<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/NCT03796221</url>
  </required_header>
  <id_info>
    <org_study_id>K23HD083439</org_study_id>
    <secondary_id>K23HD083439</secondary_id>
    <nct_id>NCT03796221</nct_id>
  </id_info>
  <brief_title>Parenting Intervention for Pediatric Obesity</brief_title>
  <official_title>Integrating Parenting Interventions Into Pediatric Obesity Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nemours Children's Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Nemours Children's Health System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to see if educational videos about how to help children develop&#xD;
      healthy behaviors, paired with treatment in a pediatric obesity clinic, can increase&#xD;
      caregiver confidence and improve child behaviors and weight. Caregivers of children between&#xD;
      the ages of 4 and 11 years old who are new patients to a pediatric obesity clinic will be&#xD;
      invited to take part in the study. All families will receive the standard treatment provided&#xD;
      in the pediatric obesity clinic. Half of the caregivers will be assigned to also watch a few&#xD;
      educational videos every month for 3 months in between clinic visits.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 11, 2019</start_date>
  <completion_date type="Actual">September 12, 2021</completion_date>
  <primary_completion_date type="Actual">February 19, 2021</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 child weight status</measure>
    <time_frame>6 months</time_frame>
    <description>Change in child BMI-z score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in child weight status</measure>
    <time_frame>6 months</time_frame>
    <description>Change in child BMI percentile (referenced to the 95th percentile)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in caregiver confidence managing child lifestyle behaviors</measure>
    <time_frame>6 months</time_frame>
    <description>Change in Lifestyle Behavior Checklist Confidence score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in child lifestyle behaviors</measure>
    <time_frame>6 months</time_frame>
    <description>Change in Lifestyle Behavior Checklist Problem score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Discussion of parenting topics during visits to the pediatric obesity clinic</measure>
    <time_frame>1 month, 2 months, 3 months, 6 months</time_frame>
    <description>Discussion helpfulness ratings at each visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in child weight status</measure>
    <time_frame>3 months</time_frame>
    <description>Change in child BMI-z score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in child weight status</measure>
    <time_frame>3 months</time_frame>
    <description>Change in child BMI percentile (referenced to the 95th percentile)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in caregiver confidence managing child lifestyle behaviors</measure>
    <time_frame>3 months</time_frame>
    <description>Change in Lifestyle Behavior Checklist Confidence score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in child lifestyle behaviors</measure>
    <time_frame>3 months</time_frame>
    <description>Change in Lifestyle Behavior Checklist Problem score</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Childhood Obesity</condition>
  <condition>Parenting</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Will receive standard pediatric obesity treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Will receive standard pediatric obesity treatment and parenting videos</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Parenting videos</intervention_name>
    <description>Brief online videos, featuring families of children with obesity of diverse backgrounds, to provide education on parenting skills and motivate families to adopt healthy lifestyle behaviors as a family. Videos will be delivered monthly for three months in between pediatric obesity clinic visits.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard pediatric obesity treatment</intervention_name>
    <description>Standard treatment in a hospital-based pediatric obesity clinic with a team of medical providers, dietitians, exercise specialists, and behavioral health specialists. Treatment includes management of obesity-related medical conditions, nutrition education, physical activity counseling, and discussion of behavioral strategies such as goal-setting and self-monitoring, with elements of motivational interviewing used to encourage behavior change and adoption of healthy lifestyle behaviors by the entire family.</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Legal guardian of a new patient to the Nemours pediatric obesity clinic&#xD;
&#xD;
          -  Child with body mass index (BMI) greater than the 95th percentile for age and sex&#xD;
&#xD;
          -  Child 4-11 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not proficient in English or Spanish&#xD;
&#xD;
          -  Not able to access the internet on any type of device&#xD;
&#xD;
          -  Child has a genetic syndrome or primary endocrine disorder associated with obesity&#xD;
&#xD;
          -  Child is taking a medication known to impact weight&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thao-Ly T Phan, MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nemours Children's Health System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nemours Alfred I. duPont Hospital for Children</name>
      <address>
        <city>Wilmington</city>
        <state>Delaware</state>
        <zip>19803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>March 22, 2022</last_update_submitted>
  <last_update_submitted_qc>March 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nemours Children's Health System</investigator_affiliation>
    <investigator_full_name>Thao-Ly Phan</investigator_full_name>
    <investigator_title>Associate Professor of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Childhood obesity</keyword>
  <keyword>Parenting intervention</keyword>
  <keyword>Video intervention</keyword>
  <keyword>Healthcare delivery</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>
  <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/NCT03796221
org study id: K23HD083439
secondary id: K23HD083439
nct id: NCT03796221
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to see if educational videos about how to help children develop
      healthy behaviors, paired with treatment in a pediatric obesity clinic, can increase
      caregiver confidence and improve child behaviors and weight. Caregivers of children between
      the ages of 4 and 11 years old who are new patients to a pediatric obesity clinic will be
      invited to take part in the study. All families will receive the standard treatment provided
      in the pediatric obesity clinic. Half of the caregivers will be assigned to also watch a few
      educational videos every month for 3 months in between clinic visits.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in child weight status
time frame: 6 months
description: Change in child BMI-z score
measure: Change in child weight status
time frame: 6 months
description: Change in child BMI percentile (referenced to the 95th percentile)
measure: Change in caregiver confidence managing child lifestyle behaviors
time frame: 6 months
description: Change in Lifestyle Behavior Checklist Confidence score
measure: Change in child lifestyle behaviors
time frame: 6 months
description: Change in Lifestyle Behavior Checklist Problem score
measure: Discussion of parenting topics during visits to the pediatric obesity clinic
time frame: 1 month, 2 months, 3 months, 6 months
description: Discussion helpfulness ratings at each visit
measure: Change in child weight status
time frame: 3 months
description: Change in child BMI-z score
measure: Change in child weight status
time frame: 3 months
description: Change in child BMI percentile (referenced to the 95th percentile)
measure: Change in caregiver confidence managing child lifestyle behaviors
time frame: 3 months
description: Change in Lifestyle Behavior Checklist Confidence score
measure: Change in child lifestyle behaviors
time frame: 3 months
description: Change in Lifestyle Behavior Checklist Problem score
arm group label: Control Group
arm group type: Active Comparator
description: Will receive standard pediatric obesity treatment
arm group label: Intervention Group
arm group type: Experimental
description: Will receive standard pediatric obesity treatment and parenting videos
intervention type: Behavioral
intervention name: Parenting videos
description: Brief online videos, featuring families of children with obesity of diverse backgrounds, to provide education on parenting skills and motivate families to adopt healthy lifestyle behaviors as a family. Videos will be delivered monthly for three months in between pediatric obesity clinic visits.
arm group label: Intervention Group
intervention type: Behavioral
intervention name: Standard pediatric obesity treatment
description: Standard treatment in a hospital-based pediatric obesity clinic with a team of medical providers, dietitians, exercise specialists, and behavioral health specialists. Treatment includes management of obesity-related medical conditions, nutrition education, physical activity counseling, and discussion of behavioral strategies such as goal-setting and self-monitoring, with elements of motivational interviewing used to encourage behavior change and adoption of healthy lifestyle behaviors by the entire family.
arm group label: Control Group
arm group label: Intervention Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Thao-Ly T Phan, MD MPH
role: Principal Investigator
affiliation: Nemours Children's Health System
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Nemours Children's Health System
investigator full name: Thao-Ly Phan
investigator title: Associate Professor of Pediatrics
mesh term: Obesity
mesh term: Pediatric Obesity
sharing ipd: No