xml: <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/NCT06029517</url>
    </required_header>
    <id_info>
      <org_study_id>I 810620</org_study_id>
      <secondary_id>R56NR019498</secondary_id>
      <nct_id>NCT06029517</nct_id>
    </id_info>
    <brief_title>A Sugar-Sweetened Beverage Reduction Intervention for Native American Men</brief_title>
    <official_title>A Novel Sugar-Sweetened Beverage Reduction Intervention for Native American Men</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Roswell Park Cancer Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Nursing Research (NINR)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Roswell Park Cancer Institute</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This clinical trial develops and tests a culturally-appropriate educational program&#xD;
        (Indigenous SIPin) for reducing sugar-sweetened beverage consumption in men affiliated with&#xD;
        Native American athletics communities. Sugary drinks are drinks like pop, soda, and juice.&#xD;
        Increased sugar consumption may lead to an increased risk of chronic diseases, including&#xD;
        obesity, diabetes, some types of obesity-related cancers, coronary heart disease,&#xD;
        hypertension, and dental decay. A culturally sensitive program may help reduce&#xD;
        sugar-sweetened beverage consumption in Native American men&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        PRIMARY OBJECTIVE:&#xD;
  &#xD;
        I. Conduct and analyze qualitative data from focus groups and key informant interviews with&#xD;
        Native American community members including Native American leaders and community members to&#xD;
        develop Sugar Sweetened Beverage (SSB) intervention for Native American men (SIPsmartER&#xD;
        Lacrosse).&#xD;
  &#xD;
        OUTLINE:&#xD;
  &#xD;
        AIM 1: Participants complete interviews over 60 minutes and attend focus groups over 90&#xD;
        minutes in support of intervention adaptation and refinement.&#xD;
  &#xD;
        AIM 2: Participants receive the Indigenous SIPin intervention over 6 months, which includes&#xD;
        in-person and/or virtual educational sessions weekly over 30 minutes for 12 weeks and text&#xD;
        message communications twice a week (BIW) for 12 weeks and then monthly thereafter up to&#xD;
        month 6.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 8, 2021</start_date>
    <completion_date type="Anticipated">October 25, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 25, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in SSB intake for men affiliated with Native American athletic communities</measure>
      <time_frame>up to 6 months</time_frame>
      <description>Will conduct half hour classes with the Native American community members on how to improve wellness and drink less sugary drinks</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Sugar sweetened beverage intake</measure>
      <time_frame>Baseline to 6 months</time_frame>
      <description>change in consumption of sugar sweetened beverages</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in body weight</measure>
      <time_frame>baseline to 6 months</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Cardiovascular Disorder</condition>
    <condition>Coronary Artery Disease</condition>
    <condition>Diabetes Mellitus</condition>
    <condition>Obesity-Related Malignant Neoplasm</condition>
    <arm_group>
      <arm_group_label>Aim 1 - interview, focus group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Participants complete interviews over 60 minutes and attend focus groups over 90 minutes in support of intervention adaptation and refinement</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Aim 2 - Indigenous SIPin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants receive the Indigenous SIPin intervention over 6 months, which includes in-person and/or virtual educational sessions weekly over 30 minutes for 12 weeks and text message communications BIW for 12 weeks and then monthly thereafter up to month 6.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Education Intervention</intervention_name>
      <description>Receive Indigneous SIPin intervention</description>
      <arm_group_label>Aim 2 - Indigenous SIPin</arm_group_label>
      <other_name>Education for Intervention</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Interview</intervention_name>
      <description>Complete interviews</description>
      <arm_group_label>Aim 1 - interview, focus group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Discussion</intervention_name>
      <description>Attend focus groups</description>
      <arm_group_label>Aim 1 - interview, focus group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  At least 18 years or older&#xD;
  &#xD;
            -  Research conducted on tribal lands require tribal government approval. Our project&#xD;
               will not be occurring on tribal lands. The project will be working with Native&#xD;
               organizations off-territory&#xD;
  &#xD;
            -  Participants only must own a smart device in order to receive study text messages&#xD;
  &#xD;
            -  At least 18 years or older&#xD;
  &#xD;
            -  Research conducted on tribal lands require tribal government approval. Our project&#xD;
               will not be occurring on tribal lands. The project will be working with Native&#xD;
               organizations off-territory&#xD;
  &#xD;
            -  Participants only must own a smart device in order to receive study text messages&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Research conducted on tribal lands require tribal government approval. Since we do not&#xD;
               currently have tribal government approval, our project will not be occurring on tribal&#xD;
               lands&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rodney Haring</last_name>
      <role>Principal Investigator</role>
      <affiliation>Roswell Park</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Rodney Haring</last_name>
      <phone>719-845-4920</phone>
      <email>Rodney.Haring@roswellpark.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Roswell Park Comprehensive Cancer Center</name>
        <address>
          <city>Buffalo</city>
          <state>New York</state>
          <zip>14263</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rodney Haring</last_name>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
      <mesh_term>Coronary Artery Disease</mesh_term>
      <mesh_term>Cardiovascular Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06029517
  org study id: I 810620
  secondary id: R56NR019498
  nct id: NCT06029517
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This clinical trial develops and tests a culturally-appropriate educational program
        (Indigenous SIPin) for reducing sugar-sweetened beverage consumption in men affiliated with
        Native American athletics communities. Sugary drinks are drinks like pop, soda, and juice.
        Increased sugar consumption may lead to an increased risk of chronic diseases, including
        obesity, diabetes, some types of obesity-related cancers, coronary heart disease,
        hypertension, and dental decay. A culturally sensitive program may help reduce
        sugar-sweetened beverage consumption in Native American men
  PRIMARY OBJECTIVE:
  
        I. Conduct and analyze qualitative data from focus groups and key informant interviews with
        Native American community members including Native American leaders and community members to
        develop Sugar Sweetened Beverage (SSB) intervention for Native American men (SIPsmartER
        Lacrosse).
  
        OUTLINE:
  
        AIM 1: Participants complete interviews over 60 minutes and attend focus groups over 90
        minutes in support of intervention adaptation and refinement.
  
        AIM 2: Participants receive the Indigenous SIPin intervention over 6 months, which includes
        in-person and/or virtual educational sessions weekly over 30 minutes for 12 weeks and text
        message communications twice a week (BIW) for 12 weeks and then monthly thereafter up to
        month 6.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Change in SSB intake for men affiliated with Native American athletic communities
  time frame: up to 6 months
  description: Will conduct half hour classes with the Native American community members on how to improve wellness and drink less sugary drinks
  measure: Sugar sweetened beverage intake
  time frame: Baseline to 6 months
  description: change in consumption of sugar sweetened beverages
  measure: Change in body weight
  time frame: baseline to 6 months
  arm group label: Aim 1 - interview, focus group
  arm group type: Other
  description: Participants complete interviews over 60 minutes and attend focus groups over 90 minutes in support of intervention adaptation and refinement
  arm group label: Aim 2 - Indigenous SIPin
  arm group type: Experimental
  description: Participants receive the Indigenous SIPin intervention over 6 months, which includes in-person and/or virtual educational sessions weekly over 30 minutes for 12 weeks and text message communications BIW for 12 weeks and then monthly thereafter up to month 6.
  intervention type: Other
  intervention name: Education Intervention
  description: Receive Indigneous SIPin intervention
  arm group label: Aim 2 - Indigenous SIPin
  other name: Education for Intervention
  intervention type: Other
  intervention name: Interview
  description: Complete interviews
  arm group label: Aim 1 - interview, focus group
  intervention type: Procedure
  intervention name: Discussion
  description: Attend focus groups
  arm group label: Aim 1 - interview, focus group
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Rodney Haring
  role: Principal Investigator
  affiliation: Roswell Park
  last name: Rodney Haring
  phone: 719-845-4920
  email: Rodney.Haring@roswellpark.org
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Neoplasms
  mesh term: Coronary Artery Disease
  mesh term: Cardiovascular Diseases
  sharing ipd: Undecided