<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/NCT03304249</url>
  </required_header>
  <id_info>
    <org_study_id>iAmHealthy 2</org_study_id>
    <secondary_id>R01NR016255-01A1</secondary_id>
    <nct_id>NCT03304249</nct_id>
  </id_info>
  <brief_title>Rural Disparities in Pediatric Obesity: The iAmHealthy Intervention</brief_title>
  <official_title>Rural Disparities in Pediatric Obesity: The iAmHealthy Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Kansas Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Nursing Research (NINR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Kansas Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to learn if providing a family-based group program using mobile&#xD;
      health technology (iAmHealthy Healthy Lifestyles Program) is effective at improving child&#xD;
      weight, nutrition, and physical activity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a cluster-randomized study that will test the iAmHealthy Healthy Lifestyles Program&#xD;
      versus a standard approach to weight loss in kids current in 2nd thru 4th grade. The&#xD;
      iAmHealthy Healthy Lifestyles Program utilizes mobile tools to deliver the weight loss&#xD;
      program to kids and families in rural settings. This study will include kids from schools in&#xD;
      rural cities/counties, and their parents, and they will be randomly assigned to a group by&#xD;
      their school.&#xD;
&#xD;
      The iAmHealthy Healthy Lifestyles Program is a rurally tailored telemedicine intervention. It&#xD;
      delivers behavioral, nutritional, and physical activity topics for kids and their families.&#xD;
      The total length of the intervention will be about 8 months, which coincides with the length&#xD;
      of a typical school year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 13, 2017</start_date>
  <completion_date type="Actual">June 20, 2022</completion_date>
  <primary_completion_date type="Actual">November 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Child Body Mass Index Z-score (BMIz) at Baseline and Month 8</measure>
    <time_frame>Baseline to Month 8</time_frame>
    <description>Body mass index z-score (BMIz) is the age and sex standardized body mass index for children. To calculate BMIz, the equation BMIz = [(BMI/M)^L - 1] ÷ (L × S) is used where M is the median, L is the power transformation to achieve normality, and S is the coefficient of variation. A z-score of 0 represents the historical population norm. A higher BMIz is indicative of higher fat mass.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Child Body Mass Index Z-score (BMIz) at Baseline and Month 20</measure>
    <time_frame>Baseline to Month 20</time_frame>
    <description>Body mass index z-score (BMIz) is the age and sex standardized body mass index for children. To calculate BMIz, the equation BMIz = [(BMI/M)^L - 1] ÷ (L × S) is used where M is the median, L is the power transformation to achieve normality, and S is the coefficient of variation. A z-score of 0 represents the historical population norm. A higher BMIz is indicative of higher fat mass.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity - Average Minutes of Moderate to Vigorous Physical Activity Per Day</measure>
    <time_frame>Baseline, Month 8, Month 20</time_frame>
    <description>Measured using ActiGraph physical activity monitors. Outcome will be calculated as the average (across valid wear days) time spent per day in moderate to vigorous physical activity (MVPA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity - % Time in Sedentary Activity</measure>
    <time_frame>Baseline, Month 8, Month 20</time_frame>
    <description>Measured using ActiGraph physical activity monitors. Outcome was calculated as the percentage of time time spent in sedentary activity compared to wear time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Fruits and Vegetables</measure>
    <time_frame>Baseline, Month 8, Month 20</time_frame>
    <description>The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Sugar-sweetened Beverages</measure>
    <time_frame>Baseline, Month 8, Month 20</time_frame>
    <description>The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance/</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of &quot;Red Foods&quot; (Foods High in Sugar and/or Fat)</measure>
    <time_frame>Baseline, Month 8, Month 20</time_frame>
    <description>The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent Body Mass Index (BMI)</measure>
    <time_frame>Baseline, Month 8, Month 20</time_frame>
    <description>Parent BMI was calculated at three time points.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">296</enrollment>
  <condition>Weight Loss</condition>
  <arm_group>
    <arm_group_label>iAmHealthy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to this arm receive the iAmHealthy Healthy Lifestyles Program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to this group receive comparable content delivered via a newsletter.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>iAmHealthy Healthy Lifestyles Program</intervention_name>
    <description>iAmHealthy is behavioral intervention focused on nutrition, behavior and physical activity that engages parents and children in treatment using mobile health (mHealth) technology. Meetings are approximately one hour. Participants will log in for 8 weekly group sessions, followed by 6 monthly sessions.</description>
    <arm_group_label>iAmHealthy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Newsletter</intervention_name>
    <description>Weight loss materials delivered via a newsletter. Each newsletter will cover nutritional, exercise, and behavioral suggestions to improve the child's health. The newsletter will be sent in the mail once a month for 8 months.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Family lives in a rural area (city and/or county population less than 20,000)&#xD;
&#xD;
          -  Child Body Mass Index (BMI) &gt;85th and &lt;99th percentile&#xD;
&#xD;
          -  Child in 2nd thru 4th grade&#xD;
&#xD;
          -  Child and Parent speak English&#xD;
&#xD;
          -  Family is available at times intervention is offered&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child has physical limitation or receives an injury which significantly limits&#xD;
             physical mobility&#xD;
&#xD;
          -  Child has significant medical issue&#xD;
&#xD;
          -  Child and Parents have significant developmental delay or cognitive impairment&#xD;
&#xD;
          -  Child has a sibling who has already enrolled in the program&#xD;
&#xD;
          -  Family moves to a non-participating school&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ann M Davis, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kansas Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <results_first_submitted>March 14, 2023</results_first_submitted>
  <results_first_submitted_qc>September 5, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">September 13, 2023</results_first_posted>
  <last_update_submitted>September 5, 2023</last_update_submitted>
  <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pediatric Obesity</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 12, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/49/NCT03304249/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited across 18 rural schools between 2017 and 2020.</recruitment_details>
      <pre_assignment_details>Of the 501 children assessed for eligibility, 148 were eligible, consented, and completed baseline measures, each of whom had a parent/caregiver participate with them.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>iAmHealthy</title>
          <description>Participants randomized to this arm receive the iAmHealthy Healthy Lifestyles Program.&#xD;
iAmHealthy Healthy Lifestyles Program: iAmHealthy is behavioral intervention focused on nutrition, behavior and physical activity that engages parents and children in treatment using mobile health (mHealth) technology. Meetings are approximately one hour. Participants will log in for 8 weekly group sessions, followed by 6 monthly sessions.</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Participants randomized to this group receive comparable content delivered via a newsletter.&#xD;
Newsletter: Weight loss materials delivered via a newsletter. Each newsletter will cover nutritional, exercise, and behavioral suggestions to improve the child's health. The newsletter will be sent in the mail once a month for 8 months.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="128">64 pediatric participants and 64 adult participants from 9 schools</participants>
                <participants group_id="P2" count="168">84 pediatric participants and 84 adult participants from 9 schools</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>8 Months</title>
              <participants_list>
                <participants group_id="P1" count="118">59 pediatric participants and 59 adult participants from 9 schools</participants>
                <participants group_id="P2" count="166">83 pediatric participants and 83 adult participants from 9 schools</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="104">52 pediatric participants and 52 adult participants from 9 schools</participants>
                <participants group_id="P2" count="154">77 pediatric participants and 77 adult participants from 9 schools</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Moved Out of District</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline data collection was focused on child participants.</population>
      <group_list>
        <group group_id="B1">
          <title>iAmHealthy</title>
          <description>Participants randomized to this arm receive the iAmHealthy Healthy Lifestyles Program.&#xD;
iAmHealthy Healthy Lifestyles Program: iAmHealthy is behavioral intervention focused on nutrition, behavior and physical activity that engages parents and children in treatment using mobile health (mHealth) technology. Meetings are approximately one hour. Participants will log in for 8 weekly group sessions, followed by 6 monthly sessions.</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Participants randomized to this group receive comparable content delivered via a newsletter.&#xD;
Newsletter: Weight loss materials delivered via a newsletter. Each newsletter will cover nutritional, exercise, and behavioral suggestions to improve the child's health. The newsletter will be sent in the mail once a month for 8 months.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="64"/>
            <count group_id="B2" value="84"/>
            <count group_id="B3" value="148"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Child age</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="64"/>
                    <count group_id="B2" value="84"/>
                    <count group_id="B3" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.9880" spread="0.8859"/>
                    <measurement group_id="B2" value="8.8880" spread="0.8402"/>
                    <measurement group_id="B3" value="8.9313" spread="0.8587"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <description>Child sex</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="64"/>
                    <count group_id="B2" value="84"/>
                    <count group_id="B3" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="84"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <description>Child ethnicity</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="64"/>
                    <count group_id="B2" value="84"/>
                    <count group_id="B3" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="70"/>
                    <measurement group_id="B3" value="128"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <description>Child race/ethnicity</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="64"/>
                    <count group_id="B2" value="84"/>
                    <count group_id="B3" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native American</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="64"/>
                    <count group_id="B2" value="84"/>
                    <count group_id="B3" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <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>
              <title>Asian/Pacific Islander</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="64"/>
                    <count group_id="B2" value="84"/>
                    <count group_id="B3" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="64"/>
                    <count group_id="B2" value="84"/>
                    <count group_id="B3" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Biracial</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="64"/>
                    <count group_id="B2" value="84"/>
                    <count group_id="B3" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Eligible for Free or Reduced Lunch</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="64"/>
                    <count group_id="B2" value="84"/>
                    <count group_id="B3" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Eligible</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Eligible</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Approximate Total Household Income (Before Taxes)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="64"/>
                    <count group_id="B2" value="84"/>
                    <count group_id="B3" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Less than $30,000</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>$30,000 to $69,999</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>$70,000 to $99,999</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>$100,000 to $149,999</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>$150,000 or more</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index Z-Score</title>
          <description>Body mass index z-score (BMIz) is the age and sex standardized body mass index for children. To calculate BMIz, the equation BMIz = [(BMI/M)^L - 1] ÷ (L × S) is used where M is the median, L is the power transformation to achieve normality, and S is the coefficient of variation. A z-score of 0 represents the historical population norm. A higher BMIz is indicative of higher fat mass.</description>
          <population>Four participants in the control group did not complete baseline height/weight measurement.</population>
          <units>z-score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="64"/>
                    <count group_id="B2" value="80"/>
                    <count group_id="B3" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.7767" spread="0.5406"/>
                    <measurement group_id="B2" value="1.9209" spread="0.4705"/>
                    <measurement group_id="B3" value="1.8568" spread="0.5062"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Child's Grade</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="64"/>
                    <count group_id="B2" value="84"/>
                    <count group_id="B3" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Child Body Mass Index Z-score (BMIz) at Baseline and Month 8</title>
        <description>Body mass index z-score (BMIz) is the age and sex standardized body mass index for children. To calculate BMIz, the equation BMIz = [(BMI/M)^L - 1] ÷ (L × S) is used where M is the median, L is the power transformation to achieve normality, and S is the coefficient of variation. A z-score of 0 represents the historical population norm. A higher BMIz is indicative of higher fat mass.</description>
        <time_frame>Baseline to Month 8</time_frame>
        <population>Six children in the iAmHealthy group and four children in the Control group dropped out or did not complete the height/weight measure at Month 8.</population>
        <group_list>
          <group group_id="O1">
            <title>iAmHealthy</title>
            <description>Participants randomized to this arm receive the iAmHealthy Healthy Lifestyles Program.&#xD;
iAmHealthy Healthy Lifestyles Program: iAmHealthy is behavioral intervention focused on nutrition, behavior and physical activity that engages parents and children in treatment using mobile health (mHealth) technology. Meetings are approximately one hour. Participants will log in for 8 weekly group sessions, followed by 6 monthly sessions.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants randomized to this group receive comparable content delivered via a newsletter.&#xD;
Newsletter: Weight loss materials delivered via a newsletter. Each newsletter will cover nutritional, exercise, and behavioral suggestions to improve the child's health. The newsletter will be sent in the mail once a month for 8 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Child Body Mass Index Z-score (BMIz) at Baseline and Month 8</title>
          <description>Body mass index z-score (BMIz) is the age and sex standardized body mass index for children. To calculate BMIz, the equation BMIz = [(BMI/M)^L - 1] ÷ (L × S) is used where M is the median, L is the power transformation to achieve normality, and S is the coefficient of variation. A z-score of 0 represents the historical population norm. A higher BMIz is indicative of higher fat mass.</description>
          <population>Six children in the iAmHealthy group and four children in the Control group dropped out or did not complete the height/weight measure at Month 8.</population>
          <units>Z-score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.78" spread="0.54"/>
                    <measurement group_id="O2" value="1.92" spread="0.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="58"/>
                    <count group_id="O2" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.78" spread="0.54"/>
                    <measurement group_id="O2" value="1.96" spread="0.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Child Body Mass Index Z-score (BMIz) at Baseline and Month 20</title>
        <description>Body mass index z-score (BMIz) is the age and sex standardized body mass index for children. To calculate BMIz, the equation BMIz = [(BMI/M)^L - 1] ÷ (L × S) is used where M is the median, L is the power transformation to achieve normality, and S is the coefficient of variation. A z-score of 0 represents the historical population norm. A higher BMIz is indicative of higher fat mass.</description>
        <time_frame>Baseline to Month 20</time_frame>
        <population>Fourteen children in the iAmHealthy group and five children in the Control group dropped out or did not complete the height/weight measure at Month 20.</population>
        <group_list>
          <group group_id="O1">
            <title>iAmHealthy</title>
            <description>Participants randomized to this arm receive the iAmHealthy Healthy Lifestyles Program.&#xD;
iAmHealthy Healthy Lifestyles Program: iAmHealthy is behavioral intervention focused on nutrition, behavior and physical activity that engages parents and children in treatment using mobile health (mHealth) technology. Meetings are approximately one hour. Participants will log in for 8 weekly group sessions, followed by 6 monthly sessions.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants randomized to this group receive comparable content delivered via a newsletter.&#xD;
Newsletter: Weight loss materials delivered via a newsletter. Each newsletter will cover nutritional, exercise, and behavioral suggestions to improve the child's health. The newsletter will be sent in the mail once a month for 8 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Child Body Mass Index Z-score (BMIz) at Baseline and Month 20</title>
          <description>Body mass index z-score (BMIz) is the age and sex standardized body mass index for children. To calculate BMIz, the equation BMIz = [(BMI/M)^L - 1] ÷ (L × S) is used where M is the median, L is the power transformation to achieve normality, and S is the coefficient of variation. A z-score of 0 represents the historical population norm. A higher BMIz is indicative of higher fat mass.</description>
          <population>Fourteen children in the iAmHealthy group and five children in the Control group dropped out or did not complete the height/weight measure at Month 20.</population>
          <units>Z-score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.78" spread="0.54"/>
                    <measurement group_id="O2" value="1.92" spread="0.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.82" spread="0.50"/>
                    <measurement group_id="O2" value="2.04" spread="0.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Physical Activity - Average Minutes of Moderate to Vigorous Physical Activity Per Day</title>
        <description>Measured using ActiGraph physical activity monitors. Outcome will be calculated as the average (across valid wear days) time spent per day in moderate to vigorous physical activity (MVPA).</description>
        <time_frame>Baseline, Month 8, Month 20</time_frame>
        <population>Participants dropped out between time points or didn't complete all measures.</population>
        <group_list>
          <group group_id="O1">
            <title>iAmHealthy</title>
            <description>Participants randomized to this arm receive the iAmHealthy Healthy Lifestyles Program.&#xD;
iAmHealthy Healthy Lifestyles Program: iAmHealthy is behavioral intervention focused on nutrition, behavior and physical activity that engages parents and children in treatment using mobile health (mHealth) technology. Meetings are approximately one hour. Participants will log in for 8 weekly group sessions, followed by 6 monthly sessions.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants randomized to this group receive comparable content delivered via a newsletter.&#xD;
Newsletter: Weight loss materials delivered via a newsletter. Each newsletter will cover nutritional, exercise, and behavioral suggestions to improve the child's health. The newsletter will be sent in the mail once a month for 8 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Physical Activity - Average Minutes of Moderate to Vigorous Physical Activity Per Day</title>
          <description>Measured using ActiGraph physical activity monitors. Outcome will be calculated as the average (across valid wear days) time spent per day in moderate to vigorous physical activity (MVPA).</description>
          <population>Participants dropped out between time points or didn't complete all measures.</population>
          <units>minutes per day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.14" spread="22.72"/>
                    <measurement group_id="O2" value="52.95" spread="18.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.16" spread="18.82"/>
                    <measurement group_id="O2" value="49.07" spread="22.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.86" spread="18.81"/>
                    <measurement group_id="O2" value="41.37" spread="18.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Physical Activity - % Time in Sedentary Activity</title>
        <description>Measured using ActiGraph physical activity monitors. Outcome was calculated as the percentage of time time spent in sedentary activity compared to wear time.</description>
        <time_frame>Baseline, Month 8, Month 20</time_frame>
        <population>Participants dropped out between time points or didn't complete all measures.</population>
        <group_list>
          <group group_id="O1">
            <title>iAmHealthy</title>
            <description>Participants randomized to this arm receive the iAmHealthy Healthy Lifestyles Program.&#xD;
iAmHealthy Healthy Lifestyles Program: iAmHealthy is behavioral intervention focused on nutrition, behavior and physical activity that engages parents and children in treatment using mobile health (mHealth) technology. Meetings are approximately one hour. Participants will log in for 8 weekly group sessions, followed by 6 monthly sessions.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants randomized to this group receive comparable content delivered via a newsletter.&#xD;
Newsletter: Weight loss materials delivered via a newsletter. Each newsletter will cover nutritional, exercise, and behavioral suggestions to improve the child's health. The newsletter will be sent in the mail once a month for 8 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Physical Activity - % Time in Sedentary Activity</title>
          <description>Measured using ActiGraph physical activity monitors. Outcome was calculated as the percentage of time time spent in sedentary activity compared to wear time.</description>
          <population>Participants dropped out between time points or didn't complete all measures.</population>
          <units>percent of time sedentary</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.14" spread="7.12"/>
                    <measurement group_id="O2" value="56.57" spread="6.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.14" spread="8.55"/>
                    <measurement group_id="O2" value="59.62" spread="9.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.89" spread="8.09"/>
                    <measurement group_id="O2" value="63.28" spread="8.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Fruits and Vegetables</title>
        <description>The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance.</description>
        <time_frame>Baseline, Month 8, Month 20</time_frame>
        <population>Participants dropped out between time points or didn't complete all measures.</population>
        <group_list>
          <group group_id="O1">
            <title>iAmHealthy</title>
            <description>Participants randomized to this arm receive the iAmHealthy Healthy Lifestyles Program.&#xD;
iAmHealthy Healthy Lifestyles Program: iAmHealthy is behavioral intervention focused on nutrition, behavior and physical activity that engages parents and children in treatment using mobile health (mHealth) technology. Meetings are approximately one hour. Participants will log in for 8 weekly group sessions, followed by 6 monthly sessions.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants randomized to this group receive comparable content delivered via a newsletter.&#xD;
Newsletter: Weight loss materials delivered via a newsletter. Each newsletter will cover nutritional, exercise, and behavioral suggestions to improve the child's health. The newsletter will be sent in the mail once a month for 8 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Fruits and Vegetables</title>
          <description>The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance.</description>
          <population>Participants dropped out between time points or didn't complete all measures.</population>
          <units>servings of fruits and vegetables</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                    <count group_id="O2" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.27" spread="1.66"/>
                    <measurement group_id="O2" value="2.68" spread="1.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.04" spread="1.68"/>
                    <measurement group_id="O2" value="2.45" spread="1.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="68"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.89" spread="1.58"/>
                    <measurement group_id="O2" value="2.58" spread="1.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Sugar-sweetened Beverages</title>
        <description>The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance/</description>
        <time_frame>Baseline, Month 8, Month 20</time_frame>
        <population>Participants dropped out between time points or didn't complete all measures.</population>
        <group_list>
          <group group_id="O1">
            <title>iAmHealthy</title>
            <description>Participants randomized to this arm receive the iAmHealthy Healthy Lifestyles Program.&#xD;
iAmHealthy Healthy Lifestyles Program: iAmHealthy is behavioral intervention focused on nutrition, behavior and physical activity that engages parents and children in treatment using mobile health (mHealth) technology. Meetings are approximately one hour. Participants will log in for 8 weekly group sessions, followed by 6 monthly sessions.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants randomized to this group receive comparable content delivered via a newsletter.&#xD;
Newsletter: Weight loss materials delivered via a newsletter. Each newsletter will cover nutritional, exercise, and behavioral suggestions to improve the child's health. The newsletter will be sent in the mail once a month for 8 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Sugar-sweetened Beverages</title>
          <description>The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance/</description>
          <population>Participants dropped out between time points or didn't complete all measures.</population>
          <units>servings of sugar-sweetened beverages</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                    <count group_id="O2" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.19" spread="0.89"/>
                    <measurement group_id="O2" value="1.14" spread="0.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.75" spread="0.66"/>
                    <measurement group_id="O2" value="1.08" spread="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="68"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.93" spread="0.84"/>
                    <measurement group_id="O2" value="1.21" spread="1.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of &quot;Red Foods&quot; (Foods High in Sugar and/or Fat)</title>
        <description>The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance.</description>
        <time_frame>Baseline, Month 8, Month 20</time_frame>
        <population>Participants dropped out between time points or didn't complete all measures.</population>
        <group_list>
          <group group_id="O1">
            <title>iAmHealthy</title>
            <description>Participants randomized to this arm receive the iAmHealthy Healthy Lifestyles Program.&#xD;
iAmHealthy Healthy Lifestyles Program: iAmHealthy is behavioral intervention focused on nutrition, behavior and physical activity that engages parents and children in treatment using mobile health (mHealth) technology. Meetings are approximately one hour. Participants will log in for 8 weekly group sessions, followed by 6 monthly sessions.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants randomized to this group receive comparable content delivered via a newsletter.&#xD;
Newsletter: Weight loss materials delivered via a newsletter. Each newsletter will cover nutritional, exercise, and behavioral suggestions to improve the child's health. The newsletter will be sent in the mail once a month for 8 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of &quot;Red Foods&quot; (Foods High in Sugar and/or Fat)</title>
          <description>The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance.</description>
          <population>Participants dropped out between time points or didn't complete all measures.</population>
          <units>servings of red foods</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                    <count group_id="O2" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.64" spread="2.43"/>
                    <measurement group_id="O2" value="7.40" spread="3.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.12" spread="1.89"/>
                    <measurement group_id="O2" value="6.28" spread="2.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="68"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.69" spread="2.00"/>
                    <measurement group_id="O2" value="6.89" spread="2.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parent Body Mass Index (BMI)</title>
        <description>Parent BMI was calculated at three time points.</description>
        <time_frame>Baseline, Month 8, Month 20</time_frame>
        <population>Nine parents in the iAmHealthy group and six parents in the Control group dropped out or did not complete the height/weight measure at Month 8. Fourteen parents in the iAmHealthy group and seven parents in the Control group dropped out or did not complete the height/weight measure at Month 20.</population>
        <group_list>
          <group group_id="O1">
            <title>iAmHealthy</title>
            <description>Participants randomized to this arm receive the iAmHealthy Healthy Lifestyles Program.&#xD;
iAmHealthy Healthy Lifestyles Program: iAmHealthy is behavioral intervention focused on nutrition, behavior and physical activity that engages parents and children in treatment using mobile health (mHealth) technology. Meetings are approximately one hour. Participants will log in for 8 weekly group sessions, followed by 6 monthly sessions.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants randomized to this group receive comparable content delivered via a newsletter.&#xD;
Newsletter: Weight loss materials delivered via a newsletter. Each newsletter will cover nutritional, exercise, and behavioral suggestions to improve the child's health. The newsletter will be sent in the mail once a month for 8 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Parent Body Mass Index (BMI)</title>
          <description>Parent BMI was calculated at three time points.</description>
          <population>Nine parents in the iAmHealthy group and six parents in the Control group dropped out or did not complete the height/weight measure at Month 8. Fourteen parents in the iAmHealthy group and seven parents in the Control group dropped out or did not complete the height/weight measure at Month 20.</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="63"/>
                <count group_id="O2" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.83" spread="9.14"/>
                    <measurement group_id="O2" value="33.69" spread="8.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.94" spread="9.73"/>
                    <measurement group_id="O2" value="33.79" spread="9.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.23" spread="9.03"/>
                    <measurement group_id="O2" value="34.31" spread="9.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>20 months</time_frame>
      <desc>Parents and children were both considered enrolled. No deaths or serious or other adverse events were reported throughout the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>iAmHealthy</title>
          <description>Participants randomized to this arm receive the iAmHealthy Healthy Lifestyles Program.&#xD;
iAmHealthy Healthy Lifestyles Program: iAmHealthy is behavioral intervention focused on nutrition, behavior and physical activity that engages parents and children in treatment using mobile health (mHealth) technology. Meetings are approximately one hour. Participants will log in for 8 weekly group sessions, followed by 6 monthly sessions.</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Participants randomized to this group receive comparable content delivered via a newsletter.&#xD;
Newsletter: Weight loss materials delivered via a newsletter. Each newsletter will cover nutritional, exercise, and behavioral suggestions to improve the child's health. The newsletter will be sent in the mail once a month for 8 months.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="168"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="168"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="168"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Megan Olalde</name_or_title>
      <organization>University of Kansas Medical Center</organization>
      <phone>913-588-2042</phone>
      <email>molalde@kumc.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/NCT03304249
org study id: iAmHealthy 2
secondary id: R01NR016255-01A1
nct id: NCT03304249
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to learn if providing a family-based group program using mobile
      health technology (iAmHealthy Healthy Lifestyles Program) is effective at improving child
      weight, nutrition, and physical activity.
This is a cluster-randomized study that will test the iAmHealthy Healthy Lifestyles Program
      versus a standard approach to weight loss in kids current in 2nd thru 4th grade. The
      iAmHealthy Healthy Lifestyles Program utilizes mobile tools to deliver the weight loss
      program to kids and families in rural settings. This study will include kids from schools in
      rural cities/counties, and their parents, and they will be randomly assigned to a group by
      their school.

      The iAmHealthy Healthy Lifestyles Program is a rurally tailored telemedicine intervention. It
      delivers behavioral, nutritional, and physical activity topics for kids and their families.
      The total length of the intervention will be about 8 months, which coincides with the length
      of a typical school year.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Child Body Mass Index Z-score (BMIz) at Baseline and Month 8
time frame: Baseline to Month 8
description: Body mass index z-score (BMIz) is the age and sex standardized body mass index for children. To calculate BMIz, the equation BMIz = [(BMI/M)^L - 1] ÷ (L × S) is used where M is the median, L is the power transformation to achieve normality, and S is the coefficient of variation. A z-score of 0 represents the historical population norm. A higher BMIz is indicative of higher fat mass.
measure: Child Body Mass Index Z-score (BMIz) at Baseline and Month 20
time frame: Baseline to Month 20
description: Body mass index z-score (BMIz) is the age and sex standardized body mass index for children. To calculate BMIz, the equation BMIz = [(BMI/M)^L - 1] ÷ (L × S) is used where M is the median, L is the power transformation to achieve normality, and S is the coefficient of variation. A z-score of 0 represents the historical population norm. A higher BMIz is indicative of higher fat mass.
measure: Physical Activity - Average Minutes of Moderate to Vigorous Physical Activity Per Day
time frame: Baseline, Month 8, Month 20
description: Measured using ActiGraph physical activity monitors. Outcome will be calculated as the average (across valid wear days) time spent per day in moderate to vigorous physical activity (MVPA).
measure: Physical Activity - % Time in Sedentary Activity
time frame: Baseline, Month 8, Month 20
description: Measured using ActiGraph physical activity monitors. Outcome was calculated as the percentage of time time spent in sedentary activity compared to wear time.
measure: Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Fruits and Vegetables
time frame: Baseline, Month 8, Month 20
description: The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance.
measure: Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Sugar-sweetened Beverages
time frame: Baseline, Month 8, Month 20
description: The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance/
measure: Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of "Red Foods" (Foods High in Sugar and/or Fat)
time frame: Baseline, Month 8, Month 20
description: The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance.
measure: Parent Body Mass Index (BMI)
time frame: Baseline, Month 8, Month 20
description: Parent BMI was calculated at three time points.
arm group label: iAmHealthy
arm group type: Experimental
description: Participants randomized to this arm receive the iAmHealthy Healthy Lifestyles Program.
arm group label: Control
arm group type: Active Comparator
description: Participants randomized to this group receive comparable content delivered via a newsletter.
intervention type: Behavioral
intervention name: iAmHealthy Healthy Lifestyles Program
description: iAmHealthy is behavioral intervention focused on nutrition, behavior and physical activity that engages parents and children in treatment using mobile health (mHealth) technology. Meetings are approximately one hour. Participants will log in for 8 weekly group sessions, followed by 6 monthly sessions.
arm group label: iAmHealthy
intervention type: Other
intervention name: Newsletter
description: Weight loss materials delivered via a newsletter. Each newsletter will cover nutritional, exercise, and behavioral suggestions to improve the child's health. The newsletter will be sent in the mail once a month for 8 months.
arm group label: Control
criteria: 
gender: All
minimum age: 5 Years
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ann M Davis, PhD, MPH
role: Principal Investigator
affiliation: University of Kansas Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pediatric Obesity
mesh term: Weight Loss
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 