<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/NCT03041415</url>
  </required_header>
  <id_info>
    <org_study_id>R01CA211048</org_study_id>
    <nct_id>NCT03041415</nct_id>
  </id_info>
  <brief_title>Citizen Science to Promote Sustained Physical Activity in Low-Income Communities</brief_title>
  <official_title>Citizen Science to Promote Sustained Physical Activity in Low-Income Communities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</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>
      While low-income midlife and older adults are disproportionately affected by chronic diseases&#xD;
      that can be alleviated by regular physical activity, few physical activity programs have been&#xD;
      developed specifically with their needs in mind. Those programs that are available typically&#xD;
      do not address the recognized local environmental factors that can impact physical activity.&#xD;
      This research aims to evaluate the added effects on two-year physical activity levels of a&#xD;
      novel citizen science neighborhood engagement program (called Our Voice) when combined with&#xD;
      an evidence-based, individually-focused physical activity program (Active Living Every Day),&#xD;
      relative to the individually-focused program alone. The programs will be delivered in&#xD;
      affordable housing settings, and represent a potentially scalable means for promoting&#xD;
      physical activity across broader income groups in the US.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The major objective of this project is to enhance the potential scalability and&#xD;
      sustainability of person-level physical activity (PA) interventions by leveraging the&#xD;
      capacity of residents themselves as local data gatherers and solution generators for&#xD;
      neighborhood environmental change. The primary aim of the group-randomized trial is to&#xD;
      systematically compare the sustained (two-year) multi-level impacts of a lay&#xD;
      advisor-delivered, person-level PA intervention that has demonstrated efficacy and&#xD;
      translatability (Active Living Every Day) [ALED Alone arm], versus the ALED program in&#xD;
      combination with a novel neighborhood-level intervention, called Our Voice [ALED+Our Voice&#xD;
      arm]. The Our Voice program teaches residents to use a simple mobile application to&#xD;
      individually and collectively identify neighborhood barriers to daily PA. They then convey&#xD;
      this information to local stakeholders and decision-makers in ways that can facilitate&#xD;
      potentially sustainable neighborhood-level improvements in support of regular PA. Up to&#xD;
      sixteen affordable housing sites serving low-income, ethnically diverse midlife and older&#xD;
      adults will be randomized to one of the two interventions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2017</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</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>group-randomized design to either a person-level physical activity intervention alone, or the person-level physical activity intervention plus a citizen science intervention aimed at making the local neighborhood more activity-supportive.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Assessors will not be told the intervention assigned of the participating housing sites</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Weekly Walking Minutes</measure>
    <time_frame>12 months</time_frame>
    <description>Self-report using the Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire. CHAMPS is a self-report physical activity questionnaire that assesses weekly frequency and duration of various activities typically undertaken by midlife and older adults over the prior 4-week period. Self-reported walking for errands is one physical activity item assessed. The measure has been shown to have good test-retest reliability (stability) and construct and concurrent validity, and has been shown to be sensitive to change in a variety of adult populations. It has seven frequency categories (from less than 1 hour a week to 9 or more hours per week). The minimum value is 0 and the maximal value is variable.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total Physical Activity</measure>
    <time_frame>12 months</time_frame>
    <description>Self-report using the Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire. CHAMPS is a self-report physical activity questionnaire that assesses weekly frequency and duration of various activities typically undertaken by midlife and older adults over the prior 4-week period. Self-reported walking for errands is one physical activity item assessed. The measure has been shown to have good test-retest reliability (stability) and construct and concurrent validity, and has been shown to be sensitive to change in a variety of adult populations. It has seven frequency categories (from less than 1 hour a week to 9 or more hours per week). The minimum value is 0 and the maximal value is variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Moderate-to-Vigorous Physical Activity</measure>
    <time_frame>12 months</time_frame>
    <description>Self-report using the Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire, supported via accelerometer (Actigraph). CHAMPS is A self-report physical activity questionnaire that assesses weekly frequency and duration of various activities typically undertaken by midlife and older adults over the prior 4-week period. Self-reported walking for errands is one physical activity item assessed. The measure has been shown to have good test-retest reliability (stability) and construct and concurrent validity, and has been shown to be sensitive to change in a variety of adult populations. It has seven frequency categories (from less than 1 hour a week to 9 or more hours per week). The minimum value is 0 and the maximal value is variable.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>ALED Alone Physical Activity Program</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Active Living Every Day (ALED) comprehensive 12-week PA training and support program is appropriate for delivery by trained instructors from diverse backgrounds.&#xD;
Participants are taught self-regulatory skills aimed at increasing and sustaining regular physical activities such as walking.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ALED + Our Voice PA Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The ALED physical activity program is combined with the Our Voice citizen science engagement program, which teaches participants how to assess the barriers and enablers of neighborhood physical activity using a simple mobile app.&#xD;
Residents then share their data and build consensus around major barriers and potential solutions, which they share with local decision makers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ALED Alone Physical Activity Program</intervention_name>
    <description>• 12-week class focused on teaching self-regulatory skills to increase regular PA</description>
    <arm_group_label>ALED Alone Physical Activity Program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ALED + Our Voice PA Program</intervention_name>
    <description>12-week class focused on teaching self-regulatory skills to increase regular PA&#xD;
Neighborhood assessment, consensus-building, &amp; advocacy program in which participants are taught skills to promote neighborhood-level changes in support of regular Physical activity</description>
    <arm_group_label>ALED + Our Voice PA Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Lives in or around a designated housing site;&#xD;
&#xD;
          -  Is insufficiently physically active based on National guidelines;&#xD;
&#xD;
          -  Can engage in moderate forms of PA such as walking;&#xD;
&#xD;
          -  No plans to move from the area over the 2-year period;&#xD;
&#xD;
          -  Willing to engage in study assessments.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Only one eligible member of a household will be enrolled;&#xD;
&#xD;
          -  Medical conditions which contraindicate participation in regular, unsupervised&#xD;
             moderate-intensity physical activity.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abby C King, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford Prevention Research Center</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305-5705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Stewart AL, Mills KM, King AC, Haskell WL, Gillis D, Ritter PL. CHAMPS physical activity questionnaire for older adults: outcomes for interventions. Med Sci Sports Exerc. 2001 Jul;33(7):1126-41. doi: 10.1097/00005768-200107000-00010.</citation>
    <PMID>11445760</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <results_first_submitted>April 21, 2022</results_first_submitted>
  <results_first_submitted_qc>August 10, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">August 12, 2022</results_first_posted>
  <last_update_submitted>August 10, 2022</last_update_submitted>
  <last_update_submitted_qc>August 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Abby C King</investigator_full_name>
    <investigator_title>Professor of Health Research &amp; Policy and Medicine</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Commensurate with current requirements, once the study data have undergone final data cleaning, analysis, and planned publication, the investigators will make the final data collected as part of the proposed research available in electronic form to researchers who request them. The investigators will request that researchers submit a data request in writing to the project principal investigator so that the requested data can be made available while protecting the confidentiality of study participants. By setting up a centralized data request process, the investigators will be able to provide requestors with information that will help to inform external research groups about duplicate data analysis activities on the part of other research groups related to the data set in question.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 31, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT03041415/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 5, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT03041415/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 31, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT03041415/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were randomized in groups/clusters (affordable housing sites) to receive the assigned interventions.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>ALED Alone Physical Activity (PA) Program</title>
          <description>The Active Living Every Day (ALED) comprehensive 12-week PA training and support program is appropriate for delivery by trained instructors from diverse backgrounds.&#xD;
Participants are taught self-regulatory skills aimed at increasing and sustaining regular physical activities such as walking.&#xD;
ALED Alone Physical Activity Program: • 12-week class focused on teaching self-regulatory skills to increase regular PA</description>
        </group>
        <group group_id="P2">
          <title>ALED + Our Voice PA Program</title>
          <description>The ALED physical activity program is combined with the Our Voice citizen science engagement program, which teaches participants how to assess the barriers and enablers of neighborhood physical activity using a simple mobile app.&#xD;
Residents then share their data and build consensus around major barriers and potential solutions, which they share with local decision makers.&#xD;
ALED + Our Voice PA Program: • 12-week class focused on teaching self-regulatory skills to increase regular PA&#xD;
• Neighborhood assessment, consensus-building, &amp; advocacy program in which participants are taught skills to promote neighborhood-level changes in support of regular Physical activity</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="140"/>
                <participants group_id="P2" count="160"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="123"/>
                <participants group_id="P2" count="145"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>ALED Alone Physical Activity Program</title>
          <description>The Active Living Every Day (ALED) comprehensive 12-week PA training and support program is appropriate for delivery by trained instructors from diverse backgrounds.&#xD;
Participants are taught self-regulatory skills aimed at increasing and sustaining regular physical activities such as walking.&#xD;
ALED Alone Physical Activity Program: • 12-week class focused on teaching self-regulatory skills to increase regular PA</description>
        </group>
        <group group_id="B2">
          <title>ALED + Our Voice PA Program</title>
          <description>The ALED physical activity program is combined with the Our Voice citizen science engagement program, which teaches participants how to assess the barriers and enablers of neighborhood physical activity using a simple mobile app.&#xD;
Residents then share their data and build consensus around major barriers and potential solutions, which they share with local decision makers.&#xD;
ALED + Our Voice PA Program: • 12-week class focused on teaching self-regulatory skills to increase regular PA&#xD;
• Neighborhood assessment, consensus-building, &amp; advocacy program in which participants are taught skills to promote neighborhood-level changes in support of regular Physical activity</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="140"/>
            <count group_id="B2" value="160"/>
            <count group_id="B3" value="300"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="92"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="92"/>
                    <measurement group_id="B2" value="116"/>
                    <measurement group_id="B3" value="208"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69.04" spread="10.91"/>
                    <measurement group_id="B2" value="69.93" spread="9.74"/>
                    <measurement group_id="B3" value="69.52" spread="10.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="102"/>
                    <measurement group_id="B2" value="119"/>
                    <measurement group_id="B3" value="221"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="121"/>
                    <measurement group_id="B2" value="124"/>
                    <measurement group_id="B3" value="245"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="87"/>
                    <measurement group_id="B2" value="88"/>
                    <measurement group_id="B3" value="175"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="140"/>
                    <measurement group_id="B2" value="160"/>
                    <measurement group_id="B3" value="300"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Weekly Walking Minutes</title>
        <description>Self-report using the Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire. CHAMPS is a self-report physical activity questionnaire that assesses weekly frequency and duration of various activities typically undertaken by midlife and older adults over the prior 4-week period. Self-reported walking for errands is one physical activity item assessed. The measure has been shown to have good test-retest reliability (stability) and construct and concurrent validity, and has been shown to be sensitive to change in a variety of adult populations. It has seven frequency categories (from less than 1 hour a week to 9 or more hours per week). The minimum value is 0 and the maximal value is variable.</description>
        <time_frame>12 months</time_frame>
        <population>Participants who completed the protocol are included in the analysis</population>
        <group_list>
          <group group_id="O1">
            <title>ALED Alone Physical Activity Program</title>
            <description>The Active Living Every Day (ALED) comprehensive 12-week PA training and support program is appropriate for delivery by trained instructors from diverse backgrounds.&#xD;
Participants are taught self-regulatory skills aimed at increasing and sustaining regular physical activities such as walking.&#xD;
ALED Alone Physical Activity Program: • 12-week class focused on teaching self-regulatory skills to increase regular PA</description>
          </group>
          <group group_id="O2">
            <title>ALED + Our Voice PA Program</title>
            <description>The ALED physical activity program is combined with the Our Voice citizen science engagement program, which teaches participants how to assess the barriers and enablers of neighborhood physical activity using a simple mobile app.&#xD;
Residents then share their data and build consensus around major barriers and potential solutions, which they share with local decision makers.&#xD;
ALED + Our Voice PA Program: • 12-week class focused on teaching self-regulatory skills to increase regular PA&#xD;
• Neighborhood assessment, consensus-building, &amp; advocacy program in which participants are taught skills to promote neighborhood-level changes in support of regular Physical activity</description>
          </group>
        </group_list>
        <measure>
          <title>Weekly Walking Minutes</title>
          <description>Self-report using the Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire. CHAMPS is a self-report physical activity questionnaire that assesses weekly frequency and duration of various activities typically undertaken by midlife and older adults over the prior 4-week period. Self-reported walking for errands is one physical activity item assessed. The measure has been shown to have good test-retest reliability (stability) and construct and concurrent validity, and has been shown to be sensitive to change in a variety of adult populations. It has seven frequency categories (from less than 1 hour a week to 9 or more hours per week). The minimum value is 0 and the maximal value is variable.</description>
          <population>Participants who completed the protocol are included in the analysis</population>
          <units>minutes/week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="123"/>
                <count group_id="O2" value="145"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="189.5" spread="227.7"/>
                    <measurement group_id="O2" value="206.7" spread="198.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Physical Activity</title>
        <description>Self-report using the Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire. CHAMPS is a self-report physical activity questionnaire that assesses weekly frequency and duration of various activities typically undertaken by midlife and older adults over the prior 4-week period. Self-reported walking for errands is one physical activity item assessed. The measure has been shown to have good test-retest reliability (stability) and construct and concurrent validity, and has been shown to be sensitive to change in a variety of adult populations. It has seven frequency categories (from less than 1 hour a week to 9 or more hours per week). The minimum value is 0 and the maximal value is variable.</description>
        <time_frame>12 months</time_frame>
        <population>Participants who completed the protocol are included in the analysis</population>
        <group_list>
          <group group_id="O1">
            <title>ALED Alone Physical Activity Program</title>
            <description>The Active Living Every Day (ALED) comprehensive 12-week PA training and support program is appropriate for delivery by trained instructors from diverse backgrounds.&#xD;
Participants are taught self-regulatory skills aimed at increasing and sustaining regular physical activities such as walking.&#xD;
ALED Alone Physical Activity Program: • 12-week class focused on teaching self-regulatory skills to increase regular PA</description>
          </group>
          <group group_id="O2">
            <title>ALED + Our Voice PA Program</title>
            <description>The ALED physical activity program is combined with the Our Voice citizen science engagement program, which teaches participants how to assess the barriers and enablers of neighborhood physical activity using a simple mobile app.&#xD;
Residents then share their data and build consensus around major barriers and potential solutions, which they share with local decision makers.&#xD;
ALED + Our Voice PA Program: • 12-week class focused on teaching self-regulatory skills to increase regular PA&#xD;
• Neighborhood assessment, consensus-building, &amp; advocacy program in which participants are taught skills to promote neighborhood-level changes in support of regular Physical activity</description>
          </group>
        </group_list>
        <measure>
          <title>Total Physical Activity</title>
          <description>Self-report using the Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire. CHAMPS is a self-report physical activity questionnaire that assesses weekly frequency and duration of various activities typically undertaken by midlife and older adults over the prior 4-week period. Self-reported walking for errands is one physical activity item assessed. The measure has been shown to have good test-retest reliability (stability) and construct and concurrent validity, and has been shown to be sensitive to change in a variety of adult populations. It has seven frequency categories (from less than 1 hour a week to 9 or more hours per week). The minimum value is 0 and the maximal value is variable.</description>
          <population>Participants who completed the protocol are included in the analysis</population>
          <units>minutes/week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="123"/>
                <count group_id="O2" value="145"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="596.2" spread="443.9"/>
                    <measurement group_id="O2" value="562.0" spread="389.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Moderate-to-Vigorous Physical Activity</title>
        <description>Self-report using the Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire, supported via accelerometer (Actigraph). CHAMPS is A self-report physical activity questionnaire that assesses weekly frequency and duration of various activities typically undertaken by midlife and older adults over the prior 4-week period. Self-reported walking for errands is one physical activity item assessed. The measure has been shown to have good test-retest reliability (stability) and construct and concurrent validity, and has been shown to be sensitive to change in a variety of adult populations. It has seven frequency categories (from less than 1 hour a week to 9 or more hours per week). The minimum value is 0 and the maximal value is variable.</description>
        <time_frame>12 months</time_frame>
        <population>Participants who completed the protocol are included in the analysis</population>
        <group_list>
          <group group_id="O1">
            <title>ALED Alone Physical Activity Program</title>
            <description>The Active Living Every Day (ALED) comprehensive 12-week PA training and support program is appropriate for delivery by trained instructors from diverse backgrounds.&#xD;
Participants are taught self-regulatory skills aimed at increasing and sustaining regular physical activities such as walking.&#xD;
ALED Alone Physical Activity Program: • 12-week class focused on teaching self-regulatory skills to increase regular PA</description>
          </group>
          <group group_id="O2">
            <title>ALED + Our Voice PA Program</title>
            <description>The ALED physical activity program is combined with the Our Voice citizen science engagement program, which teaches participants how to assess the barriers and enablers of neighborhood physical activity using a simple mobile app.&#xD;
Residents then share their data and build consensus around major barriers and potential solutions, which they share with local decision makers.&#xD;
ALED + Our Voice PA Program: • 12-week class focused on teaching self-regulatory skills to increase regular PA&#xD;
• Neighborhood assessment, consensus-building, &amp; advocacy program in which participants are taught skills to promote neighborhood-level changes in support of regular Physical activity</description>
          </group>
        </group_list>
        <measure>
          <title>Moderate-to-Vigorous Physical Activity</title>
          <description>Self-report using the Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire, supported via accelerometer (Actigraph). CHAMPS is A self-report physical activity questionnaire that assesses weekly frequency and duration of various activities typically undertaken by midlife and older adults over the prior 4-week period. Self-reported walking for errands is one physical activity item assessed. The measure has been shown to have good test-retest reliability (stability) and construct and concurrent validity, and has been shown to be sensitive to change in a variety of adult populations. It has seven frequency categories (from less than 1 hour a week to 9 or more hours per week). The minimum value is 0 and the maximal value is variable.</description>
          <population>Participants who completed the protocol are included in the analysis</population>
          <units>minutes/week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="123"/>
                <count group_id="O2" value="145"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117.4" spread="232.6"/>
                    <measurement group_id="O2" value="108.8" spread="139.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>24 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>ALED Alone Physical Activity Program</title>
          <description>The Active Living Every Day (ALED) comprehensive 12-week PA training and support program is appropriate for delivery by trained instructors from diverse backgrounds.&#xD;
Participants are taught self-regulatory skills aimed at increasing and sustaining regular physical activities such as walking.&#xD;
ALED Alone Physical Activity Program: • 12-week class focused on teaching self-regulatory skills to increase regular PA</description>
        </group>
        <group group_id="E2">
          <title>ALED + Our Voice PA Program</title>
          <description>The ALED physical activity program is combined with the Our Voice citizen science engagement program, which teaches participants how to assess the barriers and enablers of neighborhood physical activity using a simple mobile app.&#xD;
Residents then share their data and build consensus around major barriers and potential solutions, which they share with local decision makers.&#xD;
ALED + Our Voice PA Program: • 12-week class focused on teaching self-regulatory skills to increase regular PA&#xD;
• Neighborhood assessment, consensus-building, &amp; advocacy program in which participants are taught skills to promote neighborhood-level changes in support of regular Physical activity</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Principal Investigator</name_or_title>
      <organization>Stanford University</organization>
      <phone>6507235082</phone>
      <email>king@stanford.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03041415
org study id: R01CA211048
nct id: NCT03041415
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
While low-income midlife and older adults are disproportionately affected by chronic diseases
      that can be alleviated by regular physical activity, few physical activity programs have been
      developed specifically with their needs in mind. Those programs that are available typically
      do not address the recognized local environmental factors that can impact physical activity.
      This research aims to evaluate the added effects on two-year physical activity levels of a
      novel citizen science neighborhood engagement program (called Our Voice) when combined with
      an evidence-based, individually-focused physical activity program (Active Living Every Day),
      relative to the individually-focused program alone. The programs will be delivered in
      affordable housing settings, and represent a potentially scalable means for promoting
      physical activity across broader income groups in the US.
The major objective of this project is to enhance the potential scalability and
      sustainability of person-level physical activity (PA) interventions by leveraging the
      capacity of residents themselves as local data gatherers and solution generators for
      neighborhood environmental change. The primary aim of the group-randomized trial is to
      systematically compare the sustained (two-year) multi-level impacts of a lay
      advisor-delivered, person-level PA intervention that has demonstrated efficacy and
      translatability (Active Living Every Day) [ALED Alone arm], versus the ALED program in
      combination with a novel neighborhood-level intervention, called Our Voice [ALED+Our Voice
      arm]. The Our Voice program teaches residents to use a simple mobile application to
      individually and collectively identify neighborhood barriers to daily PA. They then convey
      this information to local stakeholders and decision-makers in ways that can facilitate
      potentially sustainable neighborhood-level improvements in support of regular PA. Up to
      sixteen affordable housing sites serving low-income, ethnically diverse midlife and older
      adults will be randomized to one of the two interventions.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: group-randomized design to either a person-level physical activity intervention alone, or the person-level physical activity intervention plus a citizen science intervention aimed at making the local neighborhood more activity-supportive.
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: Assessors will not be told the intervention assigned of the participating housing sites
measure: Weekly Walking Minutes
time frame: 12 months
description: Self-report using the Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire. CHAMPS is a self-report physical activity questionnaire that assesses weekly frequency and duration of various activities typically undertaken by midlife and older adults over the prior 4-week period. Self-reported walking for errands is one physical activity item assessed. The measure has been shown to have good test-retest reliability (stability) and construct and concurrent validity, and has been shown to be sensitive to change in a variety of adult populations. It has seven frequency categories (from less than 1 hour a week to 9 or more hours per week). The minimum value is 0 and the maximal value is variable.
measure: Total Physical Activity
time frame: 12 months
description: Self-report using the Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire. CHAMPS is a self-report physical activity questionnaire that assesses weekly frequency and duration of various activities typically undertaken by midlife and older adults over the prior 4-week period. Self-reported walking for errands is one physical activity item assessed. The measure has been shown to have good test-retest reliability (stability) and construct and concurrent validity, and has been shown to be sensitive to change in a variety of adult populations. It has seven frequency categories (from less than 1 hour a week to 9 or more hours per week). The minimum value is 0 and the maximal value is variable.
measure: Moderate-to-Vigorous Physical Activity
time frame: 12 months
description: Self-report using the Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire, supported via accelerometer (Actigraph). CHAMPS is A self-report physical activity questionnaire that assesses weekly frequency and duration of various activities typically undertaken by midlife and older adults over the prior 4-week period. Self-reported walking for errands is one physical activity item assessed. The measure has been shown to have good test-retest reliability (stability) and construct and concurrent validity, and has been shown to be sensitive to change in a variety of adult populations. It has seven frequency categories (from less than 1 hour a week to 9 or more hours per week). The minimum value is 0 and the maximal value is variable.
arm group label: ALED Alone Physical Activity Program
arm group type: Active Comparator
description: The Active Living Every Day (ALED) comprehensive 12-week PA training and support program is appropriate for delivery by trained instructors from diverse backgrounds.
Participants are taught self-regulatory skills aimed at increasing and sustaining regular physical activities such as walking.
arm group label: ALED + Our Voice PA Program
arm group type: Experimental
description: The ALED physical activity program is combined with the Our Voice citizen science engagement program, which teaches participants how to assess the barriers and enablers of neighborhood physical activity using a simple mobile app.
Residents then share their data and build consensus around major barriers and potential solutions, which they share with local decision makers.
intervention type: Behavioral
intervention name: ALED Alone Physical Activity Program
description: • 12-week class focused on teaching self-regulatory skills to increase regular PA
arm group label: ALED Alone Physical Activity Program
intervention type: Behavioral
intervention name: ALED + Our Voice PA Program
description: 12-week class focused on teaching self-regulatory skills to increase regular PA
Neighborhood assessment, consensus-building, & advocacy program in which participants are taught skills to promote neighborhood-level changes in support of regular Physical activity
arm group label: ALED + Our Voice PA Program
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Abby C King, PhD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
citation: Stewart AL, Mills KM, King AC, Haskell WL, Gillis D, Ritter PL. CHAMPS physical activity questionnaire for older adults: outcomes for interventions. Med Sci Sports Exerc. 2001 Jul;33(7):1126-41. doi: 10.1097/00005768-200107000-00010.
PMID: 11445760
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Abby C King
investigator title: Professor of Health Research & Policy and Medicine
sharing ipd: Yes
ipd description: Commensurate with current requirements, once the study data have undergone final data cleaning, analysis, and planned publication, the investigators will make the final data collected as part of the proposed research available in electronic form to researchers who request them. The investigators will request that researchers submit a data request in writing to the project principal investigator so that the requested data can be made available while protecting the confidentiality of study participants. By setting up a centralized data request process, the investigators will be able to provide requestors with information that will help to inform external research groups about duplicate data analysis activities on the part of other research groups related to the data set in question.
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 