<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/NCT04440449</url>
  </required_header>
  <id_info>
    <org_study_id>HSC20190019H</org_study_id>
    <secondary_id>P30AG044271</secondary_id>
    <nct_id>NCT04440449</nct_id>
  </id_info>
  <brief_title>Effect of Behavioral Lifestyle Intervention on Frailty in Older Adults With Diabetes</brief_title>
  <official_title>Effect of Behavioral Lifestyle Intervention on Frailty in Older Adults With Diabetes: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center at San Antonio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Claude D. Pepper Older Americans Independence Centers</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Texas Health Science Center at San Antonio</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study team want to see if changes in lifestyle and behaviors and self-monitoring of diet&#xD;
      and physical activity in older adults who have type 2 Diabetes (T2D) may help to prevent or&#xD;
      reduce frailty. Frailty occurs in older adults and leads people to have falls, become&#xD;
      disabled, require nursing home placement, and have increased risk of death. T2D is one of the&#xD;
      major risk factors for frailty. T2D is a significant problem in older adults and is known to&#xD;
      increase the risk of future frailty.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Behavioral lifestyle intervention: Participants (N=40) will be randomized to the mHealth+&#xD;
      group Intervention group (Group A; n=20)and mHealth+ individual intervention group (Group B;&#xD;
      n=20) group using a randomization table. (1) The mHealth+ group Intervention group (Group A)&#xD;
      will receive a modified Look AHEAD behavior lifestyle intervention with smartphone-based&#xD;
      self-monitoring of diet and physical activity. This comprises ten group sessions for&#xD;
      lifestyle intervention in 6-months. The group will receive three weekly classes in the first&#xD;
      month and then bi-weekly classes for month 2-3, and three monthly session in month four,&#xD;
      five, and six. The frequency and layout of these classes will allow participants to master&#xD;
      new skills gradually, then eventually wean off, and adopt the modified lifestyle as the part&#xD;
      of their daily lives. (2) The mHealth+ individual intervention group (Group B) will receive&#xD;
      an abbreviated behavior lifestyle intervention with smartphone-based self-monitoring of diet&#xD;
      and physical activity in one face-to-face individual session at the beginning of the study.&#xD;
      In addition, participants will receive self-study materials, from Look Ahead modules, and a&#xD;
      monthly follow-up phone calls for the duration of the study (6-months). The goal for these&#xD;
      follow up phone calls are to assess understanding of the modules, to promote continued&#xD;
      engagement with the study material, and to provide clarification on materials as needed.&#xD;
      Participants in the mHealth+ group Intervention group (Group A) and mHealth+ individual&#xD;
      intervention group (Group B will receive instruction on how to download an app to help them&#xD;
      record their diet and physical activity at the beginning of the study.&#xD;
&#xD;
      Fitbit offers a simple, easy-to-use tool for tracking food and physical activity. It helps&#xD;
      set daily calorie budget, and set and work towards goals for nutrient intake, weight loss,&#xD;
      exercise, and more. https://www.fitbit.com/inspire 04.12.20: Due to SARS-CoV2 (COVID-19) and&#xD;
      social distancing order, the study team are adding hemoglobin Hba1c home test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2019</start_date>
  <completion_date type="Actual">April 28, 2022</completion_date>
  <primary_completion_date type="Actual">October 20, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Group A - Mobile Health + group intervention&#xD;
Group B (control arm)</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frailty Scale Using Fried's Phenotype Method Based on Five Frailty Characteristics</measure>
    <time_frame>Baseline to 6 months</time_frame>
    <description>Self-reported (SR) exhaustion (Y/N ) on Center for Epidemiologic Studies Depression (CES-D) scale: &quot;Do you feel full of energy?&quot; &quot;No&quot; scored a 1 (exhausted).&#xD;
SR unintentional weight loss: &quot;In the last year, have you lost more than 10 pounds unintentionally?&quot;. &quot;Yes&quot; scored a 1.&#xD;
SR physical activity over the last year using the Minnesota Leisure Time Activity Questionnaire, (energy expenditure in kcal/week, standardized for sex). The lowest quintile for each sex group received a score of 1&#xD;
Grip strength measured (Kg) with a dynamometer in the dominant hand, standardized using body mass index quartiles and sex. The average of 3 trials was recorded. The lowest quintile for each sex group received a score of 1 (for weak).&#xD;
10 feet walked at usual pace, standardized based on height and sex. The fastest of 2 trials was recorded. Participants in the lowest quintile for each sex group were considered slow (score =1) A higher scale score from 0-5 indicates greater frailty</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glycated Hemoglobin (HbA1c)</measure>
    <time_frame>Baseline to 6 months</time_frame>
    <description>Change in HbA1c measured over the study period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Physical Performance Battery (SPPB) Balance</measure>
    <time_frame>Baseline to 6 months</time_frame>
    <description>The balance test assesses a person's ability to stand with the feet together in side-by-side, semi-tandem, and full-tandem positions for 10 seconds each, responses ranging between 0-4 with a higher score indicating better balance. Three balance tests are performed and scoring is as follows:&#xD;
Side-by-side stand: person attempts to stand with feet together, side-by-side, for 10 seconds.&#xD;
1 point if held for 10 seconds&#xD;
0 points if not held for 10 seconds or not attempted Semi-tandem stand: person attempts to stand with the side of the heel of one foot touching the big toe of the other foot for 10 seconds.&#xD;
1 point if held for 10 seconds&#xD;
0 points if not held for 10 seconds or not attempted Tandem stand: person attempts to stand with the heel of one foot in front of and touching the toes of the other foot for about 10 seconds.&#xD;
2 points if held for 10 seconds&#xD;
1 point if held for 3 to 9.99 seconds&#xD;
0 points if held for &lt;3 seconds or not attempted</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SPPB Gait Speed</measure>
    <time_frame>Baseline to 6 months</time_frame>
    <description>Gait speed at a 4-meter walk is timed in seconds as participants walk at their usual pace. Two trials were administered, time (in seconds) was recorded for each trial. The fastest walk of two trials was recorded. Score is recorded between 0-4 with a higher score indicating a faster gait speed. Scoring is as follows:&#xD;
0 points if unable to do the walk&#xD;
1 point if time is more than 8.70 sec&#xD;
2 points if time is 6.21 to 8.70 sec&#xD;
3 points if time is 4.82 to 6.20 sec&#xD;
4 points if time is less than 4.82 sec</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SPPB Chair Stands</measure>
    <time_frame>Baseline to 6 months</time_frame>
    <description>Chair stand represents the time to complete five chair rises, sit to stand from a chair, as quickly as possible, without using hands, responses ranging between 0-4. Scoring is as follows:&#xD;
0 points if unable to complete 5 chair stands or completes stands in &gt;60 seconds&#xD;
1 point if chair stand time is 16.70 sec or more&#xD;
2 points if chair stand time is 13.70 to 16.69 sec or more&#xD;
3 points if chair stand time is 11.20 to 13.69 sec&#xD;
4 points if chair stand time is 11.19 sec or less</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Frailty</condition>
  <condition>Weight, Body</condition>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Behavioral Lifestyle Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants will receive behavioral lifestyle intervention with a smartphone-based self-monitoring for diet and physical activity. This group also includes a total of 10 Group sessions over 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B control arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants use the smart-phone app to record their daily diet and physical activity, with no group sessions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lifestyle App</intervention_name>
    <description>A mobile app used to assist with lifestyle changes</description>
    <arm_group_label>Behavioral Lifestyle Intervention</arm_group_label>
    <arm_group_label>Group B control arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Look AHEAD behavior lifestyle intervention</intervention_name>
    <description>A modified Look AHEAD behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity</description>
    <arm_group_label>Behavioral Lifestyle Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Abbreviated Look AHEAD behavior lifestyle intervention</intervention_name>
    <description>An abbreviated Look AHEAD behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity</description>
    <arm_group_label>Group B control arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Community-dwelling&#xD;
&#xD;
          -  Age 65 and older&#xD;
&#xD;
          -  Men and women of all ethnic groups&#xD;
&#xD;
          -  Self-reported of provider-diagnosed with Type 2 Diabetes (T2D) for at-least 6 months.&#xD;
&#xD;
          -  Received basic diabetes self-management education&#xD;
&#xD;
          -  Stable medication regimen and no medication changes are expected over the next 6&#xD;
             months.&#xD;
&#xD;
          -  Overweight/obese (Body Mass Index (BMI) ≥25 kg/m2&#xD;
&#xD;
          -  Able to read and write in English&#xD;
&#xD;
          -  Own a smartphone&#xD;
&#xD;
          -  At PI discretion, participant is willing/able to comply with the protocol requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unsafe to walk using Exercise Assessment and Screening for You (EASY) criteria or&#xD;
             clinical judgement of the PI.&#xD;
&#xD;
          -  History of severe psychiatric disorders or cognitive impairment which interferes with&#xD;
             active participation in the study&#xD;
&#xD;
          -  Residence of long-term care facility&#xD;
&#xD;
          -  History of substance abuse in the past year&#xD;
&#xD;
          -  Unwilling to be randomized in a Mobile Health (mHealth+) individual intervention group&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rozmin Jiwani, RN, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas Health at San Antonio</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8068458/</url>
    <description>J. Frailty Aging 2021 April 24: 1-9</description>
  </link>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <results_first_submitted>May 4, 2021</results_first_submitted>
  <results_first_submitted_qc>July 14, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 16, 2021</results_first_posted>
  <last_update_submitted>May 3, 2022</last_update_submitted>
  <last_update_submitted_qc>May 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center at San Antonio</investigator_affiliation>
    <investigator_full_name>Rozmin Jiwani</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Frailty</mesh_term>
    <mesh_term>Body Weight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Information will be shared with mentors and advisors</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will be available at study completion</ipd_time_frame>
    <ipd_access_criteria>Study Teams plans on publication at completion of data analysis.</ipd_access_criteria>
  </patient_data>
  <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>October 20, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/49/NCT04440449/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The control group did not recruit any subjects due to the COVID-19 pandemic</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Behavioral Lifestyle Intervention</title>
          <description>This group will receive behavioral lifestyle intervention with a smartphone-based self-monitoring for diet and physical activity. This group also includes a total of 10 Group sessions over 6 months.&#xD;
Lifestyle App: A mobile app used to assist with lifestyle changes</description>
        </group>
        <group group_id="P2">
          <title>Group B - Control Group</title>
          <description>The mHealth+ individual intervention group (Group B) will receive an abbreviated behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity in one face-to-face individual session at the beginning of the study. In addition, participants will receive self-study materials, from Look Ahead modules, and a monthly follow-up phone calls for the duration of the study (6-months)</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="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Participants were older adults with Type 2 diabetes. Group B did not enroll any participant due to the COVID-19 pandemic.</population>
      <group_list>
        <group group_id="B1">
          <title>Behavioral Lifestyle Intervention</title>
          <description>This group will receive behavioral lifestyle intervention with a smartphone-based self-monitoring for diet and physical activity. This group also includes a total of 10 Group sessions over 6 months.&#xD;
Lifestyle App: A mobile app used to assist with lifestyle changes</description>
        </group>
        <group group_id="B2">
          <title>Group B - Control Group</title>
          <description>The mHealth+ individual intervention group (Group B) will receive an abbreviated behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity in one face-to-face individual session at the beginning of the study. In addition, participants will receive self-study materials, from Look Ahead modules, and a monthly follow-up phone calls for the duration of the study (6-months)</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="18"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="18"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71.5" spread="5.3"/>
                    <measurement group_id="B3" value="71.5" spread="5.3"/>
                  </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="10"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B3" value="8"/>
                  </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="9"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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="18"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Frailty Scale Using Fried's Phenotype Method Based on Five Frailty Characteristics</title>
        <description>Self-reported (SR) exhaustion (Y/N ) on Center for Epidemiologic Studies Depression (CES-D) scale: &quot;Do you feel full of energy?&quot; &quot;No&quot; scored a 1 (exhausted).&#xD;
SR unintentional weight loss: &quot;In the last year, have you lost more than 10 pounds unintentionally?&quot;. &quot;Yes&quot; scored a 1.&#xD;
SR physical activity over the last year using the Minnesota Leisure Time Activity Questionnaire, (energy expenditure in kcal/week, standardized for sex). The lowest quintile for each sex group received a score of 1&#xD;
Grip strength measured (Kg) with a dynamometer in the dominant hand, standardized using body mass index quartiles and sex. The average of 3 trials was recorded. The lowest quintile for each sex group received a score of 1 (for weak).&#xD;
10 feet walked at usual pace, standardized based on height and sex. The fastest of 2 trials was recorded. Participants in the lowest quintile for each sex group were considered slow (score =1) A higher scale score from 0-5 indicates greater frailty</description>
        <time_frame>Baseline to 6 months</time_frame>
        <population>The control group did not recruit any subjects due to the COVID-19 pandemic</population>
        <group_list>
          <group group_id="O1">
            <title>Behavioral Lifestyle Intervention</title>
            <description>The participants will receive behavioral lifestyle intervention with a smartphone-based self-monitoring for diet and physical activity. This group also includes a total of 10 Group sessions over 6 months.&#xD;
Lifestyle App: A mobile app used to assist with lifestyle changes</description>
          </group>
          <group group_id="O2">
            <title>Group B - Control Group</title>
            <description>The mHealth+ individual intervention group (Group B) will receive an abbreviated behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity in one face-to-face individual session at the beginning of the study. In addition, participants will receive self-study materials, from Look Ahead modules, and a monthly follow-up phone calls for the duration of the study (6-months)</description>
          </group>
        </group_list>
        <measure>
          <title>Frailty Scale Using Fried's Phenotype Method Based on Five Frailty Characteristics</title>
          <description>Self-reported (SR) exhaustion (Y/N ) on Center for Epidemiologic Studies Depression (CES-D) scale: &quot;Do you feel full of energy?&quot; &quot;No&quot; scored a 1 (exhausted).&#xD;
SR unintentional weight loss: &quot;In the last year, have you lost more than 10 pounds unintentionally?&quot;. &quot;Yes&quot; scored a 1.&#xD;
SR physical activity over the last year using the Minnesota Leisure Time Activity Questionnaire, (energy expenditure in kcal/week, standardized for sex). The lowest quintile for each sex group received a score of 1&#xD;
Grip strength measured (Kg) with a dynamometer in the dominant hand, standardized using body mass index quartiles and sex. The average of 3 trials was recorded. The lowest quintile for each sex group received a score of 1 (for weak).&#xD;
10 feet walked at usual pace, standardized based on height and sex. The fastest of 2 trials was recorded. Participants in the lowest quintile for each sex group were considered slow (score =1) A higher scale score from 0-5 indicates greater frailty</description>
          <population>The control group did not recruit any subjects due to the COVID-19 pandemic</population>
          <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="18"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.61" spread="1.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.94" spread="0.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.01</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Glycated Hemoglobin (HbA1c)</title>
        <description>Change in HbA1c measured over the study period</description>
        <time_frame>Baseline to 6 months</time_frame>
        <population>The control group did not recruit any subjects due to the pandemic</population>
        <group_list>
          <group group_id="O1">
            <title>Behavioral Lifestyle Intervention</title>
            <description>The participants will receive behavioral lifestyle intervention with a smartphone-based self-monitoring for diet and physical activity. This group also includes a total of 10 Group sessions over 6 months.&#xD;
Lifestyle App: A mobile app used to assist with lifestyle changes</description>
          </group>
          <group group_id="O2">
            <title>Group B -Control Group</title>
            <description>The mHealth+ individual intervention group (Group B) will receive an abbreviated behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity in one face-to-face individual session at the beginning of the study. In addition, participants will receive self-study materials, from Look Ahead modules, and a monthly follow-up phone calls for the duration of the study (6-months)</description>
          </group>
        </group_list>
        <measure>
          <title>Glycated Hemoglobin (HbA1c)</title>
          <description>Change in HbA1c measured over the study period</description>
          <population>The control group did not recruit any subjects due to the pandemic</population>
          <units>Percentage of glycated hemoglobin</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.95" spread="0.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.75" spread="0.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.108</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Short Physical Performance Battery (SPPB) Balance</title>
        <description>The balance test assesses a person's ability to stand with the feet together in side-by-side, semi-tandem, and full-tandem positions for 10 seconds each, responses ranging between 0-4 with a higher score indicating better balance. Three balance tests are performed and scoring is as follows:&#xD;
Side-by-side stand: person attempts to stand with feet together, side-by-side, for 10 seconds.&#xD;
1 point if held for 10 seconds&#xD;
0 points if not held for 10 seconds or not attempted Semi-tandem stand: person attempts to stand with the side of the heel of one foot touching the big toe of the other foot for 10 seconds.&#xD;
1 point if held for 10 seconds&#xD;
0 points if not held for 10 seconds or not attempted Tandem stand: person attempts to stand with the heel of one foot in front of and touching the toes of the other foot for about 10 seconds.&#xD;
2 points if held for 10 seconds&#xD;
1 point if held for 3 to 9.99 seconds&#xD;
0 points if held for &lt;3 seconds or not attempted</description>
        <time_frame>Baseline to 6 months</time_frame>
        <population>The control group did not recruit any subjects due to the COVID-19 pandemic</population>
        <group_list>
          <group group_id="O1">
            <title>Behavioral Lifestyle Intervention</title>
            <description>This group will receive behavioral lifestyle intervention with a smartphone-based self-monitoring for diet and physical activity. This group also includes a total of 10 Group sessions over 6 months.&#xD;
Lifestyle App: A mobile app used to assist with lifestyle changes</description>
          </group>
          <group group_id="O2">
            <title>Group B - Control Group</title>
            <description>The mHealth+ individual intervention group (Group B) will receive an abbreviated behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity in one face-to-face individual session at the beginning of the study. In addition, participants will receive self-study materials, from Look Ahead modules, and a monthly follow-up phone calls for the duration of the study (6-months)</description>
          </group>
        </group_list>
        <measure>
          <title>Short Physical Performance Battery (SPPB) Balance</title>
          <description>The balance test assesses a person's ability to stand with the feet together in side-by-side, semi-tandem, and full-tandem positions for 10 seconds each, responses ranging between 0-4 with a higher score indicating better balance. Three balance tests are performed and scoring is as follows:&#xD;
Side-by-side stand: person attempts to stand with feet together, side-by-side, for 10 seconds.&#xD;
1 point if held for 10 seconds&#xD;
0 points if not held for 10 seconds or not attempted Semi-tandem stand: person attempts to stand with the side of the heel of one foot touching the big toe of the other foot for 10 seconds.&#xD;
1 point if held for 10 seconds&#xD;
0 points if not held for 10 seconds or not attempted Tandem stand: person attempts to stand with the heel of one foot in front of and touching the toes of the other foot for about 10 seconds.&#xD;
2 points if held for 10 seconds&#xD;
1 point if held for 3 to 9.99 seconds&#xD;
0 points if held for &lt;3 seconds or not attempted</description>
          <population>The control group did not recruit any subjects due to the COVID-19 pandemic</population>
          <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="18"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.39" spread="0.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.89" spread="0.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>SPPB Gait Speed</title>
        <description>Gait speed at a 4-meter walk is timed in seconds as participants walk at their usual pace. Two trials were administered, time (in seconds) was recorded for each trial. The fastest walk of two trials was recorded. Score is recorded between 0-4 with a higher score indicating a faster gait speed. Scoring is as follows:&#xD;
0 points if unable to do the walk&#xD;
1 point if time is more than 8.70 sec&#xD;
2 points if time is 6.21 to 8.70 sec&#xD;
3 points if time is 4.82 to 6.20 sec&#xD;
4 points if time is less than 4.82 sec</description>
        <time_frame>Baseline to 6 months</time_frame>
        <population>Group B did not recruit any subjects due to the COVID-19 pandemic</population>
        <group_list>
          <group group_id="O1">
            <title>Behavioral Lifestyle Intervention</title>
            <description>This group will receive behavioral lifestyle intervention with a smartphone-based self-monitoring for diet and physical activity. This group also includes a total of 10 Group sessions over 6 months.&#xD;
Lifestyle App: A mobile app used to assist with lifestyle changes</description>
          </group>
          <group group_id="O2">
            <title>Group B - Control Group</title>
            <description>The mHealth+ individual intervention group (Group B) will receive an abbreviated behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity in one face-to-face individual session at the beginning of the study. In addition, participants will receive self-study materials, from Look Ahead modules, and a monthly follow-up phone calls for the duration of the study (6-months)</description>
          </group>
        </group_list>
        <measure>
          <title>SPPB Gait Speed</title>
          <description>Gait speed at a 4-meter walk is timed in seconds as participants walk at their usual pace. Two trials were administered, time (in seconds) was recorded for each trial. The fastest walk of two trials was recorded. Score is recorded between 0-4 with a higher score indicating a faster gait speed. Scoring is as follows:&#xD;
0 points if unable to do the walk&#xD;
1 point if time is more than 8.70 sec&#xD;
2 points if time is 6.21 to 8.70 sec&#xD;
3 points if time is 4.82 to 6.20 sec&#xD;
4 points if time is less than 4.82 sec</description>
          <population>Group B did not recruit any subjects due to the COVID-19 pandemic</population>
          <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="18"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.61" spread="0.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.72" spread="0.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>SPPB Chair Stands</title>
        <description>Chair stand represents the time to complete five chair rises, sit to stand from a chair, as quickly as possible, without using hands, responses ranging between 0-4. Scoring is as follows:&#xD;
0 points if unable to complete 5 chair stands or completes stands in &gt;60 seconds&#xD;
1 point if chair stand time is 16.70 sec or more&#xD;
2 points if chair stand time is 13.70 to 16.69 sec or more&#xD;
3 points if chair stand time is 11.20 to 13.69 sec&#xD;
4 points if chair stand time is 11.19 sec or less</description>
        <time_frame>Baseline to 6 months</time_frame>
        <population>Group B did not recruit any subjects due to the COVID-19 pandemic</population>
        <group_list>
          <group group_id="O1">
            <title>Behavioral Lifestyle Intervention</title>
            <description>This group will receive behavioral lifestyle intervention with a smartphone-based self-monitoring for diet and physical activity. This group also includes a total of 10 Group sessions over 6 months.&#xD;
Lifestyle App: A mobile app used to assist with lifestyle changes</description>
          </group>
          <group group_id="O2">
            <title>Group B - Control Group</title>
            <description>The mHealth+ individual intervention group (Group B) will receive an abbreviated behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity in one face-to-face individual session at the beginning of the study. In addition, participants will receive self-study materials, from Look Ahead modules, and a monthly follow-up phone calls for the duration of the study (6-months)</description>
          </group>
        </group_list>
        <measure>
          <title>SPPB Chair Stands</title>
          <description>Chair stand represents the time to complete five chair rises, sit to stand from a chair, as quickly as possible, without using hands, responses ranging between 0-4. Scoring is as follows:&#xD;
0 points if unable to complete 5 chair stands or completes stands in &gt;60 seconds&#xD;
1 point if chair stand time is 16.70 sec or more&#xD;
2 points if chair stand time is 13.70 to 16.69 sec or more&#xD;
3 points if chair stand time is 11.20 to 13.69 sec&#xD;
4 points if chair stand time is 11.19 sec or less</description>
          <population>Group B did not recruit any subjects due to the COVID-19 pandemic</population>
          <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="18"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.28" spread="1.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.44" spread="1.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected during active study participation, from baseline to 6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Behavioral Lifestyle Intervention</title>
          <description>This group will receive behavioral lifestyle intervention with a smartphone-based self-monitoring for diet and physical activity. This group also includes a total of 10 Group sessions over 6 months.&#xD;
Lifestyle App: A mobile app used to assist with lifestyle changes</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="18"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
              </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="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Rozmin Jiwani</name_or_title>
      <organization>University of Texas Health San Antonio</organization>
      <phone>210-450-8498</phone>
      <email>jiwani@uthscsa.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/NCT04440449
org study id: HSC20190019H
secondary id: P30AG044271
nct id: NCT04440449
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study team want to see if changes in lifestyle and behaviors and self-monitoring of diet
      and physical activity in older adults who have type 2 Diabetes (T2D) may help to prevent or
      reduce frailty. Frailty occurs in older adults and leads people to have falls, become
      disabled, require nursing home placement, and have increased risk of death. T2D is one of the
      major risk factors for frailty. T2D is a significant problem in older adults and is known to
      increase the risk of future frailty.
Behavioral lifestyle intervention: Participants (N=40) will be randomized to the mHealth+
      group Intervention group (Group A; n=20)and mHealth+ individual intervention group (Group B;
      n=20) group using a randomization table. (1) The mHealth+ group Intervention group (Group A)
      will receive a modified Look AHEAD behavior lifestyle intervention with smartphone-based
      self-monitoring of diet and physical activity. This comprises ten group sessions for
      lifestyle intervention in 6-months. The group will receive three weekly classes in the first
      month and then bi-weekly classes for month 2-3, and three monthly session in month four,
      five, and six. The frequency and layout of these classes will allow participants to master
      new skills gradually, then eventually wean off, and adopt the modified lifestyle as the part
      of their daily lives. (2) The mHealth+ individual intervention group (Group B) will receive
      an abbreviated behavior lifestyle intervention with smartphone-based self-monitoring of diet
      and physical activity in one face-to-face individual session at the beginning of the study.
      In addition, participants will receive self-study materials, from Look Ahead modules, and a
      monthly follow-up phone calls for the duration of the study (6-months). The goal for these
      follow up phone calls are to assess understanding of the modules, to promote continued
      engagement with the study material, and to provide clarification on materials as needed.
      Participants in the mHealth+ group Intervention group (Group A) and mHealth+ individual
      intervention group (Group B will receive instruction on how to download an app to help them
      record their diet and physical activity at the beginning of the study.

      Fitbit offers a simple, easy-to-use tool for tracking food and physical activity. It helps
      set daily calorie budget, and set and work towards goals for nutrient intake, weight loss,
      exercise, and more. https://www.fitbit.com/inspire 04.12.20: Due to SARS-CoV2 (COVID-19) and
      social distancing order, the study team are adding hemoglobin Hba1c home test.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Group A - Mobile Health + group intervention
Group B (control arm)
primary purpose: Supportive Care
masking: None (Open Label)
measure: Frailty Scale Using Fried's Phenotype Method Based on Five Frailty Characteristics
time frame: Baseline to 6 months
description: Self-reported (SR) exhaustion (Y/N ) on Center for Epidemiologic Studies Depression (CES-D) scale: "Do you feel full of energy?" "No" scored a 1 (exhausted).
SR unintentional weight loss: "In the last year, have you lost more than 10 pounds unintentionally?". "Yes" scored a 1.
SR physical activity over the last year using the Minnesota Leisure Time Activity Questionnaire, (energy expenditure in kcal/week, standardized for sex). The lowest quintile for each sex group received a score of 1
Grip strength measured (Kg) with a dynamometer in the dominant hand, standardized using body mass index quartiles and sex. The average of 3 trials was recorded. The lowest quintile for each sex group received a score of 1 (for weak).
10 feet walked at usual pace, standardized based on height and sex. The fastest of 2 trials was recorded. Participants in the lowest quintile for each sex group were considered slow (score =1) A higher scale score from 0-5 indicates greater frailty
measure: Glycated Hemoglobin (HbA1c)
time frame: Baseline to 6 months
description: Change in HbA1c measured over the study period
measure: Short Physical Performance Battery (SPPB) Balance
time frame: Baseline to 6 months
description: The balance test assesses a person's ability to stand with the feet together in side-by-side, semi-tandem, and full-tandem positions for 10 seconds each, responses ranging between 0-4 with a higher score indicating better balance. Three balance tests are performed and scoring is as follows:
Side-by-side stand: person attempts to stand with feet together, side-by-side, for 10 seconds.
1 point if held for 10 seconds
0 points if not held for 10 seconds or not attempted Semi-tandem stand: person attempts to stand with the side of the heel of one foot touching the big toe of the other foot for 10 seconds.
1 point if held for 10 seconds
0 points if not held for 10 seconds or not attempted Tandem stand: person attempts to stand with the heel of one foot in front of and touching the toes of the other foot for about 10 seconds.
2 points if held for 10 seconds
1 point if held for 3 to 9.99 seconds
0 points if held for <3 seconds or not attempted
measure: SPPB Gait Speed
time frame: Baseline to 6 months
description: Gait speed at a 4-meter walk is timed in seconds as participants walk at their usual pace. Two trials were administered, time (in seconds) was recorded for each trial. The fastest walk of two trials was recorded. Score is recorded between 0-4 with a higher score indicating a faster gait speed. Scoring is as follows:
0 points if unable to do the walk
1 point if time is more than 8.70 sec
2 points if time is 6.21 to 8.70 sec
3 points if time is 4.82 to 6.20 sec
4 points if time is less than 4.82 sec
measure: SPPB Chair Stands
time frame: Baseline to 6 months
description: Chair stand represents the time to complete five chair rises, sit to stand from a chair, as quickly as possible, without using hands, responses ranging between 0-4. Scoring is as follows:
0 points if unable to complete 5 chair stands or completes stands in >60 seconds
1 point if chair stand time is 16.70 sec or more
2 points if chair stand time is 13.70 to 16.69 sec or more
3 points if chair stand time is 11.20 to 13.69 sec
4 points if chair stand time is 11.19 sec or less
arm group label: Behavioral Lifestyle Intervention
arm group type: Experimental
description: The participants will receive behavioral lifestyle intervention with a smartphone-based self-monitoring for diet and physical activity. This group also includes a total of 10 Group sessions over 6 months.
arm group label: Group B control arm
arm group type: Other
description: Participants use the smart-phone app to record their daily diet and physical activity, with no group sessions.
intervention type: Behavioral
intervention name: Lifestyle App
description: A mobile app used to assist with lifestyle changes
arm group label: Behavioral Lifestyle Intervention
arm group label: Group B control arm
intervention type: Behavioral
intervention name: Look AHEAD behavior lifestyle intervention
description: A modified Look AHEAD behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity
arm group label: Behavioral Lifestyle Intervention
intervention type: Behavioral
intervention name: Abbreviated Look AHEAD behavior lifestyle intervention
description: An abbreviated Look AHEAD behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity
arm group label: Group B control arm
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Rozmin Jiwani, RN, PhD
role: Principal Investigator
affiliation: University of Texas Health at San Antonio
facility: 
country: United States
url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8068458/
description: J. Frailty Aging 2021 April 24: 1-9
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center at San Antonio
investigator full name: Rozmin Jiwani
investigator title: Assistant Professor
mesh term: Diabetes Mellitus
mesh term: Frailty
mesh term: Body Weight
sharing ipd: Yes
ipd description: Information will be shared with mentors and advisors
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Analytic Code
ipd time frame: Data will be available at study completion
ipd access criteria: Study Teams plans on publication at completion of data analysis.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 