<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/NCT04507464</url>
  </required_header>
  <id_info>
    <org_study_id>2020-0739</org_study_id>
    <secondary_id>2P30AG022849-16</secondary_id>
    <nct_id>NCT04507464</nct_id>
  </id_info>
  <brief_title>A Physical Activity Program to Disrupt Sedentary Time in Older Latinos</brief_title>
  <acronym>PAIS</acronym>
  <official_title>A Physical Activity Program to Disrupt Sedentary Time in Older Latinos</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Illinois at Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Illinois at Chicago</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>
      To test the feasibility of an intervention designed to replace sedentary time with physical&#xD;
      activity in older Latinos, delivered in their homes to improve cognitive function and brain&#xD;
      connectivity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After being informed of the study and potential risks, all patients giving informed consent&#xD;
      will undergo a focused phone interviews, followed by screening to determine eligibility.&#xD;
      Participants that meet inclusion criteria will undergo baseline cognitive function testing&#xD;
      via video (following NIH toolbox guidelines for remote cognitive function assessment),&#xD;
      followed by a one week measurement of sedentary time using a physical activity monitor&#xD;
      (actigraphy). At week 0, participants will be randomized into either a physical activity&#xD;
      group to break up sedentary time or activity guidelines only in a 1:1 ratio. Follow up occurs&#xD;
      at 6 weeks using the same measures as baseline.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2, 2020</start_date>
  <completion_date type="Actual">April 2, 2022</completion_date>
  <primary_completion_date type="Actual">April 2, 2022</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>This is a pilot randomized, controlled trial of a 6-week intervention for feasibility. Outcome measures will be obtained at baseline and at 6-weeks. Behavior choices and preference data will be continuously captured during the intervention. We will randomize 80 older Latinos from the Chicago Latino community to either an ecological momentary intervention using fitbits (n=40) or to physical activity guidelines (n=40).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Sedentary Bouts</measure>
    <time_frame>Baseline, 6 weeks</time_frame>
    <description>Change in number of bouts of sedentary activity at 6 weeks from baseline. One sedentary bout is defined as a 10 minute bout or longer where the activity count is less than 99 counts per minute.&#xD;
Sedentary Bout Parameters Minimum Length: 10 Minutes Minimum Count Value: 0 Counts Per Minute Maximum Count Value: 99 Counts Per Minute</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time in Sedentary Bouts</measure>
    <time_frame>Baseline, 6 weeks</time_frame>
    <description>Change from baseline to 6 weeks in minutes spent in sedentary bouts</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Trail Making Test A</measure>
    <time_frame>Baseline, 6 weeks</time_frame>
    <description>Measure of pschycomotor speed. Subjects connect a series of encircled numbers in numerical order. The score is the time in seconds it takes the subject to complete the test. A lower score/time is better. Outcome is change in time to completion of TMT-A in seconds from baseline to 6 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trail Making Test B</measure>
    <time_frame>baseline, 6 weeks</time_frame>
    <description>Measure of executive function. Subjects connect encircled numbers and letters in numerical and alphabetical order, alternating between the numbers and letters. Score is the time in seconds it takes the subject to complete the test. A lower score/time is better. Outcome is change from baseline to 6 weeks in seconds. Lower time is better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Picture Vocabulary Test</measure>
    <time_frame>Baseline, 6 weeks</time_frame>
    <description>A measure of general vocabulary knowledge and is considered to be a strong measure of crystallized abilities (those abilities that are more dependent upon past learning experiences and are relatively consistent across the adult life span). The respondent is presented with an audio recording of a word and four photographic images on the iPad screen, and is asked to select the picture that most closely matches the meaning of the word. This is repeated over 4 minutes. A theta score is very similar to a z-score, which is a statistic with a mean of zero and a standard deviation of one. A higher score is better</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>List Sorting</measure>
    <time_frame>Baseline, 6 weeks</time_frame>
    <description>The List Sorting test requires immediate recall and sequencing of different visually and orally presented stimuli (i.e., &quot;working memory&quot;). Pictures of different foods and animals are displayed with accompanying audio recording and written text (e.g., &quot;elephant&quot;), and the participant is asked to say the items back in size order from smallest to largest, first within a single dimension (either animals or foods, called 1-List) and then on two dimensions (foods, then animals, called 2-List). List Sorting is scored by summing the total number of items correctly recalled and sequenced on 1-List and 2-List, which can range from 0-26. Higher scores indicate higher levels of working memory. Change from baseline to post-test follow-up at 6-weeks is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Picture Sequence</measure>
    <time_frame>Baseline, 6 weeks</time_frame>
    <description>A measure developed for the assessment of episodic memory. Participants are asked to recall the sequence of pictures demonstrated over two learning trials; sequence length varies from 6-18 pictures. Participants are given credit for each adjacent pair of pictures they correctly placed. The number of adjacent pairs placed correctly for each of trials 1 and 2 is converted to a theta score and a standard score is generated. Change from baseline to 6 weeks is reported. This provides a gauge of improvement or decline from one assessment to another, irrespective of demographic factors. A change in a participant's Uncorrected Standard score (or theta score) from Time 1 to Time 2 represents an absolute change in the level of performance for that individual since the previous assessment. Higher score is better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oral Reading Recognition Test</measure>
    <time_frame>Baseline, 6 weeks</time_frame>
    <description>Participant is asked to read and pronounce letters and words as accurately as possible. Administrator scores them as right or wrong (number correct words is used). This test is a measure of reading decoding skill. The Reading Test is a measure of reading decoding skill and, like vocabulary, is considered among the crystallized abilities; those abilities are generally more dependent upon past learning experiences and consistent across the adult life span. Change in Reading Uncorrected score is reported and is useful in evaluating pure change in performance from one assessment to another. Higher change in Uncorrected score for Reading would mean that the participant is able to correctly identify more difficult words on the subsequent assessment, which may indicate developmental growth or a return to a previous higher level of functioning.Change from baseline to 6 weeks is reported. A higher score is better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Crystalized Cognition</measure>
    <time_frame>Baseline, 6 weeks</time_frame>
    <description>This composite includes the Picture Vocabulary and Reading Tests and represent an accumulated store of verbal knowledge and skills. The composite score is derived by averaging the standard scores of each of these measures, and then deriving standard scores based on this new distribution. Uncorrected standard score is generated and reported. Crystallized Cognition Composite score is considered a global assessment of individual verbal cognition. Crystallized abilities are presumed to be more dependent on experience and less on biological influences. They represent an accumulated store of verbal knowledge and skills. Higher scores indicate higher levels of functioning. Change in uncorrected standard score from baseline to 6 weeks is reported. Higher change scores indicate improved levels of functioning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Auditory Verbal Learning</measure>
    <time_frame>Baseline, 6 weeks</time_frame>
    <description>The Rey auditory verbal learning task is a word-list learning task in which 15 unrelated words are presented orally (via audio recording) over three consecutive learning trials1. After each presentation, the participant is asked to recall as many of the words as he/she can. The Rey is scored by taking the sum of the number of words recalled across all trials (possible range is 0-45 words). The raw score is most commonly used for interpretation of the Rey test, with higher scores representing better episodic memory. Change from baseline to post-test follow-up at 6-weeks is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Text Message Motivation.</measure>
    <time_frame>6 weeks.</time_frame>
    <description>Participant reported rating on a scale from 0-10, with 0 being no motivation and 10 being the highest motivation provided by the ecological momentary intervention text messages. Assessed at 6 weeks in the intervention group only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Enjoyment of the Text Messages.</measure>
    <time_frame>6 weeks.</time_frame>
    <description>Participant reported rating on a scale from 0-10, with 0 being none and 10 being the highest, reported enjoyment of the ecological momentary intervention text messages. Assessed at 6 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Text Messages Helping Exercise.</measure>
    <time_frame>6 weeks.</time_frame>
    <description>Participants reported rating, on a scale from 0-10 with 0 being none and 10 being the highest, of the ecological momentary intervention text messages helping them to exercise. Assessed at 6 weeks only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difficulty Understanding Text Messages</measure>
    <time_frame>6 weeks</time_frame>
    <description>Participants reported rating, on a scale from 0-10 with 0 being none and 10 being the highest, of the ecological momentary intervention text messages being difficult to understand. Assessed at 6 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Enjoyment of the Program.</measure>
    <time_frame>6 weeks.</time_frame>
    <description>Participants reported rating, on a scale from 0-10 with 0 being none and 10 being the highest, of the enjoyment of the ecological momentary intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difficulty With the FitBit.</measure>
    <time_frame>6 weeks.</time_frame>
    <description>Participants reported rating, on a scale from 0-10 with 0 being none and 10 being the highest, of difficulty using the FitBit. Assessed at 6 weeks.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Sedentary Behavior</condition>
  <condition>Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Ecological Momentary Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive real time physical activity notifications via a wearable activity tracker and smartphone application.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physical Activity Guidelines</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will be sent general guidelines for disruption of sedentary time.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Ecological Momentary Intervention</intervention_name>
    <description>Participants will wear a Fitbit that has been programmed to deliver a notification (a buzz) when activity has ceased for more than 10 minutes. They will receive suggestions on their Illumivu mEMA smartphone app on how to replace sitting time with PA such as standing up 5 times or taking 20 steps, or even performing a short (20 seconds) preferred dance routine. Fitbit data will be captured in real-time via the iCardia platform. Participants will receive reminders from their smartphones to enter real-time feedback on activity options selected and how successful they were in adopting the option. These data will allow tracking of underlying preferences for behaviors and to tailor the program accordingly.</description>
    <arm_group_label>Ecological Momentary Intervention</arm_group_label>
    <other_name>Illumivu mEMA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  no history of major head trauma&#xD;
&#xD;
          -  ownership of a smartphone&#xD;
&#xD;
          -  ability to make video calls&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Requires assistive ambulation;&#xD;
&#xD;
          -  Unstable angina,&#xD;
&#xD;
          -  Claudication&#xD;
&#xD;
          -  severe arthritis,&#xD;
&#xD;
          -  extreme dyspnea on exertion,&#xD;
&#xD;
          -  Class III-IV heart failure;&#xD;
&#xD;
          -  Current uncontrolled sustained arrhythmias,&#xD;
&#xD;
          -  severe/symptomatic aortic or mitral stenosis,&#xD;
&#xD;
          -  hypertrophic obstructive cardiomyopathy,&#xD;
&#xD;
          -  severe pulmonary hypertension,&#xD;
&#xD;
          -  active myocarditis/pericarditis,&#xD;
&#xD;
          -  thrombophlebitis,&#xD;
&#xD;
          -  recent systemic/pulmonary embolus (within 3 months);&#xD;
&#xD;
          -  Revascularization procedures within the previous 6 months;&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ulf G Bronas, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Illinois at Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Illinois at Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2020</study_first_posted>
  <results_first_submitted>April 18, 2023</results_first_submitted>
  <results_first_submitted_qc>June 30, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">July 25, 2023</results_first_posted>
  <last_update_submitted>June 30, 2023</last_update_submitted>
  <last_update_submitted_qc>June 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Illinois at Chicago</investigator_affiliation>
    <investigator_full_name>Ulf G. Bronas</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Sedentary Behavior</keyword>
  <keyword>Physical Activity</keyword>
  <keyword>Cognitive Health</keyword>
  <keyword>Older Adults</keyword>
  <keyword>Latinos</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <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>August 10, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/64/NCT04507464/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>August 10, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/64/NCT04507464/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Ecological Momentary Intervention</title>
          <description>Participants will receive real time physical activity notifications via a wearable activity tracker and smartphone application.&#xD;
Ecological Momentary Intervention: Participants will wear a Fitbit that has been programmed to deliver a notification (a buzz) when activity has ceased for more than 10 minutes. They will receive suggestions on their Illumivu mEMA smartphone app on how to replace sitting time with PA such as standing up 5 times or taking 20 steps, or even performing a short (20 seconds) preferred dance routine. Fitbit data will be captured in real-time via the iCardia platform. Participants will receive reminders from their smartphones to enter real-time feedback on activity options selected and how successful they were in adopting the option. These data will allow tracking of underlying preferences for behaviors and to tailor the program accordingly.</description>
        </group>
        <group group_id="P2">
          <title>Physical Activity Guidelines</title>
          <description>Participants will be sent general guidelines for disruption of sedentary time.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Ecological Momentary Intervention</title>
          <description>Participants will receive real time physical activity notifications via a wearable activity tracker and smartphone application.&#xD;
Ecological Momentary Intervention: Participants will wear a Fitbit that has been programmed to deliver a notification (a buzz) when activity has ceased for more than 10 minutes. They will receive suggestions on their Illumivu mEMA smartphone app on how to replace sitting time with PA such as standing up 5 times or taking 20 steps, or even performing a short (20 seconds) preferred dance routine. Fitbit data will be captured in real-time via the iCardia platform. Participants will receive reminders from their smartphones to enter real-time feedback on activity options selected and how successful they were in adopting the option. These data will allow tracking of underlying preferences for behaviors and to tailor the program accordingly.</description>
        </group>
        <group group_id="B2">
          <title>Physical Activity Guidelines</title>
          <description>Participants will be sent general guidelines for disruption of sedentary time.</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="20"/>
            <count group_id="B2" value="19"/>
            <count group_id="B3" value="39"/>
          </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="15"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="12"/>
                  </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="59.9" spread="4.99"/>
                    <measurement group_id="B2" value="62.16" spread="6.57"/>
                    <measurement group_id="B3" value="61" spread="5.85"/>
                  </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="11"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Sedentary Bouts</title>
        <description>Change in number of bouts of sedentary activity at 6 weeks from baseline. One sedentary bout is defined as a 10 minute bout or longer where the activity count is less than 99 counts per minute.&#xD;
Sedentary Bout Parameters Minimum Length: 10 Minutes Minimum Count Value: 0 Counts Per Minute Maximum Count Value: 99 Counts Per Minute</description>
        <time_frame>Baseline, 6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ecological Momentary Intervention</title>
            <description>Participants will receive real time physical activity notifications via a wearable activity tracker and smartphone application.&#xD;
Ecological Momentary Intervention: Participants will wear a Fitbit that has been programmed to deliver a notification (a buzz) when activity has ceased for more than 10 minutes. They will receive suggestions on their Illumivu mEMA smartphone app on how to replace sitting time with PA such as standing up 5 times or taking 20 steps, or even performing a short (20 seconds) preferred dance routine. Fitbit data will be captured in real-time via the iCardia platform. Participants will receive reminders from their smartphones to enter real-time feedback on activity options selected and how successful they were in adopting the option. These data will allow tracking of underlying preferences for behaviors and to tailor the program accordingly.</description>
          </group>
          <group group_id="O2">
            <title>Physical Activity Guidelines</title>
            <description>Participants will be sent general guidelines for disruption of sedentary time.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Sedentary Bouts</title>
          <description>Change in number of bouts of sedentary activity at 6 weeks from baseline. One sedentary bout is defined as a 10 minute bout or longer where the activity count is less than 99 counts per minute.&#xD;
Sedentary Bout Parameters Minimum Length: 10 Minutes Minimum Count Value: 0 Counts Per Minute Maximum Count Value: 99 Counts Per Minute</description>
          <units>Sedentary bouts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.58" spread="22.02"/>
                    <measurement group_id="O2" value="-2.47" spread="28.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time in Sedentary Bouts</title>
        <description>Change from baseline to 6 weeks in minutes spent in sedentary bouts</description>
        <time_frame>Baseline, 6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ecological Momentary Intervention</title>
            <description>Participants will receive real time physical activity notifications via a wearable activity tracker and smartphone application.&#xD;
Ecological Momentary Intervention: Participants will wear a Fitbit that has been programmed to deliver a notification (a buzz) when activity has ceased for more than 10 minutes. They will receive suggestions on their Illumivu mEMA smartphone app on how to replace sitting time with PA such as standing up 5 times or taking 20 steps, or even performing a short (20 seconds) preferred dance routine. Fitbit data will be captured in real-time via the iCardia platform. Participants will receive reminders from their smartphones to enter real-time feedback on activity options selected and how successful they were in adopting the option. These data will allow tracking of underlying preferences for behaviors and to tailor the program accordingly.</description>
          </group>
          <group group_id="O2">
            <title>Physical Activity Guidelines</title>
            <description>Participants will be sent general guidelines for disruption of sedentary time.</description>
          </group>
        </group_list>
        <measure>
          <title>Time in Sedentary Bouts</title>
          <description>Change from baseline to 6 weeks in minutes spent in sedentary bouts</description>
          <units>Minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-347.7" spread="484.98"/>
                    <measurement group_id="O2" value="-27.53" spread="811.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Trail Making Test A</title>
        <description>Measure of pschycomotor speed. Subjects connect a series of encircled numbers in numerical order. The score is the time in seconds it takes the subject to complete the test. A lower score/time is better. Outcome is change in time to completion of TMT-A in seconds from baseline to 6 weeks.</description>
        <time_frame>Baseline, 6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ecological Momentary Intervention</title>
            <description>Participants will receive real time physical activity notifications via a wearable activity tracker and smartphone application.&#xD;
Ecological Momentary Intervention: Participants will wear a Fitbit that has been programmed to deliver a notification (a buzz) when activity has ceased for more than 10 minutes. They will receive suggestions on their Illumivu mEMA smartphone app on how to replace sitting time with PA such as standing up 5 times or taking 20 steps, or even performing a short (20 seconds) preferred dance routine. Fitbit data will be captured in real-time via the iCardia platform. Participants will receive reminders from their smartphones to enter real-time feedback on activity options selected and how successful they were in adopting the option. These data will allow tracking of underlying preferences for behaviors and to tailor the program accordingly.</description>
          </group>
          <group group_id="O2">
            <title>Physical Activity Guidelines</title>
            <description>Participants will be sent general guidelines for disruption of sedentary time.</description>
          </group>
        </group_list>
        <measure>
          <title>Trail Making Test A</title>
          <description>Measure of pschycomotor speed. Subjects connect a series of encircled numbers in numerical order. The score is the time in seconds it takes the subject to complete the test. A lower score/time is better. Outcome is change in time to completion of TMT-A in seconds from baseline to 6 weeks.</description>
          <units>Seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".43" spread="1.27"/>
                    <measurement group_id="O2" value=".31" spread="1.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Trail Making Test B</title>
        <description>Measure of executive function. Subjects connect encircled numbers and letters in numerical and alphabetical order, alternating between the numbers and letters. Score is the time in seconds it takes the subject to complete the test. A lower score/time is better. Outcome is change from baseline to 6 weeks in seconds. Lower time is better.</description>
        <time_frame>baseline, 6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ecological Momentary Intervention</title>
            <description>Participants will receive real time physical activity notifications via a wearable activity tracker and smartphone application.&#xD;
Ecological Momentary Intervention: Participants will wear a Fitbit that has been programmed to deliver a notification (a buzz) when activity has ceased for more than 10 minutes. They will receive suggestions on their Illumivu mEMA smartphone app on how to replace sitting time with PA such as standing up 5 times or taking 20 steps, or even performing a short (20 seconds) preferred dance routine. Fitbit data will be captured in real-time via the iCardia platform. Participants will receive reminders from their smartphones to enter real-time feedback on activity options selected and how successful they were in adopting the option. These data will allow tracking of underlying preferences for behaviors and to tailor the program accordingly.</description>
          </group>
          <group group_id="O2">
            <title>Physical Activity Guidelines</title>
            <description>Participants will be sent general guidelines for disruption of sedentary time.</description>
          </group>
        </group_list>
        <measure>
          <title>Trail Making Test B</title>
          <description>Measure of executive function. Subjects connect encircled numbers and letters in numerical and alphabetical order, alternating between the numbers and letters. Score is the time in seconds it takes the subject to complete the test. A lower score/time is better. Outcome is change from baseline to 6 weeks in seconds. Lower time is better.</description>
          <units>Seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-35.26" spread="60.35"/>
                    <measurement group_id="O2" value="7.19" spread="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Picture Vocabulary Test</title>
        <description>A measure of general vocabulary knowledge and is considered to be a strong measure of crystallized abilities (those abilities that are more dependent upon past learning experiences and are relatively consistent across the adult life span). The respondent is presented with an audio recording of a word and four photographic images on the iPad screen, and is asked to select the picture that most closely matches the meaning of the word. This is repeated over 4 minutes. A theta score is very similar to a z-score, which is a statistic with a mean of zero and a standard deviation of one. A higher score is better</description>
        <time_frame>Baseline, 6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ecological Momentary Intervention</title>
            <description>Participants will receive real time physical activity notifications via a wearable activity tracker and smartphone application.&#xD;
Ecological Momentary Intervention: Participants will wear a Fitbit that has been programmed to deliver a notification (a buzz) when activity has ceased for more than 10 minutes. They will receive suggestions on their Illumivu mEMA smartphone app on how to replace sitting time with PA such as standing up 5 times or taking 20 steps, or even performing a short (20 seconds) preferred dance routine. Fitbit data will be captured in real-time via the iCardia platform. Participants will receive reminders from their smartphones to enter real-time feedback on activity options selected and how successful they were in adopting the option. These data will allow tracking of underlying preferences for behaviors and to tailor the program accordingly.</description>
          </group>
          <group group_id="O2">
            <title>Physical Activity Guidelines</title>
            <description>Participants will be sent general guidelines for disruption of sedentary time.</description>
          </group>
        </group_list>
        <measure>
          <title>Picture Vocabulary Test</title>
          <description>A measure of general vocabulary knowledge and is considered to be a strong measure of crystallized abilities (those abilities that are more dependent upon past learning experiences and are relatively consistent across the adult life span). The respondent is presented with an audio recording of a word and four photographic images on the iPad screen, and is asked to select the picture that most closely matches the meaning of the word. This is repeated over 4 minutes. A theta score is very similar to a z-score, which is a statistic with a mean of zero and a standard deviation of one. A higher score is better</description>
          <units>score 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="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".20" spread="1.49"/>
                    <measurement group_id="O2" value=".25" spread="1.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>List Sorting</title>
        <description>The List Sorting test requires immediate recall and sequencing of different visually and orally presented stimuli (i.e., &quot;working memory&quot;). Pictures of different foods and animals are displayed with accompanying audio recording and written text (e.g., &quot;elephant&quot;), and the participant is asked to say the items back in size order from smallest to largest, first within a single dimension (either animals or foods, called 1-List) and then on two dimensions (foods, then animals, called 2-List). List Sorting is scored by summing the total number of items correctly recalled and sequenced on 1-List and 2-List, which can range from 0-26. Higher scores indicate higher levels of working memory. Change from baseline to post-test follow-up at 6-weeks is reported.</description>
        <time_frame>Baseline, 6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ecological Momentary Intervention</title>
            <description>Participants will receive real time physical activity notifications via a wearable activity tracker and smartphone application.&#xD;
Ecological Momentary Intervention: Participants will wear a Fitbit that has been programmed to deliver a notification (a buzz) when activity has ceased for more than 10 minutes. They will receive suggestions on their Illumivu mEMA smartphone app on how to replace sitting time with PA such as standing up 5 times or taking 20 steps, or even performing a short (20 seconds) preferred dance routine. Fitbit data will be captured in real-time via the iCardia platform. Participants will receive reminders from their smartphones to enter real-time feedback on activity options selected and how successful they were in adopting the option. These data will allow tracking of underlying preferences for behaviors and to tailor the program accordingly.</description>
          </group>
          <group group_id="O2">
            <title>Physical Activity Guidelines</title>
            <description>Participants will be sent general guidelines for disruption of sedentary time.</description>
          </group>
        </group_list>
        <measure>
          <title>List Sorting</title>
          <description>The List Sorting test requires immediate recall and sequencing of different visually and orally presented stimuli (i.e., &quot;working memory&quot;). Pictures of different foods and animals are displayed with accompanying audio recording and written text (e.g., &quot;elephant&quot;), and the participant is asked to say the items back in size order from smallest to largest, first within a single dimension (either animals or foods, called 1-List) and then on two dimensions (foods, then animals, called 2-List). List Sorting is scored by summing the total number of items correctly recalled and sequenced on 1-List and 2-List, which can range from 0-26. Higher scores indicate higher levels of working memory. Change from baseline to post-test follow-up at 6-weeks is reported.</description>
          <units>score 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="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.26" spread="8.7"/>
                    <measurement group_id="O2" value="5.53" spread="9.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Picture Sequence</title>
        <description>A measure developed for the assessment of episodic memory. Participants are asked to recall the sequence of pictures demonstrated over two learning trials; sequence length varies from 6-18 pictures. Participants are given credit for each adjacent pair of pictures they correctly placed. The number of adjacent pairs placed correctly for each of trials 1 and 2 is converted to a theta score and a standard score is generated. Change from baseline to 6 weeks is reported. This provides a gauge of improvement or decline from one assessment to another, irrespective of demographic factors. A change in a participant's Uncorrected Standard score (or theta score) from Time 1 to Time 2 represents an absolute change in the level of performance for that individual since the previous assessment. Higher score is better.</description>
        <time_frame>Baseline, 6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ecological Momentary Intervention</title>
            <description>Participants will receive real time physical activity notifications via a wearable activity tracker and smartphone application.&#xD;
Ecological Momentary Intervention: Participants will wear a Fitbit that has been programmed to deliver a notification (a buzz) when activity has ceased for more than 10 minutes. They will receive suggestions on their Illumivu mEMA smartphone app on how to replace sitting time with PA such as standing up 5 times or taking 20 steps, or even performing a short (20 seconds) preferred dance routine. Fitbit data will be captured in real-time via the iCardia platform. Participants will receive reminders from their smartphones to enter real-time feedback on activity options selected and how successful they were in adopting the option. These data will allow tracking of underlying preferences for behaviors and to tailor the program accordingly.</description>
          </group>
          <group group_id="O2">
            <title>Physical Activity Guidelines</title>
            <description>Participants will be sent general guidelines for disruption of sedentary time.</description>
          </group>
        </group_list>
        <measure>
          <title>Picture Sequence</title>
          <description>A measure developed for the assessment of episodic memory. Participants are asked to recall the sequence of pictures demonstrated over two learning trials; sequence length varies from 6-18 pictures. Participants are given credit for each adjacent pair of pictures they correctly placed. The number of adjacent pairs placed correctly for each of trials 1 and 2 is converted to a theta score and a standard score is generated. Change from baseline to 6 weeks is reported. This provides a gauge of improvement or decline from one assessment to another, irrespective of demographic factors. A change in a participant's Uncorrected Standard score (or theta score) from Time 1 to Time 2 represents an absolute change in the level of performance for that individual since the previous assessment. Higher score is better.</description>
          <units>score 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="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.26" spread="13.22"/>
                    <measurement group_id="O2" value="4.32" spread="10.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Oral Reading Recognition Test</title>
        <description>Participant is asked to read and pronounce letters and words as accurately as possible. Administrator scores them as right or wrong (number correct words is used). This test is a measure of reading decoding skill. The Reading Test is a measure of reading decoding skill and, like vocabulary, is considered among the crystallized abilities; those abilities are generally more dependent upon past learning experiences and consistent across the adult life span. Change in Reading Uncorrected score is reported and is useful in evaluating pure change in performance from one assessment to another. Higher change in Uncorrected score for Reading would mean that the participant is able to correctly identify more difficult words on the subsequent assessment, which may indicate developmental growth or a return to a previous higher level of functioning.Change from baseline to 6 weeks is reported. A higher score is better.</description>
        <time_frame>Baseline, 6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ecological Momentary Intervention</title>
            <description>Participants will receive real time physical activity notifications via a wearable activity tracker and smartphone application.&#xD;
Ecological Momentary Intervention: Participants will wear a Fitbit that has been programmed to deliver a notification (a buzz) when activity has ceased for more than 10 minutes. They will receive suggestions on their Illumivu mEMA smartphone app on how to replace sitting time with PA such as standing up 5 times or taking 20 steps, or even performing a short (20 seconds) preferred dance routine. Fitbit data will be captured in real-time via the iCardia platform. Participants will receive reminders from their smartphones to enter real-time feedback on activity options selected and how successful they were in adopting the option. These data will allow tracking of underlying preferences for behaviors and to tailor the program accordingly.</description>
          </group>
          <group group_id="O2">
            <title>Physical Activity Guidelines</title>
            <description>Participants will be sent general guidelines for disruption of sedentary time.</description>
          </group>
        </group_list>
        <measure>
          <title>Oral Reading Recognition Test</title>
          <description>Participant is asked to read and pronounce letters and words as accurately as possible. Administrator scores them as right or wrong (number correct words is used). This test is a measure of reading decoding skill. The Reading Test is a measure of reading decoding skill and, like vocabulary, is considered among the crystallized abilities; those abilities are generally more dependent upon past learning experiences and consistent across the adult life span. Change in Reading Uncorrected score is reported and is useful in evaluating pure change in performance from one assessment to another. Higher change in Uncorrected score for Reading would mean that the participant is able to correctly identify more difficult words on the subsequent assessment, which may indicate developmental growth or a return to a previous higher level of functioning.Change from baseline to 6 weeks is reported. A higher score is better.</description>
          <units>Number of correctly pronouced words</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.89" spread="19.14"/>
                    <measurement group_id="O2" value="1" spread="7.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Crystalized Cognition</title>
        <description>This composite includes the Picture Vocabulary and Reading Tests and represent an accumulated store of verbal knowledge and skills. The composite score is derived by averaging the standard scores of each of these measures, and then deriving standard scores based on this new distribution. Uncorrected standard score is generated and reported. Crystallized Cognition Composite score is considered a global assessment of individual verbal cognition. Crystallized abilities are presumed to be more dependent on experience and less on biological influences. They represent an accumulated store of verbal knowledge and skills. Higher scores indicate higher levels of functioning. Change in uncorrected standard score from baseline to 6 weeks is reported. Higher change scores indicate improved levels of functioning</description>
        <time_frame>Baseline, 6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ecological Momentary Intervention</title>
            <description>Participants will receive real time physical activity notifications via a wearable activity tracker and smartphone application.&#xD;
Ecological Momentary Intervention: Participants will wear a Fitbit that has been programmed to deliver a notification (a buzz) when activity has ceased for more than 10 minutes. They will receive suggestions on their Illumivu mEMA smartphone app on how to replace sitting time with PA such as standing up 5 times or taking 20 steps, or even performing a short (20 seconds) preferred dance routine. Fitbit data will be captured in real-time via the iCardia platform. Participants will receive reminders from their smartphones to enter real-time feedback on activity options selected and how successful they were in adopting the option. These data will allow tracking of underlying preferences for behaviors and to tailor the program accordingly.</description>
          </group>
          <group group_id="O2">
            <title>Physical Activity Guidelines</title>
            <description>Participants will be sent general guidelines for disruption of sedentary time.</description>
          </group>
        </group_list>
        <measure>
          <title>Crystalized Cognition</title>
          <description>This composite includes the Picture Vocabulary and Reading Tests and represent an accumulated store of verbal knowledge and skills. The composite score is derived by averaging the standard scores of each of these measures, and then deriving standard scores based on this new distribution. Uncorrected standard score is generated and reported. Crystallized Cognition Composite score is considered a global assessment of individual verbal cognition. Crystallized abilities are presumed to be more dependent on experience and less on biological influences. They represent an accumulated store of verbal knowledge and skills. Higher scores indicate higher levels of functioning. Change in uncorrected standard score from baseline to 6 weeks is reported. Higher change scores indicate improved levels of functioning</description>
          <units>Uncorrected standard score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.95" spread="10.46"/>
                    <measurement group_id="O2" value=".95" spread="5.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Auditory Verbal Learning</title>
        <description>The Rey auditory verbal learning task is a word-list learning task in which 15 unrelated words are presented orally (via audio recording) over three consecutive learning trials1. After each presentation, the participant is asked to recall as many of the words as he/she can. The Rey is scored by taking the sum of the number of words recalled across all trials (possible range is 0-45 words). The raw score is most commonly used for interpretation of the Rey test, with higher scores representing better episodic memory. Change from baseline to post-test follow-up at 6-weeks is reported.</description>
        <time_frame>Baseline, 6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ecological Momentary Intervention</title>
            <description>Participants will receive real time physical activity notifications via a wearable activity tracker and smartphone application.&#xD;
Ecological Momentary Intervention: Participants will wear a Fitbit that has been programmed to deliver a notification (a buzz) when activity has ceased for more than 10 minutes. They will receive suggestions on their Illumivu mEMA smartphone app on how to replace sitting time with PA such as standing up 5 times or taking 20 steps, or even performing a short (20 seconds) preferred dance routine. Fitbit data will be captured in real-time via the iCardia platform. Participants will receive reminders from their smartphones to enter real-time feedback on activity options selected and how successful they were in adopting the option. These data will allow tracking of underlying preferences for behaviors and to tailor the program accordingly.</description>
          </group>
          <group group_id="O2">
            <title>Physical Activity Guidelines</title>
            <description>Participants will be sent general guidelines for disruption of sedentary time.</description>
          </group>
        </group_list>
        <measure>
          <title>Auditory Verbal Learning</title>
          <description>The Rey auditory verbal learning task is a word-list learning task in which 15 unrelated words are presented orally (via audio recording) over three consecutive learning trials1. After each presentation, the participant is asked to recall as many of the words as he/she can. The Rey is scored by taking the sum of the number of words recalled across all trials (possible range is 0-45 words). The raw score is most commonly used for interpretation of the Rey test, with higher scores representing better episodic memory. Change from baseline to post-test follow-up at 6-weeks is reported.</description>
          <units>score 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="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".26" spread="4.04"/>
                    <measurement group_id="O2" value=".47" spread="5.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Text Message Motivation.</title>
        <description>Participant reported rating on a scale from 0-10, with 0 being no motivation and 10 being the highest motivation provided by the ecological momentary intervention text messages. Assessed at 6 weeks in the intervention group only.</description>
        <time_frame>6 weeks.</time_frame>
        <population>EMI ratings apply to intervention group only.</population>
        <group_list>
          <group group_id="O1">
            <title>Ecological Momentary Intervention</title>
            <description>Participants will receive real time physical activity notifications via a wearable activity tracker and smartphone application.&#xD;
Ecological Momentary Intervention: Participants will wear a Fitbit that has been programmed to deliver a notification (a buzz) when activity has ceased for more than 10 minutes. They will receive suggestions on their Illumivu mEMA smartphone app on how to replace sitting time with PA such as standing up 5 times or taking 20 steps, or even performing a short (20 seconds) preferred dance routine. Fitbit data will be captured in real-time via the iCardia platform. Participants will receive reminders from their smartphones to enter real-time feedback on activity options selected and how successful they were in adopting the option. These data will allow tracking of underlying preferences for behaviors and to tailor the program accordingly.</description>
          </group>
          <group group_id="O2">
            <title>Physical Activity Guidelines</title>
            <description>Participants will be sent general guidelines for disruption of sedentary time.</description>
          </group>
        </group_list>
        <measure>
          <title>Text Message Motivation.</title>
          <description>Participant reported rating on a scale from 0-10, with 0 being no motivation and 10 being the highest motivation provided by the ecological momentary intervention text messages. Assessed at 6 weeks in the intervention group only.</description>
          <population>EMI ratings apply to intervention group only.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.7" lower_limit="3" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Enjoyment of the Text Messages.</title>
        <description>Participant reported rating on a scale from 0-10, with 0 being none and 10 being the highest, reported enjoyment of the ecological momentary intervention text messages. Assessed at 6 weeks.</description>
        <time_frame>6 weeks.</time_frame>
        <population>Intervention group only.</population>
        <group_list>
          <group group_id="O1">
            <title>Ecological Momentary Intervention</title>
            <description>Participants will receive real time physical activity notifications via a wearable activity tracker and smartphone application.&#xD;
Ecological Momentary Intervention: Participants will wear a Fitbit that has been programmed to deliver a notification (a buzz) when activity has ceased for more than 10 minutes. They will receive suggestions on their Illumivu mEMA smartphone app on how to replace sitting time with PA such as standing up 5 times or taking 20 steps, or even performing a short (20 seconds) preferred dance routine. Fitbit data will be captured in real-time via the iCardia platform. Participants will receive reminders from their smartphones to enter real-time feedback on activity options selected and how successful they were in adopting the option. These data will allow tracking of underlying preferences for behaviors and to tailor the program accordingly.</description>
          </group>
          <group group_id="O2">
            <title>Physical Activity Guidelines</title>
            <description>Participants will be sent general guidelines for disruption of sedentary time.</description>
          </group>
        </group_list>
        <measure>
          <title>Enjoyment of the Text Messages.</title>
          <description>Participant reported rating on a scale from 0-10, with 0 being none and 10 being the highest, reported enjoyment of the ecological momentary intervention text messages. Assessed at 6 weeks.</description>
          <population>Intervention group only.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.8" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Text Messages Helping Exercise.</title>
        <description>Participants reported rating, on a scale from 0-10 with 0 being none and 10 being the highest, of the ecological momentary intervention text messages helping them to exercise. Assessed at 6 weeks only</description>
        <time_frame>6 weeks.</time_frame>
        <population>Intervention group only.</population>
        <group_list>
          <group group_id="O1">
            <title>Ecological Momentary Intervention</title>
            <description>Participants will receive real time physical activity notifications via a wearable activity tracker and smartphone application.&#xD;
Ecological Momentary Intervention: Participants will wear a Fitbit that has been programmed to deliver a notification (a buzz) when activity has ceased for more than 10 minutes. They will receive suggestions on their Illumivu mEMA smartphone app on how to replace sitting time with PA such as standing up 5 times or taking 20 steps, or even performing a short (20 seconds) preferred dance routine. Fitbit data will be captured in real-time via the iCardia platform. Participants will receive reminders from their smartphones to enter real-time feedback on activity options selected and how successful they were in adopting the option. These data will allow tracking of underlying preferences for behaviors and to tailor the program accordingly.</description>
          </group>
          <group group_id="O2">
            <title>Physical Activity Guidelines</title>
            <description>Participants will be sent general guidelines for disruption of sedentary time.</description>
          </group>
        </group_list>
        <measure>
          <title>Text Messages Helping Exercise.</title>
          <description>Participants reported rating, on a scale from 0-10 with 0 being none and 10 being the highest, of the ecological momentary intervention text messages helping them to exercise. Assessed at 6 weeks only</description>
          <population>Intervention group only.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.9" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Difficulty Understanding Text Messages</title>
        <description>Participants reported rating, on a scale from 0-10 with 0 being none and 10 being the highest, of the ecological momentary intervention text messages being difficult to understand. Assessed at 6 weeks.</description>
        <time_frame>6 weeks</time_frame>
        <population>Intervention group only.</population>
        <group_list>
          <group group_id="O1">
            <title>Ecological Momentary Intervention</title>
            <description>Participants will receive real time physical activity notifications via a wearable activity tracker and smartphone application.&#xD;
Ecological Momentary Intervention: Participants will wear a Fitbit that has been programmed to deliver a notification (a buzz) when activity has ceased for more than 10 minutes. They will receive suggestions on their Illumivu mEMA smartphone app on how to replace sitting time with PA such as standing up 5 times or taking 20 steps, or even performing a short (20 seconds) preferred dance routine. Fitbit data will be captured in real-time via the iCardia platform. Participants will receive reminders from their smartphones to enter real-time feedback on activity options selected and how successful they were in adopting the option. These data will allow tracking of underlying preferences for behaviors and to tailor the program accordingly.</description>
          </group>
          <group group_id="O2">
            <title>Physical Activity Guidelines</title>
            <description>Participants will be sent general guidelines for disruption of sedentary time.</description>
          </group>
        </group_list>
        <measure>
          <title>Difficulty Understanding Text Messages</title>
          <description>Participants reported rating, on a scale from 0-10 with 0 being none and 10 being the highest, of the ecological momentary intervention text messages being difficult to understand. Assessed at 6 weeks.</description>
          <population>Intervention group only.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Enjoyment of the Program.</title>
        <description>Participants reported rating, on a scale from 0-10 with 0 being none and 10 being the highest, of the enjoyment of the ecological momentary intervention.</description>
        <time_frame>6 weeks.</time_frame>
        <population>Intervention group only.</population>
        <group_list>
          <group group_id="O1">
            <title>Ecological Momentary Intervention</title>
            <description>Participants will receive real time physical activity notifications via a wearable activity tracker and smartphone application.&#xD;
Ecological Momentary Intervention: Participants will wear a Fitbit that has been programmed to deliver a notification (a buzz) when activity has ceased for more than 10 minutes. They will receive suggestions on their Illumivu mEMA smartphone app on how to replace sitting time with PA such as standing up 5 times or taking 20 steps, or even performing a short (20 seconds) preferred dance routine. Fitbit data will be captured in real-time via the iCardia platform. Participants will receive reminders from their smartphones to enter real-time feedback on activity options selected and how successful they were in adopting the option. These data will allow tracking of underlying preferences for behaviors and to tailor the program accordingly.</description>
          </group>
          <group group_id="O2">
            <title>Physical Activity Guidelines</title>
            <description>Participants will be sent general guidelines for disruption of sedentary time.</description>
          </group>
        </group_list>
        <measure>
          <title>Enjoyment of the Program.</title>
          <description>Participants reported rating, on a scale from 0-10 with 0 being none and 10 being the highest, of the enjoyment of the ecological momentary intervention.</description>
          <population>Intervention group only.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.4" lower_limit="8" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Difficulty With the FitBit.</title>
        <description>Participants reported rating, on a scale from 0-10 with 0 being none and 10 being the highest, of difficulty using the FitBit. Assessed at 6 weeks.</description>
        <time_frame>6 weeks.</time_frame>
        <population>Intervention group only.</population>
        <group_list>
          <group group_id="O1">
            <title>Ecological Momentary Intervention</title>
            <description>Participants will receive real time physical activity notifications via a wearable activity tracker and smartphone application.&#xD;
Ecological Momentary Intervention: Participants will wear a Fitbit that has been programmed to deliver a notification (a buzz) when activity has ceased for more than 10 minutes. They will receive suggestions on their Illumivu mEMA smartphone app on how to replace sitting time with PA such as standing up 5 times or taking 20 steps, or even performing a short (20 seconds) preferred dance routine. Fitbit data will be captured in real-time via the iCardia platform. Participants will receive reminders from their smartphones to enter real-time feedback on activity options selected and how successful they were in adopting the option. These data will allow tracking of underlying preferences for behaviors and to tailor the program accordingly.</description>
          </group>
          <group group_id="O2">
            <title>Physical Activity Guidelines</title>
            <description>Participants will be sent general guidelines for disruption of sedentary time.</description>
          </group>
        </group_list>
        <measure>
          <title>Difficulty With the FitBit.</title>
          <description>Participants reported rating, on a scale from 0-10 with 0 being none and 10 being the highest, of difficulty using the FitBit. Assessed at 6 weeks.</description>
          <population>Intervention group only.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 weeks</time_frame>
      <desc>no difference from clinical trials definitions</desc>
      <group_list>
        <group group_id="E1">
          <title>Ecological Momentary Intervention</title>
          <description>Participants will receive real time physical activity notifications via a wearable activity tracker and smartphone application.&#xD;
Ecological Momentary Intervention: Participants will wear a Fitbit that has been programmed to deliver a notification (a buzz) when activity has ceased for more than 10 minutes. They will receive suggestions on their Illumivu mEMA smartphone app on how to replace sitting time with PA such as standing up 5 times or taking 20 steps, or even performing a short (20 seconds) preferred dance routine. Fitbit data will be captured in real-time via the iCardia platform. Participants will receive reminders from their smartphones to enter real-time feedback on activity options selected and how successful they were in adopting the option. These data will allow tracking of underlying preferences for behaviors and to tailor the program accordingly.</description>
        </group>
        <group group_id="E2">
          <title>Physical Activity Guidelines</title>
          <description>Participants will be sent general guidelines for disruption of sedentary time.</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="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </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="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Dr. Ulf Bronas</name_or_title>
      <organization>University of Illinois at Chicago</organization>
      <phone>3123555886</phone>
      <email>bronas@uic.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/NCT04507464
org study id: 2020-0739
secondary id: 2P30AG022849-16
nct id: NCT04507464
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To test the feasibility of an intervention designed to replace sedentary time with physical
      activity in older Latinos, delivered in their homes to improve cognitive function and brain
      connectivity.
After being informed of the study and potential risks, all patients giving informed consent
      will undergo a focused phone interviews, followed by screening to determine eligibility.
      Participants that meet inclusion criteria will undergo baseline cognitive function testing
      via video (following NIH toolbox guidelines for remote cognitive function assessment),
      followed by a one week measurement of sedentary time using a physical activity monitor
      (actigraphy). At week 0, participants will be randomized into either a physical activity
      group to break up sedentary time or activity guidelines only in a 1:1 ratio. Follow up occurs
      at 6 weeks using the same measures as baseline.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a pilot randomized, controlled trial of a 6-week intervention for feasibility. Outcome measures will be obtained at baseline and at 6-weeks. Behavior choices and preference data will be continuously captured during the intervention. We will randomize 80 older Latinos from the Chicago Latino community to either an ecological momentary intervention using fitbits (n=40) or to physical activity guidelines (n=40).
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Sedentary Bouts
time frame: Baseline, 6 weeks
description: Change in number of bouts of sedentary activity at 6 weeks from baseline. One sedentary bout is defined as a 10 minute bout or longer where the activity count is less than 99 counts per minute.
Sedentary Bout Parameters Minimum Length: 10 Minutes Minimum Count Value: 0 Counts Per Minute Maximum Count Value: 99 Counts Per Minute
measure: Time in Sedentary Bouts
time frame: Baseline, 6 weeks
description: Change from baseline to 6 weeks in minutes spent in sedentary bouts
measure: Trail Making Test A
time frame: Baseline, 6 weeks
description: Measure of pschycomotor speed. Subjects connect a series of encircled numbers in numerical order. The score is the time in seconds it takes the subject to complete the test. A lower score/time is better. Outcome is change in time to completion of TMT-A in seconds from baseline to 6 weeks.
measure: Trail Making Test B
time frame: baseline, 6 weeks
description: Measure of executive function. Subjects connect encircled numbers and letters in numerical and alphabetical order, alternating between the numbers and letters. Score is the time in seconds it takes the subject to complete the test. A lower score/time is better. Outcome is change from baseline to 6 weeks in seconds. Lower time is better.
measure: Picture Vocabulary Test
time frame: Baseline, 6 weeks
description: A measure of general vocabulary knowledge and is considered to be a strong measure of crystallized abilities (those abilities that are more dependent upon past learning experiences and are relatively consistent across the adult life span). The respondent is presented with an audio recording of a word and four photographic images on the iPad screen, and is asked to select the picture that most closely matches the meaning of the word. This is repeated over 4 minutes. A theta score is very similar to a z-score, which is a statistic with a mean of zero and a standard deviation of one. A higher score is better
measure: List Sorting
time frame: Baseline, 6 weeks
description: The List Sorting test requires immediate recall and sequencing of different visually and orally presented stimuli (i.e., "working memory"). Pictures of different foods and animals are displayed with accompanying audio recording and written text (e.g., "elephant"), and the participant is asked to say the items back in size order from smallest to largest, first within a single dimension (either animals or foods, called 1-List) and then on two dimensions (foods, then animals, called 2-List). List Sorting is scored by summing the total number of items correctly recalled and sequenced on 1-List and 2-List, which can range from 0-26. Higher scores indicate higher levels of working memory. Change from baseline to post-test follow-up at 6-weeks is reported.
measure: Picture Sequence
time frame: Baseline, 6 weeks
description: A measure developed for the assessment of episodic memory. Participants are asked to recall the sequence of pictures demonstrated over two learning trials; sequence length varies from 6-18 pictures. Participants are given credit for each adjacent pair of pictures they correctly placed. The number of adjacent pairs placed correctly for each of trials 1 and 2 is converted to a theta score and a standard score is generated. Change from baseline to 6 weeks is reported. This provides a gauge of improvement or decline from one assessment to another, irrespective of demographic factors. A change in a participant's Uncorrected Standard score (or theta score) from Time 1 to Time 2 represents an absolute change in the level of performance for that individual since the previous assessment. Higher score is better.
measure: Oral Reading Recognition Test
time frame: Baseline, 6 weeks
description: Participant is asked to read and pronounce letters and words as accurately as possible. Administrator scores them as right or wrong (number correct words is used). This test is a measure of reading decoding skill. The Reading Test is a measure of reading decoding skill and, like vocabulary, is considered among the crystallized abilities; those abilities are generally more dependent upon past learning experiences and consistent across the adult life span. Change in Reading Uncorrected score is reported and is useful in evaluating pure change in performance from one assessment to another. Higher change in Uncorrected score for Reading would mean that the participant is able to correctly identify more difficult words on the subsequent assessment, which may indicate developmental growth or a return to a previous higher level of functioning.Change from baseline to 6 weeks is reported. A higher score is better.
measure: Crystalized Cognition
time frame: Baseline, 6 weeks
description: This composite includes the Picture Vocabulary and Reading Tests and represent an accumulated store of verbal knowledge and skills. The composite score is derived by averaging the standard scores of each of these measures, and then deriving standard scores based on this new distribution. Uncorrected standard score is generated and reported. Crystallized Cognition Composite score is considered a global assessment of individual verbal cognition. Crystallized abilities are presumed to be more dependent on experience and less on biological influences. They represent an accumulated store of verbal knowledge and skills. Higher scores indicate higher levels of functioning. Change in uncorrected standard score from baseline to 6 weeks is reported. Higher change scores indicate improved levels of functioning
measure: Auditory Verbal Learning
time frame: Baseline, 6 weeks
description: The Rey auditory verbal learning task is a word-list learning task in which 15 unrelated words are presented orally (via audio recording) over three consecutive learning trials1. After each presentation, the participant is asked to recall as many of the words as he/she can. The Rey is scored by taking the sum of the number of words recalled across all trials (possible range is 0-45 words). The raw score is most commonly used for interpretation of the Rey test, with higher scores representing better episodic memory. Change from baseline to post-test follow-up at 6-weeks is reported.
measure: Text Message Motivation.
time frame: 6 weeks.
description: Participant reported rating on a scale from 0-10, with 0 being no motivation and 10 being the highest motivation provided by the ecological momentary intervention text messages. Assessed at 6 weeks in the intervention group only.
measure: Enjoyment of the Text Messages.
time frame: 6 weeks.
description: Participant reported rating on a scale from 0-10, with 0 being none and 10 being the highest, reported enjoyment of the ecological momentary intervention text messages. Assessed at 6 weeks.
measure: Text Messages Helping Exercise.
time frame: 6 weeks.
description: Participants reported rating, on a scale from 0-10 with 0 being none and 10 being the highest, of the ecological momentary intervention text messages helping them to exercise. Assessed at 6 weeks only
measure: Difficulty Understanding Text Messages
time frame: 6 weeks
description: Participants reported rating, on a scale from 0-10 with 0 being none and 10 being the highest, of the ecological momentary intervention text messages being difficult to understand. Assessed at 6 weeks.
measure: Enjoyment of the Program.
time frame: 6 weeks.
description: Participants reported rating, on a scale from 0-10 with 0 being none and 10 being the highest, of the enjoyment of the ecological momentary intervention.
measure: Difficulty With the FitBit.
time frame: 6 weeks.
description: Participants reported rating, on a scale from 0-10 with 0 being none and 10 being the highest, of difficulty using the FitBit. Assessed at 6 weeks.
arm group label: Ecological Momentary Intervention
arm group type: Experimental
description: Participants will receive real time physical activity notifications via a wearable activity tracker and smartphone application.
arm group label: Physical Activity Guidelines
arm group type: No Intervention
description: Participants will be sent general guidelines for disruption of sedentary time.
intervention type: Behavioral
intervention name: Ecological Momentary Intervention
description: Participants will wear a Fitbit that has been programmed to deliver a notification (a buzz) when activity has ceased for more than 10 minutes. They will receive suggestions on their Illumivu mEMA smartphone app on how to replace sitting time with PA such as standing up 5 times or taking 20 steps, or even performing a short (20 seconds) preferred dance routine. Fitbit data will be captured in real-time via the iCardia platform. Participants will receive reminders from their smartphones to enter real-time feedback on activity options selected and how successful they were in adopting the option. These data will allow tracking of underlying preferences for behaviors and to tailor the program accordingly.
arm group label: Ecological Momentary Intervention
other name: Illumivu mEMA
criteria: 
gender: All
minimum age: 55 Years
maximum age: 89 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ulf G Bronas, PhD
role: Principal Investigator
affiliation: University of Illinois at Chicago
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Illinois at Chicago
investigator full name: Ulf G. Bronas
investigator title: Associate Professor
mesh term: Cognitive Dysfunction
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 