<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/NCT01697475</url>
  </required_header>
  <id_info>
    <org_study_id>AJPM 12-0206-126R</org_study_id>
    <nct_id>NCT01697475</nct_id>
  </id_info>
  <brief_title>Text-Messaging to Motivate Walking in Older African Americans</brief_title>
  <official_title>An Motivational Text Messaging Walking Program for Older African Americans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Georgetown University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Georgetown University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study examined the impact of using a motivational mobile text messaging intervention to&#xD;
      increase step count among older community-dwelling African Americans. Secondary aims were to&#xD;
      study the effects of text messaging on self-reported leisure time exercise behavior.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      Participants in the motivational mobile text messaging group will have an increase step count&#xD;
      after 6-weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Older minority populations can benefit from increased physical activity,&#xD;
      especially walking. Text messaging interventions have the potential to encourage positive&#xD;
      changes in health behavior in these groups.&#xD;
&#xD;
      Purpose: To examine if a six week program of motivational text messaging increases physical&#xD;
      activity (step count) among older African Americans in an urban setting.&#xD;
&#xD;
      Design: Randomized, controlled trial pilot study with assignment to motivational text&#xD;
      messaging group or a control group.&#xD;
&#xD;
      Setting/Participants: Thirty-six African Americans aged 60 to 85.&#xD;
&#xD;
      Intervention: The intervention group received motivational text messages three times a day,&#xD;
      three days a week, for six weeks. Both groups received pedometers and walking manuals to&#xD;
      record step counts. Study was conducted and analyzed in 2011.&#xD;
&#xD;
      Main Outcome Measures: Primary outcome measure was step count. Secondary outcome measure was&#xD;
      perceived activity levels assessed by the Leisure Time Exercise Questionnaire (LTEQ).&#xD;
&#xD;
      Results/Conclusion: In press - American Journal of Preventive Medicine (Jan 2013)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2010</start_date>
  <completion_date type="Actual">August 2011</completion_date>
  <primary_completion_date type="Actual">July 2011</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 (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary outcome measure was step count</measure>
    <time_frame>6-weeks</time_frame>
    <description>Motivational text messaging led to greater improvements in step count (+679 vs. +398; P &lt; .05)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary outcome measure was perceived activity levels assessed by the Leisure Time Exercise Questionnaire (LTEQ).</measure>
    <time_frame>6-weeks</time_frame>
    <description>Motivational text messaging led to greater improvements perceived activity levels (P &lt; .05) than the group who did not receive any text messages.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Physical Activity</condition>
  <condition>Motor Activity</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Motivational text messaging</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Step count</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motivational text messaging</intervention_name>
    <description>Motivational text messaging was given for participants in the intervention group - 3 times a day, 3 times a week, for 6 weeks</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  African American community-dwelling adults aged 60 to 85 who were recruited from&#xD;
             senior centers.&#xD;
&#xD;
          -  had to be healthy (no restrictions and medical clearance to walk)&#xD;
&#xD;
          -  had to have a mobile phone with text messaging capability&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (a) any physical, psychological illness, or medical problems that restricted them from&#xD;
             walking; (b) did not own a mobile phone with text messaging capability; or (c) were&#xD;
             not willing or able to follow study procedures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bang Kim, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Georgetown University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Karen Glanz, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2011</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>September 27, 2012</last_update_submitted>
  <last_update_submitted_qc>September 27, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01697475
org study id: AJPM 12-0206-126R
nct id: NCT01697475
lead sponsor: 
collaborator: 
has dmc: No
This study examined the impact of using a motivational mobile text messaging intervention to
      increase step count among older community-dwelling African Americans. Secondary aims were to
      study the effects of text messaging on self-reported leisure time exercise behavior.

      Hypothesis:

      Participants in the motivational mobile text messaging group will have an increase step count
      after 6-weeks.
Background: Older minority populations can benefit from increased physical activity,
      especially walking. Text messaging interventions have the potential to encourage positive
      changes in health behavior in these groups.

      Purpose: To examine if a six week program of motivational text messaging increases physical
      activity (step count) among older African Americans in an urban setting.

      Design: Randomized, controlled trial pilot study with assignment to motivational text
      messaging group or a control group.

      Setting/Participants: Thirty-six African Americans aged 60 to 85.

      Intervention: The intervention group received motivational text messages three times a day,
      three days a week, for six weeks. Both groups received pedometers and walking manuals to
      record step counts. Study was conducted and analyzed in 2011.

      Main Outcome Measures: Primary outcome measure was step count. Secondary outcome measure was
      perceived activity levels assessed by the Leisure Time Exercise Questionnaire (LTEQ).

      Results/Conclusion: In press - American Journal of Preventive Medicine (Jan 2013)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Primary outcome measure was step count
time frame: 6-weeks
description: Motivational text messaging led to greater improvements in step count (+679 vs. +398; P < .05)
measure: Secondary outcome measure was perceived activity levels assessed by the Leisure Time Exercise Questionnaire (LTEQ).
time frame: 6-weeks
description: Motivational text messaging led to greater improvements perceived activity levels (P < .05) than the group who did not receive any text messages.
arm group label: Intervention Group
arm group type: Experimental
description: Motivational text messaging
arm group label: Control Group
arm group type: No Intervention
description: Step count
intervention type: Behavioral
intervention name: Motivational text messaging
description: Motivational text messaging was given for participants in the intervention group - 3 times a day, 3 times a week, for 6 weeks
arm group label: Intervention Group
criteria: 
gender: All
minimum age: 60 Years
maximum age: 85 Years
healthy volunteers: No
last name: Bang Kim, PhD
role: Principal Investigator
affiliation: Georgetown University
last name: Karen Glanz, PhD
role: Study Director
affiliation: University of Pennsylvania
facility: 
country: United States
responsible party type: Sponsor