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/NCT05966506</url>
    </required_header>
    <id_info>
      <org_study_id>HSC-SN-23-0576</org_study_id>
      <nct_id>NCT05966506</nct_id>
    </id_info>
    <brief_title>A Culturally Adapted, Social Support-Based, Physical Activity Interventions for South Asian Indian Women in the United States</brief_title>
    <official_title>A Culturally Adapted, Social Support-Based, Physical Activity Interventions for South Asian Indian Women in the United States: A Feasibility Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The University of Texas Health Science Center, Houston</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>M.D. Anderson Cancer Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>The University of Texas Health Science Center, Houston</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 purpose of this study is to assess the feasibility and acceptability of a peer-based&#xD;
        dyadic social support health coaching physical activity (PA) intervention in inactive South&#xD;
        Asian Indian (SAI) and to explore preliminary effects of the intervention on intermediate&#xD;
        outcomes: self-reported and objective moderate-to-vigorous physical activity (MVPA), social&#xD;
        support, and self-efficacy .&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 31, 2023</start_date>
    <completion_date type="Anticipated">July 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 30, 2024</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>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Feasibility as assessed by the percentage of participants enrolled in the study</measure>
      <time_frame>12 weeks</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility as assessed by the percentage of participants who complete the study</measure>
      <time_frame>12 weeks</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility as assessed by the number of participants who complete all the assessments</measure>
      <time_frame>12 weeks</time_frame>
      <description>Assessments include counseling calls ,use of Fitbit, receipt and review of newsletters</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility as assessed by the number of participants who adhere to treatment</measure>
      <time_frame>12 weeks</time_frame>
      <description>Treatment adherence will be calculated as the proportion of intervention sessions attended.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in physical activity as assessed by the Godin Leisure-Time Exercise Questionnaire</measure>
      <time_frame>Baseline, 12 weeks</time_frame>
      <description>This is a self reported questionnaire with 3 questions. A score of 24 units or more indicates participant is active and score of less than 14 units show participant is insufficiently active or sedentary.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in physical activity as assessed by the values on a fitbit</measure>
      <time_frame>Baseline, 12 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in self-efficacy for PA as assessed by the Self-efficacy for physical activity (SEPA) scale</measure>
      <time_frame>Baseline, 12 weeks</time_frame>
      <description>This is a five item questionnaire and is scored on a five point Likert-scale, ranging from not confident to extremely confident.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in PA-related social support as assessed by the Social Support for Physical Activity Survey</measure>
      <time_frame>Baseline, 12 weeks</time_frame>
      <description>This is a 26 item questionnaire and each is scored from 1(one) to 6(very often) a higher number indicating more social support</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in PA-related autonomy support as assessed by the Climate Questionnaire (autonomy support)</measure>
      <time_frame>Baseline, 12 weeks</time_frame>
      <description>This is a 12 item questionnaire (first 6 about partner and the next 6 about participant ) Response options are on a 7-point scale (1=not at all true, 4=somewhat true, 7=very true)</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Sedentary Behavior</condition>
    <arm_group>
      <arm_group_label>Health coaching</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Dyad-based Zoom health coaching</intervention_name>
      <description>This will be delivered by a certified nurse coach, certified in holistic nursing who will provide 6 sessions of Zoom health coaching over 12 weeks to dyads, biweekly (weeks 1, 3, 5,7, 9 &amp;11) for 45 minutes</description>
      <arm_group_label>Health coaching</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Fitbit activity monitor</intervention_name>
      <description>Participants will be instructed to use the Fitbit to monitor their partners' PA in addition to their own. All participants will be instructed to &quot;friend&quot; their health coach to enable real-time monitoring of PA to inform coaching zoom calls. The Fitbit will provide feedback on steps, active minutes, and calories burned. Participants will be asked to wear the device on most days and while they sleep.</description>
      <arm_group_label>Health coaching</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Electronic newsletters</intervention_name>
      <description>Newsletters will be sent twice monthly during months 1-3 via email or text with an online link. Newsletters will be designed to share educational PA-related information from publicly available resources. Newsletters will also contain tips for overcoming barriers to PA ,finding time to exercise, low-cost ways to be active and being active with kids.Newsletters will also contain links to brief exercise routines that participants can do in their homes and information on low cost/free exercise classes in the community, which may help to overcome perceived access barriers</description>
      <arm_group_label>Health coaching</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  inactive SAI (Physical activity (PA) &lt;150 minutes/week)&#xD;
  &#xD;
            -  physically able to engage in moderate PA&#xD;
  &#xD;
            -  speak and read English; able to enroll with an eligible adult female partner who does&#xD;
               not live in the same household&#xD;
  &#xD;
            -  willing to use the Fitbit app/device&#xD;
  &#xD;
            -  own a smartphone that is compatible with Fitbit software (up to 223.3 MB on iPhone or&#xD;
               165 MB on Android) 9)&#xD;
  &#xD;
            -  able and willing to send and receive text messages&#xD;
  &#xD;
            -  Blood pressure reading &lt;160/100 mm Hg, or with medical clearance.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  SAI women with a current/planned pregnancy&#xD;
  &#xD;
            -  cannot speak and read English&#xD;
  &#xD;
            -  those participating in a PA or weight loss program&#xD;
  &#xD;
            -  those diagnosed with a physical disability that interferes with their ability to be&#xD;
               physically active.&#xD;
  &#xD;
            -  not living in Houston, Texas&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nitha Mathew Joseph, PhD, RN, CNE</last_name>
      <role>Principal Investigator</role>
      <affiliation>The University of Texas Health Science Center, Houston</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nitha Mathew Joseph, PhD, RN, CNE</last_name>
      <phone>713-500-2165</phone>
      <email>Nitha.Mathew@uth.tmc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Maja Djukic, PhD, RN, FAAN</last_name>
      <phone>713-500-2045</phone>
      <email>Maja.Djukic@uth.tmc.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The University of Texas Health Science Center at Houston</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77030</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Nitha M Joseph, PhD, RN, CNE</last_name>
        <phone>713-500-2165</phone>
        <email>Nitha.Mathew@uth.tmc.edu</email>
      </contact>
      <contact_backup>
        <last_name>Maja Djukic, PhD, RN, FAAN</last_name>
        <phone>713-500-2045</phone>
        <email>Maja.Djukic@uth.tmc.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
      <investigator_full_name>Nitha Mathew Joseph</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>physical activity</keyword>
    <keyword>social support</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05966506
  org study id: HSC-SN-23-0576
  nct id: NCT05966506
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to assess the feasibility and acceptability of a peer-based
        dyadic social support health coaching physical activity (PA) intervention in inactive South
        Asian Indian (SAI) and to explore preliminary effects of the intervention on intermediate
        outcomes: self-reported and objective moderate-to-vigorous physical activity (MVPA), social
        support, and self-efficacy .
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Feasibility as assessed by the percentage of participants enrolled in the study
  time frame: 12 weeks
  measure: Feasibility as assessed by the percentage of participants who complete the study
  time frame: 12 weeks
  measure: Feasibility as assessed by the number of participants who complete all the assessments
  time frame: 12 weeks
  description: Assessments include counseling calls ,use of Fitbit, receipt and review of newsletters
  measure: Feasibility as assessed by the number of participants who adhere to treatment
  time frame: 12 weeks
  description: Treatment adherence will be calculated as the proportion of intervention sessions attended.
  measure: Change in physical activity as assessed by the Godin Leisure-Time Exercise Questionnaire
  time frame: Baseline, 12 weeks
  description: This is a self reported questionnaire with 3 questions. A score of 24 units or more indicates participant is active and score of less than 14 units show participant is insufficiently active or sedentary.
  measure: Change in physical activity as assessed by the values on a fitbit
  time frame: Baseline, 12 weeks
  measure: Change in self-efficacy for PA as assessed by the Self-efficacy for physical activity (SEPA) scale
  time frame: Baseline, 12 weeks
  description: This is a five item questionnaire and is scored on a five point Likert-scale, ranging from not confident to extremely confident.
  measure: Change in PA-related social support as assessed by the Social Support for Physical Activity Survey
  time frame: Baseline, 12 weeks
  description: This is a 26 item questionnaire and each is scored from 1(one) to 6(very often) a higher number indicating more social support
  measure: Change in PA-related autonomy support as assessed by the Climate Questionnaire (autonomy support)
  time frame: Baseline, 12 weeks
  description: This is a 12 item questionnaire (first 6 about partner and the next 6 about participant ) Response options are on a 7-point scale (1=not at all true, 4=somewhat true, 7=very true)
  arm group label: Health coaching
  arm group type: Experimental
  intervention type: Behavioral
  intervention name: Dyad-based Zoom health coaching
  description: This will be delivered by a certified nurse coach, certified in holistic nursing who will provide 6 sessions of Zoom health coaching over 12 weeks to dyads, biweekly (weeks 1, 3, 5,7, 9 &11) for 45 minutes
  arm group label: Health coaching
  intervention type: Behavioral
  intervention name: Fitbit activity monitor
  description: Participants will be instructed to use the Fitbit to monitor their partners' PA in addition to their own. All participants will be instructed to "friend" their health coach to enable real-time monitoring of PA to inform coaching zoom calls. The Fitbit will provide feedback on steps, active minutes, and calories burned. Participants will be asked to wear the device on most days and while they sleep.
  arm group label: Health coaching
  intervention type: Other
  intervention name: Electronic newsletters
  description: Newsletters will be sent twice monthly during months 1-3 via email or text with an online link. Newsletters will be designed to share educational PA-related information from publicly available resources. Newsletters will also contain tips for overcoming barriers to PA ,finding time to exercise, low-cost ways to be active and being active with kids.Newsletters will also contain links to brief exercise routines that participants can do in their homes and information on low cost/free exercise classes in the community, which may help to overcome perceived access barriers
  arm group label: Health coaching
  criteria: 
  gender: Female
  minimum age: 40 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Nitha Mathew Joseph, PhD, RN, CNE
  role: Principal Investigator
  affiliation: The University of Texas Health Science Center, Houston
  last name: Nitha Mathew Joseph, PhD, RN, CNE
  phone: 713-500-2165
  email: Nitha.Mathew@uth.tmc.edu
  last name: Maja Djukic, PhD, RN, FAAN
  phone: 713-500-2045
  email: Maja.Djukic@uth.tmc.edu
  facility: 
  contact: 
  contact backup: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: The University of Texas Health Science Center, Houston
  investigator full name: Nitha Mathew Joseph
  investigator title: Associate Professor
  sharing ipd: No