<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/NCT03039569</url>
  </required_header>
  <id_info>
    <org_study_id>16200</org_study_id>
    <nct_id>NCT03039569</nct_id>
  </id_info>
  <brief_title>Assessing Home Food Environment and Diabetes Self-management Among Adult Type 2 Diabetes Patients</brief_title>
  <official_title>Assessing Home Food Environment and Diabetes Self-management Among Adult Type 2 Diabetes Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nebraska Lincoln</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Methodist Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Nebraska Lincoln</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>
      In this project the investigators examined the impact of diabetes self-management education&#xD;
      using text messaging on increasing awareness of CVD risk perception, dietary intake, physical&#xD;
      activity, and diabetes self-management among adults with type 2 diabetes using a quasi&#xD;
      experimental design. The study sample included 79 adult type 2 diabetes patients (30 years or&#xD;
      older). The recruited adult type 2 diabetes patients were assigned into the intervention&#xD;
      group (40 participants) and control group (39 participants). The intervention group received&#xD;
      3 messages weekly consisting of nutrition education and diabetes self-management information&#xD;
      and skills for 3 months (12 weeks). The messages consisted of information on how to increase&#xD;
      fruits and vegetables and reduce high-fat and sugary foods intake, increase the availability&#xD;
      of fruits and vegetables and reduce high-fat and sugary foods in the home, strategies to&#xD;
      increase diabetes self-management skills, and awareness of cardiovascular disease risk&#xD;
      perception and knowledge. The text messages were derived from the American Association of&#xD;
      Diabetes Educator (AADE) handouts (&quot;Reducing Risks&quot;, &quot;Monitoring&quot;, &quot;Healthy Coping&quot;, &quot;Problem&#xD;
      Solving&quot;, &quot;Taking Medication&quot;, &quot;Healthy Eating&quot;, and &quot;Exercise&quot;) Text messages were positive&#xD;
      and motivating and included a link to a specific AADE7 handout that allows participants to&#xD;
      open and retrieve the specific AADE7 handout. The control group did not receive text&#xD;
      messages. The participants (both intervention and control group) completed surveys at&#xD;
      baseline (before study begins) and at the conclusion of the study (at three month of the&#xD;
      intervention) about their dietary and lifestyle habits, diabetes self-care management&#xD;
      activities, and awareness of cardiovascular diseases. We collected also collect patient's&#xD;
      self-report Hemoglobin A1C values at baseline and at the conclusion of the study (at three&#xD;
      month of the intervention).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Type 2 diabetes and its complications have become an important public health problem,&#xD;
      affecting nearly 350 million adults worldwide. However, successfully managing type 2 diabetes&#xD;
      through proper nutrition and healthy lifestyles remains challenging for many diabetes&#xD;
      patients. In this proposed project the investigators examined the impact of diabetes&#xD;
      self-management education using text messaging on increasing awareness of CVD risk&#xD;
      perception, dietary intake, physical activity, and diabetes self-management, and quality of&#xD;
      life among adults with type 2 diabetes among adults with Type 2 diabetes using a quasi&#xD;
      experimental design. The study sample included 79 adult type 2 diabetes patients (30 years or&#xD;
      older). Inclusion criteria for the study sample of adult type II diabetes patients were:&#xD;
      adults ages 30 or older, English speaking, and Hemoglobin A1C levels &gt; 6.5%.&#xD;
&#xD;
      Adult type 2 diabetes patients were recruited from the Center for Diabetes &amp; Nutritional&#xD;
      Health, an outpatient diabetes clinic of Methodist Hospital in Omaha with the assistance of&#xD;
      Certified Diabetes Educators and Registered Dietitians. Diagnosis of type 2 diabetes were&#xD;
      based on patient self-report and verified by the Co-Primary Investigator (who is Certified&#xD;
      Diabetes educator and registered dietitian at the Methodist Hospital. The recruited adult&#xD;
      type 2 diabetes patients were assigned into the intervention group (40 participants) and&#xD;
      control group (39 participants). The intervention group received 3 messages weekly consisting&#xD;
      of nutrition education and diabetes self-management information and skills for 3 months (12&#xD;
      weeks). The messages consisted of information on how to increase fruits and vegetables and&#xD;
      reduce high-fat and sugary foods intake, increase the availability of fruits and vegetables&#xD;
      and reduce high-fat and sugary foods in the home, strategies to increase diabetes&#xD;
      self-management skills, and awareness of cardiovascular disease risk perception and&#xD;
      knowledge. The text messages were derived from the American Association of Diabetes Educator&#xD;
      (AADE) handouts (&quot;Reducing Risks&quot;, &quot;Monitoring&quot;, &quot;Healthy Coping&quot;, &quot;Problem Solving&quot;, &quot;Taking&#xD;
      Medication&quot;, &quot;Healthy Eating&quot;, and &quot;Exercise&quot;) Text messages were positive and motivating and&#xD;
      included a link to a specific AADE7 handout that allows participants to open and retrieve the&#xD;
      specific AADE7 handout. Text messages were sent by the project investigators to the&#xD;
      participants in the intervention group via a free computer-based text messaging service. The&#xD;
      computer was password protected and can only be accessed by the investigators. Participant's&#xD;
      phone numbers used for text message intervention were kept private. Only investigators and&#xD;
      research assistant know the participant's cell phone numbers used for text message&#xD;
      intervention and each participant's cell number was not shared with anyone else including&#xD;
      other study participants. Text messages were sent by the project investigators or research&#xD;
      assistant to the patients and were one-way text messages, meaning that patient did not need&#xD;
      to reply to the text messages. If a patient had a medical concern about his/her diabetes,&#xD;
      he/she was advised not to send a text message to the investigator, but to contact his/her&#xD;
      physician or call 911 instead. The control group did not receive text messages. The&#xD;
      participants (both intervention and control group) completed surveys at baseline (before&#xD;
      study begins) and at the conclusion of the study (at three month of the intervention) about&#xD;
      their dietary and lifestyle habits, diabetes self-care management, awareness of&#xD;
      cardiovascular diseases and home food environment. The investigators also collected patient's&#xD;
      self-report Hemoglobin A1C values at baseline and at the conclusion of the study (at three&#xD;
      month of the intervention).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 28, 2017</start_date>
  <completion_date type="Actual">May 31, 2018</completion_date>
  <primary_completion_date type="Actual">May 31, 2018</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-Care Activities: Healthy Eating</measure>
    <time_frame>Three months</time_frame>
    <description>An average of summary scores of the four self-report heathy eating related items in the category (days/over the last 7 days)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diabetes Self-care Activity: Exercise</measure>
    <time_frame>Three months</time_frame>
    <description>Average of two self-report survey questions related to exercise in the category (days/over the last 7 days)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-care Activity: Blood Glucose Testing</measure>
    <time_frame>three months</time_frame>
    <description>Average of two self-report survey question items related to blood glucose testing in the category (days over the last seven days)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-care Activity: Medication Adherence</measure>
    <time_frame>three months</time_frame>
    <description>Self-report survey question (days over the last seven days)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-care Activity: Foot Care</measure>
    <time_frame>three months</time_frame>
    <description>Average of four self-report survey questions of the category (days over the last seven days)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Eat &gt;= 5 Servings Fruit and Vegetables</measure>
    <time_frame>Three months</time_frame>
    <description>Self report survey question (days/week)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-report Hemoglobin A1C</measure>
    <time_frame>Three months</time_frame>
    <description>Self-report hemoglobin for diabetes status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Concern of CVD Event</measure>
    <time_frame>Three months</time_frame>
    <description>Self-report question to measure a patient's cardiovascular disease awareness: Frequency of concern of CVD event</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Carbohydrate</measure>
    <time_frame>One month</time_frame>
    <description>A self-report food frequency questionnaire over the past month</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolic Equivalent (MET) Minutes Per Week for Moderate/Vigorous Physical Activity</measure>
    <time_frame>Three months</time_frame>
    <description>A Self-report physical activity measure over the past month. The activities were converted to metabolic equivalent (MET: a measure of exercise intensity based on oxygen consumption) minutes per week for moderate/vigorous physical activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years</measure>
    <time_frame>Three months</time_frame>
    <description>Self report survey question</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of Concern of CVD Event in Lifetime</measure>
    <time_frame>Three months</time_frame>
    <description>Self-report survey question on Cardiovascular disease (CVD) awareness: degree of concern of CVD event in lifetime</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">79</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Text messaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will not receive text message intervention. This is the measurement-only group</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Text messaging</intervention_name>
    <description>The messages will consist of information on how to increase fruits and vegetables and reduce high-fat and sugary foods intake, increase the availability of fruits and vegetables and reduce high-fat and sugary foods in the home, strategies to increase diabetes self-management skills, and awareness of cardiovascular disease risk perception and knowledge. The text messages will be derived from the American Association of Diabetes Educator (AADE) handouts (&quot;Reducing Risks&quot;, &quot;Monitoring&quot;, &quot;Healthy Coping&quot;, &quot;Problem Solving&quot;, &quot;Taking Medication&quot;, &quot;Healthy Eating&quot;, and &quot;Exercise&quot;). The control group will not receive text messages</description>
    <arm_group_label>Text messaging</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Self-report adult type 2 diabetes patients&#xD;
&#xD;
          -  Adults ages 30 or older&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Self-report Hemoglobin A1C &gt; 6.5%&#xD;
&#xD;
          -  Have a cell phone able to receive text messages&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals without Type 2 diabetes&#xD;
&#xD;
          -  Less than 30 years of age&#xD;
&#xD;
          -  Self-report Hemoglobin A1C less than 6.5%&#xD;
&#xD;
          -  Does not have a cell phone to receive text messages&#xD;
&#xD;
          -  Individuals who don't speak and understand English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Weiwen Chai, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nebraska Lincoln</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Nebraska-Lincoln (with Methodist Hospital System)</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68583-0806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Cowie CC, Rust KF, Byrd-Holt DD, Gregg EW, Ford ES, Geiss LS, Bainbridge KE, Fradkin JE. Prevalence of diabetes and high risk for diabetes using A1C criteria in the U.S. population in 1988-2006. Diabetes Care. 2010 Mar;33(3):562-8. doi: 10.2337/dc09-1524. Epub 2010 Jan 12.</citation>
    <PMID>20067953</PMID>
  </reference>
  <reference>
    <citation>American Diabetes Association Task Force for Writing Nutrition Principles and Recommendations for the Management of Diabetes and Related Complications. American Diabetes Association position statement: evidence-based nutrition principles and recommendations for the treatment and prevention of diabetes and related complications. J Am Diet Assoc. 2002 Jan;102(1):109-18. doi: 10.1016/s0002-8223(02)90031-3.</citation>
    <PMID>11794490</PMID>
  </reference>
  <reference>
    <citation>Toobert DJ, Hampson SE, Glasgow RE. The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care. 2000 Jul;23(7):943-50. doi: 10.2337/diacare.23.7.943.</citation>
    <PMID>10895844</PMID>
  </reference>
  <reference>
    <citation>Goodarzi M, Ebrahimzadeh I, Rabi A, Saedipoor B, Jafarabadi MA. Impact of distance education via mobile phone text messaging on knowledge, attitude, practice and self efficacy of patients with type 2 diabetes mellitus in Iran. J Diabetes Metab Disord. 2012 Aug 31;11(1):10. doi: 10.1186/2251-6581-11-10.</citation>
    <PMID>23497632</PMID>
  </reference>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <results_first_submitted>August 27, 2018</results_first_submitted>
  <results_first_submitted_qc>February 22, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">June 3, 2019</results_first_posted>
  <last_update_submitted>June 7, 2019</last_update_submitted>
  <last_update_submitted_qc>June 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Type 2 diabetes patients</keyword>
  <keyword>Diabetes self-management</keyword>
  <keyword>Cardiovascular diseases awareness</keyword>
  <keyword>Home food environment</keyword>
  <keyword>Text message</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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>June 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/69/NCT03039569/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Text Messaging</title>
          <description>Participants received 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).&#xD;
Text messaging: The messages consisted of information on how to increase fruits and vegetables and reduce high-fat and sugary foods intake, increase the availability of fruits and vegetables and reduce high-fat and sugary foods in the home, strategies to increase diabetes self-management skills, and awareness of cardiovascular disease risk perception and knowledge. The text messages will be derived from the American Association of Diabetes Educator (AADE) handouts (&quot;Reducing Risks&quot;, &quot;Monitoring&quot;, &quot;Healthy Coping&quot;, &quot;Problem Solving&quot;, &quot;Taking Medication&quot;, &quot;Healthy Eating&quot;, and &quot;Exercise&quot;). The control group did not receive text messages</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Participants did not receive text message intervention. This is the measurement-only group</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
              </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="5"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Text Messaging</title>
          <description>Intervention group received three text messages per week for 12 weeks</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Control group did not receive text messages</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="40"/>
            <count group_id="B2" value="39"/>
            <count group_id="B3" value="79"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.8" spread="10.6"/>
                    <measurement group_id="B2" value="55.7" spread="12.2"/>
                    <measurement group_id="B3" value="56.9" spread="11.4"/>
                  </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="26"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Self-Care Activities: Healthy Eating</title>
        <description>An average of summary scores of the four self-report heathy eating related items in the category (days/over the last 7 days)</description>
        <time_frame>Three months</time_frame>
        <population>Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.</population>
        <group_list>
          <group group_id="O1">
            <title>Text Messaging</title>
            <description>Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants will not receive text message intervention. This is the measurement-only group</description>
          </group>
        </group_list>
        <measure>
          <title>Self-Care Activities: Healthy Eating</title>
          <description>An average of summary scores of the four self-report heathy eating related items in the category (days/over the last 7 days)</description>
          <population>Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.</population>
          <units>days/week (min: 0 days; Max: 7 days)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.23" spread="0.38"/>
                    <measurement group_id="O2" value="4.67" spread="0.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.61" spread="0.40"/>
                    <measurement group_id="O2" value="4.60" spread="0.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Diabetes Self-care Activity: Exercise</title>
        <description>Average of two self-report survey questions related to exercise in the category (days/over the last 7 days)</description>
        <time_frame>Three months</time_frame>
        <population>Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.</population>
        <group_list>
          <group group_id="O1">
            <title>Text Messaging</title>
            <description>Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants will not receive text message intervention. This is the measurement-only group</description>
          </group>
        </group_list>
        <measure>
          <title>Diabetes Self-care Activity: Exercise</title>
          <description>Average of two self-report survey questions related to exercise in the category (days/over the last 7 days)</description>
          <population>Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.</population>
          <units>days/week (min: 0 days; Max: 7 days)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.13" spread="0.62"/>
                    <measurement group_id="O2" value="4.91" spread="0.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.48" spread="0.66"/>
                    <measurement group_id="O2" value="4.25" spread="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Self-care Activity: Blood Glucose Testing</title>
        <description>Average of two self-report survey question items related to blood glucose testing in the category (days over the last seven days)</description>
        <time_frame>three months</time_frame>
        <population>Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.</population>
        <group_list>
          <group group_id="O1">
            <title>Text Messaging</title>
            <description>Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants will not receive text message intervention. This is the measurement-only group</description>
          </group>
        </group_list>
        <measure>
          <title>Self-care Activity: Blood Glucose Testing</title>
          <description>Average of two self-report survey question items related to blood glucose testing in the category (days over the last seven days)</description>
          <population>Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.</population>
          <units>days/ week (min: 0 days; max: 7 days))</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.09" spread="0.64"/>
                    <measurement group_id="O2" value="5.93" spread="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.27" spread="0.68"/>
                    <measurement group_id="O2" value="5.63" spread="0.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Self-care Activity: Medication Adherence</title>
        <description>Self-report survey question (days over the last seven days)</description>
        <time_frame>three months</time_frame>
        <population>Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.</population>
        <group_list>
          <group group_id="O1">
            <title>Text Messaging</title>
            <description>Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants will not receive text message intervention. This is the measurement-only group</description>
          </group>
        </group_list>
        <measure>
          <title>Self-care Activity: Medication Adherence</title>
          <description>Self-report survey question (days over the last seven days)</description>
          <population>Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.</population>
          <units>day/week (min: 0 days; max 7 days)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.75" spread="0.22"/>
                    <measurement group_id="O2" value="5.83" spread="0.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.73" spread="0.23"/>
                    <measurement group_id="O2" value="5.67" spread="0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Self-care Activity: Foot Care</title>
        <description>Average of four self-report survey questions of the category (days over the last seven days)</description>
        <time_frame>three months</time_frame>
        <population>Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.</population>
        <group_list>
          <group group_id="O1">
            <title>Text Messaging</title>
            <description>Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants will not receive text message intervention. This is the measurement-only group</description>
          </group>
        </group_list>
        <measure>
          <title>Self-care Activity: Foot Care</title>
          <description>Average of four self-report survey questions of the category (days over the last seven days)</description>
          <population>Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.</population>
          <units>day/week (min: 0 days; max 7 days)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.17" spread="0.41"/>
                    <measurement group_id="O2" value="4.22" spread="0.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.89" spread="0.44"/>
                    <measurement group_id="O2" value="4.18" spread="0.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Eat &gt;= 5 Servings Fruit and Vegetables</title>
        <description>Self report survey question (days/week)</description>
        <time_frame>Three months</time_frame>
        <population>Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.</population>
        <group_list>
          <group group_id="O1">
            <title>Text Messaging</title>
            <description>Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).&#xD;
Text messaging: The messages will consist of information on how to increase fruits and vegetables and reduce high-fat and sugary foods intake, increase the availability of fruits and vegetables and reduce high-fat and sugary foods in the home, strategies to increase diabetes self-management skills, and awareness of cardiovascular disease risk perception and knowledge. The text messages will be derived from the American Association of Diabetes Educator (AADE) handouts (&quot;Reducing Risks&quot;, &quot;Monitoring&quot;, &quot;Healthy Coping&quot;, &quot;Problem Solving&quot;, &quot;Taking Medication&quot;, &quot;Healthy Eating&quot;, and &quot;Exercise&quot;). The control group will not receive text messages</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants will not receive text message intervention. This is the measurement-only group</description>
          </group>
        </group_list>
        <measure>
          <title>Eat &gt;= 5 Servings Fruit and Vegetables</title>
          <description>Self report survey question (days/week)</description>
          <population>Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.</population>
          <units>day/week (min: 0 days; max 7 days)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" spread="0.4"/>
                    <measurement group_id="O2" value="4.0" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Self-report Hemoglobin A1C</title>
        <description>Self-report hemoglobin for diabetes status</description>
        <time_frame>Three months</time_frame>
        <population>Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.</population>
        <group_list>
          <group group_id="O1">
            <title>Text Messaging</title>
            <description>Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants will not receive text message intervention. This is the measurement-only group</description>
          </group>
        </group_list>
        <measure>
          <title>Self-report Hemoglobin A1C</title>
          <description>Self-report hemoglobin for diabetes status</description>
          <population>Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.</population>
          <units>percentage of glycated HB in blood</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.9" spread="0.3"/>
                    <measurement group_id="O2" value="8.5" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.6" spread="0.3"/>
                    <measurement group_id="O2" value="8.0" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Concern of CVD Event</title>
        <description>Self-report question to measure a patient's cardiovascular disease awareness: Frequency of concern of CVD event</description>
        <time_frame>Three months</time_frame>
        <population>Chi-square</population>
        <group_list>
          <group group_id="O1">
            <title>Text Messaging</title>
            <description>Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants will not receive text message intervention. This is the measurement-only group</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Concern of CVD Event</title>
          <description>Self-report question to measure a patient's cardiovascular disease awareness: Frequency of concern of CVD event</description>
          <population>Chi-square</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <title>Never/rare concern</title>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Sometimes concern</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Always concern</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not answer</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>post-intervention</title>
              <category_list>
                <category>
                  <title>Never/rare concern</title>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Sometimes concern</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Always concern</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not answer</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Carbohydrate</title>
        <description>A self-report food frequency questionnaire over the past month</description>
        <time_frame>One month</time_frame>
        <population>Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.</population>
        <group_list>
          <group group_id="O1">
            <title>Text Messaging</title>
            <description>Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants will not receive text message intervention. This is the measurement-only group</description>
          </group>
        </group_list>
        <measure>
          <title>Total Carbohydrate</title>
          <description>A self-report food frequency questionnaire over the past month</description>
          <population>Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.</population>
          <units>gram/day</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="126" spread="10"/>
                    <measurement group_id="O2" value="111" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102" spread="11"/>
                    <measurement group_id="O2" value="100" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Metabolic Equivalent (MET) Minutes Per Week for Moderate/Vigorous Physical Activity</title>
        <description>A Self-report physical activity measure over the past month. The activities were converted to metabolic equivalent (MET: a measure of exercise intensity based on oxygen consumption) minutes per week for moderate/vigorous physical activity</description>
        <time_frame>Three months</time_frame>
        <population>Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.</population>
        <group_list>
          <group group_id="O1">
            <title>Text Messaging</title>
            <description>Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants will not receive text message intervention. This is the measurement-only group</description>
          </group>
        </group_list>
        <measure>
          <title>Metabolic Equivalent (MET) Minutes Per Week for Moderate/Vigorous Physical Activity</title>
          <description>A Self-report physical activity measure over the past month. The activities were converted to metabolic equivalent (MET: a measure of exercise intensity based on oxygen consumption) minutes per week for moderate/vigorous physical activity</description>
          <population>Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.</population>
          <units>MET minutes/week</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2112" spread="1451"/>
                    <measurement group_id="O2" value="1042" spread="1430"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3163" spread="1555"/>
                    <measurement group_id="O2" value="405" spread="1532"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years</title>
        <description>Self report survey question</description>
        <time_frame>Three months</time_frame>
        <population>Chi-square</population>
        <group_list>
          <group group_id="O1">
            <title>Text Messaging</title>
            <description>Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants will not receive text message intervention. This is the measurement-only group</description>
          </group>
        </group_list>
        <measure>
          <title>Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years</title>
          <description>Self report survey question</description>
          <population>Chi-square</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <title>No or low concern</title>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Somewhat concern</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Highly concern</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not answer</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>post-intervention</title>
              <category_list>
                <category>
                  <title>No or low concern</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Somewhat concern</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Highly concern</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not answer</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Degree of Concern of CVD Event in Lifetime</title>
        <description>Self-report survey question on Cardiovascular disease (CVD) awareness: degree of concern of CVD event in lifetime</description>
        <time_frame>Three months</time_frame>
        <population>Chi-square</population>
        <group_list>
          <group group_id="O1">
            <title>Text Messaging</title>
            <description>Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants will not receive text message intervention. This is the measurement-only group</description>
          </group>
        </group_list>
        <measure>
          <title>Degree of Concern of CVD Event in Lifetime</title>
          <description>Self-report survey question on Cardiovascular disease (CVD) awareness: degree of concern of CVD event in lifetime</description>
          <population>Chi-square</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <title>No concern/low concern</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Somewhat concern</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>highly concern</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not answer</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>post-intervention</title>
              <category_list>
                <category>
                  <title>No concern/low concern</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Somewhat concern</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>highly concern</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not answer</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 month</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Text Messaging</title>
          <description>Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Participants will not receive text message intervention. This is the measurement-only group</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="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</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="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
              </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>
    <limitations_and_caveats>1) The non-randomized, quasi-experimental study design; 2) Using self-report measures</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Weiwen Chai</name_or_title>
      <organization>University of Nebraska-Lincoln</organization>
      <phone>402-472-7822</phone>
      <email>wchai2@unl.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/NCT03039569
org study id: 16200
nct id: NCT03039569
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this project the investigators examined the impact of diabetes self-management education
      using text messaging on increasing awareness of CVD risk perception, dietary intake, physical
      activity, and diabetes self-management among adults with type 2 diabetes using a quasi
      experimental design. The study sample included 79 adult type 2 diabetes patients (30 years or
      older). The recruited adult type 2 diabetes patients were assigned into the intervention
      group (40 participants) and control group (39 participants). The intervention group received
      3 messages weekly consisting of nutrition education and diabetes self-management information
      and skills for 3 months (12 weeks). The messages consisted of information on how to increase
      fruits and vegetables and reduce high-fat and sugary foods intake, increase the availability
      of fruits and vegetables and reduce high-fat and sugary foods in the home, strategies to
      increase diabetes self-management skills, and awareness of cardiovascular disease risk
      perception and knowledge. The text messages were derived from the American Association of
      Diabetes Educator (AADE) handouts ("Reducing Risks", "Monitoring", "Healthy Coping", "Problem
      Solving", "Taking Medication", "Healthy Eating", and "Exercise") Text messages were positive
      and motivating and included a link to a specific AADE7 handout that allows participants to
      open and retrieve the specific AADE7 handout. The control group did not receive text
      messages. The participants (both intervention and control group) completed surveys at
      baseline (before study begins) and at the conclusion of the study (at three month of the
      intervention) about their dietary and lifestyle habits, diabetes self-care management
      activities, and awareness of cardiovascular diseases. We collected also collect patient's
      self-report Hemoglobin A1C values at baseline and at the conclusion of the study (at three
      month of the intervention).
Type 2 diabetes and its complications have become an important public health problem,
      affecting nearly 350 million adults worldwide. However, successfully managing type 2 diabetes
      through proper nutrition and healthy lifestyles remains challenging for many diabetes
      patients. In this proposed project the investigators examined the impact of diabetes
      self-management education using text messaging on increasing awareness of CVD risk
      perception, dietary intake, physical activity, and diabetes self-management, and quality of
      life among adults with type 2 diabetes among adults with Type 2 diabetes using a quasi
      experimental design. The study sample included 79 adult type 2 diabetes patients (30 years or
      older). Inclusion criteria for the study sample of adult type II diabetes patients were:
      adults ages 30 or older, English speaking, and Hemoglobin A1C levels > 6.5%.

      Adult type 2 diabetes patients were recruited from the Center for Diabetes & Nutritional
      Health, an outpatient diabetes clinic of Methodist Hospital in Omaha with the assistance of
      Certified Diabetes Educators and Registered Dietitians. Diagnosis of type 2 diabetes were
      based on patient self-report and verified by the Co-Primary Investigator (who is Certified
      Diabetes educator and registered dietitian at the Methodist Hospital. The recruited adult
      type 2 diabetes patients were assigned into the intervention group (40 participants) and
      control group (39 participants). The intervention group received 3 messages weekly consisting
      of nutrition education and diabetes self-management information and skills for 3 months (12
      weeks). The messages consisted of information on how to increase fruits and vegetables and
      reduce high-fat and sugary foods intake, increase the availability of fruits and vegetables
      and reduce high-fat and sugary foods in the home, strategies to increase diabetes
      self-management skills, and awareness of cardiovascular disease risk perception and
      knowledge. The text messages were derived from the American Association of Diabetes Educator
      (AADE) handouts ("Reducing Risks", "Monitoring", "Healthy Coping", "Problem Solving", "Taking
      Medication", "Healthy Eating", and "Exercise") Text messages were positive and motivating and
      included a link to a specific AADE7 handout that allows participants to open and retrieve the
      specific AADE7 handout. Text messages were sent by the project investigators to the
      participants in the intervention group via a free computer-based text messaging service. The
      computer was password protected and can only be accessed by the investigators. Participant's
      phone numbers used for text message intervention were kept private. Only investigators and
      research assistant know the participant's cell phone numbers used for text message
      intervention and each participant's cell number was not shared with anyone else including
      other study participants. Text messages were sent by the project investigators or research
      assistant to the patients and were one-way text messages, meaning that patient did not need
      to reply to the text messages. If a patient had a medical concern about his/her diabetes,
      he/she was advised not to send a text message to the investigator, but to contact his/her
      physician or call 911 instead. The control group did not receive text messages. The
      participants (both intervention and control group) completed surveys at baseline (before
      study begins) and at the conclusion of the study (at three month of the intervention) about
      their dietary and lifestyle habits, diabetes self-care management, awareness of
      cardiovascular diseases and home food environment. The investigators also collected patient's
      self-report Hemoglobin A1C values at baseline and at the conclusion of the study (at three
      month of the intervention).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Self-Care Activities: Healthy Eating
time frame: Three months
description: An average of summary scores of the four self-report heathy eating related items in the category (days/over the last 7 days)
measure: Diabetes Self-care Activity: Exercise
time frame: Three months
description: Average of two self-report survey questions related to exercise in the category (days/over the last 7 days)
measure: Self-care Activity: Blood Glucose Testing
time frame: three months
description: Average of two self-report survey question items related to blood glucose testing in the category (days over the last seven days)
measure: Self-care Activity: Medication Adherence
time frame: three months
description: Self-report survey question (days over the last seven days)
measure: Self-care Activity: Foot Care
time frame: three months
description: Average of four self-report survey questions of the category (days over the last seven days)
measure: Eat >= 5 Servings Fruit and Vegetables
time frame: Three months
description: Self report survey question (days/week)
measure: Self-report Hemoglobin A1C
time frame: Three months
description: Self-report hemoglobin for diabetes status
measure: Frequency of Concern of CVD Event
time frame: Three months
description: Self-report question to measure a patient's cardiovascular disease awareness: Frequency of concern of CVD event
measure: Total Carbohydrate
time frame: One month
description: A self-report food frequency questionnaire over the past month
measure: Metabolic Equivalent (MET) Minutes Per Week for Moderate/Vigorous Physical Activity
time frame: Three months
description: A Self-report physical activity measure over the past month. The activities were converted to metabolic equivalent (MET: a measure of exercise intensity based on oxygen consumption) minutes per week for moderate/vigorous physical activity
measure: Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years
time frame: Three months
description: Self report survey question
measure: Degree of Concern of CVD Event in Lifetime
time frame: Three months
description: Self-report survey question on Cardiovascular disease (CVD) awareness: degree of concern of CVD event in lifetime
arm group label: Text messaging
arm group type: Experimental
description: Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).
arm group label: Control
arm group type: No Intervention
description: Participants will not receive text message intervention. This is the measurement-only group
intervention type: Behavioral
intervention name: Text messaging
description: The messages will consist of information on how to increase fruits and vegetables and reduce high-fat and sugary foods intake, increase the availability of fruits and vegetables and reduce high-fat and sugary foods in the home, strategies to increase diabetes self-management skills, and awareness of cardiovascular disease risk perception and knowledge. The text messages will be derived from the American Association of Diabetes Educator (AADE) handouts ("Reducing Risks", "Monitoring", "Healthy Coping", "Problem Solving", "Taking Medication", "Healthy Eating", and "Exercise"). The control group will not receive text messages
arm group label: Text messaging
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
last name: Weiwen Chai, PhD
role: Principal Investigator
affiliation: University of Nebraska Lincoln
facility: 
country: United States
citation: Cowie CC, Rust KF, Byrd-Holt DD, Gregg EW, Ford ES, Geiss LS, Bainbridge KE, Fradkin JE. Prevalence of diabetes and high risk for diabetes using A1C criteria in the U.S. population in 1988-2006. Diabetes Care. 2010 Mar;33(3):562-8. doi: 10.2337/dc09-1524. Epub 2010 Jan 12.
PMID: 20067953
citation: American Diabetes Association Task Force for Writing Nutrition Principles and Recommendations for the Management of Diabetes and Related Complications. American Diabetes Association position statement: evidence-based nutrition principles and recommendations for the treatment and prevention of diabetes and related complications. J Am Diet Assoc. 2002 Jan;102(1):109-18. doi: 10.1016/s0002-8223(02)90031-3.
PMID: 11794490
citation: Toobert DJ, Hampson SE, Glasgow RE. The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care. 2000 Jul;23(7):943-50. doi: 10.2337/diacare.23.7.943.
PMID: 10895844
citation: Goodarzi M, Ebrahimzadeh I, Rabi A, Saedipoor B, Jafarabadi MA. Impact of distance education via mobile phone text messaging on knowledge, attitude, practice and self efficacy of patients with type 2 diabetes mellitus in Iran. J Diabetes Metab Disord. 2012 Aug 31;11(1):10. doi: 10.1186/2251-6581-11-10.
PMID: 23497632
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: 1) The non-randomized, quasi-experimental study design; 2) Using self-report measures
point of contact: 