<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/NCT02197390</url>
  </required_header>
  <id_info>
    <org_study_id>1U18DP003377-03</org_study_id>
    <nct_id>NCT02197390</nct_id>
  </id_info>
  <brief_title>An Ecological Approach to Addressing Childhood Obesity Issues in Imperial County</brief_title>
  <acronym>Our Choice</acronym>
  <official_title>An Ecological Approach to Addressing Childhood Obesity Issues in Imperial County</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>San Diego State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>San Diego State University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Our Choice is one of three CORD (Childhood Obesity Research Demonstration) studies funded by&#xD;
      the Centers for Disease Control and Prevention in 2011 to test multi-sector, multi-level&#xD;
      approaches to prevent and control childhood obesity. Our Choice is translating evidence-based&#xD;
      approaches for modifying behaviors, policies, systems, and environments to promote fruit and&#xD;
      vegetable consumption, physical activity, water consumption, and quality sleep. The ultimate&#xD;
      goal is to assist Children's Health Insurance Program-eligible children between 2-12 years&#xD;
      old attain a healthy weight. In addition to site-specific intervention and evaluation&#xD;
      activities, Our Choice is working with the University of Houston Evaluation Center to conduct&#xD;
      a cross-site evaluation on a set of shared measures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Our Choice is a partnership between a university-affiliated research institute, a federally&#xD;
      qualified health center, and a county public health department. We used formative research,&#xD;
      advisory committee members' recommendations, and previous research to inform the development&#xD;
      of the Our Choice project. Our theory-informed multi-sector, multi-level intervention targets&#xD;
      improvements in four health behaviors: fruit, vegetable, and water consumption, physical&#xD;
      activity, and sleep. Intervention partners include 1200 families, a federally qualified&#xD;
      health center (including three clinics), 26 early care and education centers, two elementary&#xD;
      school districts (and 20 elementary schools), three community recreation centers, and three&#xD;
      restaurants. Intervention components in all sectors target changes in behaviors, policies,&#xD;
      systems, and the social and physical environment. Evaluation activities include assessment of&#xD;
      the primary outcome, BMI z-score, at baseline, 12- and 18-months post-baseline, and sector&#xD;
      evaluations at baseline, 12, and 24-months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>May 2012</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Actual">February 2016</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>Factorial Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>BMI z-score change in 1184 children, 2-11 years old, assigned to a Health Care plus Public Health intervention, a Health Care intervention only, a Public Health intervention only, or a control condition</measure>
    <time_frame>12-month and 18-month post baseline evaluation; December 2015</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Child waist circumference</measure>
    <time_frame>12-month and 18-month post baseline evaluation; December 2015</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent waist circumference</measure>
    <time_frame>12-month and 18-month post baseline evaluation; December 2015</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent body mass index</measure>
    <time_frame>12-month and 18-month post baseline evaluation; December 2015</time_frame>
    <description>Weight and height</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent blood pressure</measure>
    <time_frame>12-month and 18-month post baseline evaluation; December 2015</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Health clinic health policy adoption</measure>
    <time_frame>12-month and 24-month post baseline sector evaluation; October 2015</time_frame>
    <description>Clinic manager interviews</description>
  </other_outcome>
  <other_outcome>
    <measure>Health clinic implementation of the assessment and treatment of child overweight and obesity guidelines at a specific percentile</measure>
    <time_frame>12-month and 24-month post baseline evaluation; October 2015</time_frame>
    <description>Electronic health records (EHR), attendance sheets of trainings attended by health clinic staff, chronic care days in place at each clinic, EHR modifications for assessment and treatment of childhood overweight and obesity, health message posters installed, satisfaction with aspects of the intervention</description>
  </other_outcome>
  <other_outcome>
    <measure>Body mass index in early care and education centers</measure>
    <time_frame>Year 1 and Year 2 of intervention; July 2014</time_frame>
    <description>Height and weight measures of children in 23 early child care and education centers.</description>
  </other_outcome>
  <other_outcome>
    <measure>Body mass index in elementary schools</measure>
    <time_frame>Year 1 and year 2 of intervention</time_frame>
    <description>Height and weight measures were collected from Kindergarten, 2nd or 3rd, and 5th grade students from 13 elementary schools.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">1184</enrollment>
  <condition>Childhood Obesity</condition>
  <arm_group>
    <arm_group_label>Health Care plus Public Health</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Health Care intervention involves the implementation of an obesity care model within a Federally Qualified Health Center (FQHC) and includes a Family Wellness Program delivered by Community Health Workers (CHWs). The Public Health intervention involves working with early care and education centers, schools, community recreation organizations, and restaurants to promote four health behaviors: fruit and vegetable consumption, physical activity, water consumption, and quality sleep.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Health Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Health Care intervention involves the implementation of an obesity care model within a Federally Qualified Health Center (FQHC) and includes a Family Wellness Program delivered by Community Health Workers (CHWs).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Public Health</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Public Health intervention involves working with early care and education centers, schools, community recreation organizations, and restaurants to promote four health behaviors: fruit and vegetable consumption, physical activity, water consumption, and quality sleep.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>No intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Family wellness workshops</intervention_name>
    <description>Nine family wellness workshops and eight family physical activity sessions facilitated by community health workers.</description>
    <arm_group_label>Health Care</arm_group_label>
    <arm_group_label>Health Care plus Public Health</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Obesity chronic care model</intervention_name>
    <arm_group_label>Health Care</arm_group_label>
    <arm_group_label>Health Care plus Public Health</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical activity, healthy eating, water drinking, healthy sleep promotion</intervention_name>
    <arm_group_label>Health Care</arm_group_label>
    <arm_group_label>Health Care plus Public Health</arm_group_label>
    <arm_group_label>Public Health</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Environment, policy, systems changes in clinic setting only</intervention_name>
    <arm_group_label>Health Care</arm_group_label>
    <arm_group_label>Health Care plus Public Health</arm_group_label>
    <arm_group_label>Public Health</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No intervention.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Environment, policy, and systems changes in schools, early child care education &amp; recreation</intervention_name>
    <arm_group_label>Health Care plus Public Health</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  If family had school-age child, child must attend one of the designated Our Choice&#xD;
             schools located in one of three designated cities.&#xD;
&#xD;
          -  If family had preschool-age child, family must reside in one of three designated&#xD;
             cities.&#xD;
&#xD;
          -  Children ages 2-11 years old&#xD;
&#xD;
          -  Maximum two children per household&#xD;
&#xD;
          -  Children above the 5th percentile body mass index&#xD;
&#xD;
          -  Family agrees to remain in the area throughout the duration of the study&#xD;
&#xD;
          -  Participating parent had to understand English or Spanish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child has any condition that significantly limits eating or physical activity in a way&#xD;
             that interventions would be impacted&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guadalupe X Ayala, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>San Diego State University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Leticia Ibarra, MPH</last_name>
    <role>Study Director</role>
    <affiliation>Clinicas de Salud del Pueblo, Inc.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Amy Binggeli-Vallarta, DrPH, RD</last_name>
    <role>Study Director</role>
    <affiliation>Imperial County Public Health Department</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Our Choice</name>
      <address>
        <city>El Centro</city>
        <state>California</state>
        <zip>92243</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Diego State University Research Foundation</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.ibachsd.org</url>
    <description>Click here for more information about the San Diego State University investigators at the Institute for Behavioral &amp; Community Health.</description>
  </link>
  <reference>
    <citation>Chuang E, Ayala GX, Schmied E, Ganter C, Gittelsohn J, Davison KK. Evaluation protocol to assess an integrated framework for the implementation of the Childhood Obesity Research Demonstration project at the California (CA-CORD) and Massachusetts (MA-CORD) sites. Child Obes. 2015 Feb;11(1):48-57. doi: 10.1089/chi.2014.0049. Epub 2014 Nov 25.</citation>
    <PMID>25423618</PMID>
  </reference>
  <reference>
    <citation>Ayala GX, Ibarra L, Binggeli-Vallarta A, Moody J, McKenzie TL, Angulo J, Hoyt H, Chuang E, Ganiats TG, Gahagan S, Ji M, Zive M, Schmied E, Arredondo EM, Elder JP. Our Choice/Nuestra Opcion: the Imperial County, California, Childhood Obesity Research Demonstration study (CA-CORD). Child Obes. 2015 Feb;11(1):37-47. doi: 10.1089/chi.2014.0080. Epub 2015 Jan 13.</citation>
    <PMID>25584664</PMID>
  </reference>
  <reference>
    <citation>Chuang E, Brunner J, Moody J, Ibarra L, Hoyt H, McKenzie TL, Binggeli-Vallarta A, Cervantes G, Finlayson TL, Ayala GX. Factors Affecting Implementation of the California Childhood Obesity Research Demonstration (CA-CORD) Project, 2013. Prev Chronic Dis. 2016 Oct 20;13:E147. doi: 10.5888/pcd13.160238.</citation>
    <PMID>27763831</PMID>
  </reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>April 18, 2020</last_update_submitted>
  <last_update_submitted_qc>April 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>San Diego State University</investigator_affiliation>
    <investigator_full_name>Guadalupe X. Ayala</investigator_full_name>
    <investigator_title>Principal Investigator/Professor</investigator_title>
  </responsible_party>
  <keyword>Childhood obesity</keyword>
  <keyword>Latino</keyword>
  <keyword>Hispanic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Pediatric Obesity</mesh_term>
  </condition_browse>
  <!-- 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/NCT02197390
org study id: 1U18DP003377-03
nct id: NCT02197390
lead sponsor: 
collaborator: 
has dmc: Yes
Our Choice is one of three CORD (Childhood Obesity Research Demonstration) studies funded by
      the Centers for Disease Control and Prevention in 2011 to test multi-sector, multi-level
      approaches to prevent and control childhood obesity. Our Choice is translating evidence-based
      approaches for modifying behaviors, policies, systems, and environments to promote fruit and
      vegetable consumption, physical activity, water consumption, and quality sleep. The ultimate
      goal is to assist Children's Health Insurance Program-eligible children between 2-12 years
      old attain a healthy weight. In addition to site-specific intervention and evaluation
      activities, Our Choice is working with the University of Houston Evaluation Center to conduct
      a cross-site evaluation on a set of shared measures.
Our Choice is a partnership between a university-affiliated research institute, a federally
      qualified health center, and a county public health department. We used formative research,
      advisory committee members' recommendations, and previous research to inform the development
      of the Our Choice project. Our theory-informed multi-sector, multi-level intervention targets
      improvements in four health behaviors: fruit, vegetable, and water consumption, physical
      activity, and sleep. Intervention partners include 1200 families, a federally qualified
      health center (including three clinics), 26 early care and education centers, two elementary
      school districts (and 20 elementary schools), three community recreation centers, and three
      restaurants. Intervention components in all sectors target changes in behaviors, policies,
      systems, and the social and physical environment. Evaluation activities include assessment of
      the primary outcome, BMI z-score, at baseline, 12- and 18-months post-baseline, and sector
      evaluations at baseline, 12, and 24-months.
allocation: Non-Randomized
intervention model: Factorial Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: BMI z-score change in 1184 children, 2-11 years old, assigned to a Health Care plus Public Health intervention, a Health Care intervention only, a Public Health intervention only, or a control condition
time frame: 12-month and 18-month post baseline evaluation; December 2015
measure: Child waist circumference
time frame: 12-month and 18-month post baseline evaluation; December 2015
measure: Parent waist circumference
time frame: 12-month and 18-month post baseline evaluation; December 2015
measure: Parent body mass index
time frame: 12-month and 18-month post baseline evaluation; December 2015
description: Weight and height
measure: Parent blood pressure
time frame: 12-month and 18-month post baseline evaluation; December 2015
measure: Health clinic health policy adoption
time frame: 12-month and 24-month post baseline sector evaluation; October 2015
description: Clinic manager interviews
measure: Health clinic implementation of the assessment and treatment of child overweight and obesity guidelines at a specific percentile
time frame: 12-month and 24-month post baseline evaluation; October 2015
description: Electronic health records (EHR), attendance sheets of trainings attended by health clinic staff, chronic care days in place at each clinic, EHR modifications for assessment and treatment of childhood overweight and obesity, health message posters installed, satisfaction with aspects of the intervention
measure: Body mass index in early care and education centers
time frame: Year 1 and Year 2 of intervention; July 2014
description: Height and weight measures of children in 23 early child care and education centers.
measure: Body mass index in elementary schools
time frame: Year 1 and year 2 of intervention
description: Height and weight measures were collected from Kindergarten, 2nd or 3rd, and 5th grade students from 13 elementary schools.
arm group label: Health Care plus Public Health
arm group type: Experimental
description: The Health Care intervention involves the implementation of an obesity care model within a Federally Qualified Health Center (FQHC) and includes a Family Wellness Program delivered by Community Health Workers (CHWs). The Public Health intervention involves working with early care and education centers, schools, community recreation organizations, and restaurants to promote four health behaviors: fruit and vegetable consumption, physical activity, water consumption, and quality sleep.
arm group label: Health Care
arm group type: Experimental
description: The Health Care intervention involves the implementation of an obesity care model within a Federally Qualified Health Center (FQHC) and includes a Family Wellness Program delivered by Community Health Workers (CHWs).
arm group label: Public Health
arm group type: Experimental
description: The Public Health intervention involves working with early care and education centers, schools, community recreation organizations, and restaurants to promote four health behaviors: fruit and vegetable consumption, physical activity, water consumption, and quality sleep.
arm group label: Control
arm group type: Experimental
description: No intervention.
intervention type: Behavioral
intervention name: Family wellness workshops
description: Nine family wellness workshops and eight family physical activity sessions facilitated by community health workers.
arm group label: Health Care
arm group label: Health Care plus Public Health
intervention type: Behavioral
intervention name: Obesity chronic care model
arm group label: Health Care
arm group label: Health Care plus Public Health
intervention type: Behavioral
intervention name: Physical activity, healthy eating, water drinking, healthy sleep promotion
arm group label: Health Care
arm group label: Health Care plus Public Health
arm group label: Public Health
intervention type: Behavioral
intervention name: Environment, policy, systems changes in clinic setting only
arm group label: Health Care
arm group label: Health Care plus Public Health
arm group label: Public Health
intervention type: Behavioral
intervention name: No intervention
description: No intervention.
arm group label: Control
intervention type: Behavioral
intervention name: Environment, policy, and systems changes in schools, early child care education & recreation
arm group label: Health Care plus Public Health
criteria: 
gender: All
minimum age: 2 Years
maximum age: 11 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Guadalupe X Ayala, PhD, MPH
role: Principal Investigator
affiliation: San Diego State University
last name: Leticia Ibarra, MPH
role: Study Director
affiliation: Clinicas de Salud del Pueblo, Inc.
last name: Amy Binggeli-Vallarta, DrPH, RD
role: Study Director
affiliation: Imperial County Public Health Department
facility: 
facility: 
country: United States
url: http://www.ibachsd.org
description: Click here for more information about the San Diego State University investigators at the Institute for Behavioral & Community Health.
citation: Chuang E, Ayala GX, Schmied E, Ganter C, Gittelsohn J, Davison KK. Evaluation protocol to assess an integrated framework for the implementation of the Childhood Obesity Research Demonstration project at the California (CA-CORD) and Massachusetts (MA-CORD) sites. Child Obes. 2015 Feb;11(1):48-57. doi: 10.1089/chi.2014.0049. Epub 2014 Nov 25.
PMID: 25423618
citation: Ayala GX, Ibarra L, Binggeli-Vallarta A, Moody J, McKenzie TL, Angulo J, Hoyt H, Chuang E, Ganiats TG, Gahagan S, Ji M, Zive M, Schmied E, Arredondo EM, Elder JP. Our Choice/Nuestra Opcion: the Imperial County, California, Childhood Obesity Research Demonstration study (CA-CORD). Child Obes. 2015 Feb;11(1):37-47. doi: 10.1089/chi.2014.0080. Epub 2015 Jan 13.
PMID: 25584664
citation: Chuang E, Brunner J, Moody J, Ibarra L, Hoyt H, McKenzie TL, Binggeli-Vallarta A, Cervantes G, Finlayson TL, Ayala GX. Factors Affecting Implementation of the California Childhood Obesity Research Demonstration (CA-CORD) Project, 2013. Prev Chronic Dis. 2016 Oct 20;13:E147. doi: 10.5888/pcd13.160238.
PMID: 27763831
responsible party type: Principal Investigator
investigator affiliation: San Diego State University
investigator full name: Guadalupe X. Ayala
investigator title: Principal Investigator/Professor
mesh term: Obesity
mesh term: Pediatric Obesity