<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/NCT01700894</url>
  </required_header>
  <id_info>
    <org_study_id>09021301-IRB01</org_study_id>
    <secondary_id>R01NR004134</secondary_id>
    <nct_id>NCT01700894</nct_id>
  </id_info>
  <brief_title>Women's Walking Program</brief_title>
  <acronym>WWP3</acronym>
  <official_title>Reducing Health Disparities in African American Women: Lifestyle Physical Activity Adherence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rush University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Nursing Research (NINR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Rush University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      African American (AA) women have the lowest physical activity (PA) levels, which contributes&#xD;
      to substantial disparities in cardiovascular health and depressive symptoms. There is a need&#xD;
      to examine ways to promote PA that are appealing, applicable to clinical practice, and&#xD;
      cost-effective. The purpose of this clinical trial is to test the efficacy of the Women's&#xD;
      Walking Program (WWP), consisting of a lifestyle PA prescription and &quot;group visit&quot; delivery&#xD;
      model, with or without tailored telephone contacts between group visits for increasing&#xD;
      adherence to PA and improving health outcomes. Two telephone contact strategies will be&#xD;
      compared against a no-telephone control condition: a person-administered contact strategy&#xD;
      using brief motivational interviewing and an automated contact strategy using a telephone&#xD;
      computer-linked system. Group visits and telephone contacts are designed to increase&#xD;
      adherence to lifestyle PA with an emphasis on accumulation of 3,000 steps daily over&#xD;
      baseline. The aims of this study are (1) to compare the initial (adoption 24 weeks) and&#xD;
      longer-term (maintenance 2nd 24 weeks) effectiveness of the WWP plus person-administered&#xD;
      telephone contacts, WWP plus automated telephone contacts, and the WWP without telephone&#xD;
      contacts on (a) increasing adherence to lifestyle PA, (b) improving health outcomes (aerobic&#xD;
      fitness, body composition, depressive symptoms), (c) improving self-efficacy (confidence in&#xD;
      one's ability to be physically active) and outcome expectations (expected benefits to being&#xD;
      more active); and (2) to compare cost-effectiveness of the three telephone treatment&#xD;
      conditions in relation to adherence to lifestyle PA and health outcomes.&#xD;
&#xD;
      The investigators will randomly assignment of the order of administering the three conditions&#xD;
      to six community health care sites. These six sites are similar with respect to race,&#xD;
      socioeconomic status, and residential mobility. The study will include 288 sedentary AA women&#xD;
      aged 40 to 65 years who have no major signs or symptoms of cardiovascular disease (CVD); no&#xD;
      history of myocardial infarction, stroke, or diabetics with elevated HgA1c; BP &lt; 160/100.&#xD;
&#xD;
      Initial screening will occur in person or over the phone. Further screening at the data&#xD;
      collection site with an advanced practice nurse will include blood work for glucose and&#xD;
      lipoproteins, a history and physical, and resting EKG. At baseline, 24 and 48 weeks all women&#xD;
      who are eligible will: be given questionnaires on physical activity, health and factors that&#xD;
      influence their physical activity; have their height, weight, waist circumference measured;&#xD;
      and do a two minute step test. All three treatment group will attend 5 group visits every 5&#xD;
      weeks during adoption (first 24 weeks) and 1 booster group visit during maintenance (week&#xD;
      36). The group visit consists of brief individual time with a staff member followed by a&#xD;
      group visit with motivational videotapes. All treatment groups will self-monitor their&#xD;
      physical activity with accelerometers and enter their step data into a voice response system.&#xD;
&#xD;
      The groups receiving the automated telephone contact strategy and the group receiving the&#xD;
      person telephone contact strategy will have the same number and spacing of the telephone&#xD;
      contacts (nine 10- to 15-minute telephone contacts delivered every two to three weeks between&#xD;
      group visits during adoption and two telephone contacts [weeks 28, 43] during maintenance).&#xD;
      Using motivational interviewing, a nurse will tailor the telephone discussion to the person&#xD;
      telephone contact group to match the participant's needs, experiences, barriers, motivation,&#xD;
      and confidence. Women in the automated telephone contact group will receive an automated call&#xD;
      with feedback on their progress based on the information they reported into the ATCL system.&#xD;
      The automated telephone contact system will deliver feedback on progress, problem solving,&#xD;
      goal-setting, and support. All information will be delivered in the voice of one of our staff&#xD;
      members. The third treatment group will receive no telephone contacts between group visits.&#xD;
&#xD;
      Potential risks exist for women who have medical problems, which contraindicate physical&#xD;
      exercise. Additional risks associated with the walking program include safety and injury.&#xD;
      There are potential risks of infection at the site of the one time finger blood withdrawal.&#xD;
      Potential benefits to subjects include improved aerobic fitness, blood cholesterol, body&#xD;
      composition and blood pressure and fewer symptoms. The subjects will be given a physical&#xD;
      activity prescription that should benefit them through life and decrease their risk for CVD.&#xD;
&#xD;
      Women will be recruited throughout the West and South side of Chicago. They will give verbal&#xD;
      consent at the screening questionnaire and sign an informed consent at the time of the&#xD;
      screening history and physical. They will be told that participation is voluntary, they may&#xD;
      decline or withdraw at will at any time, and all results will be held strictly confidential.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2010</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence to physical activity prescription</measure>
    <time_frame>baseline, 24, and 48 weeks</time_frame>
    <description>The investigators will compare the effects at 24 weeks and 48 weeks of the WWP plus three telephone conditions on increasing adherence to lifestyle physical activity over baseline physical activity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body Composition</measure>
    <time_frame>24 and 48 weeks from baseline</time_frame>
    <description>The investigators will compare the effects at 24 weeks and 48 weeks of the WWP plus three telephone conditions on decreasing body composition over baseline body composition.&#xD;
Body Composition measured with body mass index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>24 and 48 weeks from baseline</time_frame>
    <description>The investigators will compare the effects at 24 weeks and 48 weeks of the WWP plus three telephone conditions on improving depressive symptoms over baseline symptoms.&#xD;
Depression is measured with the CES-D.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stress</measure>
    <time_frame>24 and 48 weeks from baseline</time_frame>
    <description>The investigators will compare the effects at 24 weeks and 48 weeks of the WWP plus three telephone conditions on improving stress over baseline stress.&#xD;
Stress is measured with Cohen's measure of Global Perceived Stress.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">288</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>Walking Program + motivational interviewing calls</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Women's Walking Program (WWP) core included a lifestyle PA prescription with an accelerometer for self-feedback and monitoring and 6 group visits (1 every week for 5 weeks in the 1st 24 weeks and 1 3 months later) targeted to increase lifestyle PA in AA women.&#xD;
Participant in the WWP plus motivational interviewing telephone call arm receives 11 motivational interviewing telephone calls from an interventionist, with two calls in between each of the group-visits. Motivational interviewing calls are tailored to the individual and intended to sustain intervention effects between group-visits</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Walking Program + automated calls</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Women's Walking Program (WWP) core, including a lifestyle physical activity prescription with an accelerometer for self-feedback and monitoring and 6 group visits (1 every 5 weeks during the first 24 weeks and 1 3 months later) targeted to increase lifestyle physical activity in African American women.&#xD;
Participants in the WWP plus automated telephone call arm receive 11 automated calls with two calls sent between each group-visit. The automated calls are intended to supplement and sustain the intervention effects of the group-visits.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Walking Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Women's Walking Program (WWP) core, including a lifestyle physical activity prescription with an accelerometer for self-feedback and monitoring and 6 group visits (1 every 5 weeks during the first 24 weeks and 1 3 months later) targeted to increase lifestyle physical activity in African American women.&#xD;
Participants in the WWP receive no telephone calls.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Walking Program + Motivational Interviewing Calls</intervention_name>
    <arm_group_label>Walking Program + motivational interviewing calls</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Walking Program + Automated Calls</intervention_name>
    <arm_group_label>Walking Program + automated calls</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Walking Program</intervention_name>
    <arm_group_label>Walking Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  AA female&#xD;
&#xD;
          -  sedentary: Sedentary will be defined as no participation in regular planned (3 or more&#xD;
             times a week) moderate (e.g., walking) or vigorous (e.g., jogging, speed walking) in&#xD;
             the past 6 months.&#xD;
&#xD;
          -  aged 40 to 65 years&#xD;
&#xD;
          -  able to commit to attending the study group visits and have a telephone&#xD;
&#xD;
          -  without disabilities that would prevent regular participation in PA such as walking as&#xD;
             determined by the PARQ and baseline screening. PA&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women will be excluded from the study if they have major signs or symptoms of CV&#xD;
             disease&#xD;
&#xD;
          -  a history of myocardial infarction, stroke or Type 1 diabetes&#xD;
&#xD;
          -  BP &gt;160/100&#xD;
&#xD;
          -  HgA1 &gt;9 ( done on diabetics only)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>JoEllen Wilbur, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rush University College of Nursing</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Illinois at Chicago Mile Square Health Center at Back of the Yards</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Illinois at Chicago Mile Square Health Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Roseland Community Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60628</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holy Cross Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60629</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Health Center of Cook County Health &amp; Hospitals System</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60651</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westside Health Authority</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60651</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush Oak Park Hospital</name>
      <address>
        <city>Oak Park</city>
        <state>Illinois</state>
        <zip>60304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2013</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>September 17, 2013</last_update_submitted>
  <last_update_submitted_qc>September 17, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 18, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rush University Medical Center</investigator_affiliation>
    <investigator_full_name>JoEllen Wilbur, PhD, APN, FAAN</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Physical Activity</keyword>
  <keyword>African American</keyword>
  <keyword>Adherence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01700894
org study id: 09021301-IRB01
secondary id: R01NR004134
nct id: NCT01700894
lead sponsor: 
collaborator: 
has dmc: Yes
African American (AA) women have the lowest physical activity (PA) levels, which contributes
      to substantial disparities in cardiovascular health and depressive symptoms. There is a need
      to examine ways to promote PA that are appealing, applicable to clinical practice, and
      cost-effective. The purpose of this clinical trial is to test the efficacy of the Women's
      Walking Program (WWP), consisting of a lifestyle PA prescription and "group visit" delivery
      model, with or without tailored telephone contacts between group visits for increasing
      adherence to PA and improving health outcomes. Two telephone contact strategies will be
      compared against a no-telephone control condition: a person-administered contact strategy
      using brief motivational interviewing and an automated contact strategy using a telephone
      computer-linked system. Group visits and telephone contacts are designed to increase
      adherence to lifestyle PA with an emphasis on accumulation of 3,000 steps daily over
      baseline. The aims of this study are (1) to compare the initial (adoption 24 weeks) and
      longer-term (maintenance 2nd 24 weeks) effectiveness of the WWP plus person-administered
      telephone contacts, WWP plus automated telephone contacts, and the WWP without telephone
      contacts on (a) increasing adherence to lifestyle PA, (b) improving health outcomes (aerobic
      fitness, body composition, depressive symptoms), (c) improving self-efficacy (confidence in
      one's ability to be physically active) and outcome expectations (expected benefits to being
      more active); and (2) to compare cost-effectiveness of the three telephone treatment
      conditions in relation to adherence to lifestyle PA and health outcomes.

      The investigators will randomly assignment of the order of administering the three conditions
      to six community health care sites. These six sites are similar with respect to race,
      socioeconomic status, and residential mobility. The study will include 288 sedentary AA women
      aged 40 to 65 years who have no major signs or symptoms of cardiovascular disease (CVD); no
      history of myocardial infarction, stroke, or diabetics with elevated HgA1c; BP < 160/100.

      Initial screening will occur in person or over the phone. Further screening at the data
      collection site with an advanced practice nurse will include blood work for glucose and
      lipoproteins, a history and physical, and resting EKG. At baseline, 24 and 48 weeks all women
      who are eligible will: be given questionnaires on physical activity, health and factors that
      influence their physical activity; have their height, weight, waist circumference measured;
      and do a two minute step test. All three treatment group will attend 5 group visits every 5
      weeks during adoption (first 24 weeks) and 1 booster group visit during maintenance (week
      36). The group visit consists of brief individual time with a staff member followed by a
      group visit with motivational videotapes. All treatment groups will self-monitor their
      physical activity with accelerometers and enter their step data into a voice response system.

      The groups receiving the automated telephone contact strategy and the group receiving the
      person telephone contact strategy will have the same number and spacing of the telephone
      contacts (nine 10- to 15-minute telephone contacts delivered every two to three weeks between
      group visits during adoption and two telephone contacts [weeks 28, 43] during maintenance).
      Using motivational interviewing, a nurse will tailor the telephone discussion to the person
      telephone contact group to match the participant's needs, experiences, barriers, motivation,
      and confidence. Women in the automated telephone contact group will receive an automated call
      with feedback on their progress based on the information they reported into the ATCL system.
      The automated telephone contact system will deliver feedback on progress, problem solving,
      goal-setting, and support. All information will be delivered in the voice of one of our staff
      members. The third treatment group will receive no telephone contacts between group visits.

      Potential risks exist for women who have medical problems, which contraindicate physical
      exercise. Additional risks associated with the walking program include safety and injury.
      There are potential risks of infection at the site of the one time finger blood withdrawal.
      Potential benefits to subjects include improved aerobic fitness, blood cholesterol, body
      composition and blood pressure and fewer symptoms. The subjects will be given a physical
      activity prescription that should benefit them through life and decrease their risk for CVD.

      Women will be recruited throughout the West and South side of Chicago. They will give verbal
      consent at the screening questionnaire and sign an informed consent at the time of the
      screening history and physical. They will be told that participation is voluntary, they may
      decline or withdraw at will at any time, and all results will be held strictly confidential.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
measure: Adherence to physical activity prescription
time frame: baseline, 24, and 48 weeks
description: The investigators will compare the effects at 24 weeks and 48 weeks of the WWP plus three telephone conditions on increasing adherence to lifestyle physical activity over baseline physical activity.
measure: Body Composition
time frame: 24 and 48 weeks from baseline
description: The investigators will compare the effects at 24 weeks and 48 weeks of the WWP plus three telephone conditions on decreasing body composition over baseline body composition.
Body Composition measured with body mass index
measure: Depression
time frame: 24 and 48 weeks from baseline
description: The investigators will compare the effects at 24 weeks and 48 weeks of the WWP plus three telephone conditions on improving depressive symptoms over baseline symptoms.
Depression is measured with the CES-D.
measure: Stress
time frame: 24 and 48 weeks from baseline
description: The investigators will compare the effects at 24 weeks and 48 weeks of the WWP plus three telephone conditions on improving stress over baseline stress.
Stress is measured with Cohen's measure of Global Perceived Stress.
arm group label: Walking Program + motivational interviewing calls
arm group type: Experimental
description: The Women's Walking Program (WWP) core included a lifestyle PA prescription with an accelerometer for self-feedback and monitoring and 6 group visits (1 every week for 5 weeks in the 1st 24 weeks and 1 3 months later) targeted to increase lifestyle PA in AA women.
Participant in the WWP plus motivational interviewing telephone call arm receives 11 motivational interviewing telephone calls from an interventionist, with two calls in between each of the group-visits. Motivational interviewing calls are tailored to the individual and intended to sustain intervention effects between group-visits
arm group label: Walking Program + automated calls
arm group type: Experimental
description: The Women's Walking Program (WWP) core, including a lifestyle physical activity prescription with an accelerometer for self-feedback and monitoring and 6 group visits (1 every 5 weeks during the first 24 weeks and 1 3 months later) targeted to increase lifestyle physical activity in African American women.
Participants in the WWP plus automated telephone call arm receive 11 automated calls with two calls sent between each group-visit. The automated calls are intended to supplement and sustain the intervention effects of the group-visits.
arm group label: Walking Program
arm group type: Experimental
description: The Women's Walking Program (WWP) core, including a lifestyle physical activity prescription with an accelerometer for self-feedback and monitoring and 6 group visits (1 every 5 weeks during the first 24 weeks and 1 3 months later) targeted to increase lifestyle physical activity in African American women.
Participants in the WWP receive no telephone calls.
intervention type: Behavioral
intervention name: Walking Program + Motivational Interviewing Calls
arm group label: Walking Program + motivational interviewing calls
intervention type: Behavioral
intervention name: Walking Program + Automated Calls
arm group label: Walking Program + automated calls
intervention type: Behavioral
intervention name: Walking Program
arm group label: Walking Program
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: JoEllen Wilbur, PhD
role: Principal Investigator
affiliation: Rush University College of Nursing
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Rush University Medical Center
investigator full name: JoEllen Wilbur, PhD, APN, FAAN
investigator title: Professor
mesh term: Cardiovascular Diseases