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/NCT06002919</url>
    </required_header>
    <id_info>
      <org_study_id>2023-0337</org_study_id>
      <nct_id>NCT06002919</nct_id>
    </id_info>
    <brief_title>MindWalk Intervention for Older South Asian Family Caregivers of People With IDD With Perceived Psychological Stress</brief_title>
    <official_title>MindWalk: A Mindful Walking Intervention for Older South Asian Family Caregivers of People With Intellectual and/or Developmental Disabilities (IDD) With Perceived Psychological Stress</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Illinois at Chicago</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Illinois at Chicago</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>
        Older South Asian family caregivers experience elevated psychological stress and limited&#xD;
        physical activity (PA) due to caregiving responsibilities and additional factors such as lack&#xD;
        of access to services, cultural/linguistic barriers, stigma and discrimination. South Asian&#xD;
        family caregivers are especially underserved and are a growing ethnic group in the US. Both&#xD;
        PA and cognitive training (CT) have shown to improve cognitive function in older adults who&#xD;
        experience cognitive function decline because of psychological stress. However, there are no&#xD;
        studies using this approach for this population. We propose a randomized control trial pilot&#xD;
        study to address this gap. Driven by a Community Advisory Committee (CAC) we will develop&#xD;
        this 12-week mindful walking intervention using a participatory action research methodology&#xD;
        in partnership with UIC's Cognition Behavior and Mindfulness Clinic that combines the PA of&#xD;
        walking and the CT through mindfulness. We will recruit fifty participants and will randomly&#xD;
        and equally assign 25 people to the intervention and 25 people to the control group. The&#xD;
        intervention will include: 1) a mindful walking training followed by 2) a prescribed mindful&#xD;
        walking regimen, 3) self-reporting of adherence to regimen by the participants using activity&#xD;
        logbooks and use of a user-friendly PA tracker (Fitbit Charge HR) for daily step count, and&#xD;
        4) personalized text messages with reminders and motivational messages for participants to do&#xD;
        the mindful walking as prescribed including a weekly check-in call or text message for&#xD;
        accountability. The primary aim of the proposed pilot study is to evaluate the feasibility&#xD;
        and acceptability of the protocol and intervention implementation. A secondary aim will&#xD;
        evaluate the intervention to examine preliminary efficacy in reduction of psychological&#xD;
        stress, improvement in cognitive function, increase in physical activity, and increased&#xD;
        self-efficacy (self-efficacy for coping with stress, self-efficacy for physical activity, and&#xD;
        overall self-efficacy). The findings of this pilot project will provide evidence-based data&#xD;
        to support a larger scale study proposal for future funding such as the National Institute on&#xD;
        Disability, Independent Living, and Rehabilitation Research (NIDILRR) field initiative award,&#xD;
        or the National Institute of Health (NIH) Research Project Grant (R21 NIH&#xD;
        Exploratory/Developmental Research Grant Award) award, especially National Institute on Aging&#xD;
        (NIA) grants.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Older family caregivers, ages 50 and older of people with intellectual and/or developmental&#xD;
        disabilities (IDD) often experience high levels of stress and psychological distress which&#xD;
        can result in cognitive decline. Both physical activity (PA) and cognitive training (CT) have&#xD;
        shown to improve cognitive function in older adults who experience cognitive function decline&#xD;
        because of psychological stress. There are some activities such as South Asian martial arts&#xD;
        and yoga, that the South Asian community is familiar with, however there seems to be limited&#xD;
        research incorporating mindful walking as an activity combining PA and CT. Specifically,&#xD;
        mindful walking is a technique to learn to be more present and focused on the here and now&#xD;
        while engaged in the physical activity of walking. Older South Asian family caregivers&#xD;
        experience elevated psychological stress and limited physical activity due to caregiving&#xD;
        responsibilities and additional factors such as lack of access to services, cultural and&#xD;
        linguistic barriers, stigma and discrimination. South Asian family caregivers are especially&#xD;
        underserved and are a growing ethnic group in the US. However, there are no studies using&#xD;
        this approach for this population. We propose a randomized control trial pilot study to&#xD;
        address this gap titled MindWalk: A Mindful Walking Intervention for Older South Asian Family&#xD;
        Caregivers of People with Intellectual and/or Developmental Disabilities (IDD) with Perceived&#xD;
        Psychological Stress. Driven by a Community Advisory Committee (CAC) we will develop this&#xD;
        12-week mindful walking intervention using a participatory action research methodology in&#xD;
        partnership with UIC's Cognition Behavior and Mindfulness Clinic that combines the physical&#xD;
        activity of walking and the cognitive training through mindfulness. We will recruit fifty&#xD;
        participants and will randomly and equally assign 25 people to the intervention and 25 people&#xD;
        to the control group. The intervention will include: 1) a mindful walking training followed&#xD;
        by 2) a prescribed mindful walking regimen, 3) self-reporting of adherence to regimen by the&#xD;
        participants using activity logbooks and use of a user-friendly PA tracker (Fitbit Charge HR)&#xD;
        for daily step count, and 4) personalized text messages with reminders and motivational&#xD;
        messages for participants to do the mindful walking as prescribed including a weekly check-in&#xD;
        call or text message for accountability. The primary aim of the proposed pilot study is to&#xD;
        evaluate the feasibility and acceptability of the protocol and intervention implementation. A&#xD;
        secondary aim will evaluate the intervention to examine preliminary efficacy in reduction of&#xD;
        psychological stress, improvement in cognitive function, increase in physical activity, and&#xD;
        increased self-efficacy (self-efficacy for coping with stress, self-efficacy for physical&#xD;
        activity, and overall self-efficacy). The findings of this pilot project will provide&#xD;
        evidence-based data to support a larger scale study proposal for future funding such as the&#xD;
        National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR)&#xD;
        field initiative award, or the National Institute of Health (NIH) Research Project Grant (R21&#xD;
        NIH Exploratory/Developmental Research Grant Award) award, especially National Institute on&#xD;
        Aging (NIA) grants.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">May 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 31, 2024</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>This is a a two-arm parallel assignment that involves two groups of participants. One group receives the MindWalk intervention, and the other group is the control group.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Perceived Stress using the Acceptance and Action Questionnaire-II (AAQ-II)</measure>
      <time_frame>Baseline, After 12 weeks and at follow up (20weeks)</time_frame>
      <description>Perceived stress will be measured using the Acceptance and Action Questionnaire-II (AAQ-II) scale, a 7-item scale (Bond et al., 2011). Higher total scores on the AAQ-II indicate higher psychological inflexibility, experiential avoidance, and more potential psychological distress. Lower total scores mean more psychological flexibility.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Visuospatial inhibitory attention Using the NIH Toolbox Flanker Inhibitory Control and Attention Test</measure>
      <time_frame>Baseline, After 12 weeks and at follow up (20weeks)</time_frame>
      <description>Using the NIH Toolbox Flanker Inhibitory Control and Attention Test (for measuring attention and inhibitory control) from the NIH Toolbox Cognition Battery (HealthMeasures, 2020).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Executive Functioning Using the NIH Toolbox Dimensional Change Card Sort Test</measure>
      <time_frame>Baseline, After 12 weeks and at follow up (20weeks)</time_frame>
      <description>Using the NIH Toolbox Dimensional Change Card Sort Test (for measuring executive function) from the NIH Toolbox Cognition Battery (HealthMeasures, 2020).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Physical Activity using International Physical Activity Questionnaire - Short (IPAQ-S) in MET-min/week</measure>
      <time_frame>Baseline, After 12 weeks and at follow up (20weeks)</time_frame>
      <description>For physical activity measurement, participants will complete International Physical Activity Questionnaire - Short (IPAQ-S). MET minutes represent the amount of energy expended carrying out physical activity. To get a continuous variable score from the IPAQ (MET minutes a week) we will consider walking to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical Activity using Accelerometer to measure time spent on moderate-to-vigorous physical activity (MVPA)</measure>
      <time_frame>Baseline, After 12 weeks and at follow up (20weeks)</time_frame>
      <description>For physical activity measurement, participants will be asked to wear Accelerometers. Time spent on MVPA is measured.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical Activity using Accelerometer to measure step counts</measure>
      <time_frame>Baseline, After 12 weeks and at follow up (20weeks)</time_frame>
      <description>For physical activity measurement, participants will be asked to wear Accelerometers. Monitoring, step counts can serve as a proxy for the total volume of PA.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-efficacy for coping with stress using Coping with Stress Self-Efficacy Scale (CSSES)</measure>
      <time_frame>Baseline, After 12 weeks and at follow up (20weeks)</time_frame>
      <description>Self-efficacy for coping with stress will be measured using Coping with Stress Self-Efficacy Scale (CSSES) (Godoy-Izquierdo, Sola, García, 2011). The 8-item scale assesses efficacy and outcome expectations. This instrument consists of 8 items, 4 of which (items 2, 4, 5, and 7) assess the EE component, and the remaining 4 (items 1, 3, 6, and 8) assess the OE component. A global score (Total) is obtained by adding the EE and OE scores. Higher scores indicate greater confidence in one's skills for managing stress.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-Efficacy for Physical Activity using Self-Efficacy for Physical Activity (SEPA) scale</measure>
      <time_frame>Baseline, After 12 weeks and at follow up (20weeks)</time_frame>
      <description>Self-efficacy for physical activity will be measured using Self-Efficacy for Physical Activity (SEPA) scale (Marcus, Selby, Niaura, &amp; Rossi, 1992). The Self-Efficacy for Physical Activity (SEPA) scale is a 5-item Likert measure that assesses an individual's confidence for engaging in exercise in the presence of barriers</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Self-Efficacy using the NIH ToolBox Emotion Battery on Self-Efficacy for Ages 18+</measure>
      <time_frame>Baseline, After 12 weeks and at follow up (20weeks)</time_frame>
      <description>Overall Self-efficacy for coping with stress will be measured using the NIH ToolBox Emotion Battery on Self-Efficacy for Ages 18+ (HealthMeasures, 2020) is a 10-item Likert scale with higher scores denoting better outcomes</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Stress, Psychological</condition>
    <condition>Cognitive Decline</condition>
    <arm_group>
      <arm_group_label>MindWalk Intervention</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>12 week intervention: 1) a mindful walking training followed by 2) a prescribed mindful walking regimen, 3) self-reporting of adherence to regimen by the participants using activity logbooks and use of a user-friendly PA tracker (Fitbit Charge HR) for daily step count, and 4) personalized text messages with reminders and motivational messages for participants to do the mindful walking as prescribed including a weekly check-in call or text message for accountability.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>For the participants assigned to control group, there is no intervention. At the end of study, the control group participants will be given access to the recorded virtual mindful walking training only (this includes the 30 minutes introductory training and the weekly 10-minute mindfulness topics/modules).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>MindWalk Intervention</intervention_name>
      <description>The intervention will include: 1) a mindful walking training followed by 2) a prescribed mindful walking regimen, 3) self-reporting of adherence to regimen by the participants using activity logbooks and use of a user-friendly PA tracker (Fitbit Charge HR) for daily step count, and 4) personalized text messages with reminders and motivational messages for participants to do the mindful walking as prescribed including a weekly check-in call or text message for accountability.</description>
      <arm_group_label>MindWalk Intervention</arm_group_label>
      <other_name>Mindful Walking Intervention</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Older South Asian family caregivers (50 years or older) caring for a person with IDD&#xD;
               of any age&#xD;
  &#xD;
            -  Self-reported insufficient physical activity (defined as participating in moderate&#xD;
               physical activity less than 60 min/week) and not engaged in mindfulness training&#xD;
  &#xD;
            -  Self-reporting of experiencing psychological stress; having a score of &lt; 24 out of a&#xD;
               total score of 30 in the Mini Mental State Examination (MMSE)&#xD;
  &#xD;
            -  Own a smartphone with a data plan or Bluetooth-enabled device (e.g., tablets such as&#xD;
               iPad) to sync data from the Fitbit tracker to the Fitbit app and to receive text&#xD;
               messages&#xD;
  &#xD;
            -  Ability to speak, understand, read and write English; ability to provide informed&#xD;
               consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Non-South Asian caregivers&#xD;
  &#xD;
            -  Caregivers less than 50 years old&#xD;
  &#xD;
            -  Having self-reported sufficient physical activity (defined as participating in&#xD;
               moderate physical activity more than 60 min/week) and engaged in some form of&#xD;
               mindfulness training&#xD;
  &#xD;
            -  Having a score of ≥ 24 out of a total score of 30 in the MMSE&#xD;
  &#xD;
            -  Not owning a smartphone with a data plan or Bluetooth-enabled device (e.g., tablets&#xD;
               such as iPad)&#xD;
  &#xD;
            -  Mobility limitation&#xD;
  &#xD;
            -  Taking medications or other behavioral treatment for stress reduction; acute or&#xD;
               chronic diseases at baseline&#xD;
  &#xD;
            -  Inability to understand, speak, read, and write English&#xD;
  &#xD;
            -  Inability to provide informed consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sumithra Murthy</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Illinois at Chicago</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sumithra Murthy</last_name>
      <phone>312-413-1647</phone>
      <email>smurthy@uic.edu</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Illinois at Chicago</investigator_affiliation>
      <investigator_full_name>Sumithra Murthy</investigator_full_name>
      <investigator_title>Visiting Clinical Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>Caregiver of a person with IDD</keyword>
    <keyword>Perceived psychological stress</keyword>
    <keyword>Cognitive Function</keyword>
    <keyword>Mindful Walking</keyword>
    <keyword>Physical Activity</keyword>
    <keyword>Self-efficacy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cognitive Dysfunction</mesh_term>
      <mesh_term>Stress, Psychological</mesh_term>
    </condition_browse>
    <!-- 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/NCT06002919
  org study id: 2023-0337
  nct id: NCT06002919
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Older South Asian family caregivers experience elevated psychological stress and limited
        physical activity (PA) due to caregiving responsibilities and additional factors such as lack
        of access to services, cultural/linguistic barriers, stigma and discrimination. South Asian
        family caregivers are especially underserved and are a growing ethnic group in the US. Both
        PA and cognitive training (CT) have shown to improve cognitive function in older adults who
        experience cognitive function decline because of psychological stress. However, there are no
        studies using this approach for this population. We propose a randomized control trial pilot
        study to address this gap. Driven by a Community Advisory Committee (CAC) we will develop
        this 12-week mindful walking intervention using a participatory action research methodology
        in partnership with UIC's Cognition Behavior and Mindfulness Clinic that combines the PA of
        walking and the CT through mindfulness. We will recruit fifty participants and will randomly
        and equally assign 25 people to the intervention and 25 people to the control group. The
        intervention will include: 1) a mindful walking training followed by 2) a prescribed mindful
        walking regimen, 3) self-reporting of adherence to regimen by the participants using activity
        logbooks and use of a user-friendly PA tracker (Fitbit Charge HR) for daily step count, and
        4) personalized text messages with reminders and motivational messages for participants to do
        the mindful walking as prescribed including a weekly check-in call or text message for
        accountability. The primary aim of the proposed pilot study is to evaluate the feasibility
        and acceptability of the protocol and intervention implementation. A secondary aim will
        evaluate the intervention to examine preliminary efficacy in reduction of psychological
        stress, improvement in cognitive function, increase in physical activity, and increased
        self-efficacy (self-efficacy for coping with stress, self-efficacy for physical activity, and
        overall self-efficacy). The findings of this pilot project will provide evidence-based data
        to support a larger scale study proposal for future funding such as the National Institute on
        Disability, Independent Living, and Rehabilitation Research (NIDILRR) field initiative award,
        or the National Institute of Health (NIH) Research Project Grant (R21 NIH
        Exploratory/Developmental Research Grant Award) award, especially National Institute on Aging
        (NIA) grants.
  Older family caregivers, ages 50 and older of people with intellectual and/or developmental
        disabilities (IDD) often experience high levels of stress and psychological distress which
        can result in cognitive decline. Both physical activity (PA) and cognitive training (CT) have
        shown to improve cognitive function in older adults who experience cognitive function decline
        because of psychological stress. There are some activities such as South Asian martial arts
        and yoga, that the South Asian community is familiar with, however there seems to be limited
        research incorporating mindful walking as an activity combining PA and CT. Specifically,
        mindful walking is a technique to learn to be more present and focused on the here and now
        while engaged in the physical activity of walking. Older South Asian family caregivers
        experience elevated psychological stress and limited physical activity due to caregiving
        responsibilities and additional factors such as lack of access to services, cultural and
        linguistic barriers, stigma and discrimination. South Asian family caregivers are especially
        underserved and are a growing ethnic group in the US. However, there are no studies using
        this approach for this population. We propose a randomized control trial pilot study to
        address this gap titled MindWalk: A Mindful Walking Intervention for Older South Asian Family
        Caregivers of People with Intellectual and/or Developmental Disabilities (IDD) with Perceived
        Psychological Stress. Driven by a Community Advisory Committee (CAC) we will develop this
        12-week mindful walking intervention using a participatory action research methodology in
        partnership with UIC's Cognition Behavior and Mindfulness Clinic that combines the physical
        activity of walking and the cognitive training through mindfulness. We will recruit fifty
        participants and will randomly and equally assign 25 people to the intervention and 25 people
        to the control group. The intervention will include: 1) a mindful walking training followed
        by 2) a prescribed mindful walking regimen, 3) self-reporting of adherence to regimen by the
        participants using activity logbooks and use of a user-friendly PA tracker (Fitbit Charge HR)
        for daily step count, and 4) personalized text messages with reminders and motivational
        messages for participants to do the mindful walking as prescribed including a weekly check-in
        call or text message for accountability. The primary aim of the proposed pilot study is to
        evaluate the feasibility and acceptability of the protocol and intervention implementation. A
        secondary aim will evaluate the intervention to examine preliminary efficacy in reduction of
        psychological stress, improvement in cognitive function, increase in physical activity, and
        increased self-efficacy (self-efficacy for coping with stress, self-efficacy for physical
        activity, and overall self-efficacy). The findings of this pilot project will provide
        evidence-based data to support a larger scale study proposal for future funding such as the
        National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR)
        field initiative award, or the National Institute of Health (NIH) Research Project Grant (R21
        NIH Exploratory/Developmental Research Grant Award) award, especially National Institute on
        Aging (NIA) grants.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This is a a two-arm parallel assignment that involves two groups of participants. One group receives the MindWalk intervention, and the other group is the control group.
  primary purpose: Other
  masking: None (Open Label)
  measure: Perceived Stress using the Acceptance and Action Questionnaire-II (AAQ-II)
  time frame: Baseline, After 12 weeks and at follow up (20weeks)
  description: Perceived stress will be measured using the Acceptance and Action Questionnaire-II (AAQ-II) scale, a 7-item scale (Bond et al., 2011). Higher total scores on the AAQ-II indicate higher psychological inflexibility, experiential avoidance, and more potential psychological distress. Lower total scores mean more psychological flexibility.
  measure: Visuospatial inhibitory attention Using the NIH Toolbox Flanker Inhibitory Control and Attention Test
  time frame: Baseline, After 12 weeks and at follow up (20weeks)
  description: Using the NIH Toolbox Flanker Inhibitory Control and Attention Test (for measuring attention and inhibitory control) from the NIH Toolbox Cognition Battery (HealthMeasures, 2020).
  measure: Executive Functioning Using the NIH Toolbox Dimensional Change Card Sort Test
  time frame: Baseline, After 12 weeks and at follow up (20weeks)
  description: Using the NIH Toolbox Dimensional Change Card Sort Test (for measuring executive function) from the NIH Toolbox Cognition Battery (HealthMeasures, 2020).
  measure: Physical Activity using International Physical Activity Questionnaire - Short (IPAQ-S) in MET-min/week
  time frame: Baseline, After 12 weeks and at follow up (20weeks)
  description: For physical activity measurement, participants will complete International Physical Activity Questionnaire - Short (IPAQ-S). MET minutes represent the amount of energy expended carrying out physical activity. To get a continuous variable score from the IPAQ (MET minutes a week) we will consider walking to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS.
  measure: Physical Activity using Accelerometer to measure time spent on moderate-to-vigorous physical activity (MVPA)
  time frame: Baseline, After 12 weeks and at follow up (20weeks)
  description: For physical activity measurement, participants will be asked to wear Accelerometers. Time spent on MVPA is measured.
  measure: Physical Activity using Accelerometer to measure step counts
  time frame: Baseline, After 12 weeks and at follow up (20weeks)
  description: For physical activity measurement, participants will be asked to wear Accelerometers. Monitoring, step counts can serve as a proxy for the total volume of PA.
  measure: Self-efficacy for coping with stress using Coping with Stress Self-Efficacy Scale (CSSES)
  time frame: Baseline, After 12 weeks and at follow up (20weeks)
  description: Self-efficacy for coping with stress will be measured using Coping with Stress Self-Efficacy Scale (CSSES) (Godoy-Izquierdo, Sola, García, 2011). The 8-item scale assesses efficacy and outcome expectations. This instrument consists of 8 items, 4 of which (items 2, 4, 5, and 7) assess the EE component, and the remaining 4 (items 1, 3, 6, and 8) assess the OE component. A global score (Total) is obtained by adding the EE and OE scores. Higher scores indicate greater confidence in one's skills for managing stress.
  measure: Self-Efficacy for Physical Activity using Self-Efficacy for Physical Activity (SEPA) scale
  time frame: Baseline, After 12 weeks and at follow up (20weeks)
  description: Self-efficacy for physical activity will be measured using Self-Efficacy for Physical Activity (SEPA) scale (Marcus, Selby, Niaura, & Rossi, 1992). The Self-Efficacy for Physical Activity (SEPA) scale is a 5-item Likert measure that assesses an individual's confidence for engaging in exercise in the presence of barriers
  measure: Overall Self-Efficacy using the NIH ToolBox Emotion Battery on Self-Efficacy for Ages 18+
  time frame: Baseline, After 12 weeks and at follow up (20weeks)
  description: Overall Self-efficacy for coping with stress will be measured using the NIH ToolBox Emotion Battery on Self-Efficacy for Ages 18+ (HealthMeasures, 2020) is a 10-item Likert scale with higher scores denoting better outcomes
  arm group label: MindWalk Intervention
  arm group type: Active Comparator
  description: 12 week intervention: 1) a mindful walking training followed by 2) a prescribed mindful walking regimen, 3) self-reporting of adherence to regimen by the participants using activity logbooks and use of a user-friendly PA tracker (Fitbit Charge HR) for daily step count, and 4) personalized text messages with reminders and motivational messages for participants to do the mindful walking as prescribed including a weekly check-in call or text message for accountability.
  arm group label: Control group
  arm group type: No Intervention
  description: For the participants assigned to control group, there is no intervention. At the end of study, the control group participants will be given access to the recorded virtual mindful walking training only (this includes the 30 minutes introductory training and the weekly 10-minute mindfulness topics/modules).
  intervention type: Behavioral
  intervention name: MindWalk Intervention
  description: The intervention will include: 1) a mindful walking training followed by 2) a prescribed mindful walking regimen, 3) self-reporting of adherence to regimen by the participants using activity logbooks and use of a user-friendly PA tracker (Fitbit Charge HR) for daily step count, and 4) personalized text messages with reminders and motivational messages for participants to do the mindful walking as prescribed including a weekly check-in call or text message for accountability.
  arm group label: MindWalk Intervention
  other name: Mindful Walking Intervention
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Sumithra Murthy
  role: Principal Investigator
  affiliation: University of Illinois at Chicago
  last name: Sumithra Murthy
  phone: 312-413-1647
  email: smurthy@uic.edu
  responsible party type: Principal Investigator
  investigator affiliation: University of Illinois at Chicago
  investigator full name: Sumithra Murthy
  investigator title: Visiting Clinical Assistant Professor
  mesh term: Cognitive Dysfunction
  mesh term: Stress, Psychological