<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/NCT02206529</url>
  </required_header>
  <id_info>
    <org_study_id>211098</org_study_id>
    <nct_id>NCT02206529</nct_id>
  </id_info>
  <brief_title>Enhancing Family Based Treatment of Childhood Obesity Through Social Networks</brief_title>
  <acronym>CONNECT</acronym>
  <official_title>Enhancing Family Based Treatment of Childhood Obesity Through Social Networks</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaiser Permanente</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kaiser Permanente</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to develop a Social Network Engagement (SNE) Intervention that&#xD;
      will be integrated into a standard treatment program for childhood overweight. The&#xD;
      investigators will conduct a pilot trial of SNE to assess feasibility and to estimate its&#xD;
      effectiveness compared with historical controls who received standard treatment. The&#xD;
      historical controls will be participants in the FOCUS trial (Family Overweight: Comparing Use&#xD;
      of Strategies; NCT00746629).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2013</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Child BMI Z-score</measure>
    <time_frame>20 weeks after baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Child BMI Z-score</measure>
    <time_frame>One year post-treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peds QL (child self-report and parent report)</measure>
    <time_frame>20 weeks after baseline</time_frame>
    <description>Pediatric Quality of Life Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent BMI</measure>
    <time_frame>20 weeks after baseline</time_frame>
    <description>Intervention is aimed at the parent-child dyad, so parent weight status is assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peds QL (child self-report and parent report)</measure>
    <time_frame>One year post-treatment</time_frame>
    <description>Pediatric Quality of Life Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent BMI</measure>
    <time_frame>One year post-treatment</time_frame>
    <description>Intervention is aimed at the parent-child dyad, so parent weight status is assessed.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>SSQ (Social Support Questionnaire-Short Form)</measure>
    <time_frame>20 weeks after baseline</time_frame>
    <description>Global social support measure, assessed as possible mediator of effect of intervention on primary and secondary outcomes.</description>
  </other_outcome>
  <other_outcome>
    <measure>QRI (Quality of the Relationship Index)</measure>
    <time_frame>20 weeks after baseline</time_frame>
    <description>Relationship-specific social support measure, assessed as possible mediator of effect of intervention on primary and secondary outcomes.</description>
  </other_outcome>
  <other_outcome>
    <measure>SPSI-R (Social Problem-Solving Index-for Research)</measure>
    <time_frame>20 weeks after baseline</time_frame>
    <description>Measure of parental skill in problem-solving, assessed as possible mediator of effect of intervention on primary and secondary outcomes.</description>
  </other_outcome>
  <other_outcome>
    <measure>Behavioral Skill Assessment</measure>
    <time_frame>20 weeks after baseline</time_frame>
    <description>Process measure of parental use of skills taught during intervention</description>
  </other_outcome>
  <other_outcome>
    <measure>WMSI (Weight Management Support Index)</measure>
    <time_frame>20 weeks after baseline</time_frame>
    <description>Measure of parental perceived social support related to weight management, assessed as possible mediator of primary and secondary outcomes.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Child Obesity</condition>
  <arm_group>
    <arm_group_label>Social Network Engagement+Std Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Social Network Engagement = content and activities to help the parent engage his/her social network in supporting healthy lifestyle behaviors.&#xD;
Standard Treatment = family-based behavioral pediatric obesity treatment, as per protocol outlined in FOCUS trial (Family Overweight: Comparing Use of Strategies; NCT00746629)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This comparator arm consists of historical controls, participants in the FOCUS trial who received standard treatment.&#xD;
Standard Treatment = family-based behavioral pediatric obesity treatment, as per protocol outlined in FOCUS trial (Family Overweight: Comparing Use of Strategies; NCT00746629)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Social Network Engagement+Std Treatment</intervention_name>
    <arm_group_label>Social Network Engagement+Std Treatment</arm_group_label>
    <other_name>SNE</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard Treatment</intervention_name>
    <description>Standard Treatment = family-based behavioral pediatric obesity treatment, as per protocol outlined in FOCUS trial (Family Overweight: Comparing Use of Strategies; NCT00746629)</description>
    <arm_group_label>Standard Treatment</arm_group_label>
    <other_name>FOCUS Intervention</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria Children&#xD;
&#xD;
          -  Age 7-13 years&#xD;
&#xD;
          -  At or above the 85th percentile for age- and gender-specific BMI&#xD;
&#xD;
        Parents&#xD;
&#xD;
        • At least one overweight parent (BMI&gt;25.0)&#xD;
&#xD;
        Parents and children&#xD;
&#xD;
          -  English-speaking and at least at a second-grade reading level&#xD;
&#xD;
          -  Live &lt;50 miles from the treatment site.&#xD;
&#xD;
        Exclusion Children&#xD;
&#xD;
          -  Conditions known to promote obesity (e.g., Prader-Willi),&#xD;
&#xD;
          -  Participation in another weight control program&#xD;
&#xD;
          -  Recently started taking weight-affecting medications (e.g., stimulants).&#xD;
&#xD;
        Parents and children&#xD;
&#xD;
          -  Disability or illness that would preclude them from engaging in at least&#xD;
             moderate-intensity physical activity,&#xD;
&#xD;
          -  Current or prior diagnosed eating disturbance&#xD;
&#xD;
          -  Thought disorder, suicidality, or substance abuse disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paula Lozano, MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Group Health Research Institute</affiliation>
  </overall_official>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>October 11, 2017</last_update_submitted>
  <last_update_submitted_qc>October 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>obesity</keyword>
  <keyword>child</keyword>
  <keyword>weight management</keyword>
  <keyword>behavioral</keyword>
  <keyword>social networks</keyword>
  <keyword>social support</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/NCT02206529
org study id: 211098
nct id: NCT02206529
lead sponsor: 
has dmc: No
The purpose of this study is to develop a Social Network Engagement (SNE) Intervention that
      will be integrated into a standard treatment program for childhood overweight. The
      investigators will conduct a pilot trial of SNE to assess feasibility and to estimate its
      effectiveness compared with historical controls who received standard treatment. The
      historical controls will be participants in the FOCUS trial (Family Overweight: Comparing Use
      of Strategies; NCT00746629).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Child BMI Z-score
time frame: 20 weeks after baseline
measure: Child BMI Z-score
time frame: One year post-treatment
measure: Peds QL (child self-report and parent report)
time frame: 20 weeks after baseline
description: Pediatric Quality of Life Score
measure: Parent BMI
time frame: 20 weeks after baseline
description: Intervention is aimed at the parent-child dyad, so parent weight status is assessed.
measure: Peds QL (child self-report and parent report)
time frame: One year post-treatment
description: Pediatric Quality of Life Score
measure: Parent BMI
time frame: One year post-treatment
description: Intervention is aimed at the parent-child dyad, so parent weight status is assessed.
measure: SSQ (Social Support Questionnaire-Short Form)
time frame: 20 weeks after baseline
description: Global social support measure, assessed as possible mediator of effect of intervention on primary and secondary outcomes.
measure: QRI (Quality of the Relationship Index)
time frame: 20 weeks after baseline
description: Relationship-specific social support measure, assessed as possible mediator of effect of intervention on primary and secondary outcomes.
measure: SPSI-R (Social Problem-Solving Index-for Research)
time frame: 20 weeks after baseline
description: Measure of parental skill in problem-solving, assessed as possible mediator of effect of intervention on primary and secondary outcomes.
measure: Behavioral Skill Assessment
time frame: 20 weeks after baseline
description: Process measure of parental use of skills taught during intervention
measure: WMSI (Weight Management Support Index)
time frame: 20 weeks after baseline
description: Measure of parental perceived social support related to weight management, assessed as possible mediator of primary and secondary outcomes.
arm group label: Social Network Engagement+Std Treatment
arm group type: Active Comparator
description: Social Network Engagement = content and activities to help the parent engage his/her social network in supporting healthy lifestyle behaviors.
Standard Treatment = family-based behavioral pediatric obesity treatment, as per protocol outlined in FOCUS trial (Family Overweight: Comparing Use of Strategies; NCT00746629)
arm group label: Standard Treatment
arm group type: Other
description: This comparator arm consists of historical controls, participants in the FOCUS trial who received standard treatment.
Standard Treatment = family-based behavioral pediatric obesity treatment, as per protocol outlined in FOCUS trial (Family Overweight: Comparing Use of Strategies; NCT00746629)
intervention type: Behavioral
intervention name: Social Network Engagement+Std Treatment
arm group label: Social Network Engagement+Std Treatment
other name: SNE
intervention type: Behavioral
intervention name: Standard Treatment
description: Standard Treatment = family-based behavioral pediatric obesity treatment, as per protocol outlined in FOCUS trial (Family Overweight: Comparing Use of Strategies; NCT00746629)
arm group label: Standard Treatment
other name: FOCUS Intervention
criteria: 
gender: All
minimum age: 7 Years
maximum age: 13 Years
healthy volunteers: No
last name: Paula Lozano, MD MPH
role: Principal Investigator
affiliation: Group Health Research Institute
responsible party type: Sponsor
mesh term: Obesity
mesh term: Pediatric Obesity