<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/NCT03808545</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-300002096</org_study_id>
    <secondary_id>P30DK056336</secondary_id>
    <nct_id>NCT03808545</nct_id>
  </id_info>
  <brief_title>Activity and Balanced Eating to Reduce Comorbidities and Symptoms of MS</brief_title>
  <acronym>ABC's of MS</acronym>
  <official_title>Comprehensive Lifestyle Intervention for Reducing Cardiometabolic Risk and Symptom Burden in Adults With Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multiple sclerosis (MS) is the leading cause of irreversible neurological disability among&#xD;
      young women and the second leading cause of disability among young men in the U.S.&#xD;
      Cardiometabolic risk factors including obesity and hyperlipidemia are common among people&#xD;
      with MS, and these risk factors are associated with severity and frequency of MS relapses and&#xD;
      disease progression. People with MS often experience symptoms of pain, fatigue, and&#xD;
      depression, which make adhering to a healthy lifestyle difficult, as evidenced by the high&#xD;
      rates of unhealthy behaviors including poor diet and physical inactivity among this group.&#xD;
      Physical activity has reduced symptoms of MS and improved metabolic risk profiles, but little&#xD;
      research has focused on the role of a dietary intervention combined with physical activity in&#xD;
      this group. Therefore, the purpose of this study is to test the efficacy of a combined diet&#xD;
      and physical activity intervention for reducing cardiometabolic risks and MS symptoms when&#xD;
      compared to a physical activity intervention alone.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">February 26, 2019</start_date>
  <completion_date type="Actual">March 19, 2020</completion_date>
  <primary_completion_date type="Actual">March 19, 2020</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>BMI Change</measure>
    <time_frame>Baseline and16 weeks</time_frame>
    <description>BMI will be calculated using the formula weight/height2 (kg/m^2). Height will be measured with participants standing against the wall. Weight will be assessed using a digital scale. BMI change will be calculated the difference between 16 week BMI and baseline BMI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Waist Circumference Change</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>Waist circumference will be measured twice at the level of the umbilicus after normal expiration, with the participant standing. If the two values differ by &gt;1 cm, a third measurement will be taken and the results of the two or three trials averaged. Waist circumference change will be calculated as the difference between 16 week waist circumference and baseline waist circumference.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fat Mass Change</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>Participants will undergo a total body scan measuring total body composition on a Lunar iDXA with enCORE software version 13.6 (GE Healthcare, Chicago, IL). Fat mass (FM) change will be calculated the difference between 16 week FM and baseline FM.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diastolic Blood Pressure Change</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>Diastolic blood pressure (DBP) will be obtained using a sphygmomanometer. DBP will be measured twice, with a resting time of 1 minute in between each measurement. The results of the two trials will be averaged. DBP change will be calculated as the difference between 16 week DBP and baseline DBP.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic Blood Pressure Change</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>Systolic blood pressure (BP) will be obtained using a sphygmomanometer. SBP will be measured twice, with a resting time of 1 minute in between each measurement. The results of the two trials will be averaged. SBP change will be calculated as the difference between 16 week SBP and baseline SBP.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose Change</measure>
    <time_frame>Baseline and16 weeks</time_frame>
    <description>Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. Glucose, along with other blood measures, will be assessed from this blood sample. Glucose change will be calculated as the difference between 16 week glucose and baseline glucose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin Change</measure>
    <time_frame>Baseline and16 weeks</time_frame>
    <description>Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. Insulin, along with other blood measures, will be assessed from this blood sample. Insulin change will be calculated the difference between 16 week insulin and baseline insulin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides Change</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. Triglycerides, along with other blood measures, will be assessed from this blood sample. Triglyceride change will be calculated as the difference between 16 week triglycerides and baseline triglycerides.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDL-C Change</measure>
    <time_frame>Baseline and16 weeks</time_frame>
    <description>Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. LDL-C, along with other blood measures, will be assessed from this blood sample. LDL-C change will be calculated as the difference between 16 week LDL-C and baseline LDL-C.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL-C Change</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. HDL-C, along with other blood measures, will be assessed from this blood sample. HDL-C change will be calculated the difference between 16 week HDL-C and baseline HDL-C.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Cholesterol Change</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. Total cholesterol (TC), along with other blood measures, will be assessed from this blood sample. TC change will be calculated as the difference between 16 week TC and baseline TC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fatigue Severity Scale</measure>
    <time_frame>Baseline and16 weeks</time_frame>
    <description>Measured by the Fatigue Severity Scale (FSS). The total score is the sum of the 9 items. The range for scoring is 9-63, with higher scores indicating greater fatigue severity. Change in fatigue will be calculated as the difference between 16-week FSS and baseline FSS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Modified Fatigue Impact Scale</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>Measured by the Modified Fatigue Impact Scale (MFIS). The total score is the sum of the 5 items. The range for scoring is 0-20, with higher scores indicating greater fatigue. Change in fatigue will be calculated as the difference between 16-week MFIS and baseline MFIS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Depression Symptoms</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>Measured by the Hospital Anxiety and Depression Scale (HADS). The HADS consists of 14 items, divided into two 7 item subscales. The total score is the sum of the 7 items from each subscale, and ranges from 0- 21 for the depression subscale. Higher scores in the depression subscale questions indicates greater levels of depression. Change in depression symptoms will be calculated as the difference between 16-week HADS depression subscale and baseline HADS depression subscale.&#xD;
Minimum score: 0; Maximum Score Depression subscale: 21</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Anxiety</measure>
    <time_frame>Baseline and16 weeks</time_frame>
    <description>Measured by the Hospital Anxiety and Depression Scale (HADS). The HADS consists of 14 items, divided into two 7 item subscales. The total score is the sum of the 7 items from each subscale, and ranges from 0- 21 for the anxiety subscale. Higher scores in the anxiety subscale questions indicates greater levels of anxiety. Change in anxiety will be calculated as the difference between 16-week HADS anxiety subscale and baseline HADS anxiety subscale.&#xD;
Minimum score: 0; Maximum score anxiety subscale: 21</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>BIPAMS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BIPAMS + Diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS)</intervention_name>
    <description>This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.</description>
    <arm_group_label>BIPAMS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>BIPAMS + Diet</intervention_name>
    <description>For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.</description>
    <arm_group_label>BIPAMS + Diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Relapsing-Remitting MS&#xD;
&#xD;
          -  On disease modifying treatment for 6 months&#xD;
&#xD;
          -  No relapse within the previous 30 days&#xD;
&#xD;
          -  BMI 25-55 kg/m2&#xD;
&#xD;
          -  Self-identify as not currently meeting recommendations for healthy diet and physical&#xD;
             activity&#xD;
&#xD;
          -  Ambulatory with or without assistance&#xD;
&#xD;
          -  Reliable access to the internet via computer or smartphone&#xD;
&#xD;
          -  Responsible for their personal food preparation or have input into the food prepared&#xD;
             for them&#xD;
&#xD;
          -  Score indicating low cognitive functioning on the Telephone Interview for Cognitive&#xD;
             Status assessment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Physician does not approve participation&#xD;
&#xD;
          -  Use of the following diabetes medications: Acetohexamide, Chlorpropamide (Diabinese),&#xD;
             Tolbutamide (Orinase, Tol-Tab), Tolazamide (Tolinase), Glipizide (Glucotrol, Glucotrol&#xD;
             XL, Metaglip), Glyburide (Micronase, DiaBeta, Glynase, Glucovance), Glimepiride&#xD;
             (Amaryl), Humalog or lispro, Novolog or aspart, Apidra or glulisine, Regular (R)&#xD;
             humulin or novolin, Velosulin (for use in the insulin pump), NPH (N), Lente (L),&#xD;
             Ultralente (U), Lantus, Levemir or detemir, Humulin 70/30, Novolin 70/30, Novolog&#xD;
             70/30, Humulin 50/50, or Humalog mix 75/25&#xD;
&#xD;
          -  Already on a specific diet meant to improve health&#xD;
&#xD;
          -  Heart attack, stroke, or heart bypass surgery less than 6 months ago&#xD;
&#xD;
          -  Pulmonary disease, cardiovascular disease or renal failure less than 6 months ago&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Cancer, HIV or liver/kidney disease&#xD;
&#xD;
          -  Inability to travel to Lakeshore for testing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Lakeshore Foundation</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>November 9, 2018</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <results_first_submitted>July 20, 2022</results_first_submitted>
  <results_first_submitted_qc>November 16, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">November 18, 2022</results_first_posted>
  <last_update_submitted>November 16, 2022</last_update_submitted>
  <last_update_submitted_qc>November 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Brooks C. Wingo, PhD</investigator_full_name>
    <investigator_title>Primary Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 18, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT03808545/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>BIPAMS</title>
          <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.&#xD;
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.</description>
        </group>
        <group group_id="P2">
          <title>BIPAMS + Diet</title>
          <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.&#xD;
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Only study completers were analyzed.</population>
      <group_list>
        <group group_id="B1">
          <title>BIPAMS</title>
          <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.&#xD;
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.</description>
        </group>
        <group group_id="B2">
          <title>BIPAMS + Diet</title>
          <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.&#xD;
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.</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="5"/>
            <count group_id="B2" value="4"/>
            <count group_id="B3" value="9"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Only completers were analyzed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>Only study completers were analyzed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <population>Only study completers were analyzed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</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>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>BMI Change</title>
        <description>BMI will be calculated using the formula weight/height2 (kg/m^2). Height will be measured with participants standing against the wall. Weight will be assessed using a digital scale. BMI change will be calculated the difference between 16 week BMI and baseline BMI.</description>
        <time_frame>Baseline and16 weeks</time_frame>
        <population>Only study completers were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>BIPAMS</title>
            <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.&#xD;
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.</description>
          </group>
          <group group_id="O2">
            <title>BIPAMS + Diet</title>
            <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.&#xD;
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.</description>
          </group>
        </group_list>
        <measure>
          <title>BMI Change</title>
          <description>BMI will be calculated using the formula weight/height2 (kg/m^2). Height will be measured with participants standing against the wall. Weight will be assessed using a digital scale. BMI change will be calculated the difference between 16 week BMI and baseline BMI.</description>
          <population>Only study completers were analyzed.</population>
          <units>kg/m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".60" spread="1.36"/>
                    <measurement group_id="O2" value=".49" spread="1.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Waist Circumference Change</title>
        <description>Waist circumference will be measured twice at the level of the umbilicus after normal expiration, with the participant standing. If the two values differ by &gt;1 cm, a third measurement will be taken and the results of the two or three trials averaged. Waist circumference change will be calculated as the difference between 16 week waist circumference and baseline waist circumference.</description>
        <time_frame>Baseline and 16 weeks</time_frame>
        <population>Study completers</population>
        <group_list>
          <group group_id="O1">
            <title>BIPAMS</title>
            <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.&#xD;
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.</description>
          </group>
          <group group_id="O2">
            <title>BIPAMS + Diet</title>
            <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.&#xD;
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.</description>
          </group>
        </group_list>
        <measure>
          <title>Waist Circumference Change</title>
          <description>Waist circumference will be measured twice at the level of the umbilicus after normal expiration, with the participant standing. If the two values differ by &gt;1 cm, a third measurement will be taken and the results of the two or three trials averaged. Waist circumference change will be calculated as the difference between 16 week waist circumference and baseline waist circumference.</description>
          <population>Study completers</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".31" spread="3.07"/>
                    <measurement group_id="O2" value=".31" spread="5.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Fat Mass Change</title>
        <description>Participants will undergo a total body scan measuring total body composition on a Lunar iDXA with enCORE software version 13.6 (GE Healthcare, Chicago, IL). Fat mass (FM) change will be calculated the difference between 16 week FM and baseline FM.</description>
        <time_frame>Baseline and 16 weeks</time_frame>
        <population>Completers only</population>
        <group_list>
          <group group_id="O1">
            <title>BIPAMS</title>
            <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.&#xD;
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.</description>
          </group>
          <group group_id="O2">
            <title>BIPAMS + Diet</title>
            <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.&#xD;
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.</description>
          </group>
        </group_list>
        <measure>
          <title>Fat Mass Change</title>
          <description>Participants will undergo a total body scan measuring total body composition on a Lunar iDXA with enCORE software version 13.6 (GE Healthcare, Chicago, IL). Fat mass (FM) change will be calculated the difference between 16 week FM and baseline FM.</description>
          <population>Completers only</population>
          <units>lb</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.14" spread="6.07"/>
                    <measurement group_id="O2" value=".05" spread="3.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Diastolic Blood Pressure Change</title>
        <description>Diastolic blood pressure (DBP) will be obtained using a sphygmomanometer. DBP will be measured twice, with a resting time of 1 minute in between each measurement. The results of the two trials will be averaged. DBP change will be calculated as the difference between 16 week DBP and baseline DBP.</description>
        <time_frame>Baseline and 16 weeks</time_frame>
        <population>Completers only</population>
        <group_list>
          <group group_id="O1">
            <title>BIPAMS</title>
            <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.&#xD;
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.</description>
          </group>
          <group group_id="O2">
            <title>BIPAMS + Diet</title>
            <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.&#xD;
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.</description>
          </group>
        </group_list>
        <measure>
          <title>Diastolic Blood Pressure Change</title>
          <description>Diastolic blood pressure (DBP) will be obtained using a sphygmomanometer. DBP will be measured twice, with a resting time of 1 minute in between each measurement. The results of the two trials will be averaged. DBP change will be calculated as the difference between 16 week DBP and baseline DBP.</description>
          <population>Completers only</population>
          <units>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="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.20" spread="9.60"/>
                    <measurement group_id="O2" value=".00" spread="5.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Systolic Blood Pressure Change</title>
        <description>Systolic blood pressure (BP) will be obtained using a sphygmomanometer. SBP will be measured twice, with a resting time of 1 minute in between each measurement. The results of the two trials will be averaged. SBP change will be calculated as the difference between 16 week SBP and baseline SBP.</description>
        <time_frame>Baseline and 16 weeks</time_frame>
        <population>Completers only</population>
        <group_list>
          <group group_id="O1">
            <title>BIPAMS</title>
            <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.&#xD;
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.</description>
          </group>
          <group group_id="O2">
            <title>BIPAMS + Diet</title>
            <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.&#xD;
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.</description>
          </group>
        </group_list>
        <measure>
          <title>Systolic Blood Pressure Change</title>
          <description>Systolic blood pressure (BP) will be obtained using a sphygmomanometer. SBP will be measured twice, with a resting time of 1 minute in between each measurement. The results of the two trials will be averaged. SBP change will be calculated as the difference between 16 week SBP and baseline SBP.</description>
          <population>Completers only</population>
          <units>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="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.20" spread="8.93"/>
                    <measurement group_id="O2" value="-4.25" spread="14.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Glucose Change</title>
        <description>Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. Glucose, along with other blood measures, will be assessed from this blood sample. Glucose change will be calculated as the difference between 16 week glucose and baseline glucose.</description>
        <time_frame>Baseline and16 weeks</time_frame>
        <population>Completers only</population>
        <group_list>
          <group group_id="O1">
            <title>BIPAMS</title>
            <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.&#xD;
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.</description>
          </group>
          <group group_id="O2">
            <title>BIPAMS + Diet</title>
            <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.&#xD;
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.</description>
          </group>
        </group_list>
        <measure>
          <title>Glucose Change</title>
          <description>Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. Glucose, along with other blood measures, will be assessed from this blood sample. Glucose change will be calculated as the difference between 16 week glucose and baseline glucose.</description>
          <population>Completers only</population>
          <units>mg/dl</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.40" spread="7.67"/>
                    <measurement group_id="O2" value=".00" spread="14.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Insulin Change</title>
        <description>Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. Insulin, along with other blood measures, will be assessed from this blood sample. Insulin change will be calculated the difference between 16 week insulin and baseline insulin.</description>
        <time_frame>Baseline and16 weeks</time_frame>
        <population>Completers only</population>
        <group_list>
          <group group_id="O1">
            <title>BIPAMS</title>
            <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial. Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.&#xD;
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.</description>
          </group>
          <group group_id="O2">
            <title>BIPAMS + Diet</title>
            <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.&#xD;
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.</description>
          </group>
        </group_list>
        <measure>
          <title>Insulin Change</title>
          <description>Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. Insulin, along with other blood measures, will be assessed from this blood sample. Insulin change will be calculated the difference between 16 week insulin and baseline insulin.</description>
          <population>Completers only</population>
          <units>microUnits/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.76" spread="4.00"/>
                    <measurement group_id="O2" value="-2.80" spread="11.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Triglycerides Change</title>
        <description>Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. Triglycerides, along with other blood measures, will be assessed from this blood sample. Triglyceride change will be calculated as the difference between 16 week triglycerides and baseline triglycerides.</description>
        <time_frame>Baseline and 16 weeks</time_frame>
        <population>Completers only; BIPAMS group outlier lab value (n=1) was excluded from analysis</population>
        <group_list>
          <group group_id="O1">
            <title>BIPAMS</title>
            <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.&#xD;
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.</description>
          </group>
          <group group_id="O2">
            <title>BIPAMS + Diet</title>
            <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.&#xD;
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.</description>
          </group>
        </group_list>
        <measure>
          <title>Triglycerides Change</title>
          <description>Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. Triglycerides, along with other blood measures, will be assessed from this blood sample. Triglyceride change will be calculated as the difference between 16 week triglycerides and baseline triglycerides.</description>
          <population>Completers only; BIPAMS group outlier lab value (n=1) was excluded from analysis</population>
          <units>mg/dl</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.50" spread="14.20"/>
                    <measurement group_id="O2" value="-12.50" spread="14.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>LDL-C Change</title>
        <description>Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. LDL-C, along with other blood measures, will be assessed from this blood sample. LDL-C change will be calculated as the difference between 16 week LDL-C and baseline LDL-C.</description>
        <time_frame>Baseline and16 weeks</time_frame>
        <population>Completers only; BIPAMS group outlier lab value (n=1) was excluded from analysis</population>
        <group_list>
          <group group_id="O1">
            <title>BIPAMS</title>
            <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.&#xD;
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.</description>
          </group>
          <group group_id="O2">
            <title>BIPAMS + Diet</title>
            <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.&#xD;
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.</description>
          </group>
        </group_list>
        <measure>
          <title>LDL-C Change</title>
          <description>Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. LDL-C, along with other blood measures, will be assessed from this blood sample. LDL-C change will be calculated as the difference between 16 week LDL-C and baseline LDL-C.</description>
          <population>Completers only; BIPAMS group outlier lab value (n=1) was excluded from analysis</population>
          <units>mg/dl</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.40" spread="5.97"/>
                    <measurement group_id="O2" value="10.50" spread="20.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HDL-C Change</title>
        <description>Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. HDL-C, along with other blood measures, will be assessed from this blood sample. HDL-C change will be calculated the difference between 16 week HDL-C and baseline HDL-C.</description>
        <time_frame>Baseline and 16 weeks</time_frame>
        <population>Only completers were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>BIPAMS</title>
            <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial. Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.&#xD;
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.</description>
          </group>
          <group group_id="O2">
            <title>BIPAMS + Diet</title>
            <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.&#xD;
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.</description>
          </group>
        </group_list>
        <measure>
          <title>HDL-C Change</title>
          <description>Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. HDL-C, along with other blood measures, will be assessed from this blood sample. HDL-C change will be calculated the difference between 16 week HDL-C and baseline HDL-C.</description>
          <population>Only completers were analyzed.</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.40" spread="6.95"/>
                    <measurement group_id="O2" value="1.00" spread="7.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Cholesterol Change</title>
        <description>Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. Total cholesterol (TC), along with other blood measures, will be assessed from this blood sample. TC change will be calculated as the difference between 16 week TC and baseline TC.</description>
        <time_frame>Baseline and 16 weeks</time_frame>
        <population>Completers only</population>
        <group_list>
          <group group_id="O1">
            <title>BIPAMS</title>
            <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.&#xD;
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.</description>
          </group>
          <group group_id="O2">
            <title>BIPAMS + Diet</title>
            <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.&#xD;
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Cholesterol Change</title>
          <description>Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. Total cholesterol (TC), along with other blood measures, will be assessed from this blood sample. TC change will be calculated as the difference between 16 week TC and baseline TC.</description>
          <population>Completers only</population>
          <units>mg/dl</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.00" spread="19.81"/>
                    <measurement group_id="O2" value="9.00" spread="29.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Fatigue Severity Scale</title>
        <description>Measured by the Fatigue Severity Scale (FSS). The total score is the sum of the 9 items. The range for scoring is 9-63, with higher scores indicating greater fatigue severity. Change in fatigue will be calculated as the difference between 16-week FSS and baseline FSS.</description>
        <time_frame>Baseline and16 weeks</time_frame>
        <population>Completers only</population>
        <group_list>
          <group group_id="O1">
            <title>BIPAMS</title>
            <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.&#xD;
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.</description>
          </group>
          <group group_id="O2">
            <title>BIPAMS + Diet</title>
            <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.&#xD;
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Fatigue Severity Scale</title>
          <description>Measured by the Fatigue Severity Scale (FSS). The total score is the sum of the 9 items. The range for scoring is 9-63, with higher scores indicating greater fatigue severity. Change in fatigue will be calculated as the difference between 16-week FSS and baseline FSS.</description>
          <population>Completers only</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="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.20" spread="5.63"/>
                    <measurement group_id="O2" value="4.00" spread="9.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Modified Fatigue Impact Scale</title>
        <description>Measured by the Modified Fatigue Impact Scale (MFIS). The total score is the sum of the 5 items. The range for scoring is 0-20, with higher scores indicating greater fatigue. Change in fatigue will be calculated as the difference between 16-week MFIS and baseline MFIS.</description>
        <time_frame>Baseline and 16 weeks</time_frame>
        <population>Completers only</population>
        <group_list>
          <group group_id="O1">
            <title>BIPAMS</title>
            <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.&#xD;
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.</description>
          </group>
          <group group_id="O2">
            <title>BIPAMS + Diet</title>
            <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.&#xD;
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Modified Fatigue Impact Scale</title>
          <description>Measured by the Modified Fatigue Impact Scale (MFIS). The total score is the sum of the 5 items. The range for scoring is 0-20, with higher scores indicating greater fatigue. Change in fatigue will be calculated as the difference between 16-week MFIS and baseline MFIS.</description>
          <population>Completers only</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="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".40" spread="7.57"/>
                    <measurement group_id="O2" value="-2.50" spread="13.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Depression Symptoms</title>
        <description>Measured by the Hospital Anxiety and Depression Scale (HADS). The HADS consists of 14 items, divided into two 7 item subscales. The total score is the sum of the 7 items from each subscale, and ranges from 0- 21 for the depression subscale. Higher scores in the depression subscale questions indicates greater levels of depression. Change in depression symptoms will be calculated as the difference between 16-week HADS depression subscale and baseline HADS depression subscale.&#xD;
Minimum score: 0; Maximum Score Depression subscale: 21</description>
        <time_frame>Baseline and 16 weeks</time_frame>
        <population>Completers</population>
        <group_list>
          <group group_id="O1">
            <title>BIPAMS</title>
            <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.&#xD;
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.</description>
          </group>
          <group group_id="O2">
            <title>BIPAMS + Diet</title>
            <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.&#xD;
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Depression Symptoms</title>
          <description>Measured by the Hospital Anxiety and Depression Scale (HADS). The HADS consists of 14 items, divided into two 7 item subscales. The total score is the sum of the 7 items from each subscale, and ranges from 0- 21 for the depression subscale. Higher scores in the depression subscale questions indicates greater levels of depression. Change in depression symptoms will be calculated as the difference between 16-week HADS depression subscale and baseline HADS depression subscale.&#xD;
Minimum score: 0; Maximum Score Depression subscale: 21</description>
          <population>Completers</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="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.40" spread="2.19"/>
                    <measurement group_id="O2" value=".25" spread=".96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Anxiety</title>
        <description>Measured by the Hospital Anxiety and Depression Scale (HADS). The HADS consists of 14 items, divided into two 7 item subscales. The total score is the sum of the 7 items from each subscale, and ranges from 0- 21 for the anxiety subscale. Higher scores in the anxiety subscale questions indicates greater levels of anxiety. Change in anxiety will be calculated as the difference between 16-week HADS anxiety subscale and baseline HADS anxiety subscale.&#xD;
Minimum score: 0; Maximum score anxiety subscale: 21</description>
        <time_frame>Baseline and16 weeks</time_frame>
        <population>Completers only</population>
        <group_list>
          <group group_id="O1">
            <title>BIPAMS</title>
            <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.&#xD;
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.</description>
          </group>
          <group group_id="O2">
            <title>BIPAMS + Diet</title>
            <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.&#xD;
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Anxiety</title>
          <description>Measured by the Hospital Anxiety and Depression Scale (HADS). The HADS consists of 14 items, divided into two 7 item subscales. The total score is the sum of the 7 items from each subscale, and ranges from 0- 21 for the anxiety subscale. Higher scores in the anxiety subscale questions indicates greater levels of anxiety. Change in anxiety will be calculated as the difference between 16-week HADS anxiety subscale and baseline HADS anxiety subscale.&#xD;
Minimum score: 0; Maximum score anxiety subscale: 21</description>
          <population>Completers only</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="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.40" spread="2.61"/>
                    <measurement group_id="O2" value="-2.00" spread="1.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>16 weeks</time_frame>
      <desc>All hospitalizations are included, regardless of reason or relation to study participation.</desc>
      <group_list>
        <group group_id="E1">
          <title>BIPAMS</title>
          <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial. Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.&#xD;
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.</description>
        </group>
        <group group_id="E2">
          <title>BIPAMS + Diet</title>
          <description>All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.&#xD;
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.</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="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization</sub_title>
                <description>Participant was hospitalized for MS relapse.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</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="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Elevated blood pressure</sub_title>
                <description>Participant reported elevated blood pressure for 2 weeks.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Early termination leading to small numbers of subjects analyzed. Early termination was due to inability to recruit sufficient participants.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Brooks Wingo, Associate Professor</name_or_title>
      <organization>University of Alabama at Birmingham</organization>
      <phone>2059345982</phone>
      <email>bcwingo@uab.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03808545
org study id: IRB-300002096
secondary id: P30DK056336
nct id: NCT03808545
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Multiple sclerosis (MS) is the leading cause of irreversible neurological disability among
      young women and the second leading cause of disability among young men in the U.S.
      Cardiometabolic risk factors including obesity and hyperlipidemia are common among people
      with MS, and these risk factors are associated with severity and frequency of MS relapses and
      disease progression. People with MS often experience symptoms of pain, fatigue, and
      depression, which make adhering to a healthy lifestyle difficult, as evidenced by the high
      rates of unhealthy behaviors including poor diet and physical inactivity among this group.
      Physical activity has reduced symptoms of MS and improved metabolic risk profiles, but little
      research has focused on the role of a dietary intervention combined with physical activity in
      this group. Therefore, the purpose of this study is to test the efficacy of a combined diet
      and physical activity intervention for reducing cardiometabolic risks and MS symptoms when
      compared to a physical activity intervention alone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: BMI Change
time frame: Baseline and16 weeks
description: BMI will be calculated using the formula weight/height2 (kg/m^2). Height will be measured with participants standing against the wall. Weight will be assessed using a digital scale. BMI change will be calculated the difference between 16 week BMI and baseline BMI.
measure: Waist Circumference Change
time frame: Baseline and 16 weeks
description: Waist circumference will be measured twice at the level of the umbilicus after normal expiration, with the participant standing. If the two values differ by >1 cm, a third measurement will be taken and the results of the two or three trials averaged. Waist circumference change will be calculated as the difference between 16 week waist circumference and baseline waist circumference.
measure: Fat Mass Change
time frame: Baseline and 16 weeks
description: Participants will undergo a total body scan measuring total body composition on a Lunar iDXA with enCORE software version 13.6 (GE Healthcare, Chicago, IL). Fat mass (FM) change will be calculated the difference between 16 week FM and baseline FM.
measure: Diastolic Blood Pressure Change
time frame: Baseline and 16 weeks
description: Diastolic blood pressure (DBP) will be obtained using a sphygmomanometer. DBP will be measured twice, with a resting time of 1 minute in between each measurement. The results of the two trials will be averaged. DBP change will be calculated as the difference between 16 week DBP and baseline DBP.
measure: Systolic Blood Pressure Change
time frame: Baseline and 16 weeks
description: Systolic blood pressure (BP) will be obtained using a sphygmomanometer. SBP will be measured twice, with a resting time of 1 minute in between each measurement. The results of the two trials will be averaged. SBP change will be calculated as the difference between 16 week SBP and baseline SBP.
measure: Glucose Change
time frame: Baseline and16 weeks
description: Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. Glucose, along with other blood measures, will be assessed from this blood sample. Glucose change will be calculated as the difference between 16 week glucose and baseline glucose.
measure: Insulin Change
time frame: Baseline and16 weeks
description: Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. Insulin, along with other blood measures, will be assessed from this blood sample. Insulin change will be calculated the difference between 16 week insulin and baseline insulin.
measure: Triglycerides Change
time frame: Baseline and 16 weeks
description: Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. Triglycerides, along with other blood measures, will be assessed from this blood sample. Triglyceride change will be calculated as the difference between 16 week triglycerides and baseline triglycerides.
measure: LDL-C Change
time frame: Baseline and16 weeks
description: Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. LDL-C, along with other blood measures, will be assessed from this blood sample. LDL-C change will be calculated as the difference between 16 week LDL-C and baseline LDL-C.
measure: HDL-C Change
time frame: Baseline and 16 weeks
description: Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. HDL-C, along with other blood measures, will be assessed from this blood sample. HDL-C change will be calculated the difference between 16 week HDL-C and baseline HDL-C.
measure: Total Cholesterol Change
time frame: Baseline and 16 weeks
description: Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. Total cholesterol (TC), along with other blood measures, will be assessed from this blood sample. TC change will be calculated as the difference between 16 week TC and baseline TC.
measure: Change in Fatigue Severity Scale
time frame: Baseline and16 weeks
description: Measured by the Fatigue Severity Scale (FSS). The total score is the sum of the 9 items. The range for scoring is 9-63, with higher scores indicating greater fatigue severity. Change in fatigue will be calculated as the difference between 16-week FSS and baseline FSS.
measure: Change in Modified Fatigue Impact Scale
time frame: Baseline and 16 weeks
description: Measured by the Modified Fatigue Impact Scale (MFIS). The total score is the sum of the 5 items. The range for scoring is 0-20, with higher scores indicating greater fatigue. Change in fatigue will be calculated as the difference between 16-week MFIS and baseline MFIS.
measure: Change in Depression Symptoms
time frame: Baseline and 16 weeks
description: Measured by the Hospital Anxiety and Depression Scale (HADS). The HADS consists of 14 items, divided into two 7 item subscales. The total score is the sum of the 7 items from each subscale, and ranges from 0- 21 for the depression subscale. Higher scores in the depression subscale questions indicates greater levels of depression. Change in depression symptoms will be calculated as the difference between 16-week HADS depression subscale and baseline HADS depression subscale.
Minimum score: 0; Maximum Score Depression subscale: 21
measure: Change in Anxiety
time frame: Baseline and16 weeks
description: Measured by the Hospital Anxiety and Depression Scale (HADS). The HADS consists of 14 items, divided into two 7 item subscales. The total score is the sum of the 7 items from each subscale, and ranges from 0- 21 for the anxiety subscale. Higher scores in the anxiety subscale questions indicates greater levels of anxiety. Change in anxiety will be calculated as the difference between 16-week HADS anxiety subscale and baseline HADS anxiety subscale.
Minimum score: 0; Maximum score anxiety subscale: 21
arm group label: BIPAMS
arm group type: Active Comparator
description: All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.
arm group label: BIPAMS + Diet
arm group type: Experimental
description: All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.
intervention type: Behavioral
intervention name: Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS)
description: This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.
arm group label: BIPAMS
intervention type: Behavioral
intervention name: BIPAMS + Diet
description: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.
arm group label: BIPAMS + Diet
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Brooks C. Wingo, PhD
investigator title: Primary Investigator
mesh term: Multiple Sclerosis
mesh term: Sclerosis
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Early termination leading to small numbers of subjects analyzed. Early termination was due to inability to recruit sufficient participants.
point of contact: 