<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/NCT04427982</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00065214</org_study_id>
    <nct_id>NCT04427982</nct_id>
  </id_info>
  <brief_title>Dance and Diabetes/Prediabetes Self-Management</brief_title>
  <official_title>Dance as an Intervention to Improve Diabetes and Prediabetes Self-Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University 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>
      The Dance for Diabetes program was designed as a community service project for the North&#xD;
      Carolina Albert Schweitzer Fellowship. The purpose of this research is to evaluate the&#xD;
      effectiveness of the project and its impact on participants. This study will assess whether a&#xD;
      group dance workshop along with diabetes education can help people with diabetes and&#xD;
      prediabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a pilot study that will be testing whether or not a group dance workshop is useful&#xD;
      and effective. If it is, the study team will refine the workshop model and do additional&#xD;
      dance classes in the future. This research study will involve attending a dance workshop once&#xD;
      a week for 2 months using an online, video-conferencing computer application. Participants&#xD;
      will also receive information about exercise and how to manage their diabetes. Participants&#xD;
      will receive a phone call every week during the 2 months to assess their experience. Study&#xD;
      participants will also be asked to complete surveys at the beginning and end of the 2-month&#xD;
      session, as well as 1 month and 2 months after the classes end.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 3, 2020</start_date>
  <completion_date type="Actual">May 3, 2021</completion_date>
  <primary_completion_date type="Actual">May 3, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>All participants receive the dance and education interventions.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>National Health and Nutrition Examination Survey Physical Activity and Physical Fitness Questionnaire (NHANES 2019-2020 PAQ)--Activity Confirmation</measure>
    <time_frame>baseline</time_frame>
    <description>Percentage of subjects who confirm that they are physically active in questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NHANES 2019-2020 PAQ--Days Active</measure>
    <time_frame>baseline</time_frame>
    <description>Average number of days subjects report being active</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NHANES 2019-2020 PAQ--minutes active</measure>
    <time_frame>baseline</time_frame>
    <description>Average number of minutes (10-60) per day that participants engage in activity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NHANES 2019-2020 PAQ--Activity Confirmation</measure>
    <time_frame>4 weeks post intervention completion</time_frame>
    <description>Percentage of subjects who confirm that they are physically active in questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NHANES 2019-2020 PAQ--Days Active</measure>
    <time_frame>4 weeks post intervention completion</time_frame>
    <description>Average number of days subjects report being active</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NHANES 2019-2020 PAQ--minutes active</measure>
    <time_frame>4 weeks post intervention completion</time_frame>
    <description>Average number of minutes (10-60) per day that participants engage in activity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NHANES 2019-2020 PAQ--Activity Confirmation</measure>
    <time_frame>8 weeks post baseline</time_frame>
    <description>Percentage of subjects who confirm that they are physically active in questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NHANES 2019-2020 PAQ--Days Active</measure>
    <time_frame>8 weeks post baseline</time_frame>
    <description>Average number of days subjects report being active</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NHANES 2019-2020 PAQ--minutes active</measure>
    <time_frame>8 weeks post baseline</time_frame>
    <description>Average number of minutes (10-60) per day that participants engage in activity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NHANES 2019-2020 PAQ--Activity Confirmation</measure>
    <time_frame>8 weeks post intervention completion</time_frame>
    <description>Percentage of subjects who confirm that they are physically active in questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NHANES 2019-2020 PAQ--Days Active</measure>
    <time_frame>8 weeks post intervention completion</time_frame>
    <description>Average number of days subjects report being active</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NHANES 2019-2020 PAQ--minutes active</measure>
    <time_frame>8 weeks post intervention completion</time_frame>
    <description>Average number of minutes (10-60) per day that participants engage in activity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diabetes Empowerment Scale (DES) score</measure>
    <time_frame>baseline</time_frame>
    <description>Score ranges from 1 to 5, with 1 denoting a worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DES Score</measure>
    <time_frame>4 weeks post intervention completion</time_frame>
    <description>This questionnaire is given to determine if there were any changes in participants' activity level 4 weeks post intervention. Score ranges from 1 to 5, with 1 denoting a worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DES score</measure>
    <time_frame>8 weeks post baseline</time_frame>
    <description>This questionnaire is given 8 weeks post baseline in order to determine any improvements made during the intervention. Score ranges from 1 to 5, with 1 denoting a worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DES Score</measure>
    <time_frame>8 weeks post intervention completion</time_frame>
    <description>This questionnaire is given to determine if there were any changes in participants' activity level 8 weeks post intervention. Score ranges from 1 to 5, with 1 denoting a worse outcome.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Weight</measure>
    <time_frame>8 weeks post intervention completion</time_frame>
    <description>measured in kilograms</description>
  </other_outcome>
  <other_outcome>
    <measure>Body Mass Index (BMI)</measure>
    <time_frame>8 weeks post intervention completion</time_frame>
    <description>Weight in kilograms divided by the square of height in meters. A high BMI can be an indicator of high body fatness.</description>
  </other_outcome>
  <other_outcome>
    <measure>Glycated Hemoglobin (A1c)</measure>
    <time_frame>8 weeks post intervention completion</time_frame>
    <description>The A1c test is a blood test that provides information about average levels of blood glucose over the past 3 months. The A1c test can be used to diagnose type 2 diabetes and prediabetes. The A1c test result is reported as a percentage. The higher the percentage, the higher the blood glucose levels have been. A normal A1c level is below 5.7 percent</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Diabetes</condition>
  <condition>Pre Diabetes</condition>
  <arm_group>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will attend a 2-month weekly light-to-moderate intensity dance workshop followed by a brief diabetes education and discussion session.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>dance</intervention_name>
    <description>Participants will attend a 2-month weekly light-to-moderate intensity dance workshop.</description>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>diabetes education</intervention_name>
    <description>The dance classes will be followed by a brief diabetes education and discussion session.</description>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adults proficient in English with diabetes or prediabetes&#xD;
&#xD;
          -  subjects who have an established healthcare provider&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known cardiovascular disease (acute coronary syndrome, stable or unstable angina,&#xD;
             coronary or other arterial revascularization, stroke, transient ischemic attack, and&#xD;
             peripheral arterial disease) for the last 6 months&#xD;
&#xD;
          -  unwilling or unable to partake in light to moderate level of dance physical activity&#xD;
             for 1 hour because of physical impairment (e.g. wheelchair, amputation)&#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>Julienne Kirk, PharmD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wake Forest Baptist Health</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>October 26, 2021</last_update_submitted>
  <last_update_submitted_qc>October 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>dance</keyword>
  <keyword>reduce blood sugar</keyword>
  <keyword>prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Prediabetic State</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All of the individual participant data collected during the trial will be available after deidentification.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>All data will be available immediately following publication without end date.</ipd_time_frame>
    <ipd_access_criteria>Information will be available to anyone who wishes to access the data for any purpose.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 19, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT04427982/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04427982
org study id: IRB00065214
nct id: NCT04427982
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Dance for Diabetes program was designed as a community service project for the North
      Carolina Albert Schweitzer Fellowship. The purpose of this research is to evaluate the
      effectiveness of the project and its impact on participants. This study will assess whether a
      group dance workshop along with diabetes education can help people with diabetes and
      prediabetes.
This is a pilot study that will be testing whether or not a group dance workshop is useful
      and effective. If it is, the study team will refine the workshop model and do additional
      dance classes in the future. This research study will involve attending a dance workshop once
      a week for 2 months using an online, video-conferencing computer application. Participants
      will also receive information about exercise and how to manage their diabetes. Participants
      will receive a phone call every week during the 2 months to assess their experience. Study
      participants will also be asked to complete surveys at the beginning and end of the 2-month
      session, as well as 1 month and 2 months after the classes end.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: All participants receive the dance and education interventions.
primary purpose: Supportive Care
masking: None (Open Label)
measure: National Health and Nutrition Examination Survey Physical Activity and Physical Fitness Questionnaire (NHANES 2019-2020 PAQ)--Activity Confirmation
time frame: baseline
description: Percentage of subjects who confirm that they are physically active in questionnaire
measure: NHANES 2019-2020 PAQ--Days Active
time frame: baseline
description: Average number of days subjects report being active
measure: NHANES 2019-2020 PAQ--minutes active
time frame: baseline
description: Average number of minutes (10-60) per day that participants engage in activity
measure: NHANES 2019-2020 PAQ--Activity Confirmation
time frame: 4 weeks post intervention completion
description: Percentage of subjects who confirm that they are physically active in questionnaire
measure: NHANES 2019-2020 PAQ--Days Active
time frame: 4 weeks post intervention completion
description: Average number of days subjects report being active
measure: NHANES 2019-2020 PAQ--minutes active
time frame: 4 weeks post intervention completion
description: Average number of minutes (10-60) per day that participants engage in activity
measure: NHANES 2019-2020 PAQ--Activity Confirmation
time frame: 8 weeks post baseline
description: Percentage of subjects who confirm that they are physically active in questionnaire
measure: NHANES 2019-2020 PAQ--Days Active
time frame: 8 weeks post baseline
description: Average number of days subjects report being active
measure: NHANES 2019-2020 PAQ--minutes active
time frame: 8 weeks post baseline
description: Average number of minutes (10-60) per day that participants engage in activity
measure: NHANES 2019-2020 PAQ--Activity Confirmation
time frame: 8 weeks post intervention completion
description: Percentage of subjects who confirm that they are physically active in questionnaire
measure: NHANES 2019-2020 PAQ--Days Active
time frame: 8 weeks post intervention completion
description: Average number of days subjects report being active
measure: NHANES 2019-2020 PAQ--minutes active
time frame: 8 weeks post intervention completion
description: Average number of minutes (10-60) per day that participants engage in activity
measure: Diabetes Empowerment Scale (DES) score
time frame: baseline
description: Score ranges from 1 to 5, with 1 denoting a worse outcome.
measure: DES Score
time frame: 4 weeks post intervention completion
description: This questionnaire is given to determine if there were any changes in participants' activity level 4 weeks post intervention. Score ranges from 1 to 5, with 1 denoting a worse outcome.
measure: DES score
time frame: 8 weeks post baseline
description: This questionnaire is given 8 weeks post baseline in order to determine any improvements made during the intervention. Score ranges from 1 to 5, with 1 denoting a worse outcome.
measure: DES Score
time frame: 8 weeks post intervention completion
description: This questionnaire is given to determine if there were any changes in participants' activity level 8 weeks post intervention. Score ranges from 1 to 5, with 1 denoting a worse outcome.
measure: Weight
time frame: 8 weeks post intervention completion
description: measured in kilograms
measure: Body Mass Index (BMI)
time frame: 8 weeks post intervention completion
description: Weight in kilograms divided by the square of height in meters. A high BMI can be an indicator of high body fatness.
measure: Glycated Hemoglobin (A1c)
time frame: 8 weeks post intervention completion
description: The A1c test is a blood test that provides information about average levels of blood glucose over the past 3 months. The A1c test can be used to diagnose type 2 diabetes and prediabetes. The A1c test result is reported as a percentage. The higher the percentage, the higher the blood glucose levels have been. A normal A1c level is below 5.7 percent
arm group label: Experimental Group
arm group type: Experimental
description: All participants will attend a 2-month weekly light-to-moderate intensity dance workshop followed by a brief diabetes education and discussion session.
intervention type: Behavioral
intervention name: dance
description: Participants will attend a 2-month weekly light-to-moderate intensity dance workshop.
arm group label: Experimental Group
intervention type: Behavioral
intervention name: diabetes education
description: The dance classes will be followed by a brief diabetes education and discussion session.
arm group label: Experimental Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Julienne Kirk, PharmD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Prediabetic State
sharing ipd: Yes
ipd description: All of the individual participant data collected during the trial will be available after deidentification.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: All data will be available immediately following publication without end date.
ipd access criteria: Information will be available to anyone who wishes to access the data for any purpose.
provided document: 