancer. American&#xD;
      Indians (AIs) in Oklahoma are three times as likely as Whites to be food-insecure (21% vs.&#xD;
      7%) and have burdens of obesity (42%), hypertension (38%), and diabetes (15%) that exceed&#xD;
      those of the general US population. While individual-level obesity prevention efforts have&#xD;
      been implemented with AIs, few environmental interventions to reduce food insecurity and&#xD;
      improve fruit and vegetable intake have been conducted with tribal communities. Community&#xD;
      gardening interventions have been shown to increase vegetable and fruit intake, reduce food&#xD;
      insecurity, and lower BMI among children and adults; however, to date, no such interventions&#xD;
      have been evaluated with AI families. The proposed study, entitled &quot;Food Equity Resource and&#xD;
      Sustainability for Health (FRESH),&quot; will assess the impact of a tribally-initiated community&#xD;
      gardening intervention on vegetable and fruit intake, food insecurity, BMI, and blood&#xD;
      pressure in families living on the Osage Nation reservation in Oklahoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The intervention will take place in the inaugural year of Osage Nation's Bird Creek Farm and&#xD;
      Community Gardens, where 120 garden plots will be allocated to participating reservation&#xD;
      families. The study is guided by the principles of community-based participatory research&#xD;
      (CBPR) and the Indigenous food sovereignty movement, which seeks to revitalize seasonal&#xD;
      growing and gathering practices and reverse the tide of unhealthy eating caused by the&#xD;
      historical loss of tribal lands.&#xD;
&#xD;
      Aims and Methods: Led by an AI (Choctaw) Investigator, the study will:&#xD;
&#xD;
      Aim #1: Characterize the Osage Nation reservation's food environment by using both objective&#xD;
      and perceived measures, and then examine the relationships between these measures and intake&#xD;
      of vegetables and fruits, food insecurity, BMI, hypertension, and diabetes.&#xD;
&#xD;
      Aim #2: Develop a culturally relevant community gardening intervention and conduct a&#xD;
      randomized controlled trial (RCT) to evaluate its efficacy in increasing vegetable and fruit&#xD;
      intake and reducing food insecurity, BMI, and blood pressure among Osage families.&#xD;
&#xD;
      Aim #3: Create and disseminate a Web- based multimedia manual and documentary film, and&#xD;
      evaluate their effectiveness in increasing tribal readiness and capacity to improve local&#xD;
      food environments.&#xD;
&#xD;
      Innovation: The proposed study will be the first RCT ever conducted of a community gardening&#xD;
      intervention, as well as the first community gardening intervention with AI families. The&#xD;
      study will also be one of the first environmental interventions o simultaneously address&#xD;
      healthy food production, access, preference, and intake among AIs.&#xD;
&#xD;
      Significance and Impact: The community gardening intervention will be developed as part of a&#xD;
      larger Osage Nation initiative on food security and food sovereignty and as such, is likely&#xD;
      to be sustainable if it proves effective. Research findings and products will be disseminated&#xD;
      to AI/AN communities nationwide and will help to identify environmental strategies that will&#xD;
      improve tribal food environments and the health and quality of life of AI families.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 22, 2017</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vegetable and fruit intake among children aged 3-5</measure>
    <time_frame>Measured before and after the 15 week intervention</time_frame>
    <description>Targeted quarter cup increase in vegetable and fruit intake per day</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">522</enrollment>
  <condition>BMI</condition>
  <condition>Blood Pressure</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15 week healthy eating and gardening curriculum to be implemented in Osage Nation Early Childhood Programs; 15 week healthy eating parenting curriculum to be implemented online to parents of enrolled children</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Wait list control -- to receive intervention after serving as wait list group</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>healthy eating and gardening</intervention_name>
    <description>15 week healthy eating and gardening intervention for children aged 3-5 years; 15 week online parenting intervention to promote healthy eating; Menu change in early childhood center to promote healthy eating</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Indian Children aged 3-5 who attend one of the Osage Nation Early Childhood&#xD;
             Programs&#xD;
&#xD;
          -  Parents of American Indian children who are aged 18 years and older and whose children&#xD;
             are enrolled in Osage Nation Early Childhood Programs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anyone not meeting the aforementioned inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Valarie BB Jernigan, DrPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oklahoma State University Center for Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oklahoma State Univeristy Center for Health Sciences</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>March 15, 2019</last_update_submitted>
  <last_update_submitted_qc>March 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vegetable and fruit intake</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03251950
org study id: R01MD011266
secondary id: R01MD011266
nct id: NCT03251950
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Food insecurity increases the risk of obesity, diabetes, hypertension, and cancer. American
      Indians (AIs) in Oklahoma are three times as likely as Whites to be food-insecure (21% vs.
      7%) and have burdens of obesity (42%), hypertension (38%), and diabetes (15%) that exceed
      those of the general US population. While individual-level obesity prevention efforts have
      been implemented with AIs, few environmental interventions to reduce food insecurity and
      improve fruit and vegetable intake have been conducted with tribal communities. Community
      gardening interventions have been shown to increase vegetable and fruit intake, reduce food
      insecurity, and lower BMI among children and adults; however, to date, no such interventions
      have been evaluated with AI families. The proposed study, entitled "Food Equity Resource and
      Sustainability for Health (FRESH)," will assess the impact of a tribally-initiated community
      gardening intervention on vegetable and fruit intake, food insecurity, BMI, and blood
      pressure in families living on the Osage Nation reservation in Oklahoma.
The intervention will take place in the inaugural year of Osage Nation's Bird Creek Farm and
      Community Gardens, where 120 garden plots will be allocated to participating reservation
      families. The study is guided by the principles of community-based participatory research
      (CBPR) and the Indigenous food sovereignty movement, which seeks to revitalize seasonal
      growing and gathering practices and reverse the tide of unhealthy eating caused by the
      historical loss of tribal lands.

      Aims and Methods: Led by an AI (Choctaw) Investigator, the study will:

      Aim #1: Characterize the Osage Nation reservation's food environment by using both objective
      and perceived measures, and then examine the relationships between these measures and intake
      of vegetables and fruits, food insecurity, BMI, hypertension, and diabetes.

      Aim #2: Develop a culturally relevant community gardening intervention and conduct a
      randomized controlled trial (RCT) to evaluate its efficacy in increasing vegetable and fruit
      intake and reducing food insecurity, BMI, and blood pressure among Osage families.

      Aim #3: Create and disseminate a Web- based multimedia manual and documentary film, and
      evaluate their effectiveness in increasing tribal readiness and capacity to improve local
      food environments.

      Innovation: The proposed study will be the first RCT ever conducted of a community gardening
      intervention, as well as the first community gardening intervention with AI families. The
      study will also be one of the first environmental interventions o simultaneously address
      healthy food production, access, preference, and intake among AIs.

      Significance and Impact: The community gardening intervention will be developed as part of a
      larger Osage Nation initiative on food security and food sovereignty and as such, is likely
      to be sustainable if it proves effective. Research findings and products will be disseminated
      to AI/AN communities nationwide and will help to identify environmental strategies that will
      improve tribal food environments and the health and quality of life of AI families.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Vegetable and fruit intake among children aged 3-5
time frame: Measured before and after the 15 week intervention
description: Targeted quarter cup increase in vegetable and fruit intake per day
arm group label: Intervention group
arm group type: Experimental
description: 15 week healthy eating and gardening curriculum to be implemented in Osage Nation Early Childhood Programs; 15 week healthy eating parenting curriculum to be implemented online to parents of enrolled children
arm group label: Control group
arm group type: Other
description: Wait list control -- to receive intervention after serving as wait list group
intervention type: Behavioral
intervention name: healthy eating and gardening
description: 15 week healthy eating and gardening intervention for children aged 3-5 years; 15 week online parenting intervention to promote healthy eating; Menu change in early childhood center to promote healthy eating
arm group label: Control group
arm group label: Intervention group
criteria: 
gender: All
minimum age: 3 Years
maximum age: N/A
healthy volunteers: No
last name: Valarie BB Jernigan, DrPH
role: Principal Investigator
affiliation: Oklahoma State University Center for Health Sciences
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No