<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/NCT02982759</url>
  </required_header>
  <id_info>
    <org_study_id>8417</org_study_id>
    <secondary_id>1U01MD010540-01</secondary_id>
    <secondary_id>NCI-2018-02632</secondary_id>
    <secondary_id>RG1001379</secondary_id>
    <nct_id>NCT02982759</nct_id>
  </id_info>
  <brief_title>Together We STRIDE (Strategizing Together Relevant Interventions for Diet and Exercise)</brief_title>
  <official_title>Together We STRIDE (Strategizing Together Relevant Interventions for Diet and Exercise)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fred Hutchinson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Minority Health and Health Disparities (NIMHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Fred Hutchinson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obesity among Hispanic children in the Lower Yakima Valley of Washington State is alarmingly&#xD;
      high. This study proposes to implement a comprehensive, multi-level intervention among&#xD;
      children, families, the schools, and the community to combat this problem. The two year&#xD;
      intervention will be measured by examining changes in children's body mass index.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Childhood obesity rates in the Lower Yakima Valley of Washington State are alarming: 34% of&#xD;
      youth are obese compared to the state average of 23%. A large proportion of those children&#xD;
      are Hispanic; Hispanics represent 47% of the population in Yakima County and 67% of the&#xD;
      population in the Lower Yakima Valley. In January 2013, the investigators study received a&#xD;
      planning grant from the National Institute of Minority Health and Health Disparities to build&#xD;
      and enhance community capacity and infrastructure on childhood obesity initiatives in the&#xD;
      Lower Yakima Valley. This project began with the community as they expressed concern at the&#xD;
      high incidence of obesity among Hispanic children in the Valley. In the ensuing two and a&#xD;
      half years, the investigators and the community used community-based participatory research&#xD;
      (CBPR) to 1) form a community advisory board (CAB); 2) build a Steering Committee; 3) conduct&#xD;
      a comprehensive multi-level needs assessment; 4) develop and institute a pilot study; and 5)&#xD;
      evaluate our activities. In response to RFA MD-15-010, the investigators and the community&#xD;
      are now prepared to implement the intervention activities that were successful in our pilot&#xD;
      study into a large-scale quasi-experimental intervention trial. The multi-level interventions&#xD;
      will include activities at the individual level, family level, school level, and community&#xD;
      level. Activities include distributing comic books to students about healthy eating and&#xD;
      physical activity, a multi-generational level family intervention that teaches families about&#xD;
      healthy eating and cooking skills as well as physical activity, a variety of school events to&#xD;
      teach children about the food industry as well as encourage them to be physically activity at&#xD;
      small intervals in the classroom, and community activities to foster the idea of the&#xD;
      community being a healthy place for kids. The overall goal of this project is to continue to&#xD;
      use a CBPR approach; in so doing, test the effectiveness of the comprehensive, multi-level&#xD;
      intervention on reducing children's BMI z-scores, the primary endpoint. BMI z scores will be&#xD;
      assessed by taking height and weight measures of the children at baseline, 12 months, and 24&#xD;
      months. This study will recruit and enroll a total of 900 Hispanic children in grades 3rd to&#xD;
      5th (ages 8-12 years) who attend the four elementary schools in the intervention community&#xD;
      and the four elementary schools in the comparison community. Schools in both communities will&#xD;
      be matched based on student standardized test scores, percent of students eligible to receive&#xD;
      free or reduced-price lunch, and school size. Secondary outcomes include dietary patterns and&#xD;
      accelerometer data of physical activity in a subgroup of 180 Hispanic children. Community&#xD;
      participation in this project has been extraordinary and our letters of support indicate the&#xD;
      communities' enthusiasm for this project.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2016</start_date>
  <completion_date type="Actual">August 28, 2020</completion_date>
  <primary_completion_date type="Actual">August 28, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Body Mass Index z-score</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical Activity with accelerometer</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary Pattern with questionnaire</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">888</enrollment>
  <condition>Obesity, Childhood</condition>
  <arm_group>
    <arm_group_label>Comparison Arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The comparison group will receive 2 generic newsletters</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention arm will receive the multi-level intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Multi-Level Intervention</intervention_name>
    <description>The multi-level interventions will include activities at the individual level, family level, school level, and community level.</description>
    <arm_group_label>Intervention Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Genetic Newsletters</intervention_name>
    <description>The comparison will receive generic newsletters</description>
    <arm_group_label>Comparison Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hispanic children in grade levels 3rd-5th (ages 8-12 years) who attend elementary&#xD;
             schools in these two communities will be eligible to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria include children with clinically-diagnosed dementia, terminal (&lt;5&#xD;
             years) illness, major psychiatric illness, severe hearing impairment, and inability to&#xD;
             move, which will be assessed during the distribution of the study recruitment packets&#xD;
             to parents.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Linda K Ko, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fred Hutchinson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fred Hutchinson Cancer Research Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>January 19, 2021</last_update_submitted>
  <last_update_submitted_qc>January 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2021</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02982759
org study id: 8417
secondary id: 1U01MD010540-01
secondary id: NCI-2018-02632
secondary id: RG1001379
nct id: NCT02982759
lead sponsor: 
collaborator: 
has dmc: No
Obesity among Hispanic children in the Lower Yakima Valley of Washington State is alarmingly
      high. This study proposes to implement a comprehensive, multi-level intervention among
      children, families, the schools, and the community to combat this problem. The two year
      intervention will be measured by examining changes in children's body mass index.
Childhood obesity rates in the Lower Yakima Valley of Washington State are alarming: 34% of
      youth are obese compared to the state average of 23%. A large proportion of those children
      are Hispanic; Hispanics represent 47% of the population in Yakima County and 67% of the
      population in the Lower Yakima Valley. In January 2013, the investigators study received a
      planning grant from the National Institute of Minority Health and Health Disparities to build
      and enhance community capacity and infrastructure on childhood obesity initiatives in the
      Lower Yakima Valley. This project began with the community as they expressed concern at the
      high incidence of obesity among Hispanic children in the Valley. In the ensuing two and a
      half years, the investigators and the community used community-based participatory research
      (CBPR) to 1) form a community advisory board (CAB); 2) build a Steering Committee; 3) conduct
      a comprehensive multi-level needs assessment; 4) develop and institute a pilot study; and 5)
      evaluate our activities. In response to RFA MD-15-010, the investigators and the community
      are now prepared to implement the intervention activities that were successful in our pilot
      study into a large-scale quasi-experimental intervention trial. The multi-level interventions
      will include activities at the individual level, family level, school level, and community
      level. Activities include distributing comic books to students about healthy eating and
      physical activity, a multi-generational level family intervention that teaches families about
      healthy eating and cooking skills as well as physical activity, a variety of school events to
      teach children about the food industry as well as encourage them to be physically activity at
      small intervals in the classroom, and community activities to foster the idea of the
      community being a healthy place for kids. The overall goal of this project is to continue to
      use a CBPR approach; in so doing, test the effectiveness of the comprehensive, multi-level
      intervention on reducing children's BMI z-scores, the primary endpoint. BMI z scores will be
      assessed by taking height and weight measures of the children at baseline, 12 months, and 24
      months. This study will recruit and enroll a total of 900 Hispanic children in grades 3rd to
      5th (ages 8-12 years) who attend the four elementary schools in the intervention community
      and the four elementary schools in the comparison community. Schools in both communities will
      be matched based on student standardized test scores, percent of students eligible to receive
      free or reduced-price lunch, and school size. Secondary outcomes include dietary patterns and
      accelerometer data of physical activity in a subgroup of 180 Hispanic children. Community
      participation in this project has been extraordinary and our letters of support indicate the
      communities' enthusiasm for this project.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Body Mass Index z-score
time frame: 3 years
measure: Physical Activity with accelerometer
time frame: 3 years
measure: Dietary Pattern with questionnaire
time frame: 3 years
arm group label: Comparison Arm
arm group type: Other
description: The comparison group will receive 2 generic newsletters
arm group label: Intervention Arm
arm group type: Experimental
description: The intervention arm will receive the multi-level intervention.
intervention type: Behavioral
intervention name: Multi-Level Intervention
description: The multi-level interventions will include activities at the individual level, family level, school level, and community level.
arm group label: Intervention Arm
intervention type: Behavioral
intervention name: Genetic Newsletters
description: The comparison will receive generic newsletters
arm group label: Comparison Arm
criteria: 
gender: All
minimum age: 8 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Linda K Ko, PhD
role: Principal Investigator
affiliation: Fred Hutchinson Cancer Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pediatric Obesity
sharing ipd: No