<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/NCT02976454</url>
  </required_header>
  <id_info>
    <org_study_id>R40MC29452</org_study_id>
    <nct_id>NCT02976454</nct_id>
  </id_info>
  <brief_title>Guided Self-Help Obesity Treatment in the Doctor's Office - GOT Doc</brief_title>
  <acronym>GOTDoc</acronym>
  <official_title>Using a Guided Self-Help Treatment Model for Childhood Obesity Management in the Primary Care Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>HRSA/Maternal and Child Health Bureau</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Diego</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      One-third of our nations' children are overweight or obese (OW/OB). The cornerstone of&#xD;
      obesity treatment involves intensive family-based behavioral therapy, yet these programs&#xD;
      often exist in tertiary care academic settings that have long wait lists and are too far away&#xD;
      for families to access. Primary care providers (PCP) have been called on by several&#xD;
      organizations to be the front line of obesity management, yet they are limited by a lack of&#xD;
      time, resources, and skills. Thus, if we are to offer effective obesity management in the&#xD;
      healthcare setting, other care models need to be developed and tested. The goal of this&#xD;
      proposal is to deliver Guided Self-Help (GSH) treatment of childhood obesity in the primary&#xD;
      care setting. This program relies on classic behavioral therapy strategies, self-regulation&#xD;
      theory, and provides the support needed for patient/family self-management of weight loss.&#xD;
      Implementing this program in the primary care setting will increase our ability to deliver&#xD;
      nutrition and weight-related counseling in the primary care office and serve patients closer&#xD;
      to home, thereby increasing access to effective treatment, improving adherence to recommended&#xD;
      changes, and meeting the goals of Healthy People 2020.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Currently 1/3 of our nation's children are overweight or obese. The goal of Healthy People&#xD;
      2020 is to reduce the proportion of children who are obese and increase the proportion of&#xD;
      primary care visits that include nutrition and weight-related counseling. However, there are&#xD;
      a lack of resources and providers that can offer effective weight-related counseling and&#xD;
      treatment. Gold-standard family-based weight control programs for children are often provided&#xD;
      at tertiary care academic centers and can be difficult to access. Furthermore, primary care&#xD;
      providers (PCPs), who have been identified as key players in the treatment of childhood&#xD;
      obesity, are not well-equipped to address this issue, engage in behavior&#xD;
      modification/lifestyle counseling, or provide effective treatment in the primary care&#xD;
      setting. As a result, new models of care are needed so that a greater proportion of&#xD;
      overweight/obese (OW/OB) children and their parents can access care and receive quality&#xD;
      treatment for obesity. The investigators propose to train health coaches in the primary care&#xD;
      setting to deliver Guided Self-Help (GSH) treatment of childhood obesity. Implementing this&#xD;
      program in the primary care setting will increase our ability to deliver nutrition and&#xD;
      weight-related counseling in the primary care office and serve patients closer to home,&#xD;
      thereby increasing access to effective treatment, improving adherence to recommended changes,&#xD;
      and meeting the goals of Healthy People 2020.&#xD;
&#xD;
      The goal of this study is to conduct a pragmatic clinical trial in two large pediatric&#xD;
      practices in San Diego County (n=200) where 38% and 39% of children are OW/OB. The&#xD;
      intervention group will receive GSH (14 sessions over 6 months) delivered by a health coach&#xD;
      in the clinic. The control group will receive usual care, i.e. PCP provides obesity&#xD;
      management using decision support tools in the electronic health record and refers to a&#xD;
      tertiary care program (20 sessions over 6 months) at the academic center.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 12, 2016</start_date>
  <completion_date type="Actual">July 30, 2020</completion_date>
  <primary_completion_date type="Actual">December 30, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in BMI percentile</measure>
    <time_frame>6 months and 1 year</time_frame>
    <description>Change in BMI percentile within and between study groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference in percentage of sessions that were attended</measure>
    <time_frame>6 months</time_frame>
    <description>Difference in percentage of sessions that were attended between groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Societal cost for each 0.1 unit BMI z-score change</measure>
    <time_frame>6 months and 1 year</time_frame>
    <description>Cost-effectiveness from a societal perspective including cost of delivering intervention, parental costs, and primary care office costs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity Support scale</measure>
    <time_frame>6 months</time_frame>
    <description>Difference in parent support behaviors to encourage physical activity between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent self-efficacy for health related behaviors scale</measure>
    <time_frame>6 months</time_frame>
    <description>Difference in parent self-efficacy to engage in weight loss between intervention parents and control parents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary History Questionnaire II</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in child dietary behavior from baseline to post treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Godin Physical Activity Scale</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in child physical activity level from baseline to post treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary Support scale (modified)</measure>
    <time_frame>6 months</time_frame>
    <description>Difference in parent support behaviors to encourage healthy dietary behaviors between groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">230</enrollment>
  <condition>Pediatric Obesity</condition>
  <arm_group>
    <arm_group_label>Guided Self-Help Obesity Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Guided Self-Help obesity treatment will include 14 meetings over 6 months to mimic the structure of the proposed Medicare funding for obesity treatment for adults. These meetings will include a single one-hour meeting and 13 twenty-minute meetings that occur in the clinic. During this time, the health coach will assess patient/parent readiness to engage in behavior change, assess barriers and facilitators to behavior change, engage in behavior change and problem solving, and provide feedback and accountability.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Family-based behavioral obesity treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The active control group will receive usual care, i.e. PCP provides obesity management using decision support tools in the electronic health record and refers to a tertiary care program at the academic center. This program is the traditional family-based behavioral weight control program which consists of 20 one-hour, group-based sessions over 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Guided Self-Help Obesity Treatment</intervention_name>
    <description>Guided Self-Help obesity treatment will be provided by a health coach in the clinic. The treatment involves 14 sessions: 1 one-hour session and 13 twenty-minute sessions with the health coach who will provide behavioral obesity treatment.</description>
    <arm_group_label>Guided Self-Help Obesity Treatment</arm_group_label>
    <other_name>Guided self-help</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Family-based behavioral obesity treatment</intervention_name>
    <description>Traditional family-based, group-based behavioral weight control program. The treatment involves 20 hourly group-based sessions for parents and children separately, which occurs weekly for 16 weeks, then every other week for the last 2 months (4 session).</description>
    <arm_group_label>Family-based behavioral obesity treatment</arm_group_label>
    <other_name>FBT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  an OW/OB child (BMI ≥ 85th%ile for age and gender) in the family who is between the&#xD;
             ages of 5 and 13 years old&#xD;
&#xD;
          -  parent who is responsible for food preparation willing to participate&#xD;
&#xD;
          -  parent who can read English or Spanish at a minimum of a 5th grade level&#xD;
&#xD;
          -  family who is willing to commit to attendance at all assessment visits&#xD;
&#xD;
          -  family not moving out of the San Diego area within the time frame of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  child who is taking medications that may impact weight&#xD;
&#xD;
          -  child or parent with a psychiatric or behavioral illness that will impact their&#xD;
             ability to participate in treatment&#xD;
&#xD;
          -  child with physical difficulties that limit the ability to exercise&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of California, San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 24, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>August 19, 2020</last_update_submitted>
  <last_update_submitted_qc>August 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Diego</investigator_affiliation>
    <investigator_full_name>Kay Rhee</investigator_full_name>
    <investigator_title>Associate Professor of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Obesity treatment</keyword>
  <keyword>Primary care</keyword>
  <keyword>Guided Self-Help</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/NCT02976454
org study id: R40MC29452
nct id: NCT02976454
lead sponsor: 
collaborator: 
has dmc: No
One-third of our nations' children are overweight or obese (OW/OB). The cornerstone of
      obesity treatment involves intensive family-based behavioral therapy, yet these programs
      often exist in tertiary care academic settings that have long wait lists and are too far away
      for families to access. Primary care providers (PCP) have been called on by several
      organizations to be the front line of obesity management, yet they are limited by a lack of
      time, resources, and skills. Thus, if we are to offer effective obesity management in the
      healthcare setting, other care models need to be developed and tested. The goal of this
      proposal is to deliver Guided Self-Help (GSH) treatment of childhood obesity in the primary
      care setting. This program relies on classic behavioral therapy strategies, self-regulation
      theory, and provides the support needed for patient/family self-management of weight loss.
      Implementing this program in the primary care setting will increase our ability to deliver
      nutrition and weight-related counseling in the primary care office and serve patients closer
      to home, thereby increasing access to effective treatment, improving adherence to recommended
      changes, and meeting the goals of Healthy People 2020.
Currently 1/3 of our nation's children are overweight or obese. The goal of Healthy People
      2020 is to reduce the proportion of children who are obese and increase the proportion of
      primary care visits that include nutrition and weight-related counseling. However, there are
      a lack of resources and providers that can offer effective weight-related counseling and
      treatment. Gold-standard family-based weight control programs for children are often provided
      at tertiary care academic centers and can be difficult to access. Furthermore, primary care
      providers (PCPs), who have been identified as key players in the treatment of childhood
      obesity, are not well-equipped to address this issue, engage in behavior
      modification/lifestyle counseling, or provide effective treatment in the primary care
      setting. As a result, new models of care are needed so that a greater proportion of
      overweight/obese (OW/OB) children and their parents can access care and receive quality
      treatment for obesity. The investigators propose to train health coaches in the primary care
      setting to deliver Guided Self-Help (GSH) treatment of childhood obesity. Implementing this
      program in the primary care setting will increase our ability to deliver nutrition and
      weight-related counseling in the primary care office and serve patients closer to home,
      thereby increasing access to effective treatment, improving adherence to recommended changes,
      and meeting the goals of Healthy People 2020.

      The goal of this study is to conduct a pragmatic clinical trial in two large pediatric
      practices in San Diego County (n=200) where 38% and 39% of children are OW/OB. The
      intervention group will receive GSH (14 sessions over 6 months) delivered by a health coach
      in the clinic. The control group will receive usual care, i.e. PCP provides obesity
      management using decision support tools in the electronic health record and refers to a
      tertiary care program (20 sessions over 6 months) at the academic center.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in BMI percentile
time frame: 6 months and 1 year
description: Change in BMI percentile within and between study groups
measure: Difference in percentage of sessions that were attended
time frame: 6 months
description: Difference in percentage of sessions that were attended between groups
measure: Societal cost for each 0.1 unit BMI z-score change
time frame: 6 months and 1 year
description: Cost-effectiveness from a societal perspective including cost of delivering intervention, parental costs, and primary care office costs
measure: Activity Support scale
time frame: 6 months
description: Difference in parent support behaviors to encourage physical activity between groups
measure: Parent self-efficacy for health related behaviors scale
time frame: 6 months
description: Difference in parent self-efficacy to engage in weight loss between intervention parents and control parents
measure: Dietary History Questionnaire II
time frame: 6 months
description: Changes in child dietary behavior from baseline to post treatment
measure: Godin Physical Activity Scale
time frame: 6 months
description: Changes in child physical activity level from baseline to post treatment
measure: Dietary Support scale (modified)
time frame: 6 months
description: Difference in parent support behaviors to encourage healthy dietary behaviors between groups
arm group label: Guided Self-Help Obesity Treatment
arm group type: Experimental
description: Guided Self-Help obesity treatment will include 14 meetings over 6 months to mimic the structure of the proposed Medicare funding for obesity treatment for adults. These meetings will include a single one-hour meeting and 13 twenty-minute meetings that occur in the clinic. During this time, the health coach will assess patient/parent readiness to engage in behavior change, assess barriers and facilitators to behavior change, engage in behavior change and problem solving, and provide feedback and accountability.
arm group label: Family-based behavioral obesity treatment
arm group type: Active Comparator
description: The active control group will receive usual care, i.e. PCP provides obesity management using decision support tools in the electronic health record and refers to a tertiary care program at the academic center. This program is the traditional family-based behavioral weight control program which consists of 20 one-hour, group-based sessions over 6 months.
intervention type: Behavioral
intervention name: Guided Self-Help Obesity Treatment
description: Guided Self-Help obesity treatment will be provided by a health coach in the clinic. The treatment involves 14 sessions: 1 one-hour session and 13 twenty-minute sessions with the health coach who will provide behavioral obesity treatment.
arm group label: Guided Self-Help Obesity Treatment
other name: Guided self-help
intervention type: Behavioral
intervention name: Family-based behavioral obesity treatment
description: Traditional family-based, group-based behavioral weight control program. The treatment involves 20 hourly group-based sessions for parents and children separately, which occurs weekly for 16 weeks, then every other week for the last 2 months (4 session).
arm group label: Family-based behavioral obesity treatment
other name: FBT
criteria: 
gender: All
minimum age: 5 Years
maximum age: 13 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, San Diego
investigator full name: Kay Rhee
investigator title: Associate Professor of Pediatrics
mesh term: Obesity
mesh term: Pediatric Obesity