<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/NCT03012126</url>
  </required_header>
  <id_info>
    <org_study_id>937121</org_study_id>
    <nct_id>NCT03012126</nct_id>
  </id_info>
  <brief_title>Clinical &amp; Community Approaches to Weight Management</brief_title>
  <acronym>CORD 2</acronym>
  <official_title>Childhood Obesity Research Demonstration Project 2.0 (CORD 2.0)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Massachusetts Department of Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Y-USA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yale School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Harvard School of Public Health (HSPH)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project seeks to build on innovative strategies to optimize the care of low-income&#xD;
      children with a BMI ≥ 85th percentile. To accomplish this goal, investigators will implement&#xD;
      a new clinical-community intervention, theoretically grounded in the Integrated Clinical and&#xD;
      Community Systems of Care Model, to address obesity through optimized screening and&#xD;
      management known to be effective, e-Referrals, Healthy Weight Clinics, and the YMCA's Healthy&#xD;
      Weight and Your Child weight management program (originally known as MEND). The study will&#xD;
      examine outcomes for children that matter most to a broad group of stakeholders including&#xD;
      parents, clinicians, and public health practitioners as well as inform the care of &gt;7 million&#xD;
      children with obesity covered by the Children's Health Insurance Program or Medicaid.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a 2-arm RCT. Enrolled patients are randomized to a pediatric weight management&#xD;
      intervention (PWMI): 1)a Healthy Weight Clinic based at a federally-qualified health center&#xD;
      (FQHC), or 2) a modified Healthy Weight and Your Child intervention delivered in YMCAs. A&#xD;
      comparison sample of children receiving care in eight demographically similar FQHCs serve as&#xD;
      a comparison group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">September 2019</completion_date>
  <primary_completion_date type="Actual">September 2019</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>
    <intervention_model_description>Children were randomized to either: 1) federally qualified health center-based Healthy Weight Clinic, or 2) YMCA community-based Healthy Weight and Your Child Program.&#xD;
A comparison sample of children receiving care in eight demographically similar FQHCs serve as a comparison group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Child BMI at 12 months</measure>
    <time_frame>0-12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Child BMI percent of the 95th percentile at 12 months</measure>
    <time_frame>0-12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Screen Time at 12 months</measure>
    <time_frame>0-12 months</time_frame>
    <description>Average hours per day of screen time as reported by parent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sleep Duration at 12 months</measure>
    <time_frame>0-12 months</time_frame>
    <description>Average hours per day of sleep as reported by parent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Physical Activity at 12 months</measure>
    <time_frame>0-12 months</time_frame>
    <description>Average number of days (0-7) child is physically active for at least 60 minutes as reported by parent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Diet at 12 months</measure>
    <time_frame>0-12 months</time_frame>
    <description>Average daily intake of sugar-sweetened beverages and weekly intake of fast food as reported by parent</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">407</enrollment>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>Clinically Based: Healthy Weight Clinic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All families referred to the Healthy Weight Clinic intervention arm will be scheduled for a 30-45 minute orientation clinic visit to orient the child and family to the program. During this visit, the family will meet with the community health worker who will provide a schedule of clinic visits and dietitian contacts. The community health worker will assess the child's social and environmental context to allow treatment tailoring. For the first 6 months, each family will be asked to attend two clinic visits per month and complete weekly 20-30 minute contacts with the dietitian via telephone. The program aims to deliver approximately 30 contact hours in the 6-month period. This will be followed by monthly visits to the Healthy Weight Clinic and monthly calls with their dietitian.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Community Based: Healthy Weight &amp; Your Child</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All families referred to the Healthy Weight and Your Child intervention arm will be scheduled for a 60-minute family information session to orient the child and family to the program. During this visit, the family will receive information about the program and logistics such as program schedule and format and attendance. The program is delivered over 12 months, which includes 16 weekly sessions, followed by 4 sessions delivered every other week and concluding with 5 monthly sessions. Most sessions are 2 hours in length and include a group of about 8-15 children and their caregivers. The first hour is delivered in a classroom setting and the second hour in an additional area conducive for physical activity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Healthy Weight Clinic</intervention_name>
    <arm_group_label>Clinically Based: Healthy Weight Clinic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Healthy Weight and Your Child</intervention_name>
    <arm_group_label>Community Based: Healthy Weight &amp; Your Child</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  child is age 6.0 through 12.9 years at referral&#xD;
&#xD;
          -  child's BMI meets or exceeds the 85th percentile for age and sex&#xD;
&#xD;
          -  parent can read and respond to interviews and questionnaires in English and Spanish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  children who do not have at least one parent who is able to follow study procedures&#xD;
             for 1 year&#xD;
&#xD;
          -  families who plan to leave their primary care health center within the study time&#xD;
             frame&#xD;
&#xD;
          -  families for whom the primary care clinician thinks the intervention is inappropriate,&#xD;
             e.g., emotional or cognitive difficulties&#xD;
&#xD;
          -  children who were taking medications that substantially interfere with growth&#xD;
&#xD;
          -  children who have a sibling enrolled in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elsie Taveras, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>MassGeneral Hospital for Children</affiliation>
  </overall_official>
  <reference>
    <citation>Fiechtner L, Perkins M, Biggs V, Langhans N, Sharifi M, O'Connor G, Price S, Locascio J, Kuhlthau K, Kwass JA, Nelson C, Land T, Longjohn M, Lawson V, Hohman K, Taveras EM. Rationale and design of the Clinic and Community Approaches to Healthy Weight Randomized Trial. Contemp Clin Trials. 2018 Apr;67:16-22. doi: 10.1016/j.cct.2018.01.002. Epub 2018 Jan 10.</citation>
    <PMID>29330083</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>February 3, 2021</last_update_submitted>
  <last_update_submitted_qc>February 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Elsie Taveras, MD</investigator_full_name>
    <investigator_title>Chief, Division of General Academic Pediatrics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual-level data may be shared upon request, under the conditions that an analysis plan is prepared and approved by the PI/Co-Is, IRB approval has been obtained, and all necessary data sharing agreements have been executed.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Data can be requested by emailing the PI or Project Manager.</ipd_time_frame>
    <ipd_access_criteria>An analysis plan is prepared and approved by the PI/Co-Is&#xD;
IRB approval has been obtained, and&#xD;
all necessary data sharing agreements have been executed.</ipd_access_criteria>
  </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/NCT03012126
org study id: 937121
nct id: NCT03012126
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This project seeks to build on innovative strategies to optimize the care of low-income
      children with a BMI ≥ 85th percentile. To accomplish this goal, investigators will implement
      a new clinical-community intervention, theoretically grounded in the Integrated Clinical and
      Community Systems of Care Model, to address obesity through optimized screening and
      management known to be effective, e-Referrals, Healthy Weight Clinics, and the YMCA's Healthy
      Weight and Your Child weight management program (originally known as MEND). The study will
      examine outcomes for children that matter most to a broad group of stakeholders including
      parents, clinicians, and public health practitioners as well as inform the care of >7 million
      children with obesity covered by the Children's Health Insurance Program or Medicaid.
This is a 2-arm RCT. Enrolled patients are randomized to a pediatric weight management
      intervention (PWMI): 1)a Healthy Weight Clinic based at a federally-qualified health center
      (FQHC), or 2) a modified Healthy Weight and Your Child intervention delivered in YMCAs. A
      comparison sample of children receiving care in eight demographically similar FQHCs serve as
      a comparison group.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Children were randomized to either: 1) federally qualified health center-based Healthy Weight Clinic, or 2) YMCA community-based Healthy Weight and Your Child Program.
A comparison sample of children receiving care in eight demographically similar FQHCs serve as a comparison group.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Child BMI at 12 months
time frame: 0-12 months
measure: Change in Child BMI percent of the 95th percentile at 12 months
time frame: 0-12 months
measure: Change in Screen Time at 12 months
time frame: 0-12 months
description: Average hours per day of screen time as reported by parent
measure: Change in Sleep Duration at 12 months
time frame: 0-12 months
description: Average hours per day of sleep as reported by parent
measure: Change in Physical Activity at 12 months
time frame: 0-12 months
description: Average number of days (0-7) child is physically active for at least 60 minutes as reported by parent
measure: Change in Diet at 12 months
time frame: 0-12 months
description: Average daily intake of sugar-sweetened beverages and weekly intake of fast food as reported by parent
arm group label: Clinically Based: Healthy Weight Clinic
arm group type: Experimental
description: All families referred to the Healthy Weight Clinic intervention arm will be scheduled for a 30-45 minute orientation clinic visit to orient the child and family to the program. During this visit, the family will meet with the community health worker who will provide a schedule of clinic visits and dietitian contacts. The community health worker will assess the child's social and environmental context to allow treatment tailoring. For the first 6 months, each family will be asked to attend two clinic visits per month and complete weekly 20-30 minute contacts with the dietitian via telephone. The program aims to deliver approximately 30 contact hours in the 6-month period. This will be followed by monthly visits to the Healthy Weight Clinic and monthly calls with their dietitian.
arm group label: Community Based: Healthy Weight & Your Child
arm group type: Experimental
description: All families referred to the Healthy Weight and Your Child intervention arm will be scheduled for a 60-minute family information session to orient the child and family to the program. During this visit, the family will receive information about the program and logistics such as program schedule and format and attendance. The program is delivered over 12 months, which includes 16 weekly sessions, followed by 4 sessions delivered every other week and concluding with 5 monthly sessions. Most sessions are 2 hours in length and include a group of about 8-15 children and their caregivers. The first hour is delivered in a classroom setting and the second hour in an additional area conducive for physical activity.
intervention type: Behavioral
intervention name: Healthy Weight Clinic
arm group label: Clinically Based: Healthy Weight Clinic
intervention type: Behavioral
intervention name: Healthy Weight and Your Child
arm group label: Community Based: Healthy Weight & Your Child
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: No
last name: Elsie Taveras, MD, MPH
role: Principal Investigator
affiliation: MassGeneral Hospital for Children
citation: Fiechtner L, Perkins M, Biggs V, Langhans N, Sharifi M, O'Connor G, Price S, Locascio J, Kuhlthau K, Kwass JA, Nelson C, Land T, Longjohn M, Lawson V, Hohman K, Taveras EM. Rationale and design of the Clinic and Community Approaches to Healthy Weight Randomized Trial. Contemp Clin Trials. 2018 Apr;67:16-22. doi: 10.1016/j.cct.2018.01.002. Epub 2018 Jan 10.
PMID: 29330083
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Elsie Taveras, MD
investigator title: Chief, Division of General Academic Pediatrics
mesh term: Obesity
mesh term: Overweight
sharing ipd: Yes
ipd description: Individual-level data may be shared upon request, under the conditions that an analysis plan is prepared and approved by the PI/Co-Is, IRB approval has been obtained, and all necessary data sharing agreements have been executed.
ipd info type: Study Protocol
ipd time frame: Data can be requested by emailing the PI or Project Manager.
ipd access criteria: An analysis plan is prepared and approved by the PI/Co-Is
IRB approval has been obtained, and
all necessary data sharing agreements have been executed.