<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/NCT01707693</url>
  </required_header>
  <id_info>
    <org_study_id>135603</org_study_id>
    <nct_id>NCT01707693</nct_id>
  </id_info>
  <brief_title>A Lifestyle Physical Activity Intervention for Older Sedentary Women</brief_title>
  <acronym>LPAW</acronym>
  <official_title>A Lifestyle Physical Activity Intervention for Older Sedentary Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arkansas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Arkansas</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Making physical activity an integral part of daily life is imperative to the health and&#xD;
      well-being of our nation's older adults. However, no intervention strategy to encourage daily&#xD;
      physical activity for older adults, especially older women, has been effective. This&#xD;
      feasibility study will test a multi-tailored motivational intervention to increase usual&#xD;
      lifestyle physical activity of older sedentary women to reduce their coronary heart disease&#xD;
      risks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Over 98% of older women do not meet national guidelines for physical activity (PA). There is&#xD;
      clear evidence that a physically active lifestyle reduces the human and economic cost of&#xD;
      heart disease in a dose-response relationship; but current efforts to increase long-term PA&#xD;
      in older women are inadequate. The aims of this proposed research are to: 1) determine the&#xD;
      feasibility of using an individually tailored motivational counseling intervention method to&#xD;
      promote lifestyle physical activity (LPA) in older sedentary women; 2) examine intervention&#xD;
      effects by comparing baseline to outcome measures at 3 and 6 months in treatment and&#xD;
      information/attention comparison groups; and 3) explore stage of behavior change and&#xD;
      self-efficacy and their relationship to LPA, along with functional health.&#xD;
&#xD;
      This will be a single blinded randomized controlled study of sedentary women aged 60 years&#xD;
      and older. We will replace &quot;structured aerobic exercise&quot; with lifestyle physical activity&#xD;
      (LPA), i.e., self-selected activities performed daily in a purposeful manner to meet the&#xD;
      national PA guidelines. A total of 120 older women who are ambulatory and cognitively intact&#xD;
      will be recruited from a senior health clinic and randomized to receive either the&#xD;
      motivational LPA intervention or information/attention. Women will be assessed at baseline, 3&#xD;
      and 6 months. The theoretically based behavioral intervention is derived from the&#xD;
      Transtheoretical Model and other evidence-based physical activity research. We will use a&#xD;
      Motivational Interviewing counseling technique delivered by a social worker to individually&#xD;
      tailor the LPA intervention to participant preferences, taking into consideration their&#xD;
      functional ability and need for information, readiness to change, and self-efficacy. Outcomes&#xD;
      of the LPA intervention sessions will include tailored goals and an LPA plan. Intervention&#xD;
      participants will also receive the newly developed NIA &quot;Exercise &amp; You&quot; LPA informational&#xD;
      booklet with companion digital video disc (DVD) as well as motivational coaching via&#xD;
      telephone calls, tapering in frequency for 6 months. The control group will receive the NIA&#xD;
      LPA booklet with DVD and attention telephone calls. We will assess changes from baseline in&#xD;
      LPA (primary outcome), readiness to change, self-efficacy and function (secondary outcomes)&#xD;
      and examine the associations between primary and secondary outcomes in both groups. The&#xD;
      allied disciplines of Nursing, Gerontology, Social Work, and Medicine will collaborate to&#xD;
      promote PA and cardiovascular health of older women. Undergraduate and graduate student&#xD;
      research assistants will contribute to this project. This research has the potential to&#xD;
      increase PA of sedentary older women and reduce coronary heart disease risks. If we could&#xD;
      increase physical activity in our rapidly growing older population -even modestly, we could&#xD;
      make a significant impact to the health of our nation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 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>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Accelerometer Vector Magnitude Counts</measure>
    <time_frame>3 and 6 months</time_frame>
    <description>motion data counts calculated from three axes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Step of Counts (Per Day)</measure>
    <time_frame>3 and 6 months</time_frame>
    <description>Number of steps that a person takes per day</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Self-Efficacy</measure>
    <time_frame>Baseline, 3mths, 6mths</time_frame>
    <description>Self-Efficacy for Exercise Scale used to estimate the strength of self-efficacy beliefs; The tool contains 9 items with an 0-10 answer format from &quot;Not Confident to Very Confident&quot; and summed numerical ratings; higher scores indicate greater self-efficacy.</description>
  </other_outcome>
  <other_outcome>
    <measure>Stage of Change (SOC)</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>Exercise Stage of Change information on how ready an individual is to make a change related to participating in physical activity. It consists of four questions (Yes or No response format) in which the individual is rated on current stage of change</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">121</enrollment>
  <condition>Coronary Heart Disease</condition>
  <arm_group>
    <arm_group_label>Lifestyle Physical Activity Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the women will be randomized to either the LPA Intervention or Information/Attention Comparison groups using a permuted block randomization scheme. Participants in both groups will be followed longitudinally with repeated assessments of LPA (accelerometer &amp; LPA diary), stage of change, and self-efficacy at baseline and 3 and 6 months; and functional health and well-being (SF36) at baseline and 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Information/Attention Comparison</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>the women will be randomized to either the LPA Intervention or Information/Attention Comparison groups using a permuted block randomization scheme. Participants in both groups will be followed longitudinally with repeated assessments of LPA (accelerometer &amp; LPA diary), stage of change, and self-efficacy at baseline and 3 and 6 months; and functional health and well-being (SF36) at baseline and 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lifestyle Physical Activity Intervention</intervention_name>
    <description>Physical Activity Information given plus Behavioral counseling using motivational interviewing &amp; follow-up</description>
    <arm_group_label>Lifestyle Physical Activity Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Information / Attention Comparison</intervention_name>
    <description>Physical Activity information given &amp; follow-up, no behavioral counseling</description>
    <arm_group_label>Information/Attention Comparison</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women &gt; 60 years of age who are Senior Health clinic patients&#xD;
&#xD;
          -  health care provider's approval to participate&#xD;
&#xD;
          -  ability to speak/read English&#xD;
&#xD;
          -  access to a telephone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  report participation in a regular physical activity program&#xD;
&#xD;
          -  report an unresolved acute illness, such as pneumonia or flu&#xD;
&#xD;
          -  fail screening for capacity to provide informed consent&#xD;
&#xD;
          -  fail a simple functional screen or are currently nonambulatory&#xD;
&#xD;
          -  are unable to complete activities of daily living&#xD;
&#xD;
          -  have uncorrectable severe hearing or vision deficits&#xD;
&#xD;
          -  have a history of falls in the past 3 months&#xD;
&#xD;
          -  have other unforeseen pathology that precludes safe participation&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leanne L Lefler, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Arkansas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Arkansas for Medical Sciences</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>October 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <results_first_submitted>June 20, 2019</results_first_submitted>
  <results_first_submitted_qc>September 24, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 11, 2019</results_first_posted>
  <last_update_submitted>September 24, 2019</last_update_submitted>
  <last_update_submitted_qc>September 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>physical activity</keyword>
  <keyword>prevention</keyword>
  <keyword>coronary heart disease</keyword>
  <keyword>women</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Physical Activity Motivational Interviewing Counseling INTERV</title>
          <description>Received educational material on physical activity from the NIH (Physical Activity &amp; You booklet and Go4Life DVD) Received motivational interviewing behavioral counseling intervention times 2 in month Received motivational interviewing counseling and follow-up over the telephone for 6 months, decreasing in frequency.&#xD;
This is the active intervention group</description>
        </group>
        <group group_id="P2">
          <title>Information/Attention Without Counseling CONTROL</title>
          <description>Received informational/educational material on physical activity from the NIH (Physical Activity &amp; You booklet and Go4Life DVD) Received attention phone calls and follow up over 6 months with theme of &quot;overall health&quot; (without counseling).&#xD;
This is the Control Group</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study Allocation</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="59"/>
                <participants group_id="P2" count="62"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
                <participants group_id="P2" count="54"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Time 3 Measures @ 6 Mth</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
                <participants group_id="P2" count="54"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
                <participants group_id="P2" count="49"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Lifestyle Physical Activity Intervention</title>
          <description>the women will be randomized to either the LPA Intervention (n=60) or Information/Attention Comparison (I/A, n=60) groups using a permuted block randomization scheme. Participants in both groups will be followed longitudinally with repeated assessments of LPA (accelerometer &amp; LPA diary), stage of change, and self-efficacy at baseline and 3 and 6 months; and functional health and well-being (SF36) at baseline and 6 months.&#xD;
Lifestyle Physical Activity Intervention: Behavioral counseling</description>
        </group>
        <group group_id="B2">
          <title>Information/Attention Comparison</title>
          <description>the women will be randomized to either the LPA Intervention (n=60) or Information/Attention Comparison (I/A, n=60) groups using a permuted block randomization scheme. Participants in both groups will be followed longitudinally with repeated assessments of LPA (accelerometer &amp; LPA diary), stage of change, and self-efficacy at baseline and 3 and 6 months; and functional health and well-being (SF36) at baseline and 6 months.&#xD;
Information / Attention Comparison: Information and attention comparison</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="59"/>
            <count group_id="B2" value="62"/>
            <count group_id="B3" value="121"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="69.9" spread="6.1"/>
                    <measurement group_id="B2" value="68.3" spread="6.8"/>
                    <measurement group_id="B3" value="69.1" spread="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="121"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</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>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="17"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="77"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </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>Total Household Yearly Income</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;10K</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>10-20K</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>20K-30K</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>30K-40K</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>40-50K</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;50K</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Refused/DK</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>My living status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Married (live with spouse)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Live alone</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Live with children/relative/friend</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Highest Grade Level</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade School</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>Some HS</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>HS Graduate/GED</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Vocation or Trade School</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Some College</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>College Graduate</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Graduate School</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of people in household</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>0</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoker Category</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>1_Current Smoker</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2_Past Smoker</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3_Non-Smoker, with 2nd-Hand Exposure</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4_Non-Smoker, without 2nd-Hand Exposure</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cardiovascular Disease History</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of High Blood Pressure</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="86"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of Diabetes/Borderline Diabetes</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Heart Diseases/Angina</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="110"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Peripheral Vascular Diseases (Poor Circulation)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Kidney or Renal Failure</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="119"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stroke</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</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>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Abdominal Aortic Aneurysm</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>High Cholesterol</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>No History of Relevant Issues</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Family hx: heart attack or stroke</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Family hx: High Blood Pressure</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="91"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Follows heart-healthy or low fat/sodium diet</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cholesterol check in last 2 years</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="113"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>DK</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Currently works outside the home</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>employment status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>No/Not Answered for 1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="84"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Part time</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Full time (40 hours/week)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Major provider of care for another person</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Accelerometer Vector Magnitude Counts</title>
        <description>motion data counts calculated from three axes</description>
        <time_frame>3 and 6 months</time_frame>
        <population>Number of participants with completed data</population>
        <group_list>
          <group group_id="O1">
            <title>Physical Activity Motivational Interviewing Counseling INTERV</title>
            <description>Received educational material on physical activity from the NIH (Physical Activity &amp; You booklet and Go4Life DVD) Received motivational interviewing behavioral counseling intervention times 2 in month Received motivational interviewing counseling and follow-up over the telephone for 6 months, decreasing in frequency.&#xD;
This is the active intervention group</description>
          </group>
          <group group_id="O2">
            <title>Information/Attention Without Counseling CONTROL</title>
            <description>Received informational/educational material on physical activity from the NIH (Physical Activity &amp; You booklet and Go4Life DVD) Received attention phone calls and follow up over 6 months with theme of &quot;overall health&quot; (without counseling).&#xD;
This is the Control Group</description>
          </group>
        </group_list>
        <measure>
          <title>Accelerometer Vector Magnitude Counts</title>
          <description>motion data counts calculated from three axes</description>
          <population>Number of participants with completed data</population>
          <units>Vector Magnitude Counts</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="345,000" lower_limit="263,000" upper_limit="439,000"/>
                    <measurement group_id="O2" value="324,000" lower_limit="241,000" upper_limit="411,000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="324,000" lower_limit="256,000" upper_limit="438,000"/>
                    <measurement group_id="O2" value="309,000" lower_limit="243,000" upper_limit="364,000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>repeated measures mixed model analysis of covariance, with the baseline measurement as a covariate.</non_inferiority_desc>
            <p_value>0.023</p_value>
            <p_value_desc>P-value calculated from repeated measures model adjusting for age with a log transformation applied. P-values are one-sided.</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Step of Counts (Per Day)</title>
        <description>Number of steps that a person takes per day</description>
        <time_frame>3 and 6 months</time_frame>
        <population>Attrition of 5 participants</population>
        <group_list>
          <group group_id="O1">
            <title>Physical Activity Motivational Interviewing Counseling INTERV</title>
            <description>Received educational material on physical activity from the NIH (Physical Activity &amp; You booklet and Go4Life DVD) Received motivational interviewing behavioral counseling intervention times 2 in month Received motivational interviewing counseling and follow-up over the telephone for 6 months, decreasing in frequency.&#xD;
This is the active intervention group</description>
          </group>
          <group group_id="O2">
            <title>Information/Attention Without Counseling CONTROL</title>
            <description>Received informational/educational material on physical activity from the NIH (Physical Activity &amp; You booklet and Go4Life DVD) Received attention phone calls and follow up over 6 months with theme of &quot;overall health&quot; (without counseling).&#xD;
This is the Control Group</description>
          </group>
        </group_list>
        <measure>
          <title>Step of Counts (Per Day)</title>
          <description>Number of steps that a person takes per day</description>
          <population>Attrition of 5 participants</population>
          <units>Steps per day</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>3 month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3982" lower_limit="2787" upper_limit="5157"/>
                    <measurement group_id="O2" value="3476" lower_limit="2691" upper_limit="4683"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3783" lower_limit="2840" upper_limit="4727"/>
                    <measurement group_id="O2" value="3160" lower_limit="2634" upper_limit="3891"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.011</p_value>
            <p_value_desc>* P-value calculated from repeated measures model adjusting for age with a log transformation applied.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>* P-value calculated from repeated measures model adjusting for age with a log transformation applied.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Self-Efficacy</title>
        <description>Self-Efficacy for Exercise Scale used to estimate the strength of self-efficacy beliefs; The tool contains 9 items with an 0-10 answer format from &quot;Not Confident to Very Confident&quot; and summed numerical ratings; higher scores indicate greater self-efficacy.</description>
        <time_frame>Baseline, 3mths, 6mths</time_frame>
        <population>8 participants withdrew from the control group and 13 withdrew from the PA intervention at 3 months. At 6 months 5 participants withdrew from the control group and no withdrawals from the PA intervention group</population>
        <group_list>
          <group group_id="O1">
            <title>Physical Activity Motivational Interviewing Counseling INTERV</title>
            <description>Received educational material on physical activity from the NIH (Physical Activity &amp; You booklet and Go4Life DVD) Received motivational interviewing behavioral counseling intervention times 2 in month Received motivational interviewing counseling and follow-up over the telephone for 6 months, decreasing in frequency.&#xD;
This is the active intervention group</description>
          </group>
          <group group_id="O2">
            <title>Information/Attention Without Counseling CONTROL</title>
            <description>Received informational/educational material on physical activity from the NIH (Physical Activity &amp; You booklet and Go4Life DVD) Received attention phone calls and follow up over 6 months with theme of &quot;overall health&quot; (without counseling).&#xD;
This is the Control Group</description>
          </group>
        </group_list>
        <measure>
          <title>Self-Efficacy</title>
          <description>Self-Efficacy for Exercise Scale used to estimate the strength of self-efficacy beliefs; The tool contains 9 items with an 0-10 answer format from &quot;Not Confident to Very Confident&quot; and summed numerical ratings; higher scores indicate greater self-efficacy.</description>
          <population>8 participants withdrew from the control group and 13 withdrew from the PA intervention at 3 months. At 6 months 5 participants withdrew from the control group and no withdrawals from the PA intervention group</population>
          <units>mean score on a (0-10) scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.8" spread="2.4"/>
                    <measurement group_id="O2" value="7.0" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7" spread="1.5"/>
                    <measurement group_id="O2" value="5.9" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6- month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.2" spread="2.3"/>
                    <measurement group_id="O2" value="5.9" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>2-sided Wilcoxon Rank Sum test</non_inferiority_desc>
            <p_value>0.033</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Stage of Change (SOC)</title>
        <description>Exercise Stage of Change information on how ready an individual is to make a change related to participating in physical activity. It consists of four questions (Yes or No response format) in which the individual is rated on current stage of change</description>
        <time_frame>Baseline, 3 and 6 months</time_frame>
        <population>8 participants withdrew from the control group and 13 withdrew from the PA intervention at 3 months. At 6 months 5 participants withdrew from the control group and no withdrawals from the PA intervention group</population>
        <group_list>
          <group group_id="O1">
            <title>Physical Activity Motivational Interviewing Counseling INTERV</title>
            <description>Received educational material on physical activity from the NIH (Physical Activity &amp; You booklet and Go4Life DVD) Received motivational interviewing behavioral counseling intervention times 2 in month Received motivational interviewing counseling and follow-up over the telephone for 6 months, decreasing in frequency.&#xD;
This is the active intervention group</description>
          </group>
          <group group_id="O2">
            <title>Information/Attention Without Counseling CONTROL</title>
            <description>Information/Attention without Counseling CONTROL Received informational/educational material on physical activity from the NIH (Physical Activity &amp; You booklet and Go4Life DVD) Received attention phone calls and follow up over 6 months with theme of &quot;overall health&quot; (without counseling).&#xD;
This is the Control Group</description>
          </group>
        </group_list>
        <measure>
          <title>Stage of Change (SOC)</title>
          <description>Exercise Stage of Change information on how ready an individual is to make a change related to participating in physical activity. It consists of four questions (Yes or No response format) in which the individual is rated on current stage of change</description>
          <population>8 participants withdrew from the control group and 13 withdrew from the PA intervention at 3 months. At 6 months 5 participants withdrew from the control group and no withdrawals from the PA intervention group</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline SOC</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Pre-Contemplation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Contemplation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Preparation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Action</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Maintenance</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Month SOC</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Pre-Contemplation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Contemplation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Preparation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Action</title>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Maintenance</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 month SOC</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Pre-Contemplation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Contemplation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Preparation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Action</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Maintenance</title>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>counts of stage of change</non_inferiority_desc>
            <p_value>.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>2-sided Cochran-Armitage trend test</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From enrollment to 3 months to 6 months</time_frame>
      <desc>Staff assessed presence of adverse events via regular contact with participants from both study arms throughout the duration of the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Physical Activitiy Motiviational Interviewing Counseling INTER</title>
          <description>Received educational material on physical activity from the NIH (Physical Activity &amp; You booklet and Go4Life DVD) Received motivational interviewing behavioral counseling intervention times 2 in month Received motivational interviewing counseling and follow-up over the telephone for 6 months, decreasing in frequency.&#xD;
This is the active intervention group</description>
        </group>
        <group group_id="E2">
          <title>Information/Attention Without Counseling CONTROL</title>
          <description>Received informational/educational material on physical activity from the NIH (Physical Activity &amp; You booklet and Go4Life DVD) Received attention phone calls and follow up over 6 months with theme of &quot;overall health&quot; (without counseling).&#xD;
This is the Control Group</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="59"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Back Injury</sub_title>
                <description>Patient was diagnosed with L1 compression fracture &amp; underwent vertebroplasty. Past medical history of osteoporosis. Chart review did not support that compression fracture was related to study activities (control group)</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </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="59"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </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>Leanne L. Lefler, PhD, APN, RN Principal Investigator</name_or_title>
      <organization>University of Arkansas for Medical Sciences</organization>
      <phone>5012961939</phone>
      <email>LeflerLeanne@uams.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/NCT01707693
org study id: 135603
nct id: NCT01707693
lead sponsor: 
has dmc: Yes
Making physical activity an integral part of daily life is imperative to the health and
      well-being of our nation's older adults. However, no intervention strategy to encourage daily
      physical activity for older adults, especially older women, has been effective. This
      feasibility study will test a multi-tailored motivational intervention to increase usual
      lifestyle physical activity of older sedentary women to reduce their coronary heart disease
      risks.
Over 98% of older women do not meet national guidelines for physical activity (PA). There is
      clear evidence that a physically active lifestyle reduces the human and economic cost of
      heart disease in a dose-response relationship; but current efforts to increase long-term PA
      in older women are inadequate. The aims of this proposed research are to: 1) determine the
      feasibility of using an individually tailored motivational counseling intervention method to
      promote lifestyle physical activity (LPA) in older sedentary women; 2) examine intervention
      effects by comparing baseline to outcome measures at 3 and 6 months in treatment and
      information/attention comparison groups; and 3) explore stage of behavior change and
      self-efficacy and their relationship to LPA, along with functional health.

      This will be a single blinded randomized controlled study of sedentary women aged 60 years
      and older. We will replace "structured aerobic exercise" with lifestyle physical activity
      (LPA), i.e., self-selected activities performed daily in a purposeful manner to meet the
      national PA guidelines. A total of 120 older women who are ambulatory and cognitively intact
      will be recruited from a senior health clinic and randomized to receive either the
      motivational LPA intervention or information/attention. Women will be assessed at baseline, 3
      and 6 months. The theoretically based behavioral intervention is derived from the
      Transtheoretical Model and other evidence-based physical activity research. We will use a
      Motivational Interviewing counseling technique delivered by a social worker to individually
      tailor the LPA intervention to participant preferences, taking into consideration their
      functional ability and need for information, readiness to change, and self-efficacy. Outcomes
      of the LPA intervention sessions will include tailored goals and an LPA plan. Intervention
      participants will also receive the newly developed NIA "Exercise & You" LPA informational
      booklet with companion digital video disc (DVD) as well as motivational coaching via
      telephone calls, tapering in frequency for 6 months. The control group will receive the NIA
      LPA booklet with DVD and attention telephone calls. We will assess changes from baseline in
      LPA (primary outcome), readiness to change, self-efficacy and function (secondary outcomes)
      and examine the associations between primary and secondary outcomes in both groups. The
      allied disciplines of Nursing, Gerontology, Social Work, and Medicine will collaborate to
      promote PA and cardiovascular health of older women. Undergraduate and graduate student
      research assistants will contribute to this project. This research has the potential to
      increase PA of sedentary older women and reduce coronary heart disease risks. If we could
      increase physical activity in our rapidly growing older population -even modestly, we could
      make a significant impact to the health of our nation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Accelerometer Vector Magnitude Counts
time frame: 3 and 6 months
description: motion data counts calculated from three axes
measure: Step of Counts (Per Day)
time frame: 3 and 6 months
description: Number of steps that a person takes per day
measure: Self-Efficacy
time frame: Baseline, 3mths, 6mths
description: Self-Efficacy for Exercise Scale used to estimate the strength of self-efficacy beliefs; The tool contains 9 items with an 0-10 answer format from "Not Confident to Very Confident" and summed numerical ratings; higher scores indicate greater self-efficacy.
measure: Stage of Change (SOC)
time frame: Baseline, 3 and 6 months
description: Exercise Stage of Change information on how ready an individual is to make a change related to participating in physical activity. It consists of four questions (Yes or No response format) in which the individual is rated on current stage of change
arm group label: Lifestyle Physical Activity Intervention
arm group type: Experimental
description: the women will be randomized to either the LPA Intervention or Information/Attention Comparison groups using a permuted block randomization scheme. Participants in both groups will be followed longitudinally with repeated assessments of LPA (accelerometer & LPA diary), stage of change, and self-efficacy at baseline and 3 and 6 months; and functional health and well-being (SF36) at baseline and 6 months.
arm group label: Information/Attention Comparison
arm group type: Active Comparator
description: the women will be randomized to either the LPA Intervention or Information/Attention Comparison groups using a permuted block randomization scheme. Participants in both groups will be followed longitudinally with repeated assessments of LPA (accelerometer & LPA diary), stage of change, and self-efficacy at baseline and 3 and 6 months; and functional health and well-being (SF36) at baseline and 6 months.
intervention type: Behavioral
intervention name: Lifestyle Physical Activity Intervention
description: Physical Activity Information given plus Behavioral counseling using motivational interviewing & follow-up
arm group label: Lifestyle Physical Activity Intervention
intervention type: Behavioral
intervention name: Information / Attention Comparison
description: Physical Activity information given & follow-up, no behavioral counseling
arm group label: Information/Attention Comparison
criteria: 
gender: Female
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Leanne L Lefler, PhD
role: Principal Investigator
affiliation: University of Arkansas
facility: 
country: United States
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Coronary Disease
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 