<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/NCT03028935</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00011637</org_study_id>
    <secondary_id>NCI-2016-01321</secondary_id>
    <secondary_id>IRB00011637</secondary_id>
    <secondary_id>P30CA069533</secondary_id>
    <secondary_id>R03CA197657</secondary_id>
    <nct_id>NCT03028935</nct_id>
  </id_info>
  <brief_title>Exercise and Nutrition Program in Improving Physical Activity and Dietary Behavior in Non-Active, Overweight, or Obese Latinas</brief_title>
  <official_title>Fuerte y Sanas: Exercise and Nutrition Program in Improving Physical Activity and Dietary Behavior in Non-Active, Overweight, or Obese Latinas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OHSU Knight Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>OHSU Knight Cancer Institute</source>
  <brief_summary>
    <textblock>
      This pilot clinical trial studies how well an evidence-based exercise and nutrition program&#xD;
      adapted for Latinas works in improving physical activity and dietary behavior in non-active,&#xD;
      overweight, or obese rural Latinas. An exercise and nutrition program may reduce the risk for&#xD;
      developing certain cancers, obesity, and chronic health conditions in Latinas who are&#xD;
      non-active, overweight, or obese.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Adapt an effective evidence-based exercise and nutrition program to meet the needs of&#xD;
      rural Latinas.&#xD;
&#xD;
      II. Implement the adapted program in a rural Latina population. III. Evaluate feasibility and&#xD;
      potential to improve physical activity and dietary behavior of the adapted program in a rural&#xD;
      Latina population.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Phase I: Create a community advisory board to adapt Strong Women Healthy Hearts Program&#xD;
      (SWHHP) using feedback on the existing SWHHP from Latinas residing in the community.&#xD;
&#xD;
      Phase II: Conduct a small pilot study to assess effectiveness of the adapted program (one&#xD;
      group pre-post design, with data collected at three time points).&#xD;
&#xD;
      INTERVENTION GROUP: Participants undergo instructor-led exercise and nutrition education&#xD;
      classes for 60 minutes each twice a week for 12 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 5, 2016</start_date>
  <completion_date type="Actual">March 19, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2017</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>Change in weight</measure>
    <time_frame>Baseline up to post intervention, up to 7 months</time_frame>
    <description>Mean and standard deviation will be calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in fitness level as assessed by the 6 minute walk test</measure>
    <time_frame>Baseline up to post intervention, up to 7 months</time_frame>
    <description>The distance walked in 6 minutes will be recorded. Mean and standard deviation will be calculated.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Obesity</condition>
  <condition>Overweight</condition>
  <arm_group>
    <arm_group_label>Prevention (exercise, nutrition education program)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise Intervention &amp; Nutritional Intervention. Participants undergo instructor-led exercise and nutrition education classes for 60 minutes twice a week for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise Intervention</intervention_name>
    <description>Undergo instructor-led exercise program</description>
    <arm_group_label>Prevention (exercise, nutrition education program)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nutritional Intervention</intervention_name>
    <description>Undergo instructor-led nutritional education program</description>
    <arm_group_label>Prevention (exercise, nutrition education program)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Phase I:&#xD;
&#xD;
          -  Bilingual Latina&#xD;
&#xD;
          -  Live in the community&#xD;
&#xD;
          -  Phase II:&#xD;
&#xD;
          -  Latina&#xD;
&#xD;
          -  Currently non-active (exercise two days or less per week)&#xD;
&#xD;
          -  Overweight or obese (body mass index [BMI] of 24 or greater)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A medical condition that precludes moderate-vigorous physical activity as determined&#xD;
             by health care provider&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cynthia Perry</last_name>
    <role>Principal Investigator</role>
    <affiliation>OHSU Knight Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OHSU Knight Cancer Institute</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>September 22, 2016</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>June 22, 2018</last_update_submitted>
  <last_update_submitted_qc>June 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>OHSU Knight Cancer Institute</investigator_affiliation>
    <investigator_full_name>Cynthia Perry</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <!-- 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/NCT03028935
org study id: IRB00011637
secondary id: NCI-2016-01321
secondary id: IRB00011637
secondary id: P30CA069533
secondary id: R03CA197657
nct id: NCT03028935
lead sponsor: 
collaborator: 
This pilot clinical trial studies how well an evidence-based exercise and nutrition program
      adapted for Latinas works in improving physical activity and dietary behavior in non-active,
      overweight, or obese rural Latinas. An exercise and nutrition program may reduce the risk for
      developing certain cancers, obesity, and chronic health conditions in Latinas who are
      non-active, overweight, or obese.
PRIMARY OBJECTIVES:

      I. Adapt an effective evidence-based exercise and nutrition program to meet the needs of
      rural Latinas.

      II. Implement the adapted program in a rural Latina population. III. Evaluate feasibility and
      potential to improve physical activity and dietary behavior of the adapted program in a rural
      Latina population.

      OUTLINE:

      Phase I: Create a community advisory board to adapt Strong Women Healthy Hearts Program
      (SWHHP) using feedback on the existing SWHHP from Latinas residing in the community.

      Phase II: Conduct a small pilot study to assess effectiveness of the adapted program (one
      group pre-post design, with data collected at three time points).

      INTERVENTION GROUP: Participants undergo instructor-led exercise and nutrition education
      classes for 60 minutes each twice a week for 12 weeks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in weight
time frame: Baseline up to post intervention, up to 7 months
description: Mean and standard deviation will be calculated.
measure: Change in fitness level as assessed by the 6 minute walk test
time frame: Baseline up to post intervention, up to 7 months
description: The distance walked in 6 minutes will be recorded. Mean and standard deviation will be calculated.
arm group label: Prevention (exercise, nutrition education program)
arm group type: Experimental
description: Exercise Intervention & Nutritional Intervention. Participants undergo instructor-led exercise and nutrition education classes for 60 minutes twice a week for 12 weeks.
intervention type: Behavioral
intervention name: Exercise Intervention
description: Undergo instructor-led exercise program
arm group label: Prevention (exercise, nutrition education program)
intervention type: Behavioral
intervention name: Nutritional Intervention
description: Undergo instructor-led nutritional education program
arm group label: Prevention (exercise, nutrition education program)
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Cynthia Perry
role: Principal Investigator
affiliation: OHSU Knight Cancer Institute
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: OHSU Knight Cancer Institute
investigator full name: Cynthia Perry
investigator title: Principal Investigator
mesh term: Overweight