<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/NCT02973815</url>
  </required_header>
  <id_info>
    <org_study_id>1509S78583</org_study_id>
    <secondary_id>1R01HL123699</secondary_id>
    <nct_id>NCT02973815</nct_id>
  </id_info>
  <brief_title>New Ulm at HOME (Healthy Offerings Via the Mealtime Environment), NU-HOME</brief_title>
  <acronym>NU-HOME</acronym>
  <official_title>New Ulm at HOME (Healthy Offerings Via the Mealtime Environment), NU-HOME</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Allina Health System</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Minneapolis Heart Institute Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of the proposed project is to see if an innovative family-based intervention can&#xD;
      reduce childhood obesity by actively engaging the whole family in promoting healthy behaviors&#xD;
      in the home. In addition, the project will also examine how the NU-HOME family intervention&#xD;
      influences children's dietary intake, availability of healthy and unhealthy foods in the home&#xD;
      and served at meals and snacks, physical activity as a family, and child screen time (TV,&#xD;
      game systems). The study will build upon a similar project conducted in an urban area and&#xD;
      translate the lessons learned and adapt the program for a rural community.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Childhood obesity is a serious public health problem. Although previous environmental&#xD;
      approaches to obesity prevention show some promise, most studies have not shown excess weight&#xD;
      gain reductions. Moreover, few childhood obesity prevention studies significantly engage&#xD;
      parents or focus on the home environment, which is essential to promote healthy behaviors at&#xD;
      home. Children in rural communities are particularly vulnerable regarding increased risk for&#xD;
      obesity; thus, successful programs that engage families in rural communities to prevent&#xD;
      excess weight gain are critical. The proposed research project, New Ulm at Home (NU-HOME), is&#xD;
      a unique collaboration between leaders in a rural community (New Ulm, Minnesota) and&#xD;
      successful academic obesity researchers. The residents of New Ulm are poised for and are&#xD;
      requesting interventions to promote healthful behavior change, particularly for youth. In&#xD;
      conjunction with our many community stakeholder groups, the objective of the proposed&#xD;
      research is to test the effectiveness of the NU-HOME program, a 7-month, family-based health&#xD;
      promotion intervention to prevent excess weight gain (assessed via BMI z-score) among 7-10&#xD;
      year old children (n=114) in the New Ulm rural community. The intervention program is based&#xD;
      on Social Cognitive Theory and a socio-ecological framework and will focus on novel health&#xD;
      promotion components to prevent childhood obesity, including: 1) promoting regular meals in&#xD;
      which family members cook and eat together (i.e., family meals), 2) promoting&#xD;
      nutritionally-sound and appropriately-portioned snacks and meals, 3) reducing sedentary&#xD;
      behavior, particularly screen time in the home setting, and 4) promoting physical activity&#xD;
      through collaboration with community partners. The NU-HOME study is designed in four stages,&#xD;
      including substantial formative work between the academic and community partners, a two-arm&#xD;
      randomized controlled trial (RCT; intervention and wait-list control), and two activities to&#xD;
      facilitate sustainability (delayed intervention delivery for control group participants and&#xD;
      dissemination). A community-based participatory research (CBPR) approach will be used to&#xD;
      adapt an existing program, HOME Plus that was piloted and shown to be effective in urban&#xD;
      communities. The NU-HOME program has high translation potential and is likely to be&#xD;
      immediately useful to rural families of school-age children because it will be tested in a&#xD;
      real-world setting in collaboration with engaged, knowledgeable and influential community&#xD;
      partners.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2016</start_date>
  <completion_date type="Actual">August 2022</completion_date>
  <primary_completion_date type="Actual">January 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Child Body Mass Index (BMI) Z-score</measure>
    <time_frame>Post intervention (9 months after baseline)</time_frame>
    <description>Trained study staff will measure weight and height to calculate body mass index (BMI) then adjust for the child's age and sex to get BMI percentiles and z-scores. A Z-score of 0 represents the population mean with a z-score above zero indicating BMI above the population mean and a negative z-score indicating values below the population mean.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Home Availability of Fruits</measure>
    <time_frame>Post intervention (9 months after baseline)</time_frame>
    <description>Participants will report the number of fruits available in their home using the Home Food Inventory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Home Availability of Vegetables</measure>
    <time_frame>Post Intervention (9 months after baseline)</time_frame>
    <description>Participants will report the number of vegetables available in their home using the Home Food Inventory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Quality of Food and Beverages Served at Family Meals</measure>
    <time_frame>Post intervention (9 months after baseline)</time_frame>
    <description>Participants will report details of food offerings at 7 days of evening meals using the Evening Meal Screener and the quality will be assessed by using a healthfulness score that combines multiple aspects of the meal into a single score. We created the Healthfulness of the Evening Meal Scale which has a range of (-4 to 11) where higher values represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Dietary Intake of Vegetables</measure>
    <time_frame>Post intervention (9 months after baseline)</time_frame>
    <description>Child dietary intake will be assessed using mean number of servings of vegetables from two 24-hour dietary recalls</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Child Dietary Intake of Fruit</measure>
    <time_frame>Post intervention (9 months after baseline)</time_frame>
    <description>Child dietary intake will be assessed using mean number of servings of fruit from two 24-hour dietary recalls</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Minutes of Child Moderate to Vigorous Physical Activity</measure>
    <time_frame>Post intervention (9 months after baseline)</time_frame>
    <description>Children will wear an accelerometer (ActiGraph wGT3X-BT and GT3XP-BTLE models) for 7 days to measure their activity levels (e.g., minutes of Moderate-to-vigorous physical activity). Trained research staff distributed the monitors to child participants who wore the monitors on their right hip for 7 consecutive days during most waking hours, except when sleeping or doing water-related activities. Data were collected in 10-second epochs. Accelerometer data were analyzed with ActiLife software (version 6.9.1). Non-wear time was defined as any period of &gt;60 minutes of consecutive zeros. To be included in the analyses, participants had to have a minimum of &gt;8 hours of wear time on &gt;3 days. Evenson cutpoints for children were used to classify physical activity intensites: sedentary (0-100), light (101-2295), moderate (2296-4011), and vigorous (&gt;4012). Minutes engaged in Moderate to Vigorous Physical activity was analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Child Screen Time Use</measure>
    <time_frame>Post intervention (9 months after baseline)</time_frame>
    <description>Parents will report on child's daily minutes of screen time.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">228</enrollment>
  <condition>Obesity, Childhood</condition>
  <condition>Physical Activity</condition>
  <condition>Food Intake</condition>
  <condition>Rural Health</condition>
  <arm_group>
    <arm_group_label>NU-HOME Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to the intervention condition will receive the NU-HOME family intervention program that includes group sessions with other families focused on nutrition education, cooking skills, and physical activity. The intervention program also includes individual goal setting phone calls with parents and online, complementary materials.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed Intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants randomized to the delayed intervention condition will not receive any educational materials or training until after the final data collection. Once all data collection is completed, they will receive a shortened version of the NU-HOME intervention program that was offered to the intervention families.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>NU-HOME Intervention</intervention_name>
    <description>The NU-HOME family intervention program consists of seven monthly group sessions, individual goal setting calls and online materials to support the sessions. The intervention focuses on promoting healthful family meals where parents and children cook and eat together, healthful home food and physical activity environments, and being active together as a family.</description>
    <arm_group_label>NU-HOME Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  child between the ages of 7-10 who lives with the target adult at least 50% of the&#xD;
             time&#xD;
&#xD;
          -  parent/guardian must be the primary-meal preparing parent/guardian&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  planning to move out of the area in the next 6 months&#xD;
&#xD;
          -  medical condition that would prevent family from participating in group sessions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jayne A Fulkerson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Minnesota, School of Nursing</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>November 8, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <results_first_submitted>March 31, 2022</results_first_submitted>
  <results_first_submitted_qc>September 11, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">October 7, 2022</results_first_posted>
  <last_update_submitted>September 11, 2022</last_update_submitted>
  <last_update_submitted_qc>September 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>family meals</keyword>
  <keyword>home food availability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pediatric Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 22, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT02973815/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 11, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT02973815/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>228 participants representing 114 parent/child dyads were recruited in 2 cohorts (summers of 2017 and 2018)</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>NU-HOME Intervention</title>
          <description>Participants randomized to the intervention condition will receive the NU-HOME family intervention program that includes group sessions with other families focused on nutrition education, cooking skills, and physical activity. The intervention program also includes individual goal setting phone calls with parents and online, complementary materials.&#xD;
NU-HOME Intervention: The NU-HOME family intervention program consists of seven monthly group sessions, individual goal setting calls and online materials to support the sessions. The intervention focuses on promoting healthful family meals where parents and children cook and eat together, healthful home food and physical activity environments, and being active together as a family.</description>
        </group>
        <group group_id="P2">
          <title>Delayed Intervention</title>
          <description>Participants randomized to the delayed intervention condition will not receive any educational materials or training until after the final data collection. Once all data collection is completed, they will receive a shortened version of the NU-HOME intervention program that was offered to the intervention families.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Post Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="116">58 parent/child dyads</participants>
                <participants group_id="P2" count="112">56 parent/child dyads</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="108">54 parent/child dyads</participants>
                <participants group_id="P2" count="88">44 parent/child dyads</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="108">54 parent/child dyads</participants>
                <participants group_id="P2" count="88">44 parent/child dyads</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="106">53 parent/child dyads</participants>
                <participants group_id="P2" count="88">44 parent/child dyads</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>114 parent/child dyads</population>
      <group_list>
        <group group_id="B1">
          <title>NU-HOME Intervention</title>
          <description>Participants randomized to the intervention condition will receive the NU-HOME family intervention program that includes group sessions with other families focused on nutrition education, cooking skills, and physical activity. The intervention program also includes individual goal setting phone calls with parents and online, complementary materials.&#xD;
NU-HOME Intervention: The NU-HOME family intervention program consists of seven monthly group sessions, individual goal setting calls and online materials to support the sessions. The intervention focuses on promoting healthful family meals where parents and children cook and eat together, healthful home food and physical activity environments, and being active together as a family.</description>
        </group>
        <group group_id="B2">
          <title>Delayed Intervention</title>
          <description>Participants randomized to the delayed intervention condition will not receive any educational materials or training until after the final data collection. Once all data collection is completed, they will receive a shortened version of the NU-HOME intervention program that was offered to the intervention families.</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="116"/>
            <count group_id="B2" value="112"/>
            <count group_id="B3" value="228"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <population>Mean age is reported separately for the child participant and the parent participant.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Child mean age</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="58"/>
                    <count group_id="B2" value="56"/>
                    <count group_id="B3" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.0" spread="1.0"/>
                    <measurement group_id="B2" value="9.0" spread="1.1"/>
                    <measurement group_id="B3" value="9.0" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Parent mean age</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="58"/>
                    <count group_id="B2" value="56"/>
                    <count group_id="B3" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37.8" spread="5.0"/>
                    <measurement group_id="B2" value="37.8" spread="5.6"/>
                    <measurement group_id="B3" value="37.8" spread="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <population>Child and parent data are reported separately</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Child sex</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="58"/>
                    <count group_id="B2" value="56"/>
                    <count group_id="B3" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Parent sex</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="58"/>
                    <count group_id="B2" value="56"/>
                    <count group_id="B3" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="111"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <population>Parent and child data reported separately</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Child Hispanic</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="58"/>
                    <count group_id="B2" value="56"/>
                    <count group_id="B3" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Parent Hispanic</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="58"/>
                    <count group_id="B2" value="56"/>
                    <count group_id="B3" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <population>Parent and child data reported separately</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Child</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="58"/>
                    <count group_id="B2" value="56"/>
                    <count group_id="B3" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Black, Indigenous, Person of Color</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Parent</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="58"/>
                    <count group_id="B2" value="56"/>
                    <count group_id="B3" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Black, Indigenous, Person of Color</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="110"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="116"/>
                    <count group_id="B2" value="112"/>
                    <count group_id="B3" value="228"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="116"/>
                    <measurement group_id="B2" value="112"/>
                    <measurement group_id="B3" value="228"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Child Body Mass Index (BMI) Z-score</title>
        <description>Trained study staff will measure weight and height to calculate body mass index (BMI) then adjust for the child's age and sex to get BMI percentiles and z-scores. A Z-score of 0 represents the population mean with a z-score above zero indicating BMI above the population mean and a negative z-score indicating values below the population mean.</description>
        <time_frame>Post intervention (9 months after baseline)</time_frame>
        <population>102 post intervention BMI z-scores</population>
        <group_list>
          <group group_id="O1">
            <title>NU-HOME Intervention</title>
            <description>Participants randomized to the intervention condition will receive the NU-HOME family intervention program that includes group sessions with other families focused on nutrition education, cooking skills, and physical activity. The intervention program also includes individual goal setting phone calls with parents and online, complementary materials.&#xD;
NU-HOME Intervention: The NU-HOME family intervention program consists of seven monthly group sessions, individual goal setting calls and online materials to support the sessions. The intervention focuses on promoting healthful family meals where parents and children cook and eat together, healthful home food and physical activity environments, and being active together as a family.</description>
          </group>
          <group group_id="O2">
            <title>Delayed Intervention</title>
            <description>Participants randomized to the delayed intervention condition will not receive any educational materials or training until after the final data collection. Once all data collection is completed, they will receive a shortened version of the NU-HOME intervention program that was offered to the intervention families.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Child Body Mass Index (BMI) Z-score</title>
          <description>Trained study staff will measure weight and height to calculate body mass index (BMI) then adjust for the child's age and sex to get BMI percentiles and z-scores. A Z-score of 0 represents the population mean with a z-score above zero indicating BMI above the population mean and a negative z-score indicating values below the population mean.</description>
          <population>102 post intervention BMI z-scores</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="56"/>
                <count group_id="O2" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.69" spread="1.00"/>
                    <measurement group_id="O2" value="1.03" spread="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>This was adjusted for the baseline BMI-Z score, child sex, baseline child age, and economic assistance</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.342</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.062</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.065</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.194</ci_lower_limit>
            <ci_upper_limit>0.067</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Home Availability of Fruits</title>
        <description>Participants will report the number of fruits available in their home using the Home Food Inventory.</description>
        <time_frame>Post intervention (9 months after baseline)</time_frame>
        <population>94 change scores analyzed total (takes into account missingness in the predictors variables)</population>
        <group_list>
          <group group_id="O1">
            <title>NU-HOME Intervention</title>
            <description>Participants randomized to the intervention condition will receive the NU-HOME family intervention program that includes group sessions with other families focused on nutrition education, cooking skills, and physical activity. The intervention program also includes individual goal setting phone calls with parents and online, complementary materials.&#xD;
NU-HOME Intervention: The NU-HOME family intervention program consists of seven monthly group sessions, individual goal setting calls and online materials to support the sessions. The intervention focuses on promoting healthful family meals where parents and children cook and eat together, healthful home food and physical activity environments, and being active together as a family.</description>
          </group>
          <group group_id="O2">
            <title>Delayed Intervention</title>
            <description>Participants randomized to the delayed intervention condition will not receive any educational materials or training until after the final data collection. Once all data collection is completed, they will receive a shortened version of the NU-HOME intervention program that was offered to the intervention families.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Home Availability of Fruits</title>
          <description>Participants will report the number of fruits available in their home using the Home Food Inventory.</description>
          <population>94 change scores analyzed total (takes into account missingness in the predictors variables)</population>
          <units>fruits</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.87" spread="3.62"/>
                    <measurement group_id="O2" value="0.57" spread="4.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adjusted for: baseline HFI Fruit value, and economic assistance status</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.09</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.25</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.73104</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.20</ci_lower_limit>
            <ci_upper_limit>2.71</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Home Availability of Vegetables</title>
        <description>Participants will report the number of vegetables available in their home using the Home Food Inventory.</description>
        <time_frame>Post Intervention (9 months after baseline)</time_frame>
        <population>94 change scores analyzed total (takes into account missingness in the predictors variables)</population>
        <group_list>
          <group group_id="O1">
            <title>NU-HOME Intervention</title>
            <description>Participants randomized to the intervention condition will receive the NU-HOME family intervention program that includes group sessions with other families focused on nutrition education, cooking skills, and physical activity. The intervention program also includes individual goal setting phone calls with parents and online, complementary materials.&#xD;
NU-HOME Intervention: The NU-HOME family intervention program consists of seven monthly group sessions, individual goal setting calls and online materials to support the sessions. The intervention focuses on promoting healthful family meals where parents and children cook and eat together, healthful home food and physical activity environments, and being active together as a family.</description>
          </group>
          <group group_id="O2">
            <title>Delayed Intervention</title>
            <description>Participants randomized to the delayed intervention condition will not receive any educational materials or training until after the final data collection. Once all data collection is completed, they will receive a shortened version of the NU-HOME intervention program that was offered to the intervention families.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Home Availability of Vegetables</title>
          <description>Participants will report the number of vegetables available in their home using the Home Food Inventory.</description>
          <population>94 change scores analyzed total (takes into account missingness in the predictors variables)</population>
          <units>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="52"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.52" spread="3.37"/>
                    <measurement group_id="O2" value="-0.76" spread="2.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adjusted for: baseline HFI Vegetable value, and economic assistance status</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.047</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.23</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.61</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.02</ci_lower_limit>
            <ci_upper_limit>2.44</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Quality of Food and Beverages Served at Family Meals</title>
        <description>Participants will report details of food offerings at 7 days of evening meals using the Evening Meal Screener and the quality will be assessed by using a healthfulness score that combines multiple aspects of the meal into a single score. We created the Healthfulness of the Evening Meal Scale which has a range of (-4 to 11) where higher values represent a better outcome.</description>
        <time_frame>Post intervention (9 months after baseline)</time_frame>
        <population>92 change scores analyzed total (takes into account missingness in the predictors variables)</population>
        <group_list>
          <group group_id="O1">
            <title>NU-HOME Intervention</title>
            <description>Participants randomized to the intervention condition will receive the NU-HOME family intervention program that includes group sessions with other families focused on nutrition education, cooking skills, and physical activity. The intervention program also includes individual goal setting phone calls with parents and online, complementary materials.&#xD;
NU-HOME Intervention: The NU-HOME family intervention program consists of seven monthly group sessions, individual goal setting calls and online materials to support the sessions. The intervention focuses on promoting healthful family meals where parents and children cook and eat together, healthful home food and physical activity environments, and being active together as a family.</description>
          </group>
          <group group_id="O2">
            <title>Delayed Intervention</title>
            <description>Participants randomized to the delayed intervention condition will not receive any educational materials or training until after the final data collection. Once all data collection is completed, they will receive a shortened version of the NU-HOME intervention program that was offered to the intervention families.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Quality of Food and Beverages Served at Family Meals</title>
          <description>Participants will report details of food offerings at 7 days of evening meals using the Evening Meal Screener and the quality will be assessed by using a healthfulness score that combines multiple aspects of the meal into a single score. We created the Healthfulness of the Evening Meal Scale which has a range of (-4 to 11) where higher values represent a better outcome.</description>
          <population>92 change scores analyzed total (takes into account missingness in the predictors variables)</population>
          <units>units 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="49"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.18" spread="0.96"/>
                    <measurement group_id="O2" value="-0.19" spread="1.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adjusted for: baseline healthfulness score and economic assistance status</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.019</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.48</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.20</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.08</ci_lower_limit>
            <ci_upper_limit>0.88</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Dietary Intake of Vegetables</title>
        <description>Child dietary intake will be assessed using mean number of servings of vegetables from two 24-hour dietary recalls</description>
        <time_frame>Post intervention (9 months after baseline)</time_frame>
        <population>98 change scores analyzed total (takes into account missingness in the predictors variables)</population>
        <group_list>
          <group group_id="O1">
            <title>NU-HOME Intervention</title>
            <description>Participants randomized to the intervention condition will receive the NU-HOME family intervention program that includes group sessions with other families focused on nutrition education, cooking skills, and physical activity. The intervention program also includes individual goal setting phone calls with parents and online, complementary materials.&#xD;
NU-HOME Intervention: The NU-HOME family intervention program consists of seven monthly group sessions, individual goal setting calls and online materials to support the sessions. The intervention focuses on promoting healthful family meals where parents and children cook and eat together, healthful home food and physical activity environments, and being active together as a family.</description>
          </group>
          <group group_id="O2">
            <title>Delayed Intervention</title>
            <description>Participants randomized to the delayed intervention condition will not receive any educational materials or training until after the final data collection. Once all data collection is completed, they will receive a shortened version of the NU-HOME intervention program that was offered to the intervention families.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Dietary Intake of Vegetables</title>
          <description>Child dietary intake will be assessed using mean number of servings of vegetables from two 24-hour dietary recalls</description>
          <population>98 change scores analyzed total (takes into account missingness in the predictors variables)</population>
          <units>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="54"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.27" spread="0.94"/>
                    <measurement group_id="O2" value="-0.01" spread="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adjusted for: baseline vegetable intake, child age (baseline), parent education status (bachelors or higher vs lower)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.218</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.15</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.4</ci_lower_limit>
            <ci_upper_limit>0.09</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Child Dietary Intake of Fruit</title>
        <description>Child dietary intake will be assessed using mean number of servings of fruit from two 24-hour dietary recalls</description>
        <time_frame>Post intervention (9 months after baseline)</time_frame>
        <population>98 change scores analyzed total (takes into account missingness in the predictors variables)</population>
        <group_list>
          <group group_id="O1">
            <title>NU-HOME Intervention</title>
            <description>Participants randomized to the intervention condition will receive the NU-HOME family intervention program that includes group sessions with other families focused on nutrition education, cooking skills, and physical activity. The intervention program also includes individual goal setting phone calls with parents and online, complementary materials.&#xD;
NU-HOME Intervention: The NU-HOME family intervention program consists of seven monthly group sessions, individual goal setting calls and online materials to support the sessions. The intervention focuses on promoting healthful family meals where parents and children cook and eat together, healthful home food and physical activity environments, and being active together as a family.</description>
          </group>
          <group group_id="O2">
            <title>Delayed Intervention</title>
            <description>Participants randomized to the delayed intervention condition will not receive any educational materials or training until after the final data collection. Once all data collection is completed, they will receive a shortened version of the NU-HOME intervention program that was offered to the intervention families.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Child Dietary Intake of Fruit</title>
          <description>Child dietary intake will be assessed using mean number of servings of fruit from two 24-hour dietary recalls</description>
          <population>98 change scores analyzed total (takes into account missingness in the predictors variables)</population>
          <units>fruits</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.28" spread="1.41"/>
                    <measurement group_id="O2" value="-0.02" spread="0.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adjusted for: baseline fruit intake, child age (baseline), parent education status (bachelors or higher vs lower)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.066</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.37</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.2</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.03</ci_lower_limit>
            <ci_upper_limit>0.77</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Minutes of Child Moderate to Vigorous Physical Activity</title>
        <description>Children will wear an accelerometer (ActiGraph wGT3X-BT and GT3XP-BTLE models) for 7 days to measure their activity levels (e.g., minutes of Moderate-to-vigorous physical activity). Trained research staff distributed the monitors to child participants who wore the monitors on their right hip for 7 consecutive days during most waking hours, except when sleeping or doing water-related activities. Data were collected in 10-second epochs. Accelerometer data were analyzed with ActiLife software (version 6.9.1). Non-wear time was defined as any period of &gt;60 minutes of consecutive zeros. To be included in the analyses, participants had to have a minimum of &gt;8 hours of wear time on &gt;3 days. Evenson cutpoints for children were used to classify physical activity intensites: sedentary (0-100), light (101-2295), moderate (2296-4011), and vigorous (&gt;4012). Minutes engaged in Moderate to Vigorous Physical activity was analyzed.</description>
        <time_frame>Post intervention (9 months after baseline)</time_frame>
        <population>91 change scores analyzed total (takes into account missingness in the predictors variables)</population>
        <group_list>
          <group group_id="O1">
            <title>NU-HOME Intervention</title>
            <description>Participants randomized to the intervention condition will receive the NU-HOME family intervention program that includes group sessions with other families focused on nutrition education, cooking skills, and physical activity. The intervention program also includes individual goal setting phone calls with parents and online, complementary materials.&#xD;
NU-HOME Intervention: The NU-HOME family intervention program consists of seven monthly group sessions, individual goal setting calls and online materials to support the sessions. The intervention focuses on promoting healthful family meals where parents and children cook and eat together, healthful home food and physical activity environments, and being active together as a family.</description>
          </group>
          <group group_id="O2">
            <title>Delayed Intervention</title>
            <description>Participants randomized to the delayed intervention condition will not receive any educational materials or training until after the final data collection. Once all data collection is completed, they will receive a shortened version of the NU-HOME intervention program that was offered to the intervention families.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Minutes of Child Moderate to Vigorous Physical Activity</title>
          <description>Children will wear an accelerometer (ActiGraph wGT3X-BT and GT3XP-BTLE models) for 7 days to measure their activity levels (e.g., minutes of Moderate-to-vigorous physical activity). Trained research staff distributed the monitors to child participants who wore the monitors on their right hip for 7 consecutive days during most waking hours, except when sleeping or doing water-related activities. Data were collected in 10-second epochs. Accelerometer data were analyzed with ActiLife software (version 6.9.1). Non-wear time was defined as any period of &gt;60 minutes of consecutive zeros. To be included in the analyses, participants had to have a minimum of &gt;8 hours of wear time on &gt;3 days. Evenson cutpoints for children were used to classify physical activity intensites: sedentary (0-100), light (101-2295), moderate (2296-4011), and vigorous (&gt;4012). Minutes engaged in Moderate to Vigorous Physical activity was analyzed.</description>
          <population>91 change scores analyzed total (takes into account missingness in the predictors variables)</population>
          <units>Minutes of physical activity</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.06" spread="21.47"/>
                    <measurement group_id="O2" value="-1.21" spread="23.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adjusted for: baseline MVPA, child age (baseline), and child sex</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.28</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-4.79</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4.41</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.56</ci_lower_limit>
            <ci_upper_limit>3.98</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Child Screen Time Use</title>
        <description>Parents will report on child's daily minutes of screen time.</description>
        <time_frame>Post intervention (9 months after baseline)</time_frame>
        <population>98 change scores analyzed total (takes into account missingness in the predictors variables)</population>
        <group_list>
          <group group_id="O1">
            <title>NU-HOME Intervention</title>
            <description>Participants randomized to the intervention condition will receive the NU-HOME family intervention program that includes group sessions with other families focused on nutrition education, cooking skills, and physical activity. The intervention program also includes individual goal setting phone calls with parents and online, complementary materials.&#xD;
NU-HOME Intervention: The NU-HOME family intervention program consists of seven monthly group sessions, individual goal setting calls and online materials to support the sessions. The intervention focuses on promoting healthful family meals where parents and children cook and eat together, healthful home food and physical activity environments, and being active together as a family.</description>
          </group>
          <group group_id="O2">
            <title>Delayed Intervention</title>
            <description>Participants randomized to the delayed intervention condition will not receive any educational materials or training until after the final data collection. Once all data collection is completed, they will receive a shortened version of the NU-HOME intervention program that was offered to the intervention families.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Child Screen Time Use</title>
          <description>Parents will report on child's daily minutes of screen time.</description>
          <population>98 change scores analyzed total (takes into account missingness in the predictors variables)</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.19" spread="0.89"/>
                    <measurement group_id="O2" value="-0.20" spread="0.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adjusted for: baseline screentime, child age (baseline), and child sex</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.928</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.01</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.17</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.31</ci_lower_limit>
            <ci_upper_limit>0.34</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>from baseline to post intervention (9 months)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>NU-HOME Intervention</title>
          <description>Participants randomized to the intervention condition will receive the NU-HOME family intervention program that includes group sessions with other families focused on nutrition education, cooking skills, and physical activity. The intervention program also includes individual goal setting phone calls with parents and online, complementary materials.&#xD;
NU-HOME Intervention: The NU-HOME family intervention program consists of seven monthly group sessions, individual goal setting calls and online materials to support the sessions. The intervention focuses on promoting healthful family meals where parents and children cook and eat together, healthful home food and physical activity environments, and being active together as a family.</description>
        </group>
        <group group_id="E2">
          <title>Delayed Intervention</title>
          <description>Participants randomized to the delayed intervention condition will not receive any educational materials or training until after the final data collection. Once all data collection is completed, they will receive a shortened version of the NU-HOME intervention program that was offered to the intervention families.</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="1" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </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="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </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>Dr. Jayne A. Fulkerson</name_or_title>
      <organization>School of Nursing, University of Minnesota</organization>
      <phone>612-624-4823</phone>
      <email>fulke001@umn.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/NCT02973815
org study id: 1509S78583
secondary id: 1R01HL123699
nct id: NCT02973815
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of the proposed project is to see if an innovative family-based intervention can
      reduce childhood obesity by actively engaging the whole family in promoting healthy behaviors
      in the home. In addition, the project will also examine how the NU-HOME family intervention
      influences children's dietary intake, availability of healthy and unhealthy foods in the home
      and served at meals and snacks, physical activity as a family, and child screen time (TV,
      game systems). The study will build upon a similar project conducted in an urban area and
      translate the lessons learned and adapt the program for a rural community.
Childhood obesity is a serious public health problem. Although previous environmental
      approaches to obesity prevention show some promise, most studies have not shown excess weight
      gain reductions. Moreover, few childhood obesity prevention studies significantly engage
      parents or focus on the home environment, which is essential to promote healthy behaviors at
      home. Children in rural communities are particularly vulnerable regarding increased risk for
      obesity; thus, successful programs that engage families in rural communities to prevent
      excess weight gain are critical. The proposed research project, New Ulm at Home (NU-HOME), is
      a unique collaboration between leaders in a rural community (New Ulm, Minnesota) and
      successful academic obesity researchers. The residents of New Ulm are poised for and are
      requesting interventions to promote healthful behavior change, particularly for youth. In
      conjunction with our many community stakeholder groups, the objective of the proposed
      research is to test the effectiveness of the NU-HOME program, a 7-month, family-based health
      promotion intervention to prevent excess weight gain (assessed via BMI z-score) among 7-10
      year old children (n=114) in the New Ulm rural community. The intervention program is based
      on Social Cognitive Theory and a socio-ecological framework and will focus on novel health
      promotion components to prevent childhood obesity, including: 1) promoting regular meals in
      which family members cook and eat together (i.e., family meals), 2) promoting
      nutritionally-sound and appropriately-portioned snacks and meals, 3) reducing sedentary
      behavior, particularly screen time in the home setting, and 4) promoting physical activity
      through collaboration with community partners. The NU-HOME study is designed in four stages,
      including substantial formative work between the academic and community partners, a two-arm
      randomized controlled trial (RCT; intervention and wait-list control), and two activities to
      facilitate sustainability (delayed intervention delivery for control group participants and
      dissemination). A community-based participatory research (CBPR) approach will be used to
      adapt an existing program, HOME Plus that was piloted and shown to be effective in urban
      communities. The NU-HOME program has high translation potential and is likely to be
      immediately useful to rural families of school-age children because it will be tested in a
      real-world setting in collaboration with engaged, knowledgeable and influential community
      partners.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in Child Body Mass Index (BMI) Z-score
time frame: Post intervention (9 months after baseline)
description: Trained study staff will measure weight and height to calculate body mass index (BMI) then adjust for the child's age and sex to get BMI percentiles and z-scores. A Z-score of 0 represents the population mean with a z-score above zero indicating BMI above the population mean and a negative z-score indicating values below the population mean.
measure: Change in Home Availability of Fruits
time frame: Post intervention (9 months after baseline)
description: Participants will report the number of fruits available in their home using the Home Food Inventory.
measure: Change in Home Availability of Vegetables
time frame: Post Intervention (9 months after baseline)
description: Participants will report the number of vegetables available in their home using the Home Food Inventory.
measure: Change in the Quality of Food and Beverages Served at Family Meals
time frame: Post intervention (9 months after baseline)
description: Participants will report details of food offerings at 7 days of evening meals using the Evening Meal Screener and the quality will be assessed by using a healthfulness score that combines multiple aspects of the meal into a single score. We created the Healthfulness of the Evening Meal Scale which has a range of (-4 to 11) where higher values represent a better outcome.
measure: Change in Dietary Intake of Vegetables
time frame: Post intervention (9 months after baseline)
description: Child dietary intake will be assessed using mean number of servings of vegetables from two 24-hour dietary recalls
measure: Change in Child Dietary Intake of Fruit
time frame: Post intervention (9 months after baseline)
description: Child dietary intake will be assessed using mean number of servings of fruit from two 24-hour dietary recalls
measure: Change in Minutes of Child Moderate to Vigorous Physical Activity
time frame: Post intervention (9 months after baseline)
description: Children will wear an accelerometer (ActiGraph wGT3X-BT and GT3XP-BTLE models) for 7 days to measure their activity levels (e.g., minutes of Moderate-to-vigorous physical activity). Trained research staff distributed the monitors to child participants who wore the monitors on their right hip for 7 consecutive days during most waking hours, except when sleeping or doing water-related activities. Data were collected in 10-second epochs. Accelerometer data were analyzed with ActiLife software (version 6.9.1). Non-wear time was defined as any period of >60 minutes of consecutive zeros. To be included in the analyses, participants had to have a minimum of >8 hours of wear time on >3 days. Evenson cutpoints for children were used to classify physical activity intensites: sedentary (0-100), light (101-2295), moderate (2296-4011), and vigorous (>4012). Minutes engaged in Moderate to Vigorous Physical activity was analyzed.
measure: Change in Child Screen Time Use
time frame: Post intervention (9 months after baseline)
description: Parents will report on child's daily minutes of screen time.
arm group label: NU-HOME Intervention
arm group type: Experimental
description: Participants randomized to the intervention condition will receive the NU-HOME family intervention program that includes group sessions with other families focused on nutrition education, cooking skills, and physical activity. The intervention program also includes individual goal setting phone calls with parents and online, complementary materials.
arm group label: Delayed Intervention
arm group type: No Intervention
description: Participants randomized to the delayed intervention condition will not receive any educational materials or training until after the final data collection. Once all data collection is completed, they will receive a shortened version of the NU-HOME intervention program that was offered to the intervention families.
intervention type: Behavioral
intervention name: NU-HOME Intervention
description: The NU-HOME family intervention program consists of seven monthly group sessions, individual goal setting calls and online materials to support the sessions. The intervention focuses on promoting healthful family meals where parents and children cook and eat together, healthful home food and physical activity environments, and being active together as a family.
arm group label: NU-HOME Intervention
criteria: 
gender: All
minimum age: 7 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jayne A Fulkerson, PhD
role: Principal Investigator
affiliation: University of Minnesota
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pediatric Obesity
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 