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/NCT06038643</url>
    </required_header>
    <id_info>
      <org_study_id>IUSMD-20-38</org_study_id>
      <nct_id>NCT06038643</nct_id>
    </id_info>
    <brief_title>Intergenerational Behavioral Intervention to Enhance Physical Activity in Older Adults at Risk for Alzheimer's Disease</brief_title>
    <acronym>HABS</acronym>
    <official_title>The Healthy Aging Brain Study: A Remote Behavioral Intervention to Enhance Physical Activity in Older Adults.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Douglas Mental Health University Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Montreal Neurological Institute and Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>McGill University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Douglas Mental Health University 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 is a twelve-week pilot randomized controlled trial of a behavioral intervention in older&#xD;
        adults at risk for Alzheimer's disease. Older participants are a subgroup from the PREVENT-AD&#xD;
        longitudinal cohort. We will test whether a four-week intergenerational social motivation&#xD;
        using a technology-based platform (intervention group) enhances physical activity relative to&#xD;
        a control group. After a washout period, the two groups will be offered the opportunity to&#xD;
        cross-over into the alternate condition.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a two-arm, single site cross-over randomized controlled trial to test whether a&#xD;
        four-week technology-based intergenerational social motivation intervention enhances physical&#xD;
        activity in 60 cognitively normal older adults with a first-degree history of Alzheimer's&#xD;
        disease. These at-risk older adults will be recruited as a subgroup from a longitudinal&#xD;
        cohort at McGill University, PREVENT-AD. At the outset, half of the participants will be&#xD;
        randomized to the intergenerational social motivation condition (intervention group) and the&#xD;
        other half will be randomized to the control group (1:1). A multimodal AD risk score based on&#xD;
        older participants' already acquired AD biomarker, health and cognitive data will be used as&#xD;
        strata for randomization to ensure equal assignment of high-risk participants to Intervention&#xD;
        and control groups, using a permuted block method with random blocks. The primary measure of&#xD;
        interest is increased physical activity as measured by accelerometry (average minutes in&#xD;
        sedentary behavior/day, average steps per day, and average minutes in moderate-to-vigorous&#xD;
        physical activity/day). After an initial visit consisting of behavioral testing and&#xD;
        structural and functional MRI, participants in the Intervention Group will be paired with&#xD;
        younger adults (14 to 40 years) to form intergenerational dyads. Younger adults are either a&#xD;
        family member of the older adult or a younger adult recruited from the community.&#xD;
        Participants in the intervention group will receive personalized, positive daily messages&#xD;
        over a four-week period via their device using the 'Our Family Garden' technology platform.&#xD;
        These daily messages combine (1) pro-social goals (donation to charity after reaching&#xD;
        exercise goals), (2) intergenerational social engagement and (3) positive personalized&#xD;
        messages from their younger study partners. This study will have 6 visits over a 2-month&#xD;
        period in addition to the four-week intervention period (3 months total). Cognitive and&#xD;
        behavioral data will be collected at each visit and physical activity data will be collected&#xD;
        over the intervention period. All participants will be offered the opportunity to cross-over,&#xD;
        after a 6-week washout period, into the alternate condition in order to ensure access to the&#xD;
        intervention in all participants and longer-term follow up. The primary endpoint is defined&#xD;
        as the end of the initial period.&#xD;
  &#xD;
        Data collected are stored in one of three ways; (1) Physical activity monitoring data are&#xD;
        extracted from their respective software packages and uploaded directly to a secure data&#xD;
        storage environment at a high-performance computing facility. All pen-and-paper psychosocial&#xD;
        and neuropsychological assessments are scored and entered in REDCap. Computerized&#xD;
        psychosocial assessments are collected directly in REDCap and computerized neuropsychological&#xD;
        assessments are entered in REDCap. The oTree library is used to distribute the daily&#xD;
        intervention messages and collect survey data. This system runs on a Heroku server, a&#xD;
        cloud-based system that sends and receives hash-encrypted links. Collected anonymized data&#xD;
        are stored on the messaging site behind an administrative login on the Heroku server. All&#xD;
        data from RedCAP will be exported to CSV files using the data de-identification feature for&#xD;
        subsequent analysis with R and SPSS statistical analysis packages. After compiling all data&#xD;
        across the 3 different data servers, data will be checked for completeness and correctness&#xD;
        using frequency distributions (for missing data and out-of-range values). For the final&#xD;
        dataset, the multiple imputation by chained equations (MICE) will be used for imputing&#xD;
        missing values with 10 imputations.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 20, 2023</start_date>
    <completion_date type="Anticipated">May 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 20, 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>Crossover Assignment</intervention_model>
      <intervention_model_description>Intergenerational Social Motivation Behavioral Intervention using a Technology-based Platform&#xD;
  Our research will test an innovative, technology-based, and readily scalable cross-generational social behavior intervention to enhance physical activity in at-risk older adults within a cross-over randomized controlled trial to enhance physical activity.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Sedentary behavior (average min/day)</measure>
      <time_frame>Baseline; 4-week</time_frame>
      <description>This metric quantifies the change in the average amount of time spent sedentary each day, from the baseline period to the 4-week period. It is a marker of time spent inactive.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Total step count (average steps/day)</measure>
      <time_frame>Baseline; 4-week</time_frame>
      <description>This metric quantifies the change in the average number of steps taken each day, from the baseline period to the 4-week period. It is a marker of change in habitual ambulatory activity.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Moderate-vigorous activity (average min/day)</measure>
      <time_frame>Baseline; 4-week</time_frame>
      <description>This metric quantifies the change in the average amount of time spent engaged in moderate-vigorous physical activity each day, from the baseline period to the 4-week followup period. It is a marker of physical activity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>UCLA Loneliness Scale</measure>
      <time_frame>Baseline; 4-week</time_frame>
      <description>A questionnaire that measures perceived level of loneliness.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pittsburgh Sleep Quality Index</measure>
      <time_frame>Baseline; 4-week</time_frame>
      <description>A questionnaire measuring sleep quality.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Modified Differential Emotions Scale</measure>
      <time_frame>Baseline; 4-week</time_frame>
      <description>A questionnaire that assesses mood and feelings.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Test My Brain Digital Neuropsychology Toolkit</measure>
      <time_frame>Baseline; 4-week</time_frame>
      <description>This metric assessed cognitive status across multiple domains (e.g., memory, executive function, processing speed)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Barriers to Self-Efficacy Scale</measure>
      <time_frame>Baseline; 4-week</time_frame>
      <description>A questionnaire to assess physical activity confidence when faced with challenges (e.g., bad weather).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived Stress Scale (PSS)</measure>
      <time_frame>Baseline; 4-week</time_frame>
      <description>This common test assesses the perception of stress.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Physical Inactivity</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Social motivation intervention, self-transcendence daily messages, and daily accelerometry.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Active Control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Daily accelerometry.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Motivational behavioural intervention and daily activities monitoring</intervention_name>
      <description>Social motivation manipulation, self-transcendence daily messaging, and daily activities monitoring through accelerometry. Participants in this arm will have a study partner who receives daily feedback on the main participant's daily step count.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Active Control</intervention_name>
      <description>Daily activities monitored through accelerometry.</description>
      <arm_group_label>Active Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            -  Men and women &gt; 60 years&#xD;
  &#xD;
            -  Part of the PREVENT-AD Longitudinal Cohort at McGill&#xD;
  &#xD;
            -  No contraindications to MRI imaging&#xD;
  &#xD;
            -  Normal cognition&#xD;
  &#xD;
            -  Not exercising more than 150 minutes of moderate-intensity exercise per week or&#xD;
               sitting more than 8 hours per day&#xD;
  &#xD;
            -  Fluency in English or French&#xD;
  &#xD;
            -  Access to computer or smartphone with internet&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  Primary care physician does not approve additional physical activity&#xD;
  &#xD;
            -  An inability to ambulate without the assistance of another person or severe pain&#xD;
  &#xD;
            -  Any unstable medical condition&#xD;
  &#xD;
          Younger Adult Inclusion Criteria:&#xD;
  &#xD;
            -  Can be identified as child or grandchild of participant (biological or adopted), 14&#xD;
               years or older.&#xD;
  &#xD;
            -  Can be a young adult (18 years or older) who is not a relative of the main&#xD;
               participant, in case a grandchild or child is not available.&#xD;
  &#xD;
            -  Stable on antidepressants for more than 6 months.&#xD;
  &#xD;
            -  In contact with the primary participant more than once per 12 months at baseline&#xD;
  &#xD;
            -  Lives anywhere accessible by mail in Canada if 18 years and older, or anywhere&#xD;
               accessible by mail in Quebec if 14 years and older but younger than 18 years.&#xD;
  &#xD;
            -  Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to&#xD;
               complete the cognitive tasks&#xD;
  &#xD;
            -  Able to speak, read, and write English or French&#xD;
  &#xD;
            -  No diagnosis of a neurological disease or unstable health condition&#xD;
  &#xD;
            -  Regular access to a computer with internet or a smartphone&#xD;
  &#xD;
          Study Partner exclusion criteria&#xD;
  &#xD;
          • Not in contact with the primary participant more than once per 12 months at baseline&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>95 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Maiya R Geddes, MD PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>McGill University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Maiya R Geddes, MD PhD</last_name>
      <phone>514 761-6131</phone>
      <phone_ext>3329</phone_ext>
      <email>maiya.geddes@mcgill.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Adrián Noriega de la Colina, MD PhD</last_name>
      <phone>514 761-6131</phone>
      <phone_ext>2708</phone_ext>
      <email>adrian.noriegadelacolina@mcgill.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Douglas Mental Health University Institute</name>
        <address>
          <city>Montréal</city>
          <state>Quebec</state>
          <zip>H4H 1R3</zip>
          <country>Canada</country>
        </address>
      </facility>
      <contact>
        <last_name>Maiya R Geddes, MD PhD</last_name>
        <phone>514-761-6131</phone>
        <phone_ext>3329</phone_ext>
        <email>maiya.geddes@mcgill.ca</email>
      </contact>
      <contact_backup>
        <last_name>Adrián Noriega de la Colina, MD PhD</last_name>
        <phone>514 761-6131</phone>
        <phone_ext>2708</phone_ext>
        <email>adrian.noriegadelacolina@mcgill.ca</email>
      </contact_backup>
      <investigator>
        <last_name>Maiya R Geddes, MD PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Adrián Noriega de la Colina, MD PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Sylvia Villeneuve, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Judes Poirier, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Arthur F Kramer, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>April 25, 2022</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Douglas Mental Health University Institute</investigator_affiliation>
      <investigator_full_name>Maiya R. Geddes, MD PhD</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>Risk Factors</keyword>
    <keyword>Disease Prevention</keyword>
    <keyword>Alzheimer's Disease</keyword>
    <keyword>Motivation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alzheimer Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Statistical Analysis Plan</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>March 7, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT06038643/SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT06038643
  org study id: IUSMD-20-38
  nct id: NCT06038643
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a twelve-week pilot randomized controlled trial of a behavioral intervention in older
        adults at risk for Alzheimer's disease. Older participants are a subgroup from the PREVENT-AD
        longitudinal cohort. We will test whether a four-week intergenerational social motivation
        using a technology-based platform (intervention group) enhances physical activity relative to
        a control group. After a washout period, the two groups will be offered the opportunity to
        cross-over into the alternate condition.
  This study is a two-arm, single site cross-over randomized controlled trial to test whether a
        four-week technology-based intergenerational social motivation intervention enhances physical
        activity in 60 cognitively normal older adults with a first-degree history of Alzheimer's
        disease. These at-risk older adults will be recruited as a subgroup from a longitudinal
        cohort at McGill University, PREVENT-AD. At the outset, half of the participants will be
        randomized to the intergenerational social motivation condition (intervention group) and the
        other half will be randomized to the control group (1:1). A multimodal AD risk score based on
        older participants' already acquired AD biomarker, health and cognitive data will be used as
        strata for randomization to ensure equal assignment of high-risk participants to Intervention
        and control groups, using a permuted block method with random blocks. The primary measure of
        interest is increased physical activity as measured by accelerometry (average minutes in
        sedentary behavior/day, average steps per day, and average minutes in moderate-to-vigorous
        physical activity/day). After an initial visit consisting of behavioral testing and
        structural and functional MRI, participants in the Intervention Group will be paired with
        younger adults (14 to 40 years) to form intergenerational dyads. Younger adults are either a
        family member of the older adult or a younger adult recruited from the community.
        Participants in the intervention group will receive personalized, positive daily messages
        over a four-week period via their device using the 'Our Family Garden' technology platform.
        These daily messages combine (1) pro-social goals (donation to charity after reaching
        exercise goals), (2) intergenerational social engagement and (3) positive personalized
        messages from their younger study partners. This study will have 6 visits over a 2-month
        period in addition to the four-week intervention period (3 months total). Cognitive and
        behavioral data will be collected at each visit and physical activity data will be collected
        over the intervention period. All participants will be offered the opportunity to cross-over,
        after a 6-week washout period, into the alternate condition in order to ensure access to the
        intervention in all participants and longer-term follow up. The primary endpoint is defined
        as the end of the initial period.
  
        Data collected are stored in one of three ways; (1) Physical activity monitoring data are
        extracted from their respective software packages and uploaded directly to a secure data
        storage environment at a high-performance computing facility. All pen-and-paper psychosocial
        and neuropsychological assessments are scored and entered in REDCap. Computerized
        psychosocial assessments are collected directly in REDCap and computerized neuropsychological
        assessments are entered in REDCap. The oTree library is used to distribute the daily
        intervention messages and collect survey data. This system runs on a Heroku server, a
        cloud-based system that sends and receives hash-encrypted links. Collected anonymized data
        are stored on the messaging site behind an administrative login on the Heroku server. All
        data from RedCAP will be exported to CSV files using the data de-identification feature for
        subsequent analysis with R and SPSS statistical analysis packages. After compiling all data
        across the 3 different data servers, data will be checked for completeness and correctness
        using frequency distributions (for missing data and out-of-range values). For the final
        dataset, the multiple imputation by chained equations (MICE) will be used for imputing
        missing values with 10 imputations.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: Intergenerational Social Motivation Behavioral Intervention using a Technology-based Platform
  Our research will test an innovative, technology-based, and readily scalable cross-generational social behavior intervention to enhance physical activity in at-risk older adults within a cross-over randomized controlled trial to enhance physical activity.
  primary purpose: Prevention
  masking: Double (Participant, Investigator)
  measure: Sedentary behavior (average min/day)
  time frame: Baseline; 4-week
  description: This metric quantifies the change in the average amount of time spent sedentary each day, from the baseline period to the 4-week period. It is a marker of time spent inactive.
  measure: Total step count (average steps/day)
  time frame: Baseline; 4-week
  description: This metric quantifies the change in the average number of steps taken each day, from the baseline period to the 4-week period. It is a marker of change in habitual ambulatory activity.
  measure: Moderate-vigorous activity (average min/day)
  time frame: Baseline; 4-week
  description: This metric quantifies the change in the average amount of time spent engaged in moderate-vigorous physical activity each day, from the baseline period to the 4-week followup period. It is a marker of physical activity.
  measure: UCLA Loneliness Scale
  time frame: Baseline; 4-week
  description: A questionnaire that measures perceived level of loneliness.
  measure: Pittsburgh Sleep Quality Index
  time frame: Baseline; 4-week
  description: A questionnaire measuring sleep quality.
  measure: Modified Differential Emotions Scale
  time frame: Baseline; 4-week
  description: A questionnaire that assesses mood and feelings.
  measure: Test My Brain Digital Neuropsychology Toolkit
  time frame: Baseline; 4-week
  description: This metric assessed cognitive status across multiple domains (e.g., memory, executive function, processing speed)
  measure: Barriers to Self-Efficacy Scale
  time frame: Baseline; 4-week
  description: A questionnaire to assess physical activity confidence when faced with challenges (e.g., bad weather).
  measure: Perceived Stress Scale (PSS)
  time frame: Baseline; 4-week
  description: This common test assesses the perception of stress.
  arm group label: Intervention
  arm group type: Experimental
  description: Social motivation intervention, self-transcendence daily messages, and daily accelerometry.
  arm group label: Active Control
  arm group type: Active Comparator
  description: Daily accelerometry.
  intervention type: Behavioral
  intervention name: Motivational behavioural intervention and daily activities monitoring
  description: Social motivation manipulation, self-transcendence daily messaging, and daily activities monitoring through accelerometry. Participants in this arm will have a study partner who receives daily feedback on the main participant's daily step count.
  arm group label: Intervention
  intervention type: Behavioral
  intervention name: Active Control
  description: Daily activities monitored through accelerometry.
  arm group label: Active Control
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: 95 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Maiya R Geddes, MD PhD
  role: Principal Investigator
  affiliation: McGill University
  last name: Maiya R Geddes, MD PhD
  phone: 514 761-6131
  phone ext: 3329
  email: maiya.geddes@mcgill.ca
  last name: Adrián Noriega de la Colina, MD PhD
  phone: 514 761-6131
  phone ext: 2708
  email: adrian.noriegadelacolina@mcgill.ca
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Canada
  responsible party type: Principal Investigator
  investigator affiliation: Douglas Mental Health University Institute
  investigator full name: Maiya R. Geddes, MD PhD
  investigator title: Assistant Professor
  mesh term: Alzheimer Disease
  sharing ipd: No
  provided document: 