<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/NCT03260140</url>
  </required_header>
  <id_info>
    <org_study_id>IIR 15-364</org_study_id>
    <secondary_id>I01HX002113</secondary_id>
    <nct_id>NCT03260140</nct_id>
  </id_info>
  <brief_title>DVD Lifestyle Intervention</brief_title>
  <acronym>D-ELITE</acronym>
  <official_title>DVD Lifestyle Intervention (D-ELITE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Most Veterans who receive VA healthcare have obesity (41%) or are classified as overweight&#xD;
      (37%), putting them at higher risk for multiple serious chronic health conditions. Providing&#xD;
      evidence-based behavioral weight management programs to Veterans with obesity is a priority&#xD;
      for the VA National Center for Health Promotion and Disease Prevention (NCP). While the VA&#xD;
      NCP's MOVE! program-primarily delivered with in-person group visits-helps Veterans with&#xD;
      obesity lose weight, its reach has been limited because of various barriers to care. Some&#xD;
      Veterans may do better with a program they can complete from home at their own pace. In this&#xD;
      trial, study investigators are examining the effectiveness among Veterans of a previously&#xD;
      proven self-directed lifestyle intervention (called DVD Lifestyle Intervention (D-ELITE))&#xD;
      that targets modest, clinically meaningful weight loss over the course of a year using&#xD;
      recorded video lessons (DVD or online streaming), written self-study aids, and optional&#xD;
      lifestyle coaching. The study will compare participants randomly assigned to receive D-ELITE&#xD;
      to those continuing in usual care on weight and self-reported general physical health status,&#xD;
      one year after enrollment. Secondary outcomes include weight and general physical health&#xD;
      status two years after enrollment; and obesity-related biometric measures (blood pressure and&#xD;
      HbA1c) and self-report psychological and behavioral factors such as physical activity and&#xD;
      sleep quality, at one- and two-years following enrollment.&#xD;
&#xD;
      Veterans with obesity living in the western US were identified using the VA Corporate Data&#xD;
      Warehouse (CDW), recruited to participate via mail and telephone, and randomly assigned to&#xD;
      receive the study intervention or usual care alone. The study uses CDW to assess weight&#xD;
      change and biometric outcomes. To assess self-report outcomes, participants completed&#xD;
      questionnaires, by mail or telephone, at baseline and 12 months after randomization, and are&#xD;
      currently completing 24-month follow-up questionnaires. The D-ELITE intervention focuses on&#xD;
      gradual lifestyle behavior change aimed at improving eating habits and increasing physical&#xD;
      activity. It encourages participants to gradually achieve and maintain a 5-10% loss of&#xD;
      baseline body weight and at least 150 minutes of moderate-intensity physical activity, such&#xD;
      as brisk walking, each week. The D-ELITE intervention program consists of watching one video,&#xD;
      completing corresponding written self-guided learning materials, and tracking food intake and&#xD;
      physical activity each week for the first 12 weeks, then working through 10 additional&#xD;
      written handouts and continued food and activity tracking for the next nine months.&#xD;
      Intervention participants have access to a lifestyle coach, as desired, for the full 12-month&#xD;
      intervention period. In addition to patient outcomes, this study will examine the cost of&#xD;
      delivering the intervention, information relevant to decision-makers and potential future&#xD;
      dissemination. Evidence-based programs like this, which can be delivered remotely and with&#xD;
      likely minimal resources required from the VA healthcare system, are greatly needed,&#xD;
      especially now as the SARS-CoV-2 pandemic has required VA to rapidly transition to providing&#xD;
      more remotely-delivered care.&#xD;
&#xD;
      Impact: The DELITE trial has potential to provide the evidence needed for deciding whether a&#xD;
      low-cost, low-technology, self-directed program can be used to expand the treatment of&#xD;
      obesity to a population-based level by improving access to obesity treatment regardless of&#xD;
      Veteran place of residence.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2018</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">April 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The investigators will randomly assign participants to one of two groups.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Body Weight</measure>
    <time_frame>Weight closest to 12 months from baseline between 9-15 months post-baseline</time_frame>
    <description>Weights were obtained from the VA electronic health record. For the weight variable, baseline is the weight used to identify Veterans for recruitment to participate.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Short Form (SF)-12 PCS</measure>
    <time_frame>12 months post baseline</time_frame>
    <description>The SF-12 is a health-related quality of life measure that assesses general physical (PCS) and mental health (MCS) functioning and well-being, with the PCS score serving as co-primary outcome. The investigators scored the SF-12 using QualityMetric's scoring software. PCS scores range from 0-100 with higher scores indicating better general physical health.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>International Physical Activity Questionnaire (IPAQ)</measure>
    <time_frame>12 months post baseline</time_frame>
    <description>7-item short form of the IPAQ, which evaluates weekly walking, vigorous and moderate-intensity activity. The investigators report here the number of participants engaging in at least 150 minutes of activity per week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>&quot;Starting the Conversation&quot;</measure>
    <time_frame>12 months post baseline</time_frame>
    <description>8-item self-report measure of diet quality that assesses intake of various types of food (e.g., fruit and vegetable, sugary beverages). Scores range from 0-16 with higher scores indicating better diet quality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey Change</measure>
    <time_frame>12 months post baseline</time_frame>
    <description>4-item self-report scale indicating sleep disturbance. Raw scores are converted into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher scores represent more sleep disturbance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Survey Change</measure>
    <time_frame>12 months post baseline</time_frame>
    <description>8-item self-report scale indicating sleep impairment. Raw scores are converted into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher scores represent more sleep impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary Self-efficacy</measure>
    <time_frame>12 months post baseline</time_frame>
    <description>Three items measuring diet self-efficacy from the Patient-centered Assessment and Counseling for Exercise plus Nutrition (PACE+) Adult Psychosocial Questionnaire. Scores range from 1-5 with higher scores representing higher diet self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin A1c (HbA1c)</measure>
    <time_frame>HbA1c closest to 12 months from baseline between 9-15 months post-baseline</time_frame>
    <description>HbA1c values were obtained from the VA electronic health record. HbA1c is a measure of the percentage of glucose in the blood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form (SF)-12 Mental Component Score (MCS)</measure>
    <time_frame>12 months post baseline</time_frame>
    <description>The SF-12 is a health-related quality of life measure that assesses general physical (PCS) and mental health (MCS) functioning and well-being, with the MCS score assessing mental health status. The investigators scored the SF-12 using QualityMetric's scoring software. MCS scores range from 0-100 with higher scores indicating better general menal health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic Blood Pressure (DBP)</measure>
    <time_frame>DBP closest to 12 months from baseline between 9-15 months post-baseline</time_frame>
    <description>DBP values were obtained from the VA electronic health record. DBP is a measure of artery pressure when the heart rests between beats.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic Blood Pressure (SBP)</measure>
    <time_frame>SBP closest to 12 months from baseline between 9-15 months post-baseline</time_frame>
    <description>SBP values were obtained from the VA electronic health record. SBP is a measure of how much pressure blood is exerting against artery walls when the heart beats.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">511</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>behavioral lifestyle intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The investigators will provide participants with the the behavioral lifestyle intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>usual care control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>participant in this arm will continue with usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>behavioral lifestyle intervention</intervention_name>
    <description>The investigators will provide participants with the behavioral lifestyle intervention</description>
    <arm_group_label>behavioral lifestyle intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Recent VA primary care measured BMI between 30.0-44.9 kg/m2 (at facility in pacific or&#xD;
             mountain time zone)&#xD;
&#xD;
          -  Access to DVD player or internet&#xD;
&#xD;
          -  Able to participate fully in all study protocol/procedures including informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to speak, read, or understand English&#xD;
&#xD;
          -  Recent weight loss interventions including use of prescription weight-loss&#xD;
             medications, participation in group or individual weight loss programs provided by&#xD;
             trained personnel, bariatric surgery (or plans for during the study period)&#xD;
&#xD;
          -  Expected weight loss because of alternate explanations such as from illness&#xD;
&#xD;
          -  High variability in weight due to fluctuations in volume status (ascites - liver&#xD;
             disease, chronic heart failure)&#xD;
&#xD;
          -  Safety and/or adherence concerns due to severe physical or mental health issues, or&#xD;
             life expectancy &lt;24 months&#xD;
&#xD;
          -  Pregnant, lactating, or planning to become pregnant during the study period;&#xD;
&#xD;
          -  Participation in other intervention studies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katherine D Hoerster, PhD MPH BA</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Puget Sound Health Care System Seattle Division, Seattle, WA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA Puget Sound Health Care System Seattle Division, Seattle, WA</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98108-1532</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Hoerster KD, Collins MP, Au DH, Lane A, Epler E, McDowell J, Baron AE, Rise P, Plumley R, Nguyen T, Schooler M, Schuttner L, Ma J. Testing a self-directed lifestyle intervention among veterans: The D-ELITE pragmatic clinical trial. Contemp Clin Trials. 2020 Aug;95:106045. doi: 10.1016/j.cct.2020.106045. Epub 2020 May 28.</citation>
    <PMID>32473403</PMID>
  </results_reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <results_first_submitted>April 6, 2022</results_first_submitted>
  <results_first_submitted_qc>November 4, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">November 7, 2022</results_first_posted>
  <last_update_submitted>July 19, 2023</last_update_submitted>
  <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>weight loss</keyword>
  <keyword>lifestyle</keyword>
  <keyword>diet</keyword>
  <keyword>exercise</keyword>
  <keyword>randomized controlled trial</keyword>
  <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>April 8, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT03260140/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Behavioral Lifestyle Intervention</title>
          <description>behavioral lifestyle intervention: The investigators will provide participants with the behavioral lifestyle intervention</description>
        </group>
        <group group_id="P2">
          <title>Usual Care Control</title>
          <description>participant in this arm will continue with usual care</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="254"/>
                <participants group_id="P2" count="257"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="249"/>
                <participants group_id="P2" count="252"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <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>Behavioral Lifestyle Intervention</title>
          <description>The investigators will provide participants with the the behavioral lifestyle intervention&#xD;
behavioral lifestyle intervention: The investigators will provide participants with the behavioral lifestyle intervention</description>
        </group>
        <group group_id="B2">
          <title>Usual Care Control</title>
          <description>participant in this arm will continue with usual care</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="254"/>
            <count group_id="B2" value="257"/>
            <count group_id="B3" value="511"/>
          </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="56.8" spread="14.17"/>
                    <measurement group_id="B2" value="58.1" spread="13.58"/>
                    <measurement group_id="B3" value="57.4" spread="13.88"/>
                  </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="118"/>
                    <measurement group_id="B2" value="112"/>
                    <measurement group_id="B3" value="230"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="136"/>
                    <measurement group_id="B2" value="145"/>
                    <measurement group_id="B3" value="281"/>
                  </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="37"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="217"/>
                    <measurement group_id="B2" value="223"/>
                    <measurement group_id="B3" value="440"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="203"/>
                    <measurement group_id="B2" value="206"/>
                    <measurement group_id="B3" value="409"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Body Weight</title>
        <description>Weights were obtained from the VA electronic health record. For the weight variable, baseline is the weight used to identify Veterans for recruitment to participate.</description>
        <time_frame>Weight closest to 12 months from baseline between 9-15 months post-baseline</time_frame>
        <population>The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results.</population>
        <group_list>
          <group group_id="O1">
            <title>Behavioral Lifestyle Intervention</title>
            <description>behavioral lifestyle intervention: the investigators will provide participants with the behavioral lifestyle intervention</description>
          </group>
          <group group_id="O2">
            <title>Usual Care Control</title>
            <description>participant in this arm will continue with usual care</description>
          </group>
        </group_list>
        <measure>
          <title>Body Weight</title>
          <description>Weights were obtained from the VA electronic health record. For the weight variable, baseline is the weight used to identify Veterans for recruitment to participate.</description>
          <population>The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results.</population>
          <units>kilogram (kg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="217"/>
                <count group_id="O2" value="212"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.8" spread="15.8"/>
                    <measurement group_id="O2" value="101.0" spread="15.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Linear mixed model analysis comparing the average 12-month weight between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Difference in average weight at 12 months between control and intervention groups.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.93</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.24</ci_lower_limit>
            <ci_upper_limit>-0.61</ci_upper_limit>
            <estimate_desc>Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Short Form (SF)-12 PCS</title>
        <description>The SF-12 is a health-related quality of life measure that assesses general physical (PCS) and mental health (MCS) functioning and well-being, with the PCS score serving as co-primary outcome. The investigators scored the SF-12 using QualityMetric's scoring software. PCS scores range from 0-100 with higher scores indicating better general physical health.</description>
        <time_frame>12 months post baseline</time_frame>
        <population>The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results.</population>
        <group_list>
          <group group_id="O1">
            <title>Behavioral Lifestyle Intervention</title>
            <description>behavioral lifestyle intervention: the investigators will provide participants with the behavioral lifestyle intervention</description>
          </group>
          <group group_id="O2">
            <title>Usual Care Control</title>
            <description>participant in this arm will continue with usual care</description>
          </group>
        </group_list>
        <measure>
          <title>Short Form (SF)-12 PCS</title>
          <description>The SF-12 is a health-related quality of life measure that assesses general physical (PCS) and mental health (MCS) functioning and well-being, with the PCS score serving as co-primary outcome. The investigators scored the SF-12 using QualityMetric's scoring software. PCS scores range from 0-100 with higher scores indicating better general physical health.</description>
          <population>The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results.</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="191"/>
                <count group_id="O2" value="219"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.3" spread="10.7"/>
                    <measurement group_id="O2" value="43.2" spread="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Linear mixed model analysis comparing the 12-month SF-12 PCS between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.388</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Difference in average SF-12 PCS score at 12 months between control and intervention groups.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.69</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.11</ci_lower_limit>
            <ci_upper_limit>2.49</ci_upper_limit>
            <estimate_desc>Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>International Physical Activity Questionnaire (IPAQ)</title>
        <description>7-item short form of the IPAQ, which evaluates weekly walking, vigorous and moderate-intensity activity. The investigators report here the number of participants engaging in at least 150 minutes of activity per week.</description>
        <time_frame>12 months post baseline</time_frame>
        <population>The investigators report here the unadjusted number of participants engaging in at least 150 minutes of activity per week. The analysis population for adjusted between-group differences includes study participants with measurements at both baseline and 12 months; see Statistical Analysis 1 for those results.</population>
        <group_list>
          <group group_id="O1">
            <title>Behavioral Lifestyle Intervention</title>
            <description>behavioral lifestyle intervention: the investigators will provide participants with the behavioral lifestyle intervention</description>
          </group>
          <group group_id="O2">
            <title>Usual Care Control</title>
            <description>participant in this arm will continue with usual care</description>
          </group>
        </group_list>
        <measure>
          <title>International Physical Activity Questionnaire (IPAQ)</title>
          <description>7-item short form of the IPAQ, which evaluates weekly walking, vigorous and moderate-intensity activity. The investigators report here the number of participants engaging in at least 150 minutes of activity per week.</description>
          <population>The investigators report here the unadjusted number of participants engaging in at least 150 minutes of activity per week. The analysis population for adjusted between-group differences includes study participants with measurements at both baseline and 12 months; see Statistical Analysis 1 for those results.</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="193"/>
                <count group_id="O2" value="219"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="149"/>
                    <measurement group_id="O2" value="143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Group-specific McNemar's Chi-Square tests were applied to examine the change from baseline to follow-up in dichotomized IPAQ (&gt;=150 vs &lt;150) minutes of physical activity per week. To compare intervention vs. control at 12 months, we applied an F test. The intervention effect was an odds ratio of the ratios of discordant pairs in the intervention vs the control group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.308</p_value>
            <method>F test-ratio of 2 McNemar's Chi-Squares</method>
            <param_type>Sign test</param_type>
            <param_value>1.76</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.85</ci_lower_limit>
            <ci_upper_limit>3.66</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>&quot;Starting the Conversation&quot;</title>
        <description>8-item self-report measure of diet quality that assesses intake of various types of food (e.g., fruit and vegetable, sugary beverages). Scores range from 0-16 with higher scores indicating better diet quality.</description>
        <time_frame>12 months post baseline</time_frame>
        <population>The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results.</population>
        <group_list>
          <group group_id="O1">
            <title>Behavioral Lifestyle Intervention</title>
            <description>behavioral lifestyle intervention: the investigators will provide participants with the behavioral lifestyle intervention</description>
          </group>
          <group group_id="O2">
            <title>Usual Care Control</title>
            <description>participant in this arm will continue with usual care</description>
          </group>
        </group_list>
        <measure>
          <title>&quot;Starting the Conversation&quot;</title>
          <description>8-item self-report measure of diet quality that assesses intake of various types of food (e.g., fruit and vegetable, sugary beverages). Scores range from 0-16 with higher scores indicating better diet quality.</description>
          <population>The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results.</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="191"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2" spread="2.6"/>
                    <measurement group_id="O2" value="6.4" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Linear mixed model analysis comparing the average 12-month score between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.396</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Difference in average weight at 12 months between control and intervention groups.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.18</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.61</ci_lower_limit>
            <ci_upper_limit>0.24</ci_upper_limit>
            <estimate_desc>Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey Change</title>
        <description>4-item self-report scale indicating sleep disturbance. Raw scores are converted into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher scores represent more sleep disturbance.</description>
        <time_frame>12 months post baseline</time_frame>
        <population>The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results</population>
        <group_list>
          <group group_id="O1">
            <title>Behavioral Lifestyle Intervention</title>
            <description>behavioral lifestyle intervention: the investigators will provide participants with the behavioral lifestyle intervention</description>
          </group>
          <group group_id="O2">
            <title>Usual Care Control</title>
            <description>participant in this arm will continue with usual care</description>
          </group>
        </group_list>
        <measure>
          <title>Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey Change</title>
          <description>4-item self-report scale indicating sleep disturbance. Raw scores are converted into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher scores represent more sleep disturbance.</description>
          <population>The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results</population>
          <units>T-score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="192"/>
                <count group_id="O2" value="219"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.5" spread="9.2"/>
                    <measurement group_id="O2" value="52.0" spread="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Linear mixed model analysis comparing the average 12-month score between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.657</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Difference in average score at 12 months between control and intervention groups.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.30</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.02</ci_lower_limit>
            <ci_upper_limit>1.61</ci_upper_limit>
            <estimate_desc>Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Survey Change</title>
        <description>8-item self-report scale indicating sleep impairment. Raw scores are converted into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher scores represent more sleep impairment.</description>
        <time_frame>12 months post baseline</time_frame>
        <population>The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results.</population>
        <group_list>
          <group group_id="O1">
            <title>Behavioral Lifestyle Intervention</title>
            <description>behavioral lifestyle intervention: the investigators will provide participants with the behavioral lifestyle intervention</description>
          </group>
          <group group_id="O2">
            <title>Usual Care Control</title>
            <description>participant in this arm will continue with usual care</description>
          </group>
        </group_list>
        <measure>
          <title>Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Survey Change</title>
          <description>8-item self-report scale indicating sleep impairment. Raw scores are converted into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher scores represent more sleep impairment.</description>
          <population>The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results.</population>
          <units>T-score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="193"/>
                <count group_id="O2" value="218"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.7" spread="10.7"/>
                    <measurement group_id="O2" value="52.2" spread="10.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Linear mixed model analysis comparing the average 12-month score between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.281</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Difference in average score at 12 months between control and intervention groups.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.83</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.33</ci_lower_limit>
            <ci_upper_limit>0.68</ci_upper_limit>
            <estimate_desc>Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Dietary Self-efficacy</title>
        <description>Three items measuring diet self-efficacy from the Patient-centered Assessment and Counseling for Exercise plus Nutrition (PACE+) Adult Psychosocial Questionnaire. Scores range from 1-5 with higher scores representing higher diet self-efficacy.</description>
        <time_frame>12 months post baseline</time_frame>
        <population>The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results.</population>
        <group_list>
          <group group_id="O1">
            <title>Behavioral Lifestyle Intervention</title>
            <description>behavioral lifestyle intervention: the investigators will provide participants with the behavioral lifestyle intervention</description>
          </group>
          <group group_id="O2">
            <title>Usual Care Control</title>
            <description>participant in this arm will continue with usual care</description>
          </group>
        </group_list>
        <measure>
          <title>Dietary Self-efficacy</title>
          <description>Three items measuring diet self-efficacy from the Patient-centered Assessment and Counseling for Exercise plus Nutrition (PACE+) Adult Psychosocial Questionnaire. Scores range from 1-5 with higher scores representing higher diet self-efficacy.</description>
          <population>The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results.</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="193"/>
                <count group_id="O2" value="219"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="1.0"/>
                    <measurement group_id="O2" value="3.0" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Linear mixed model analysis comparing the average score between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.483</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Difference in average score at 12 months between control and intervention groups.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.11</ci_lower_limit>
            <ci_upper_limit>0.23</ci_upper_limit>
            <estimate_desc>Standard errors estimated using Kenward-Rodgers adjustment for the denominator degrees of freedom.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hemoglobin A1c (HbA1c)</title>
        <description>HbA1c values were obtained from the VA electronic health record. HbA1c is a measure of the percentage of glucose in the blood.</description>
        <time_frame>HbA1c closest to 12 months from baseline between 9-15 months post-baseline</time_frame>
        <population>The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results.</population>
        <group_list>
          <group group_id="O1">
            <title>Behavioral Lifestyle Intervention</title>
            <description>behavioral lifestyle intervention: the investigators will provide participants with the behavioral lifestyle intervention</description>
          </group>
          <group group_id="O2">
            <title>Usual Care Control</title>
            <description>participant in this arm will continue with usual care</description>
          </group>
        </group_list>
        <measure>
          <title>Hemoglobin A1c (HbA1c)</title>
          <description>HbA1c values were obtained from the VA electronic health record. HbA1c is a measure of the percentage of glucose in the blood.</description>
          <population>The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results.</population>
          <units>percentage of glycosylated 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="135"/>
                <count group_id="O2" value="133"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3" spread="1.5"/>
                    <measurement group_id="O2" value="6.4" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Linear mixed model analysis on log-transformed HbA1c comparing the average HbA1c between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.985</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Difference in average HbA1c at 12 months between control and intervention groups.</method_desc>
            <param_type>Mean percent change in HbA1c</param_type>
            <param_value>0.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.57</ci_lower_limit>
            <ci_upper_limit>2.69</ci_upper_limit>
            <estimate_desc>Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Short Form (SF)-12 Mental Component Score (MCS)</title>
        <description>The SF-12 is a health-related quality of life measure that assesses general physical (PCS) and mental health (MCS) functioning and well-being, with the MCS score assessing mental health status. The investigators scored the SF-12 using QualityMetric's scoring software. MCS scores range from 0-100 with higher scores indicating better general menal health.</description>
        <time_frame>12 months post baseline</time_frame>
        <population>The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results.</population>
        <group_list>
          <group group_id="O1">
            <title>Behavioral Lifestyle Intervention</title>
            <description>behavioral lifestyle intervention: the investigators will provide participants with the behavioral lifestyle intervention</description>
          </group>
          <group group_id="O2">
            <title>Usual Care Control</title>
            <description>participant in this arm will continue with usual care</description>
          </group>
        </group_list>
        <measure>
          <title>Short Form (SF)-12 Mental Component Score (MCS)</title>
          <description>The SF-12 is a health-related quality of life measure that assesses general physical (PCS) and mental health (MCS) functioning and well-being, with the MCS score assessing mental health status. The investigators scored the SF-12 using QualityMetric's scoring software. MCS scores range from 0-100 with higher scores indicating better general menal health.</description>
          <population>The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results.</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="191"/>
                <count group_id="O2" value="219"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.2" spread="12.4"/>
                    <measurement group_id="O2" value="48.1" spread="11.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Linear mixed model analysis comparing the average 12-month MCS between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.806</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Difference in average SF-12 MCS score at 12 months between control and intervention groups.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.22</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.99</ci_lower_limit>
            <ci_upper_limit>1.55</ci_upper_limit>
            <estimate_desc>Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Diastolic Blood Pressure (DBP)</title>
        <description>DBP values were obtained from the VA electronic health record. DBP is a measure of artery pressure when the heart rests between beats.</description>
        <time_frame>DBP closest to 12 months from baseline between 9-15 months post-baseline</time_frame>
        <population>The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results.</population>
        <group_list>
          <group group_id="O1">
            <title>Behavioral Lifestyle Intervention</title>
            <description>behavioral lifestyle intervention: the investigators will provide participants with the behavioral lifestyle intervention</description>
          </group>
          <group group_id="O2">
            <title>Usual Care Control</title>
            <description>participant in this arm will continue with usual care</description>
          </group>
        </group_list>
        <measure>
          <title>Diastolic Blood Pressure (DBP)</title>
          <description>DBP values were obtained from the VA electronic health record. DBP is a measure of artery pressure when the heart rests between beats.</description>
          <population>The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results.</population>
          <units>millimeters of mercury (mmHg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="205"/>
                <count group_id="O2" value="194"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.4" spread="8.0"/>
                    <measurement group_id="O2" value="77.2" spread="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Linear mixed model analysis comparing the average 12-month DBP between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.620</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Difference in average DBP at 12 months between control and intervention groups.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.36</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.77</ci_lower_limit>
            <ci_upper_limit>1.05</ci_upper_limit>
            <estimate_desc>Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Systolic Blood Pressure (SBP)</title>
        <description>SBP values were obtained from the VA electronic health record. SBP is a measure of how much pressure blood is exerting against artery walls when the heart beats.</description>
        <time_frame>SBP closest to 12 months from baseline between 9-15 months post-baseline</time_frame>
        <population>The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results.</population>
        <group_list>
          <group group_id="O1">
            <title>Behavioral Lifestyle Intervention</title>
            <description>behavioral lifestyle intervention: the investigators will provide participants with the behavioral lifestyle intervention</description>
          </group>
          <group group_id="O2">
            <title>Usual Care Control</title>
            <description>participant in this arm will continue with usual care</description>
          </group>
        </group_list>
        <measure>
          <title>Systolic Blood Pressure (SBP)</title>
          <description>SBP values were obtained from the VA electronic health record. SBP is a measure of how much pressure blood is exerting against artery walls when the heart beats.</description>
          <population>The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results.</population>
          <units>millimeters of mercury (mmHg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="205"/>
                <count group_id="O2" value="194"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="127.3" spread="11.6"/>
                    <measurement group_id="O2" value="126.9" spread="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Linear mixed model analysis comparing the average SBP between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.987</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Difference in average SPB at 12 months between control and intervention groups.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.32</ci_lower_limit>
            <ci_upper_limit>2.28</ci_upper_limit>
            <estimate_desc>Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.</time_frame>
      <desc>Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.</desc>
      <group_list>
        <group group_id="E1">
          <title>Behavioral Lifestyle Intervention</title>
          <description>The investigators will provide participants with the the behavioral lifestyle intervention&#xD;
behavioral lifestyle intervention: The investigators will provide participants with the behavioral lifestyle intervention</description>
        </group>
        <group group_id="E2">
          <title>Usual Care Control</title>
          <description>participant in this arm will continue with usual care</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="254"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="257"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="47" subjects_at_risk="254"/>
                <counts group_id="E2" subjects_affected="42" subjects_at_risk="257"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Hematological</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="254"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="257"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiovascular</sub_title>
                <counts group_id="E1" events="16" subjects_affected="12" subjects_at_risk="254"/>
                <counts group_id="E2" events="18" subjects_affected="18" subjects_at_risk="257"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="254"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="257"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Other</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="254"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="257"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatobiliary</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="254"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="257"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Metabolic</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="254"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="257"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="254"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="257"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Neurological</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="254"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="257"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychological</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="254"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="257"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal/Urologic</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="254"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="257"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary/Respiratory</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="254"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="257"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatological</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="254"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="257"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="124" subjects_at_risk="254"/>
                <counts group_id="E2" subjects_affected="105" subjects_at_risk="257"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Hematological</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="254"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="257"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiovascular</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="254"/>
                <counts group_id="E2" events="15" subjects_affected="14" subjects_at_risk="257"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal</sub_title>
                <counts group_id="E1" events="22" subjects_affected="21" subjects_at_risk="254"/>
                <counts group_id="E2" events="16" subjects_affected="16" subjects_at_risk="257"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Other</sub_title>
                <counts group_id="E1" events="33" subjects_affected="29" subjects_at_risk="254"/>
                <counts group_id="E2" events="23" subjects_affected="22" subjects_at_risk="257"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatobiliary</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="254"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="257"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Metabolic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="254"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="257"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal</sub_title>
                <counts group_id="E1" events="79" subjects_affected="65" subjects_at_risk="254"/>
                <counts group_id="E2" events="44" subjects_affected="38" subjects_at_risk="257"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Neurological</sub_title>
                <counts group_id="E1" events="20" subjects_affected="18" subjects_at_risk="254"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="257"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychological</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="254"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="257"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal/Urologic</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="254"/>
                <counts group_id="E2" events="11" subjects_affected="9" subjects_at_risk="257"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary/Respiratory</sub_title>
                <counts group_id="E1" events="19" subjects_affected="17" subjects_at_risk="254"/>
                <counts group_id="E2" events="18" subjects_affected="16" subjects_at_risk="257"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatological</sub_title>
                <counts group_id="E1" events="25" subjects_affected="19" subjects_at_risk="254"/>
                <counts group_id="E2" events="13" subjects_affected="12" subjects_at_risk="257"/>
              </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>Margaret P. Collins</name_or_title>
      <organization>VA Puget Sound Health Care Sysem</organization>
      <phone>206.764.2085</phone>
      <email>margaret.collins@va.gov</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/NCT03260140
org study id: IIR 15-364
secondary id: I01HX002113
nct id: NCT03260140
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Most Veterans who receive VA healthcare have obesity (41%) or are classified as overweight
      (37%), putting them at higher risk for multiple serious chronic health conditions. Providing
      evidence-based behavioral weight management programs to Veterans with obesity is a priority
      for the VA National Center for Health Promotion and Disease Prevention (NCP). While the VA
      NCP's MOVE! program-primarily delivered with in-person group visits-helps Veterans with
      obesity lose weight, its reach has been limited because of various barriers to care. Some
      Veterans may do better with a program they can complete from home at their own pace. In this
      trial, study investigators are examining the effectiveness among Veterans of a previously
      proven self-directed lifestyle intervention (called DVD Lifestyle Intervention (D-ELITE))
      that targets modest, clinically meaningful weight loss over the course of a year using
      recorded video lessons (DVD or online streaming), written self-study aids, and optional
      lifestyle coaching. The study will compare participants randomly assigned to receive D-ELITE
      to those continuing in usual care on weight and self-reported general physical health status,
      one year after enrollment. Secondary outcomes include weight and general physical health
      status two years after enrollment; and obesity-related biometric measures (blood pressure and
      HbA1c) and self-report psychological and behavioral factors such as physical activity and
      sleep quality, at one- and two-years following enrollment.

      Veterans with obesity living in the western US were identified using the VA Corporate Data
      Warehouse (CDW), recruited to participate via mail and telephone, and randomly assigned to
      receive the study intervention or usual care alone. The study uses CDW to assess weight
      change and biometric outcomes. To assess self-report outcomes, participants completed
      questionnaires, by mail or telephone, at baseline and 12 months after randomization, and are
      currently completing 24-month follow-up questionnaires. The D-ELITE intervention focuses on
      gradual lifestyle behavior change aimed at improving eating habits and increasing physical
      activity. It encourages participants to gradually achieve and maintain a 5-10% loss of
      baseline body weight and at least 150 minutes of moderate-intensity physical activity, such
      as brisk walking, each week. The D-ELITE intervention program consists of watching one video,
      completing corresponding written self-guided learning materials, and tracking food intake and
      physical activity each week for the first 12 weeks, then working through 10 additional
      written handouts and continued food and activity tracking for the next nine months.
      Intervention participants have access to a lifestyle coach, as desired, for the full 12-month
      intervention period. In addition to patient outcomes, this study will examine the cost of
      delivering the intervention, information relevant to decision-makers and potential future
      dissemination. Evidence-based programs like this, which can be delivered remotely and with
      likely minimal resources required from the VA healthcare system, are greatly needed,
      especially now as the SARS-CoV-2 pandemic has required VA to rapidly transition to providing
      more remotely-delivered care.

      Impact: The DELITE trial has potential to provide the evidence needed for deciding whether a
      low-cost, low-technology, self-directed program can be used to expand the treatment of
      obesity to a population-based level by improving access to obesity treatment regardless of
      Veteran place of residence.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The investigators will randomly assign participants to one of two groups.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Body Weight
time frame: Weight closest to 12 months from baseline between 9-15 months post-baseline
description: Weights were obtained from the VA electronic health record. For the weight variable, baseline is the weight used to identify Veterans for recruitment to participate.
measure: Short Form (SF)-12 PCS
time frame: 12 months post baseline
description: The SF-12 is a health-related quality of life measure that assesses general physical (PCS) and mental health (MCS) functioning and well-being, with the PCS score serving as co-primary outcome. The investigators scored the SF-12 using QualityMetric's scoring software. PCS scores range from 0-100 with higher scores indicating better general physical health.
measure: International Physical Activity Questionnaire (IPAQ)
time frame: 12 months post baseline
description: 7-item short form of the IPAQ, which evaluates weekly walking, vigorous and moderate-intensity activity. The investigators report here the number of participants engaging in at least 150 minutes of activity per week.
measure: "Starting the Conversation"
time frame: 12 months post baseline
description: 8-item self-report measure of diet quality that assesses intake of various types of food (e.g., fruit and vegetable, sugary beverages). Scores range from 0-16 with higher scores indicating better diet quality.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey Change
time frame: 12 months post baseline
description: 4-item self-report scale indicating sleep disturbance. Raw scores are converted into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher scores represent more sleep disturbance.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Survey Change
time frame: 12 months post baseline
description: 8-item self-report scale indicating sleep impairment. Raw scores are converted into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher scores represent more sleep impairment.
measure: Dietary Self-efficacy
time frame: 12 months post baseline
description: Three items measuring diet self-efficacy from the Patient-centered Assessment and Counseling for Exercise plus Nutrition (PACE+) Adult Psychosocial Questionnaire. Scores range from 1-5 with higher scores representing higher diet self-efficacy.
measure: Hemoglobin A1c (HbA1c)
time frame: HbA1c closest to 12 months from baseline between 9-15 months post-baseline
description: HbA1c values were obtained from the VA electronic health record. HbA1c is a measure of the percentage of glucose in the blood.
measure: Short Form (SF)-12 Mental Component Score (MCS)
time frame: 12 months post baseline
description: The SF-12 is a health-related quality of life measure that assesses general physical (PCS) and mental health (MCS) functioning and well-being, with the MCS score assessing mental health status. The investigators scored the SF-12 using QualityMetric's scoring software. MCS scores range from 0-100 with higher scores indicating better general menal health.
measure: Diastolic Blood Pressure (DBP)
time frame: DBP closest to 12 months from baseline between 9-15 months post-baseline
description: DBP values were obtained from the VA electronic health record. DBP is a measure of artery pressure when the heart rests between beats.
measure: Systolic Blood Pressure (SBP)
time frame: SBP closest to 12 months from baseline between 9-15 months post-baseline
description: SBP values were obtained from the VA electronic health record. SBP is a measure of how much pressure blood is exerting against artery walls when the heart beats.
arm group label: behavioral lifestyle intervention
arm group type: Experimental
description: The investigators will provide participants with the the behavioral lifestyle intervention
arm group label: usual care control
arm group type: No Intervention
description: participant in this arm will continue with usual care
intervention type: Behavioral
intervention name: behavioral lifestyle intervention
description: The investigators will provide participants with the behavioral lifestyle intervention
arm group label: behavioral lifestyle intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Katherine D Hoerster, PhD MPH BA
role: Principal Investigator
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
facility: 
country: United States
citation: Hoerster KD, Collins MP, Au DH, Lane A, Epler E, McDowell J, Baron AE, Rise P, Plumley R, Nguyen T, Schooler M, Schuttner L, Ma J. Testing a self-directed lifestyle intervention among veterans: The D-ELITE pragmatic clinical trial. Contemp Clin Trials. 2020 Aug;95:106045. doi: 10.1016/j.cct.2020.106045. Epub 2020 May 28.
PMID: 32473403
responsible party type: Sponsor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 