<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/NCT03254576</url>
  </required_header>
  <id_info>
    <org_study_id>161468</org_study_id>
    <secondary_id>R01DK111106</secondary_id>
    <nct_id>NCT03254576</nct_id>
  </id_info>
  <brief_title>Cue-Reward Learning and Weight Gain in Youth</brief_title>
  <acronym>ChildLearn</acronym>
  <official_title>Cue-Reward Learning and Weight Gain in Youth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Diego</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>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Diego</source>
  <oversight_info>
    <has_dmc>Yes</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 objective of the study is to compare children at low risk for obesity (two healthy weight&#xD;
      parents) to children at high risk for obesity (two overweight parents) in their response rate&#xD;
      to food taste and in their rate of learning using fMRI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary aim of this project is to conduct an adequately powered study that compares&#xD;
      children at low risk for obesity to children at high risk for obesity on their brain&#xD;
      responses to food tastes during a pavlovian learning task. Seven assessment visits will be&#xD;
      conducted at three separate time points; baseline, 1-year follow up, and 2-year follow up.&#xD;
      Assessments will include anthropometry, interviews, computer tasks, questionnaires, and an&#xD;
      fMRI scan. This program of research tests a novel hypothesis regarding overeating and the&#xD;
      development of obesity in children, and could provide critical data on individual&#xD;
      vulnerabilities to overeating for further research. Furthermore, this study could provide&#xD;
      mechanisms for intervention with regards to cue-reward learning in children, to ultimately&#xD;
      prevent obesity in youth.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cue-reward learning</measure>
    <time_frame>Baseline only</time_frame>
    <description>Whether rate of the shift in BOLD response from food cue to neutral cue is different between high and low-risk children</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reward Sensitivity</measure>
    <time_frame>Baseline only</time_frame>
    <description>Whether the BOLD response to food cue differs between high and low-risk children</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Weight gain</measure>
    <time_frame>Change from baseline at an average of 12 months and 24 months</time_frame>
    <description>Whether rate of cue reward and reward sensitivity predict weight gain</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">147</enrollment>
  <condition>Overweight</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Children at high-risk for obesity</arm_group_label>
    <description>Healthy-weight children (5th-75thBMI%) with two overweight/obese parents (BMI&gt;25)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Children at low-risk for obesity</arm_group_label>
    <description>Healthy-weight children (5th-75thBMI%) with two healthy-weight parents (BMI = 18-24.9)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Functional MRI</intervention_name>
    <arm_group_label>Children at high-risk for obesity</arm_group_label>
    <arm_group_label>Children at low-risk for obesity</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy-weight children (5-75thBMI%) between the ages of 8 and 11 years old with either two&#xD;
        over-weight parents (BMI&gt;25) or two healthy-weight parents (BMI = 18-24.9)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy weight children between the ages of 8 and 11 Years&#xD;
&#xD;
          -  BMI 5-75th percentile&#xD;
&#xD;
          -  Child must be right-handed&#xD;
&#xD;
          -  Child must be willing to participate in an fMRI scan&#xD;
&#xD;
          -  Either two biological parents who are overweight/obese or no biological parents that&#xD;
             are overweight/obese&#xD;
&#xD;
          -  One biological parent willing to bring child to assessment visits&#xD;
&#xD;
          -  Child and participating parent Fluent in English for speaking, reading, and writing&#xD;
&#xD;
          -  Child must like cheese pizza and chocolate milkshake&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child overweight (BMI≥85th percentile)&#xD;
&#xD;
          -  Child diagnoses of a serious chronic physical disease (e.g., diabetes) for which&#xD;
             physician supervision of diet and exercise prescription are needed&#xD;
&#xD;
          -  Child who is taking medications that may impact brain responses (can take kids who are&#xD;
             stable on meds)&#xD;
&#xD;
          -  Child with MRI contraindications (presence of metallic foreign object or device in&#xD;
             body, piercings that cannot be removed, tattooed permanent makeup that contain metal,&#xD;
             braces, head trauma, claustrophobia, use of Bigen permanent hair dye)&#xD;
&#xD;
          -  Child with an active eating disorder (reported on EDE interview) or with first degree&#xD;
             relative with Anorexia Nervosa or Bulimia Nervosa&#xD;
&#xD;
          -  Cognitive impairment or disability determined through parent and child self-report&#xD;
             measures, and parent reported child individual education plan&#xD;
&#xD;
          -  Vision problems uncorrectable with lenses&#xD;
&#xD;
          -  Food allergies related to cheese pizza, chocolate milkshake, or the snack foods used&#xD;
             in the study&#xD;
&#xD;
          -  Menarche in female participants at time of enrollment&#xD;
&#xD;
          -  Children scoring within the midpubertal range or higher based on the Pubertal&#xD;
             Development Scale&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kerri Boutelle, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCSD</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCSD Center for Healthy Eating and Activity Research (CHEAR)</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>
  <reference>
    <citation>Boutelle KN, Wierenga CE, Bischoff-Grethe A, Melrose AJ, Grenesko-Stevens E, Paulus MP, Kaye WH. Increased brain response to appetitive tastes in the insula and amygdala in obese compared with healthy weight children when sated. Int J Obes (Lond). 2015 Apr;39(4):620-8. doi: 10.1038/ijo.2014.206. Epub 2014 Dec 11.</citation>
    <PMID>25582522</PMID>
  </reference>
  <reference>
    <citation>Mestre ZL, Bischoff-Grethe A, Eichen DM, Wierenga CE, Strong D, Boutelle KN. Hippocampal atrophy and altered brain responses to pleasant tastes among obese compared with healthy weight children. Int J Obes (Lond). 2017 Oct;41(10):1496-1502. doi: 10.1038/ijo.2017.130. Epub 2017 Jun 2.</citation>
    <PMID>28572588</PMID>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>August 2, 2023</last_update_submitted>
  <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2023</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>Kerri Boutelle</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Overweight</keyword>
  <keyword>Obesity</keyword>
  <keyword>Body Mass Index</keyword>
  <keyword>Weight</keyword>
  <keyword>Brain imaging</keyword>
  <keyword>Child</keyword>
  <keyword>Learning</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Weight Gain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03254576
org study id: 161468
secondary id: R01DK111106
nct id: NCT03254576
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of the study is to compare children at low risk for obesity (two healthy weight
      parents) to children at high risk for obesity (two overweight parents) in their response rate
      to food taste and in their rate of learning using fMRI.
The primary aim of this project is to conduct an adequately powered study that compares
      children at low risk for obesity to children at high risk for obesity on their brain
      responses to food tastes during a pavlovian learning task. Seven assessment visits will be
      conducted at three separate time points; baseline, 1-year follow up, and 2-year follow up.
      Assessments will include anthropometry, interviews, computer tasks, questionnaires, and an
      fMRI scan. This program of research tests a novel hypothesis regarding overeating and the
      development of obesity in children, and could provide critical data on individual
      vulnerabilities to overeating for further research. Furthermore, this study could provide
      mechanisms for intervention with regards to cue-reward learning in children, to ultimately
      prevent obesity in youth.
observational model: Cohort
time perspective: Prospective
measure: Cue-reward learning
time frame: Baseline only
description: Whether rate of the shift in BOLD response from food cue to neutral cue is different between high and low-risk children
measure: Reward Sensitivity
time frame: Baseline only
description: Whether the BOLD response to food cue differs between high and low-risk children
measure: Weight gain
time frame: Change from baseline at an average of 12 months and 24 months
description: Whether rate of cue reward and reward sensitivity predict weight gain
arm group label: Children at high-risk for obesity
description: Healthy-weight children (5th-75thBMI%) with two overweight/obese parents (BMI>25)
arm group label: Children at low-risk for obesity
description: Healthy-weight children (5th-75thBMI%) with two healthy-weight parents (BMI = 18-24.9)
intervention type: Other
intervention name: Functional MRI
arm group label: Children at high-risk for obesity
arm group label: Children at low-risk for obesity
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 8 Years
maximum age: 11 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kerri Boutelle, Ph.D.
role: Principal Investigator
affiliation: UCSD
facility: 
country: United States
citation: Boutelle KN, Wierenga CE, Bischoff-Grethe A, Melrose AJ, Grenesko-Stevens E, Paulus MP, Kaye WH. Increased brain response to appetitive tastes in the insula and amygdala in obese compared with healthy weight children when sated. Int J Obes (Lond). 2015 Apr;39(4):620-8. doi: 10.1038/ijo.2014.206. Epub 2014 Dec 11.
PMID: 25582522
citation: Mestre ZL, Bischoff-Grethe A, Eichen DM, Wierenga CE, Strong D, Boutelle KN. Hippocampal atrophy and altered brain responses to pleasant tastes among obese compared with healthy weight children. Int J Obes (Lond). 2017 Oct;41(10):1496-1502. doi: 10.1038/ijo.2017.130. Epub 2017 Jun 2.
PMID: 28572588
responsible party type: Principal Investigator
investigator affiliation: University of California, San Diego
investigator full name: Kerri Boutelle
investigator title: Professor
mesh term: Overweight
mesh term: Weight Gain
sharing ipd: Undecided