<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/NCT03803085</url>
  </required_header>
  <id_info>
    <org_study_id>18131</org_study_id>
    <nct_id>NCT03803085</nct_id>
  </id_info>
  <brief_title>A Group-Based Walking Study Using WeChat to Enhance Physical Activity Among Older Adults</brief_title>
  <official_title>A Group-Based Walking Study Using WeChat to Enhance Physical Activity Among Older Adults: The Role of Social Engagement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brandeis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brandeis University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim for the study is to use the function WeRun in the application WeChat to encourage&#xD;
      physical activity and social engagement among community dwelling older adults and their&#xD;
      family members and friends. The specific aims are to test the effectiveness of a social&#xD;
      contact and comparison intervention for increasing regular daily physical activity among&#xD;
      community dwelling older adults, and to examine the potential effectiveness of WeChat in&#xD;
      cultivating social engagement and well-being among community dwelling older adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim for the study is to use the function WeRun in the application WeChat to encourage&#xD;
      physical activity and social engagement among community dwelling older adults. The&#xD;
      investigators asked participants in the social engagement group to use the WeRun function in&#xD;
      WeChat to track their daily walking steps and to compare their performance with their group&#xD;
      members for 4 weeks. To encourage social engagement among their group members, the daily&#xD;
      walking steps were calculated and the participant who has the highest step count in the group&#xD;
      will be indicated each day.Those in the control group will only use the WeRun function in&#xD;
      WeChat to track their own walking steps.&#xD;
&#xD;
      The investigators expected that the participants in the social contact group will walk more&#xD;
      often and report more social activities than those in the control group, who will not compete&#xD;
      with their peers in daily walking. To test these predictions, daily walking steps and the&#xD;
      total walking steps per week were obtained and compared across groups. The nature and the&#xD;
      extent of change was analyzed over the four weeks. Exercise self-efficacy was measured using&#xD;
      a measure based on Bandura's model. Social engagement was measured using the short Lubben&#xD;
      Social Network Scale, a self report measure of social engagement on a 12-item scale, and&#xD;
      physical activity was measured using International Physical Activity Questionnaire (IPAQ), a&#xD;
      self-report measure of physical activity on a 12-item scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 30, 2018</start_date>
  <completion_date type="Actual">July 2, 2019</completion_date>
  <primary_completion_date type="Actual">June 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>A total of 60 adults were recruited and randomly assigned to either the control condition (n=30) or the treatment condition (n=30). The 60 participants completed the study in one of three subgroups, with 20 participants randomly assigned to two groups (10 in the treatment group and 10 in the control group). Both conditions will use the WeChat App for use on a smartphone. The control group used the WeRun program to count their own steps. The treatment condition used the WeRun to engage in social contact and compare their steps with others in the group.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Steps Walked</measure>
    <time_frame>[Time Frame: Baseline (pretest) Week, Week 4 (posttest) and Week 8 (one month follow up)]</time_frame>
    <description>Weekly average number of steps recorded with WeRun on the phone [ (averaged across 7 days at Baseline week and averaged across 7 days at Week 4 (Posttest) and averaged across 7 days at Week 8 (one month follow up)].</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Social Engagement</measure>
    <time_frame>Pretest given 1 week before the intervention and then at the posttest after the 4 week study and one month follow up</time_frame>
    <description>Short Lubben Social Network Scale-Revised, a self-report measure of social engagement on a 12-item scale. The total score is calculated by the sum of all the items. The total score ranges between 0 and 60, with a higher score indicating more social engagement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise Self Efficacy</measure>
    <time_frame>Pretest given 1 week before the intervention and then at the posttest after the 4 week study and one month follow up</time_frame>
    <description>This scale is a self-report of exercise self-efficacy. Total score is calculated by summing the responses to each question. This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Inactivity</condition>
  <condition>Sedentary Behavior</condition>
  <arm_group>
    <arm_group_label>Control Condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants only saw their own daily walking steps using the WeRun function in WeChat. They did not use WeChat to see other group members' daily steps and did not engage in social contact with their group members.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants saw their own and other group member's daily walking steps using the WeRun function in WeChat and they were able to contact the other members of their group using We Chat.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control condition</intervention_name>
    <description>Participants in the control group only saw their own daily walking steps using the WeChat. They did not use WeChat to see other group members' daily steps and did not contact other group members. The participants were asked to use the app every day. A message (through WeChat) was sent to remind them to use the application if they had not done so within three days.</description>
    <arm_group_label>Control Condition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Treatment condition</intervention_name>
    <description>Participants in the experimental condition used WeChat for 4 weeks to see their own and other's walking steps and also were able to contact other group members. The participants were asked to use the application every day. A message (through the group chat) was sent to remind them to use the application if they have not done so within three days.</description>
    <arm_group_label>Treatment condition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants who are 60 or older who have a cellphone, with either android or iPhone&#xD;
             system with data plan.&#xD;
&#xD;
          -  They must be fit enough to walk for at least 20 minutes at a time.&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to walk more than 20 minutes;&#xD;
&#xD;
          -  do not have smart phone with data plan.&#xD;
&#xD;
          -  younger than 60&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Brandeis University</name>
      <address>
        <city>Waltham</city>
        <state>Massachusetts</state>
        <zip>02453</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>September 24, 2018</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <results_first_submitted>August 13, 2020</results_first_submitted>
  <results_first_submitted_qc>October 19, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">November 9, 2020</results_first_posted>
  <last_update_submitted>October 19, 2020</last_update_submitted>
  <last_update_submitted_qc>October 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 22, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/85/NCT03803085/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 22, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/85/NCT03803085/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Control Condition</title>
          <description>Participants only saw their own daily walking steps using the WeRun function in WeChat. They did not use WeChat to see other group members' daily steps and did not engage in social contact with their group members.&#xD;
Control condition: Participants in the control group only saw their own daily walking steps using the WeChat. They did not use WeChat to see other group members' daily steps and did not contact other group members. The participants were asked to use the app every day. A message (through WeChat) was sent to remind them to use the application if they had not done so within three days.</description>
        </group>
        <group group_id="P2">
          <title>Treatment Condition</title>
          <description>Participants saw their own and other group member's daily walking steps using the WeRun function in WeChat and they were able to contact the other members of their group using We Chat.&#xD;
Treatment condition: Participants in the treatment condition used WeChat for 4 weeks to see their own and other's walking steps and also were able to contact other group members. The participants were asked to use the application every day. A message (through the group chat) was sent to remind them to use the application if they have not done so within three days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Control Condition</title>
          <description>Participants only saw their own daily walking steps using the WeRun function in WeChat. They did not use WeChat to see other group members' daily steps and did not engage in social contact with their group members.&#xD;
Control condition: Participants in the control group only saw their own daily walking steps using the WeChat. They did not use WeChat to see other group members' daily steps and did not contact other group members. The participants were asked to use the app every day. A message (through WeChat) was sent to remind them to use the application if they had not done so within three days.</description>
        </group>
        <group group_id="B2">
          <title>Treatment Condition</title>
          <description>Participants saw their own and other group member's daily walking steps using the WeRun function in WeChat and they were able to contact the other members of their group using We Chat.&#xD;
Experimental condition: Participants in the treatment condition used WeChat for 4 weeks to see their own and other's walking steps and also were able to contact other group members. The participants were asked to use the application every day. A message (through the group chat) was sent to remind them to use the application if they have not done so within three days.</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="30"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="60"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.2" spread="5.32"/>
                    <measurement group_id="B2" value="65.5" spread="5.24"/>
                    <measurement group_id="B3" value="65.4" spread="5.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="15"/>
                  </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="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </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="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>Unknown or Not Reported</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>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Steps Walked</title>
        <description>Weekly average number of steps recorded with WeRun on the phone [ (averaged across 7 days at Baseline week and averaged across 7 days at Week 4 (Posttest) and averaged across 7 days at Week 8 (one month follow up)].</description>
        <time_frame>[Time Frame: Baseline (pretest) Week, Week 4 (posttest) and Week 8 (one month follow up)]</time_frame>
        <population>Analysis population based on participants that successfully synced their WeRun and did not withdraw before the start of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Condition</title>
            <description>Participants only saw their own daily walking steps using the WeRun function in WeChat. They did not use WeChat to see other group members' daily steps and did not engage in social contact with their group members.&#xD;
Control condition: Participants in the control group only saw their own daily walking steps using the WeChat. They did not use WeChat to see other group members' daily steps and did not contact other group members. The participants were asked to use the app every day. A message (through WeChat) was sent to remind them to use the application if they had not done so within three days.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Condition</title>
            <description>Participants saw their own and other group member's daily walking steps using the WeRun function in WeChat and they were able to contact the other members of their group using We Chat.&#xD;
Treatment condition: Participants in the experimental condition used WeChat for 4 weeks to see their own and other's walking steps and also were able to contact other group members. The participants were asked to use the application every day. A message (through the group chat) was sent to remind them to use the application if they have not done so within three days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Steps Walked</title>
          <description>Weekly average number of steps recorded with WeRun on the phone [ (averaged across 7 days at Baseline week and averaged across 7 days at Week 4 (Posttest) and averaged across 7 days at Week 8 (one month follow up)].</description>
          <population>Analysis population based on participants that successfully synced their WeRun and did not withdraw before the start of the study.</population>
          <units>steps</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pretest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3992" spread="2388"/>
                    <measurement group_id="O2" value="4125" spread="2693"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Posttest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4171" spread="3122"/>
                    <measurement group_id="O2" value="5872" spread="3494"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up test</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4330" spread="3185"/>
                    <measurement group_id="O2" value="5911" spread="3467"/>
                  </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>0.02</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Social Engagement</title>
        <description>Short Lubben Social Network Scale-Revised, a self-report measure of social engagement on a 12-item scale. The total score is calculated by the sum of all the items. The total score ranges between 0 and 60, with a higher score indicating more social engagement.</description>
        <time_frame>Pretest given 1 week before the intervention and then at the posttest after the 4 week study and one month follow up</time_frame>
        <population>Analysis population based on those who completed social engagement measurement at each testing point.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Condition</title>
            <description>Participants only saw their own daily walking steps using the WeRun function in WeChat. They did not use WeChat to see other group members' daily steps and did not engage in social contact with their group members.&#xD;
Control condition: Participants in the control group only saw their own daily walking steps using the WeChat. They did not use WeChat to see other group members' daily steps and did not contact other group members. The participants were asked to use the app every day. A message (through WeChat) was sent to remind them to use the application if they had not done so within three days.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Condition</title>
            <description>Participants saw their own and other group member's daily walking steps using the WeRun function in WeChat and they were able to contact the other members of their group using We Chat.&#xD;
Treatment condition: Participants in the treatment condition used WeChat for 4 weeks to see their own and other's walking steps and also were able to contact other group members. The participants were asked to use the application every day. A message (through the group chat) was sent to remind them to use the application if they have not done so within three days.</description>
          </group>
        </group_list>
        <measure>
          <title>Social Engagement</title>
          <description>Short Lubben Social Network Scale-Revised, a self-report measure of social engagement on a 12-item scale. The total score is calculated by the sum of all the items. The total score ranges between 0 and 60, with a higher score indicating more social engagement.</description>
          <population>Analysis population based on those who completed social engagement measurement at each testing point.</population>
          <units>units on a 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="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pretest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.1" spread="11.5"/>
                    <measurement group_id="O2" value="35.9" spread="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Posttest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.1" spread="8.3"/>
                    <measurement group_id="O2" value="45.7" spread="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up test</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.7" spread="8.9"/>
                    <measurement group_id="O2" value="44.1" spread="10.8"/>
                  </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>0.03</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Exercise Self Efficacy</title>
        <description>This scale is a self-report of exercise self-efficacy. Total score is calculated by summing the responses to each question. This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise.</description>
        <time_frame>Pretest given 1 week before the intervention and then at the posttest after the 4 week study and one month follow up</time_frame>
        <population>Analysis population based on those who completed exercise self-efficacy measurement at each testing point.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Condition</title>
            <description>Participants only saw their own daily walking steps using the WeRun function in WeChat. They did not use WeChat to see other group members' daily steps and did not engage in social contact with their group members.&#xD;
Control condition: Participants in the control group only saw their own daily walking steps using the WeChat. They did not use WeChat to see other group members' daily steps and did not contact other group members. The participants were asked to use the app every day. A message (through WeChat) was sent to remind them to use the application if they had not done so within three days.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Condition</title>
            <description>Participants saw their own and other group member's daily walking steps using the WeRun function in WeChat and they were able to contact the other members of their group using We Chat.&#xD;
Treatment condition: Participants in the treatment condition used WeChat for 4 weeks to see their own and other's walking steps and also were able to contact other group members. The participants were asked to use the application every day. A message (through the group chat) was sent to remind them to use the application if they have not done so within three days.</description>
          </group>
        </group_list>
        <measure>
          <title>Exercise Self Efficacy</title>
          <description>This scale is a self-report of exercise self-efficacy. Total score is calculated by summing the responses to each question. This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise.</description>
          <population>Analysis population based on those who completed exercise self-efficacy measurement at each testing point.</population>
          <units>units on a 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="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pretest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.7" spread="22.8"/>
                    <measurement group_id="O2" value="60.3" spread="22.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Posttest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.8" spread="21.8"/>
                    <measurement group_id="O2" value="67.0" spread="21.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up test</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.2" spread="21.4"/>
                    <measurement group_id="O2" value="60.3" spread="22.5"/>
                  </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>0.06</p_value>
            <p_value_desc>p&lt;0.05 was considered significant.</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From enrollment through study completion, an average of 2 months</time_frame>
      <desc>The risks of participation were low. We included individuals whose functional health is sufficient for normal walking. We provided goals that increased their activity level, and were tailored to their current level of activity.</desc>
      <group_list>
        <group group_id="E1">
          <title>Control Condition</title>
          <description>Participants only saw their own daily walking steps using the WeRun function in WeChat. They did not use WeChat to see other group members' daily steps and did not engage in social contact with their group members.&#xD;
Control condition: Participants in the control group only saw their own daily walking steps using the WeChat. They did not use WeChat to see other group members' daily steps and did not contact other group members. The participants were asked to use the app every day. A message (through WeChat) was sent to remind them to use the application if they had not done so within three days.</description>
        </group>
        <group group_id="E2">
          <title>Treatment Condition</title>
          <description>Participants saw their own and other group member's daily walking steps using the WeRun function in WeChat and they were able to contact the other members of their group using We Chat.&#xD;
Treatment condition: Participants in the treatment condition used WeChat for 4 weeks to see their own and other's walking steps and also were able to contact other group members. The participants were asked to use the application every day. A message (through the group chat) was sent to remind them to use the application if they have not done so within three days.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </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="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </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>Yujun Liu</name_or_title>
      <organization>Brandeis University</organization>
      <phone>781-736-3300</phone>
      <email>lyujun@brandeis.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/NCT03803085
org study id: 18131
nct id: NCT03803085
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim for the study is to use the function WeRun in the application WeChat to encourage
      physical activity and social engagement among community dwelling older adults and their
      family members and friends. The specific aims are to test the effectiveness of a social
      contact and comparison intervention for increasing regular daily physical activity among
      community dwelling older adults, and to examine the potential effectiveness of WeChat in
      cultivating social engagement and well-being among community dwelling older adults.
The aim for the study is to use the function WeRun in the application WeChat to encourage
      physical activity and social engagement among community dwelling older adults. The
      investigators asked participants in the social engagement group to use the WeRun function in
      WeChat to track their daily walking steps and to compare their performance with their group
      members for 4 weeks. To encourage social engagement among their group members, the daily
      walking steps were calculated and the participant who has the highest step count in the group
      will be indicated each day.Those in the control group will only use the WeRun function in
      WeChat to track their own walking steps.

      The investigators expected that the participants in the social contact group will walk more
      often and report more social activities than those in the control group, who will not compete
      with their peers in daily walking. To test these predictions, daily walking steps and the
      total walking steps per week were obtained and compared across groups. The nature and the
      extent of change was analyzed over the four weeks. Exercise self-efficacy was measured using
      a measure based on Bandura's model. Social engagement was measured using the short Lubben
      Social Network Scale, a self report measure of social engagement on a 12-item scale, and
      physical activity was measured using International Physical Activity Questionnaire (IPAQ), a
      self-report measure of physical activity on a 12-item scale.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A total of 60 adults were recruited and randomly assigned to either the control condition (n=30) or the treatment condition (n=30). The 60 participants completed the study in one of three subgroups, with 20 participants randomly assigned to two groups (10 in the treatment group and 10 in the control group). Both conditions will use the WeChat App for use on a smartphone. The control group used the WeRun program to count their own steps. The treatment condition used the WeRun to engage in social contact and compare their steps with others in the group.
primary purpose: Prevention
masking: None (Open Label)
measure: Number of Steps Walked
time frame: [Time Frame: Baseline (pretest) Week, Week 4 (posttest) and Week 8 (one month follow up)]
description: Weekly average number of steps recorded with WeRun on the phone [ (averaged across 7 days at Baseline week and averaged across 7 days at Week 4 (Posttest) and averaged across 7 days at Week 8 (one month follow up)].
measure: Social Engagement
time frame: Pretest given 1 week before the intervention and then at the posttest after the 4 week study and one month follow up
description: Short Lubben Social Network Scale-Revised, a self-report measure of social engagement on a 12-item scale. The total score is calculated by the sum of all the items. The total score ranges between 0 and 60, with a higher score indicating more social engagement.
measure: Exercise Self Efficacy
time frame: Pretest given 1 week before the intervention and then at the posttest after the 4 week study and one month follow up
description: This scale is a self-report of exercise self-efficacy. Total score is calculated by summing the responses to each question. This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise.
arm group label: Control Condition
arm group type: Experimental
description: Participants only saw their own daily walking steps using the WeRun function in WeChat. They did not use WeChat to see other group members' daily steps and did not engage in social contact with their group members.
arm group label: Treatment condition
arm group type: Experimental
description: Participants saw their own and other group member's daily walking steps using the WeRun function in WeChat and they were able to contact the other members of their group using We Chat.
intervention type: Behavioral
intervention name: Control condition
description: Participants in the control group only saw their own daily walking steps using the WeChat. They did not use WeChat to see other group members' daily steps and did not contact other group members. The participants were asked to use the app every day. A message (through WeChat) was sent to remind them to use the application if they had not done so within three days.
arm group label: Control Condition
intervention type: Behavioral
intervention name: Treatment condition
description: Participants in the experimental condition used WeChat for 4 weeks to see their own and other's walking steps and also were able to contact other group members. The participants were asked to use the application every day. A message (through the group chat) was sent to remind them to use the application if they have not done so within three days.
arm group label: Treatment condition
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 