<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/NCT04422951</url>
  </required_header>
  <id_info>
    <org_study_id>54341</org_study_id>
    <secondary_id>R01DK123286</secondary_id>
    <nct_id>NCT04422951</nct_id>
  </id_info>
  <brief_title>Wise Social Psychological Interventions to Improve Outcomes of Behavioral Weight Control in Children With Obesity</brief_title>
  <official_title>Wise Social Psychological Interventions to Improve Outcomes of Behavioral Weight Control in Children With Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford University</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>
      A 2-arm, parallel group, randomized controlled trial to evaluate overall differences in body&#xD;
      mass index (BMI) trajectories over 6 months between 10-16-year-old children with obesity&#xD;
      randomized to receive the wise social psychological interventions plus a usual care&#xD;
      behavioral intervention for weight management compared to children randomized to receive&#xD;
      additional education plus a usual care behavioral intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 6, 2023</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2024</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>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in body mass index from baseline to 6 months</measure>
    <time_frame>Change from baseline to 6 months</time_frame>
    <description>body mass index = weight in kilograms divided by the squared height in meters</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Obesity, Childhood</condition>
  <arm_group>
    <arm_group_label>Wise interventions plus behavioral Rx</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Wise social psychological interventions (growth mindset and values self-affirmation) plus a usual care behavioral intervention for weight control.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Education plus behavioral Rx</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Health education plus a usual care behavioral intervention for weight control</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Wise interventions -- values self-affirmation and growth mindset -- plus usual care behavioral treatment</intervention_name>
    <description>Addition of two wise wise social psychological interventions-growth mindset and self-affirmation-to a 6-month usual care behavioral intervention for weight control in children with obesity</description>
    <arm_group_label>Wise interventions plus behavioral Rx</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education plus usual care behavioral treatment</intervention_name>
    <description>6-month health education plus usual care behavioral intervention for weight control in children with obesity</description>
    <arm_group_label>Education plus behavioral Rx</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  10-16 year old children with obesity (BMI ≥ 95th percentile on the 2000 Centers for&#xD;
             Disease Control and Prevention BMI reference) on the date of randomization.&#xD;
             Participation in a behavioral weight control program. Standard behavioral weight&#xD;
             control program eligibility criteria will apply: Child and at least one&#xD;
             parent/guardian must agree to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical conditions affecting growth - diagnosed with a genetic or metabolic&#xD;
             disease/syndrome associated obesity, Type 1 diabetes, Type 2 diabetes taking&#xD;
             medication, chronic gastrointestinal diseases, Chronic renal diseases, uncorrected&#xD;
             structural heart disease, heart failure, heart transplant, anorexia nervosa or bulimia&#xD;
             nervosa or binge eating disorder (present or past), AIDS or HIV infection, pregnancy&#xD;
&#xD;
        Medications affecting growth - systemic corticosteroids more than 2 weeks in the past year,&#xD;
        insulin, oral hypoglycemics, thyroid hormone, growth hormone&#xD;
&#xD;
        Conditions limiting participation in the interventions - e.g., unable to participate in&#xD;
        routine physical education classes at school, requiring oxygen supplementation for&#xD;
        exertion, developmental or physical disability preventing participation in interventions,&#xD;
        children or parents/guardians who cannot medically participate in mild dietary restrictions&#xD;
        and/or increased physical activity for any reason&#xD;
&#xD;
        Conditions limiting participation in the assessments - child or primary caregiver not able&#xD;
        to read surveys in English or Spanish, child two or more grade levels delayed in school for&#xD;
        reading and writing in his/her native language&#xD;
&#xD;
        Unable to read, understand or complete informed consent in English or Spanish&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Robinson, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Thomas Robinson, MD, MPH</last_name>
    <phone>650-723-5895</phone>
    <email>tom.robinson@stanford.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Donna Matheson, PhD</last_name>
      <phone>650-724-5790</phone>
      <email>donna.matheson@stanford.edu</email>
    </contact>
    <investigator>
      <last_name>Thomas N Robinson, MD, MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>April 11, 2023</last_update_submitted>
  <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Thomas Robinson</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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>Yes</sharing_ipd>
    <ipd_description>Data sharing will be based on the policy for data sharing issued by the NIH and consistent with HIPAA privacy standards. Our data management team will prepare de-identified public use data set from this study for deposition in a repository.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Limited access data will be shared within six months of the publication date for the primary outcome publication or within two years of the date that the database is locked for analysis, whichever occurs first.</ipd_time_frame>
    <ipd_access_criteria>User registration will be required. Users must agree to the conditions of use governing access to the public release data (a data use agreement), including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource.</ipd_access_criteria>
  </patient_data>
  <pending_results>
    <submitted>August 16, 2023</submitted>
    <returned>September 6, 2023</returned>
    <submitted>September 7, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04422951
org study id: 54341
secondary id: R01DK123286
nct id: NCT04422951
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A 2-arm, parallel group, randomized controlled trial to evaluate overall differences in body
      mass index (BMI) trajectories over 6 months between 10-16-year-old children with obesity
      randomized to receive the wise social psychological interventions plus a usual care
      behavioral intervention for weight management compared to children randomized to receive
      additional education plus a usual care behavioral intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: Change in body mass index from baseline to 6 months
time frame: Change from baseline to 6 months
description: body mass index = weight in kilograms divided by the squared height in meters
arm group label: Wise interventions plus behavioral Rx
arm group type: Experimental
description: Wise social psychological interventions (growth mindset and values self-affirmation) plus a usual care behavioral intervention for weight control.
arm group label: Education plus behavioral Rx
arm group type: Active Comparator
description: Health education plus a usual care behavioral intervention for weight control
intervention type: Behavioral
intervention name: Wise interventions -- values self-affirmation and growth mindset -- plus usual care behavioral treatment
description: Addition of two wise wise social psychological interventions-growth mindset and self-affirmation-to a 6-month usual care behavioral intervention for weight control in children with obesity
arm group label: Wise interventions plus behavioral Rx
intervention type: Behavioral
intervention name: Education plus usual care behavioral treatment
description: 6-month health education plus usual care behavioral intervention for weight control in children with obesity
arm group label: Education plus behavioral Rx
criteria: 
gender: All
minimum age: 10 Years
maximum age: 16 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Thomas Robinson, MD, MPH
role: Principal Investigator
affiliation: Stanford University
last name: Thomas Robinson, MD, MPH
phone: 650-723-5895
email: tom.robinson@stanford.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Thomas Robinson
investigator title: Professor
mesh term: Obesity
mesh term: Pediatric Obesity
sharing ipd: Yes
ipd description: Data sharing will be based on the policy for data sharing issued by the NIH and consistent with HIPAA privacy standards. Our data management team will prepare de-identified public use data set from this study for deposition in a repository.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Limited access data will be shared within six months of the publication date for the primary outcome publication or within two years of the date that the database is locked for analysis, whichever occurs first.
ipd access criteria: User registration will be required. Users must agree to the conditions of use governing access to the public release data (a data use agreement), including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource.
submitted: August 16, 2023
returned: September 6, 2023
submitted: September 7, 2023