<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/NCT04400253</url>
  </required_header>
  <id_info>
    <org_study_id>STU00211374:</org_study_id>
    <nct_id>NCT04400253</nct_id>
  </id_info>
  <brief_title>South Asians Active Together (SAATH) Study</brief_title>
  <official_title>A Multilevel Physical Activity Intervention for South Asian Women and Girls (SAATH)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Skokie Health Department</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Skokie Park District</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Illinois at Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Metropolitan Asian Family Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ann &amp; Robert H Lurie Children's Hospital of Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwestern 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>
      South Asian immigrant women and girls are at increased risk for insufficient physical&#xD;
      activity and are not being reached by current approaches to physical activity promotion. This&#xD;
      randomized control trial study will test the effectiveness and implementation of a multi&#xD;
      component physical activity intervention directed at the environment, family, interpersonal&#xD;
      and individual levels to promote physical activity among South Asian immigrant mothers and&#xD;
      daughters.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">July 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Averaged daily minutes spent in moderate- and vigorous-intensity physical activity measured by ActiGraph accelerometers</measure>
    <time_frame>The outcome will be assessed before the intervention (week 0) and after the intervention (week 18)</time_frame>
    <description>Moderate- and vigorous-intensity physical activity will be identified based on the accelerometer count cut-point for moderate intensity and daily minutes spent in moderate- and vigorous-intensity physical activity estimated for seven days will be averaged</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Averaged daily minutes spent in walking or running behavior measured by ActiGraph accelerometers</measure>
    <time_frame>The outcome will be assessed before the intervention (week 0) and after the intervention (week 18)</time_frame>
    <description>Walking and running behavior will be recognized using a machine learning activity recognition algorithm and daily minutes spent in walking or running behavior estimated for seven days will be averaged</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Averaged daily hours spent in sedentary behaviors measured by ActiGraph accelerometers</measure>
    <time_frame>The outcome will be assessed before the intervention (week 0) and after the intervention (week 18)</time_frame>
    <description>Sedentary behaviors will be identified based on the accelerometer count cut-point for sedentary behaviors and daily minutes spent in sedentary behaviors estimated for seven days will be averaged</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic and diastolic blood pressure (mmHg) measured by a sphygmomanometer</measure>
    <time_frame>The outcome will be assessed before the intervention (week 0) and after the intervention (week 18)</time_frame>
    <description>Blood pressure will be measured three times while sitting down and relaxing on a chair and the last two measures will be averaged</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy score measured by the Exercise Confidence Survey</measure>
    <time_frame>The outcome will be assessed before the intervention (week 0) and after the intervention (week 18)</time_frame>
    <description>The self-efficacy score will be calculated by averaging the responses (scored 1 to 5 point for the responses of strongly disagree to strongly agree) from each question item</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy score measured by Dishman's Barriers to Self-Efficacy questionnaire</measure>
    <time_frame>The outcome will be assessed before the intervention (week 0) and after the intervention (week 18)</time_frame>
    <description>The self-efficacy score will be calculated by averaging the responses (scored 1 to 5 point; higher scores mean higher self-efficacy [a better outcome])</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">320</enrollment>
  <condition>Physical Inactivity</condition>
  <condition>South Asian</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group will receive a 18-week in-person program. The program includes the following components: multi family group counseling, group exercise classes, mother group discussion, daughter group discussion and Fitbit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The group group will receive print materials about physical activity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SAATH Intervention</intervention_name>
    <description>SAATH intervention is a physical activity intervention for South Asian mothers and daughters with group exercise classes and discussion groups.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        The sample of this study is South Asian mothers and their daughters. The inclusion criteria&#xD;
        for the mother include:&#xD;
&#xD;
          -  Identifying herself as South Asian,&#xD;
&#xD;
          -  having a sedentary lifestyle as assessed using a self-report questionnaire&#xD;
&#xD;
          -  having ability to communicate in Hindi, Gujarati, Urdu, or English.&#xD;
&#xD;
          -  Having a daughter aged 11-16 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  having known medical condition that restricts ability to participate in moderate&#xD;
             intensity PA&#xD;
&#xD;
          -  Unable to complete study procedures (including not wearing accelerometer during&#xD;
             run-in)&#xD;
&#xD;
          -  Currently pregnant&#xD;
&#xD;
          -  Unable to provide informed consent or assent.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>South Asian girls and women</gender_description>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Namratha Kandula, MD, MPH</last_name>
    <phone>+1 312 503 6470</phone>
    <email>n-kandula@northwestern.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Emily Anderson</last_name>
    <phone>312 503 6288</phone>
    <email>emily.anderson1@northwestern.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Northwestern University-Feinberg School of Medicine</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emily Anderson</last_name>
      <phone>312-503-6288</phone>
      <email>emily.anderson1@northwestern.edu</email>
    </contact>
    <investigator>
      <last_name>Namratha Kandula</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>May 11, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>October 18, 2022</last_update_submitted>
  <last_update_submitted_qc>October 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Namratha Kandula</investigator_full_name>
    <investigator_title>Prinicipal Investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT04400253
org study id: STU00211374:
nct id: NCT04400253
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
South Asian immigrant women and girls are at increased risk for insufficient physical
      activity and are not being reached by current approaches to physical activity promotion. This
      randomized control trial study will test the effectiveness and implementation of a multi
      component physical activity intervention directed at the environment, family, interpersonal
      and individual levels to promote physical activity among South Asian immigrant mothers and
      daughters.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: Averaged daily minutes spent in moderate- and vigorous-intensity physical activity measured by ActiGraph accelerometers
time frame: The outcome will be assessed before the intervention (week 0) and after the intervention (week 18)
description: Moderate- and vigorous-intensity physical activity will be identified based on the accelerometer count cut-point for moderate intensity and daily minutes spent in moderate- and vigorous-intensity physical activity estimated for seven days will be averaged
measure: Averaged daily minutes spent in walking or running behavior measured by ActiGraph accelerometers
time frame: The outcome will be assessed before the intervention (week 0) and after the intervention (week 18)
description: Walking and running behavior will be recognized using a machine learning activity recognition algorithm and daily minutes spent in walking or running behavior estimated for seven days will be averaged
measure: Averaged daily hours spent in sedentary behaviors measured by ActiGraph accelerometers
time frame: The outcome will be assessed before the intervention (week 0) and after the intervention (week 18)
description: Sedentary behaviors will be identified based on the accelerometer count cut-point for sedentary behaviors and daily minutes spent in sedentary behaviors estimated for seven days will be averaged
measure: Systolic and diastolic blood pressure (mmHg) measured by a sphygmomanometer
time frame: The outcome will be assessed before the intervention (week 0) and after the intervention (week 18)
description: Blood pressure will be measured three times while sitting down and relaxing on a chair and the last two measures will be averaged
measure: Self-efficacy score measured by the Exercise Confidence Survey
time frame: The outcome will be assessed before the intervention (week 0) and after the intervention (week 18)
description: The self-efficacy score will be calculated by averaging the responses (scored 1 to 5 point for the responses of strongly disagree to strongly agree) from each question item
measure: Self-efficacy score measured by Dishman's Barriers to Self-Efficacy questionnaire
time frame: The outcome will be assessed before the intervention (week 0) and after the intervention (week 18)
description: The self-efficacy score will be calculated by averaging the responses (scored 1 to 5 point; higher scores mean higher self-efficacy [a better outcome])
arm group label: Intervention group
arm group type: Experimental
description: The intervention group will receive a 18-week in-person program. The program includes the following components: multi family group counseling, group exercise classes, mother group discussion, daughter group discussion and Fitbit.
arm group label: Control group
arm group type: No Intervention
description: The group group will receive print materials about physical activity.
intervention type: Behavioral
intervention name: SAATH Intervention
description: SAATH intervention is a physical activity intervention for South Asian mothers and daughters with group exercise classes and discussion groups.
arm group label: Intervention group
criteria: 
gender: Female
gender based: Yes
gender description: South Asian girls and women
minimum age: 11 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Namratha Kandula, MD, MPH
phone: +1 312 503 6470
email: n-kandula@northwestern.edu
last name: Emily Anderson
phone: 312 503 6288
email: emily.anderson1@northwestern.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Namratha Kandula
investigator title: Prinicipal Investigator