<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/NCT02254902</url>
  </required_header>
  <id_info>
    <org_study_id>ACS-MRSG-13-069</org_study_id>
    <nct_id>NCT02254902</nct_id>
  </id_info>
  <brief_title>Physical Activity and Education Program for Somali Women</brief_title>
  <official_title>Physical Activity and Education to Reduce Cancer Risk Among Somali Women (Ladnaan Project)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Cancer Society, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Diego</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is a significant need for culturally adapted and effective health education programs to&#xD;
      address rising rates of obesity and chronic disease concerns for refugee communities.&#xD;
      Physical activity has been identified as an important prevention tool to prevent numerous&#xD;
      chronic health conditions. This research tests the feasibility and acceptability of a&#xD;
      culturally adapted physical activity intervention for sedentary adult Somali women. Study&#xD;
      participants will be randomized to a 3-month physical activity program or a wait-list control&#xD;
      group. The primary outcome is increases in physical activity between baseline and the end of&#xD;
      the program as measured by pedometer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants in the physical activity program will participate in 12 weekly 1.5-hour sessions&#xD;
      focused on increasing physical activity. The group sessions will include participating in&#xD;
      physical activity as well as group discussions on the barriers and opportunities for&#xD;
      increasing physical activity in their daily life. The 12-week program covers educational&#xD;
      topics related to physical activity (e.g. overcoming barriers to activity, exercising safely,&#xD;
      relapse prevention strategies) and the program gradually increases the amount of physical&#xD;
      activity completed during the group sessions over the course of the 12 weeks. Over a 3-month&#xD;
      wait period, individuals in the wait-list control group will be offered monthly sessions on&#xD;
      health and wellness topics before being offered the physical activity program. Measurement&#xD;
      visits will occur at baseline, at the end of the12-week program, and approximately 12-weeks&#xD;
      after the end of the intervention. During the measurement sessions participants will complete&#xD;
      assessments related to their physical activity and other health behaviors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Changes in funding status&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in physical activity as measured by pedometer from baseline to 3 months</measure>
    <time_frame>Baseline and 3 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Sedentary Lifestyle</condition>
  <arm_group>
    <arm_group_label>Physical Activity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the Physical Activity intervention arm of the study receive culturally-modified, materials through participation in 12 weekly 1-.5-hour sessions focused on increasing daily step counts and bouts of moderate intensity physical activity. The group sessions include participation in different forms of physical activity as well as group discussions on the barriers and opportunities for increasing physical activity in daily life.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait List Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the Wait List Control will be offered the program after a 3-month wait period. While waiting for the program, participants are offered to attend monthly sessions on various wellness and prevention topics.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical Activity intervention</intervention_name>
    <description>The Physical Activity intervention is a 3-month group-based program based on an efficacious physical activity intervention that has been culturally adapted for use with adult Somali women. The program targets increased physical activity through educational and experiential opportunities.</description>
    <arm_group_label>Physical Activity</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sedentary (less than 90 minutes per week of moderate or vigorous physical activity)&#xD;
&#xD;
          -  Self-identify as Somali&#xD;
&#xD;
          -  Planning on living in the area for the next 6 months&#xD;
&#xD;
          -  Ability to attend 12-weeks of in-person group sessions at a designated community site&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently pregnant or within 3 months of delivery&#xD;
&#xD;
          -  BMI greater than or equal to 40&#xD;
&#xD;
          -  Medical conditions or physical problems that interfere with physical activity or&#xD;
             require medical supervision to exercise&#xD;
&#xD;
          -  Have another member of the household participating in the study&#xD;
&#xD;
          -  Employment by one of the collaborating organizations&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kate E Murray, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Diego</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093-0725</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>May 11, 2016</last_update_submitted>
  <last_update_submitted_qc>May 11, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Diego</investigator_affiliation>
    <investigator_full_name>Kate Murray, PhD, MPH</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>sedentary lifestyle</keyword>
  <keyword>physical activity</keyword>
  <keyword>Somali women</keyword>
  <keyword>prevention</keyword>
  <!-- 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/NCT02254902
org study id: ACS-MRSG-13-069
nct id: NCT02254902
lead sponsor: 
collaborator: 
has dmc: No
There is a significant need for culturally adapted and effective health education programs to
      address rising rates of obesity and chronic disease concerns for refugee communities.
      Physical activity has been identified as an important prevention tool to prevent numerous
      chronic health conditions. This research tests the feasibility and acceptability of a
      culturally adapted physical activity intervention for sedentary adult Somali women. Study
      participants will be randomized to a 3-month physical activity program or a wait-list control
      group. The primary outcome is increases in physical activity between baseline and the end of
      the program as measured by pedometer.
Participants in the physical activity program will participate in 12 weekly 1.5-hour sessions
      focused on increasing physical activity. The group sessions will include participating in
      physical activity as well as group discussions on the barriers and opportunities for
      increasing physical activity in their daily life. The 12-week program covers educational
      topics related to physical activity (e.g. overcoming barriers to activity, exercising safely,
      relapse prevention strategies) and the program gradually increases the amount of physical
      activity completed during the group sessions over the course of the 12 weeks. Over a 3-month
      wait period, individuals in the wait-list control group will be offered monthly sessions on
      health and wellness topics before being offered the physical activity program. Measurement
      visits will occur at baseline, at the end of the12-week program, and approximately 12-weeks
      after the end of the intervention. During the measurement sessions participants will complete
      assessments related to their physical activity and other health behaviors.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in physical activity as measured by pedometer from baseline to 3 months
time frame: Baseline and 3 months
arm group label: Physical Activity
arm group type: Experimental
description: Participants in the Physical Activity intervention arm of the study receive culturally-modified, materials through participation in 12 weekly 1-.5-hour sessions focused on increasing daily step counts and bouts of moderate intensity physical activity. The group sessions include participation in different forms of physical activity as well as group discussions on the barriers and opportunities for increasing physical activity in daily life.
arm group label: Wait List Control
arm group type: No Intervention
description: Participants in the Wait List Control will be offered the program after a 3-month wait period. While waiting for the program, participants are offered to attend monthly sessions on various wellness and prevention topics.
intervention type: Behavioral
intervention name: Physical Activity intervention
description: The Physical Activity intervention is a 3-month group-based program based on an efficacious physical activity intervention that has been culturally adapted for use with adult Somali women. The program targets increased physical activity through educational and experiential opportunities.
arm group label: Physical Activity
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kate E Murray, PhD, MPH
role: Principal Investigator
affiliation: University of California, San Diego
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, San Diego
investigator full name: Kate Murray, PhD, MPH
investigator title: Assistant Professor