<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/NCT03284112</url>
  </required_header>
  <id_info>
    <org_study_id>AAAR5473</org_study_id>
    <nct_id>NCT03284112</nct_id>
  </id_info>
  <brief_title>Old SCHOOL Hip-Hop: Improve Alzheimer's Disease Knowledge</brief_title>
  <official_title>Old SCHOOL Hip-Hop: A Randomized Controlled Trial to Improve Alzheimer's Disease Knowledge</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Columbia 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 research study is to evaluate the knowledge of parents and children with&#xD;
      respect to dementia symptoms, risk factors, and response before and after an interactive&#xD;
      dementia education program that uses music and dance to enhance a health education curriculum&#xD;
      at 1-week and 3-months after the intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Public awareness of Cardinal Alzheimer's disease (AD) symptoms remains low. Adults often&#xD;
      underestimate personal dementia risk; minority populations are more likely to have low&#xD;
      dementia literacy and be unaware of it. Cultural dementia belief in minority groups are&#xD;
      complex and pose barriers to diagnosis, with dementia symptoms being considered a part of&#xD;
      normal aging, or that discussion may be taboo even when recognized. A key barrier to timely&#xD;
      AD diagnosis in African Americans is delayed physician contact, often years-long, following&#xD;
      the onset of first symptoms. Despite studies demonstrating that dementia concepts first&#xD;
      develop in elementary school periods, apart from our work, no dementia awareness programs&#xD;
      focus on children. This intervention therefore addresses a major gap regarding optimal&#xD;
      approaches for shifting cultural perceptions of dementia in low-income minority populations&#xD;
      and reducing barriers to its timely diagnosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 18, 2018</start_date>
  <completion_date type="Anticipated">July 2023</completion_date>
  <primary_completion_date type="Anticipated">July 2023</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Dementia Symptom and Response Knowledge Assessment Score</measure>
    <time_frame>Baseline, 1 week, 3 months</time_frame>
    <description>An instrument with multiple choice questions to assess knowledge of recognition of 6 key signs/symptoms and ability to formulate the correct action plan in response to recognizing dementia.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">6000</enrollment>
  <condition>Dementia</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>School population without the Old SCHOOL Hip-Hop program, but with the My Plate program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>School population with the Old SCHOOL Hip-Hop program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Old SCHOOL Hip-Hop</intervention_name>
    <description>A school-based intervention called &quot;Old S.C.H.O.O.L. Hip-Hop&quot; (OSHH) or Seniors Can Have Optimal aging and Ongoing Longevity, to educate 4th and 5th grade students (ages 9-11y) about key dementia signs and symptoms, basic pathophysiology of Alzheimer disease, and the importance of early recognition, care-seeking behavior, and preventative measures (lifelong healthy lifestyle decisions). The intervention is delivered in a classroom or school auditorium setting, using an innovative, modular, multimedia program and home-based activities, to increase parental and family dementia literacy.</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>OSHH Program</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>My Plate</intervention_name>
    <description>The program selected for the control arm, &quot;My Plate,&quot; will address nutrition, physical activity, and obesity education. This program was selected because nutrition, physical activity, and wellness programs are now being incorporated into New York City public school curriculums as part of a legislative directive. Trained facilitators will conduct &quot;My Plate&quot; as an entry point for the USDA's My Plate nutrition program. Students will learn about My Plate across the 3-day one-hour-a-day program.</description>
    <arm_group_label>Control</arm_group_label>
    <other_name>My Plate nutrition program</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  4th and 5th-grade children (ages 9-11y) and their parents (age &gt; 20 years).&#xD;
&#xD;
          -  Selected New York City public schools with similar socio-demographic composition.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Schools have already received pilot OSHH and the U.S. Department of Health and Human&#xD;
             Services (HHS) programming.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James Noble, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant Professor of Neurology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>James Noble, MD</last_name>
    <phone>212-342-4126</phone>
    <email>jn2054@columbia.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>James Noble, MD</last_name>
      <phone>212-342-4126</phone>
      <email>jn2054@columbia.edu</email>
    </contact>
    <investigator>
      <last_name>James Noble, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>July 18, 2022</last_update_submitted>
  <last_update_submitted_qc>July 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>James M Noble, MD, MS, CPH, FAAN</investigator_full_name>
    <investigator_title>Assistant Professor of Neurology (in the Taub Institute and the Sergievsky Center) at the Columbia University Medical Center, Dept Neur Aging &amp; Dementia</investigator_title>
  </responsible_party>
  <keyword>Dementia, Schools, Nutrition, Health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Dementia</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/NCT03284112
org study id: AAAR5473
nct id: NCT03284112
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this research study is to evaluate the knowledge of parents and children with
      respect to dementia symptoms, risk factors, and response before and after an interactive
      dementia education program that uses music and dance to enhance a health education curriculum
      at 1-week and 3-months after the intervention.
Public awareness of Cardinal Alzheimer's disease (AD) symptoms remains low. Adults often
      underestimate personal dementia risk; minority populations are more likely to have low
      dementia literacy and be unaware of it. Cultural dementia belief in minority groups are
      complex and pose barriers to diagnosis, with dementia symptoms being considered a part of
      normal aging, or that discussion may be taboo even when recognized. A key barrier to timely
      AD diagnosis in African Americans is delayed physician contact, often years-long, following
      the onset of first symptoms. Despite studies demonstrating that dementia concepts first
      develop in elementary school periods, apart from our work, no dementia awareness programs
      focus on children. This intervention therefore addresses a major gap regarding optimal
      approaches for shifting cultural perceptions of dementia in low-income minority populations
      and reducing barriers to its timely diagnosis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in Dementia Symptom and Response Knowledge Assessment Score
time frame: Baseline, 1 week, 3 months
description: An instrument with multiple choice questions to assess knowledge of recognition of 6 key signs/symptoms and ability to formulate the correct action plan in response to recognizing dementia.
arm group label: Control
arm group type: Placebo Comparator
description: School population without the Old SCHOOL Hip-Hop program, but with the My Plate program.
arm group label: Intervention
arm group type: Experimental
description: School population with the Old SCHOOL Hip-Hop program.
intervention type: Behavioral
intervention name: Old SCHOOL Hip-Hop
description: A school-based intervention called "Old S.C.H.O.O.L. Hip-Hop" (OSHH) or Seniors Can Have Optimal aging and Ongoing Longevity, to educate 4th and 5th grade students (ages 9-11y) about key dementia signs and symptoms, basic pathophysiology of Alzheimer disease, and the importance of early recognition, care-seeking behavior, and preventative measures (lifelong healthy lifestyle decisions). The intervention is delivered in a classroom or school auditorium setting, using an innovative, modular, multimedia program and home-based activities, to increase parental and family dementia literacy.
arm group label: Intervention
other name: OSHH Program
intervention type: Behavioral
intervention name: My Plate
description: The program selected for the control arm, "My Plate," will address nutrition, physical activity, and obesity education. This program was selected because nutrition, physical activity, and wellness programs are now being incorporated into New York City public school curriculums as part of a legislative directive. Trained facilitators will conduct "My Plate" as an entry point for the USDA's My Plate nutrition program. Students will learn about My Plate across the 3-day one-hour-a-day program.
arm group label: Control
other name: My Plate nutrition program
criteria: 
gender: All
minimum age: 9 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: James Noble, MD
role: Principal Investigator
affiliation: Assistant Professor of Neurology
last name: James Noble, MD
phone: 212-342-4126
email: jn2054@columbia.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: James M Noble, MD, MS, CPH, FAAN
investigator title: Assistant Professor of Neurology (in the Taub Institute and the Sergievsky Center) at the Columbia University Medical Center, Dept Neur Aging & Dementia
mesh term: Alzheimer Disease
mesh term: Dementia
sharing ipd: No