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/NCT06034548</url>
    </required_header>
    <id_info>
      <org_study_id>1607202245</org_study_id>
      <nct_id>NCT06034548</nct_id>
    </id_info>
    <brief_title>Diabetes and Hypertension Self Management Program</brief_title>
    <official_title>Diabetes and Hypertension Self Management Program</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>West Virginia University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>West Virginia University</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>
        The purpose of this R15 project is to test the feasibility and effectiveness of a 12-week&#xD;
        diabetes and hypertension self-management program using trained health coaches.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        West Virginia has high prevalence of comorbid diabetes and hypertension. Most diabetes&#xD;
        self-management programs are hospital or clinic based and none are tailored to address the&#xD;
        unique needs of rural WV adults with comorbid diabetes (T2DM) and hypertension (HTN). There&#xD;
        is a critical need for new and creative community-based, culturally appropriate&#xD;
        self-management programs in this medically underserved state. This study will use a&#xD;
        wait-listed randomized control trial (RCT) design, using evidence-based interventions, to&#xD;
        improve patient self-management behaviors and health outcomes (HbA1c and BP). Eligible adults&#xD;
        with comorbid T2DM and HTN will be randomized with a 1:1 ratio to the immediate diabetes and&#xD;
        hypertension self-management program (DHSMP; n=35) or to 6-month wait-listed control group&#xD;
        (N=35), based on an allocation sequence generated by the biostatistician using a randomly&#xD;
        varying block randomization method to ensure equal distribution among treatment groups.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 27, 2018</start_date>
    <completion_date type="Actual">August 12, 2020</completion_date>
    <primary_completion_date type="Actual">August 12, 2020</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>RCT with wait-listed control</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Clinical outcomes - A1c</measure>
      <time_frame>6 months after enrollment</time_frame>
      <description>The difference in A1c between baseline and end of program.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical outcomes - BP</measure>
      <time_frame>6 months after enrollment</time_frame>
      <description>The difference in BP between baseline and end of program.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Behavioral outcome - healthy eating plan; questions</measure>
      <time_frame>6 months after enrollment</time_frame>
      <description>Dietary analysis will be based on following a healthy eating plan at baseline and completion of the Program. All participants will be assessed regarding the number of days they followed a healthful eating plan using a survey question from the Summary of Diabetes Self-care activities measure by Toolbert et al., Diabetes Care, 2000. &quot;How many of the last SEVEN DAYS have you followed a healthful eating plan?&quot; 0 1 2 3 4 5 6 7. Changes in mean number of days followed a healthy eating plan will be assessed at baseline and at the completion of the program.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Behavioral outcome - exercise; questions</measure>
      <time_frame>6 months after enrollment</time_frame>
      <description>All participants will be assessed regarding the number of days they exercise using two survey questions from the Summary of Diabetes Self-care activities measure by Toolbert et al., Diabetes Care, 2000. The description of the questions are as follow: Q1. &quot;On how many of the last SEVEN DAYS did you participate in at least 30 minutes of physical activity? (please list the total minutes of continuous activity, including walking)&quot; 0 1 2 3 4 5 6 7 &amp; Q2. &quot;On how many of the last SEVEN DAYS did you participate in a specific exercise session (such as swimming, walking, biking) other than what you do around the house or as part of your work?&quot; 0 1 2 3 4 5 6 7). The total exercise score will be calculated by the mean number of days for the two questions). Changes in mean number of days exercised will be assessed at baseline and at the completion of the program.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">74</enrollment>
    <condition>Diabetes Mellitus, Type 2</condition>
    <condition>Hypertension</condition>
    <arm_group>
      <arm_group_label>diabetes and hypertension self-management</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>12-week lifestyle and disease self-management</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Wait-list control</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>diabetes and hypertension self-management</intervention_name>
      <description>12-weeks of 75 minutes of educational sessions</description>
      <arm_group_label>diabetes and hypertension self-management</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  English speaking adults &gt;= 18 years of age;&#xD;
  &#xD;
            -  co-occurring diagnosis of T2DM and HTN;&#xD;
  &#xD;
            -  body mass index &gt;= 25.0&#xD;
  &#xD;
            -  willing to be randomized and complete all assessments.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  currently pregnant or breastfeeding;&#xD;
  &#xD;
            -  diagnosed with a severe mental illness;&#xD;
  &#xD;
            -  have any condition that requires physical activity limitations or is contraindicated&#xD;
               for the Dietary Assessment to Stop Hypertension (DASH) diet;&#xD;
  &#xD;
            -  inability to complete the study protocol.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ranjita Misra, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>West Virginia University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>West Virginia University</name>
        <address>
          <city>Morgantown</city>
          <state>West Virginia</state>
          <zip>26508</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>April 18, 2018</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>West Virginia University</investigator_affiliation>
      <investigator_full_name>Ranjita Misra</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypertension</mesh_term>
      <mesh_term>Diabetes Mellitus</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT06034548
  org study id: 1607202245
  nct id: NCT06034548
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this R15 project is to test the feasibility and effectiveness of a 12-week
        diabetes and hypertension self-management program using trained health coaches.
  West Virginia has high prevalence of comorbid diabetes and hypertension. Most diabetes
        self-management programs are hospital or clinic based and none are tailored to address the
        unique needs of rural WV adults with comorbid diabetes (T2DM) and hypertension (HTN). There
        is a critical need for new and creative community-based, culturally appropriate
        self-management programs in this medically underserved state. This study will use a
        wait-listed randomized control trial (RCT) design, using evidence-based interventions, to
        improve patient self-management behaviors and health outcomes (HbA1c and BP). Eligible adults
        with comorbid T2DM and HTN will be randomized with a 1:1 ratio to the immediate diabetes and
        hypertension self-management program (DHSMP; n=35) or to 6-month wait-listed control group
        (N=35), based on an allocation sequence generated by the biostatistician using a randomly
        varying block randomization method to ensure equal distribution among treatment groups.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: RCT with wait-listed control
  primary purpose: Other
  masking: None (Open Label)
  measure: Clinical outcomes - A1c
  time frame: 6 months after enrollment
  description: The difference in A1c between baseline and end of program.
  measure: Clinical outcomes - BP
  time frame: 6 months after enrollment
  description: The difference in BP between baseline and end of program.
  measure: Behavioral outcome - healthy eating plan; questions
  time frame: 6 months after enrollment
  description: Dietary analysis will be based on following a healthy eating plan at baseline and completion of the Program. All participants will be assessed regarding the number of days they followed a healthful eating plan using a survey question from the Summary of Diabetes Self-care activities measure by Toolbert et al., Diabetes Care, 2000. "How many of the last SEVEN DAYS have you followed a healthful eating plan?" 0 1 2 3 4 5 6 7. Changes in mean number of days followed a healthy eating plan will be assessed at baseline and at the completion of the program.
  measure: Behavioral outcome - exercise; questions
  time frame: 6 months after enrollment
  description: All participants will be assessed regarding the number of days they exercise using two survey questions from the Summary of Diabetes Self-care activities measure by Toolbert et al., Diabetes Care, 2000. The description of the questions are as follow: Q1. "On how many of the last SEVEN DAYS did you participate in at least 30 minutes of physical activity? (please list the total minutes of continuous activity, including walking)" 0 1 2 3 4 5 6 7 & Q2. "On how many of the last SEVEN DAYS did you participate in a specific exercise session (such as swimming, walking, biking) other than what you do around the house or as part of your work?" 0 1 2 3 4 5 6 7). The total exercise score will be calculated by the mean number of days for the two questions). Changes in mean number of days exercised will be assessed at baseline and at the completion of the program.
  arm group label: diabetes and hypertension self-management
  arm group type: Experimental
  description: 12-week lifestyle and disease self-management
  arm group label: Control
  arm group type: No Intervention
  description: Wait-list control
  intervention type: Behavioral
  intervention name: diabetes and hypertension self-management
  description: 12-weeks of 75 minutes of educational sessions
  arm group label: diabetes and hypertension self-management
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: Ranjita Misra, PhD
  role: Principal Investigator
  affiliation: West Virginia University
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: West Virginia University
  investigator full name: Ranjita Misra
  investigator title: Principal Investigator
  mesh term: Hypertension
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2
  sharing ipd: No