<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/NCT03774277</url>
  </required_header>
  <id_info>
    <org_study_id>7614</org_study_id>
    <nct_id>NCT03774277</nct_id>
  </id_info>
  <brief_title>Chickasaw Healthy Eating Environments Research Study</brief_title>
  <acronym>CHEERS</acronym>
  <official_title>Chickasaw Healthy Eating Environments Research Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oklahoma State University Center for Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Chickasaw Nation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Washington State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oklahoma State University Center for Health Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study, the Chickasaw Healthy Eating Environments Research Study (CHEERS), will be&#xD;
      conducted in partnership with Chickasaw Nation. CHEERS comprises several mutually reinforcing&#xD;
      strategies to improve blood pressure (BP) control in people with hypertension. Environmental&#xD;
      strategies include the investigator's innovative &quot;Packed Promise for a Healthy Heart&quot; program&#xD;
      that provides hypertensive adults ages 18 and older with a voucher for fresh vegetables and&#xD;
      fruits (referred to as a &quot;fresh check&quot;) and home delivered food boxes that contain Dietary&#xD;
      Approaches to Stop Hypertension (DASH)-approved ingredients for preparing low-salt, and&#xD;
      traditional healthy Chickasaw meals. The study facilitates demonstrations of healthy cooking&#xD;
      practices in participating communities. At the individual level, tribal members with&#xD;
      uncontrolled hypertension will receive heart-healthy recipes (available at&#xD;
      getfreshcooking.com) that are tailored to traditional Chickasaw diet and culture, educational&#xD;
      materials, along with invitations to attend cooking demonstrations, fresh checks to improve&#xD;
      access to fresh produce, and a Chickasaw Nation culturally-informed smartphone walking app&#xD;
      called &quot;AYA.&quot; At the policy level, CHEERS will culminate in a multimedia documentary&#xD;
      presentation for tribal leadership detailing the intervention and featuring personal success&#xD;
      stories by hypertensive community members. Study findings, including a health economics&#xD;
      assessment, will be used to encourage policies for further expansion of the Packed Promise&#xD;
      for a Healthy Heart Program; and policies promoting expansion of brick and mortar grocery&#xD;
      outlets in rural Chickasaw communities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is guided by the principles of community-based participatory research (CBPR).&#xD;
&#xD;
      Aims and Methods: Co-led by an AI (Choctaw) Investigator, the study will:&#xD;
&#xD;
      Aim #1: Evaluate CHEERS' ability to improve healthy food access by collecting quantitative&#xD;
      data on changes in perceived ability to purchase and prepare healthy food, and by using&#xD;
      qualitative methods to evaluate the reach, saturation, and acceptability of the CHEERS&#xD;
      intervention.&#xD;
&#xD;
      Aim #2: Measure the intervention's effect on change in BP and secondary outcomes among&#xD;
      hypertensive community members with poorly controlled hypertension.&#xD;
&#xD;
      Aim #3:Disseminate a multimedia documentary of the study's findings and evaluate the&#xD;
      documentary's effect on tribal leaders across the Chickasaw Nation and other tribal&#xD;
      communities.&#xD;
&#xD;
      Innovation: This study will evaluate the effects of a multilevel, tribally-run, food&#xD;
      environment intervention. The study will also be one of the few food environment&#xD;
      interventions ever implemented in an AI community, and the first to objectively measure its&#xD;
      effects on BP and BMI.&#xD;
&#xD;
      Significance and Impact: Study findings, including a health economics assessment, will be&#xD;
      used to encourage policies for further expansion of the Packed Promise for a Healthy Heart&#xD;
      Program; and policies promoting expansion of brick and mortar grocery outlets in rural&#xD;
      Chickasaw communities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 10, 2018</start_date>
  <completion_date type="Anticipated">February 2021</completion_date>
  <primary_completion_date type="Anticipated">February 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in systolic blood pressure</measure>
    <time_frame>Measured before and after the 6 month intervention</time_frame>
    <description>Targeted 2.9 mm Hg decrease in systolic blood pressure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in body mass index</measure>
    <time_frame>Measured before and after the 6 month intervention</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Food access</measure>
    <time_frame>Measured before and after the 6 month intervention</time_frame>
    <description>USDA Household Food Security Scale (6 Item Short Module) - The sum of affirmative responses provides a household raw score. Food security status of households with raw scores of 0-1 are high or marginally food secure, raw scores of 2-4 are low secure, and raw scores of 5-6 are very low food secure. High raw scores indicate food insecure households.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diet</measure>
    <time_frame>Measured before and after the 6 month intervention</time_frame>
    <description>ASA24, a self-administered recall system (https://asa24.nci.nih.gov/)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walking</measure>
    <time_frame>Measured during 6 month intervention</time_frame>
    <description>Fitbit dashboard</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self-reported physical activity</measure>
    <time_frame>Measured before and after the 6 month intervention</time_frame>
    <description>International Physical Activity Questionnaire (Short Version) provides separate scores on walking, moderate-intensity, and vigorous-intensity activity. Total scores are calculated by summing the duration (in minutes) and frequency (days) of walking, moderate-intensity, and vigorous-intensity activities. High scores indicate better levels of physical activity.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Blood Pressure</condition>
  <condition>Body Weight</condition>
  <arm_group>
    <arm_group_label>Intervention Communities</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Packed Promise for a Healthy Heart intervention, free Tribal Wellness Center membership, a Fitbit, and the AYA culturally based mobile walking app.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Communities</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Free Tribal Wellness Center membership, Fitbit, and the AYA culturally based mobile walking app</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Packed Promise for a Healthy Heart</intervention_name>
    <description>Voucher for fresh vegetables and fruits (referred to as a &quot;fresh check&quot;); Home delivered food boxes that contain Dietary Approaches to Stop Hypertension (DASH)-approved ingredients for preparing low-salt, and traditional healthy Chickasaw meals; Heart-healthy recipes (available at getfreshcooking.com) that are tailored to traditional Chickasaw diet and culture; Educational materials; Personalized invitation to attend local cooking demonstrations; Assistance to link the Fitbit and AYA app</description>
    <arm_group_label>Intervention Communities</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥18 years old&#xD;
&#xD;
          -  Self-identify as American Indian/Alaska Native&#xD;
&#xD;
          -  Currently reside in the four communities and do not plan on moving for 12 months&#xD;
&#xD;
          -  Not currently pregnant, or ≥ 6 weeks postpartum&#xD;
&#xD;
          -  Ability to understand written and spoken English&#xD;
&#xD;
          -  Ability and willingness to follow study protocols&#xD;
&#xD;
          -  Self-reported previous diagnosis of hypertension by a medical professional and a&#xD;
             measured systolic BP ≥ 130 mm Hg at time of enrollment or no previous hypertension&#xD;
             diagnosis and a measured systolic BP ≥ 130 mm Hg at both the initial screening and&#xD;
             prior to finalizing enrollment (i.e. on two separate days)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Anyone not meeting the aforementioned inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Valarie BB Jernigan, DrPH, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oklahoma State University Center for Health Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joy Standridge, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Chickasaw Nation</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cassandra D Camp, MPH</last_name>
    <phone>918-561-1576</phone>
    <email>cdcamp@okstate.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Charlotte Love, MPH</last_name>
    <phone>918-978-5957</phone>
    <email>charlie.love@okstate.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Chickasaw Nation</name>
      <address>
        <city>Ada</city>
        <state>Oklahoma</state>
        <zip>74820</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joy Standridge, MPH</last_name>
      <phone>580-310-6463</phone>
      <email>Joy.Standridge@Chickasaw.Net</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>June 29, 2020</last_update_submitted>
  <last_update_submitted_qc>June 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hypertension</keyword>
  <keyword>Blood Pressure</keyword>
  <keyword>DASH-Diet</keyword>
  <keyword>BMI</keyword>
  <keyword>American Indian</keyword>
  <keyword>Food Environment</keyword>
  <keyword>CBPR</keyword>
  <keyword>CHEERS</keyword>
  <keyword>Native American</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Weight</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/NCT03774277
org study id: 7614
nct id: NCT03774277
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study, the Chickasaw Healthy Eating Environments Research Study (CHEERS), will be
      conducted in partnership with Chickasaw Nation. CHEERS comprises several mutually reinforcing
      strategies to improve blood pressure (BP) control in people with hypertension. Environmental
      strategies include the investigator's innovative "Packed Promise for a Healthy Heart" program
      that provides hypertensive adults ages 18 and older with a voucher for fresh vegetables and
      fruits (referred to as a "fresh check") and home delivered food boxes that contain Dietary
      Approaches to Stop Hypertension (DASH)-approved ingredients for preparing low-salt, and
      traditional healthy Chickasaw meals. The study facilitates demonstrations of healthy cooking
      practices in participating communities. At the individual level, tribal members with
      uncontrolled hypertension will receive heart-healthy recipes (available at
      getfreshcooking.com) that are tailored to traditional Chickasaw diet and culture, educational
      materials, along with invitations to attend cooking demonstrations, fresh checks to improve
      access to fresh produce, and a Chickasaw Nation culturally-informed smartphone walking app
      called "AYA." At the policy level, CHEERS will culminate in a multimedia documentary
      presentation for tribal leadership detailing the intervention and featuring personal success
      stories by hypertensive community members. Study findings, including a health economics
      assessment, will be used to encourage policies for further expansion of the Packed Promise
      for a Healthy Heart Program; and policies promoting expansion of brick and mortar grocery
      outlets in rural Chickasaw communities.
This study is guided by the principles of community-based participatory research (CBPR).

      Aims and Methods: Co-led by an AI (Choctaw) Investigator, the study will:

      Aim #1: Evaluate CHEERS' ability to improve healthy food access by collecting quantitative
      data on changes in perceived ability to purchase and prepare healthy food, and by using
      qualitative methods to evaluate the reach, saturation, and acceptability of the CHEERS
      intervention.

      Aim #2: Measure the intervention's effect on change in BP and secondary outcomes among
      hypertensive community members with poorly controlled hypertension.

      Aim #3:Disseminate a multimedia documentary of the study's findings and evaluate the
      documentary's effect on tribal leaders across the Chickasaw Nation and other tribal
      communities.

      Innovation: This study will evaluate the effects of a multilevel, tribally-run, food
      environment intervention. The study will also be one of the few food environment
      interventions ever implemented in an AI community, and the first to objectively measure its
      effects on BP and BMI.

      Significance and Impact: Study findings, including a health economics assessment, will be
      used to encourage policies for further expansion of the Packed Promise for a Healthy Heart
      Program; and policies promoting expansion of brick and mortar grocery outlets in rural
      Chickasaw communities.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in systolic blood pressure
time frame: Measured before and after the 6 month intervention
description: Targeted 2.9 mm Hg decrease in systolic blood pressure
measure: Change in body mass index
time frame: Measured before and after the 6 month intervention
measure: Food access
time frame: Measured before and after the 6 month intervention
description: USDA Household Food Security Scale (6 Item Short Module) - The sum of affirmative responses provides a household raw score. Food security status of households with raw scores of 0-1 are high or marginally food secure, raw scores of 2-4 are low secure, and raw scores of 5-6 are very low food secure. High raw scores indicate food insecure households.
measure: Diet
time frame: Measured before and after the 6 month intervention
description: ASA24, a self-administered recall system (https://asa24.nci.nih.gov/)
measure: Walking
time frame: Measured during 6 month intervention
description: Fitbit dashboard
measure: Change in self-reported physical activity
time frame: Measured before and after the 6 month intervention
description: International Physical Activity Questionnaire (Short Version) provides separate scores on walking, moderate-intensity, and vigorous-intensity activity. Total scores are calculated by summing the duration (in minutes) and frequency (days) of walking, moderate-intensity, and vigorous-intensity activities. High scores indicate better levels of physical activity.
arm group label: Intervention Communities
arm group type: Experimental
description: Packed Promise for a Healthy Heart intervention, free Tribal Wellness Center membership, a Fitbit, and the AYA culturally based mobile walking app.
arm group label: Control Communities
arm group type: No Intervention
description: Free Tribal Wellness Center membership, Fitbit, and the AYA culturally based mobile walking app
intervention type: Behavioral
intervention name: Packed Promise for a Healthy Heart
description: Voucher for fresh vegetables and fruits (referred to as a "fresh check"); Home delivered food boxes that contain Dietary Approaches to Stop Hypertension (DASH)-approved ingredients for preparing low-salt, and traditional healthy Chickasaw meals; Heart-healthy recipes (available at getfreshcooking.com) that are tailored to traditional Chickasaw diet and culture; Educational materials; Personalized invitation to attend local cooking demonstrations; Assistance to link the Fitbit and AYA app
arm group label: Intervention Communities
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Valarie BB Jernigan, DrPH, MPH
role: Principal Investigator
affiliation: Oklahoma State University Center for Health Sciences
last name: Joy Standridge, MPH
role: Principal Investigator
affiliation: The Chickasaw Nation
last name: Cassandra D Camp, MPH
phone: 918-561-1576
email: cdcamp@okstate.edu
last name: Charlotte Love, MPH
phone: 918-978-5957
email: charlie.love@okstate.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Body Weight
sharing ipd: No