<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/NCT03783390</url>
  </required_header>
  <id_info>
    <org_study_id>00000096</org_study_id>
    <nct_id>NCT03783390</nct_id>
  </id_info>
  <brief_title>Brain, Appetite, Teens, and Exercise</brief_title>
  <acronym>BATE</acronym>
  <official_title>Brain, Activity, Teens, and Exercise (BATE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Mercy Hospital Kansas City</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Kansas Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Mercy Hospital Kansas City</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 long-term goal is to develop effective, evidence-based lifestyle interventions to prevent&#xD;
      and treat childhood obesity and related co-morbidities. The short-term goal, and the purpose&#xD;
      of this application, is to quantify appetite and neural mechanisms of food reward in&#xD;
      overweight/obese (OW/OB) sedentary youth and to quantify changes following the implementation&#xD;
      of a physical activity intervention. The central hypothesis is that appetite becomes&#xD;
      dysregulated at low levels of physical activity via neural reward pathways, and appetite&#xD;
      control will improve following a long-term exercise intervention. The investigators consider&#xD;
      this project a pilot study designed to generate data to be used for future external funding&#xD;
      opportunities, demonstrate collaboration between researchers, and test the feasibility of the&#xD;
      protocols.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specific Aim 1: To identify associations between neural, psychological, and hormonal appetite&#xD;
      control pathways using subjective and objective measures of appetite and neurocognitive&#xD;
      assessments of reward pre-intervention.&#xD;
&#xD;
      Hypothesis 1: There will be significant cross-modulation of appetite across neural (brain&#xD;
      activation), psychological (subjective hunger), and hormonal pathways (satiety biomarkers),&#xD;
      though the temporal relationship between each in response to feeding is unknown.&#xD;
&#xD;
      Specific Aim 2: To assess the effectiveness of a physical activity intervention on eating&#xD;
      behavior in adolescents; OW/OB inactive adolescents will be randomly assigned to a 3-month&#xD;
      exercise intervention (Exercise +Newsletter), or a control condition (Newsletter).&#xD;
&#xD;
      Hypothesis 2a: Those exposed to the exercise intervention will have greater improvements&#xD;
      (compared to control group) in appetite (subjective self-reported hunger and palatability&#xD;
      responses, and, objectively, satiety and appetite hormones glucose, insulin, ghrelin, and&#xD;
      leptin, and calories consumed during ad libitum meal).&#xD;
&#xD;
      Hypothesis 2B. Compared to pre-intervention, OB/OW youth in the exercise group will show&#xD;
      decreased reward activation in regions of the brain when making decisions about appetizing&#xD;
      foods compared to post-intervention when hungry and when fed. In self-control regions,&#xD;
      compared to pre-intervention, the investigators will observe increased activity in both&#xD;
      hungry and fed conditions.&#xD;
&#xD;
      At the end of the proposed study, it is the expectation that the investigators will have&#xD;
      collected important preliminary data regarding how long-term structured exercise acts upon&#xD;
      appetite and neural mechanisms related to food reward in adolescents. Findings are key not&#xD;
      only to interventions targeting OW/OB youth, but also to public policy and health&#xD;
      recommendations for the importance of physical activity in children.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Actual">August 10, 2019</completion_date>
  <primary_completion_date type="Actual">August 10, 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>
    <intervention_model_description>To assess the effectiveness of a physical activity intervention on eating behavior in adolescents; OW/OB inactive adolescents will be randomly assigned to a 3-month exercise intervention (Exercise +Newsletter), or a control condition (Newsletter).</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assess the effectiveness of a physical activity intervention on eating behavior- subjective responses</measure>
    <time_frame>12 monthts</time_frame>
    <description>To assess the effectiveness of a physical activity intervention on eating behavior in adolescents; OW/OB inactive adolescents will be randomly assigned to a 3-month exercise intervention (Exercise +Newsletter), or a control condition (Newsletter).&#xD;
Those exposed to the exercise intervention will have greater improvements (compared to control group) in appetite (subjective self-reported hunger responses).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess changes in structural and functional MRI in response to an exercise intervention- prefrontal and hippocampal volume</measure>
    <time_frame>12 months</time_frame>
    <description>Assess changes in structural and functional MRI pre- to post- intervention in sedentary youth at risk for type 2 diabetes.&#xD;
Youth randomized to the exercise intervention will exhibit increases in prefrontal and hippocampal volume compared to controls.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess changes in structural and functional MRI in response to an exercise intervention- reward and control</measure>
    <time_frame>12 months</time_frame>
    <description>Assess changes in structural and functional MRI pre- to post- intervention in sedentary youth at risk for type 2 diabetes.&#xD;
Compared to pre-intervention, youth in the exercise group will show de-creased activation in reward regions (orbitofrontal cortex, ventral striatum) when making food/activity choices; increased activation in control regions (dorsolateral PFC, inferior frontal gyrus) during food/activity choices.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the effectiveness of a physical activity intervention on eating behavior- subjective responses</measure>
    <time_frame>12 monthts</time_frame>
    <description>To assess the effectiveness of a physical activity intervention on eating behavior in adolescents; OW/OB inactive adolescents will be randomly assigned to a 3-month exercise intervention (Exercise +Newsletter), or a control condition (Newsletter).&#xD;
Those exposed to the exercise intervention will have greater improvements (compared to control group) in appetite (subjective self-reported hunger responses).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the effectiveness of a physical activity intervention on eating behavior- biological responses</measure>
    <time_frame>12 monthts</time_frame>
    <description>To assess the effectiveness of a physical activity intervention on eating behavior in adolescents; OW/OB inactive adolescents will be randomly assigned to a 3-month exercise intervention (Exercise +Newsletter), or a control condition (Newsletter).&#xD;
Those exposed to the exercise intervention will have greater improvements (compared to control group) in appetite hormones ghrelin, and leptin.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Energy Balance</condition>
  <condition>Appetitive Behavior</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Orientation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Informed consent, height, weight, and blood pressure measurement. A link to an online survey the participant and their parent can fill out at home about the participant's medical history will be given.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Measurement session Pre/Post Intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Questionnaires completed, blood draws, and fixed and ad lib meals completed to measure appetite and hormones. DXA completed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Home Assessments Pre/Post intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>24-hour dietary recalls. Physical activity measured by monitors (Actigraph, ActivPAL).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physical Activity Session Pre/Post intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>DXA, and Fitness testing to measure VO2submax and VO2max. Cognitive assessments will be administered.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>fMRI Session Pre/Post intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The participant will have an fMRI completed and answer questions related to 60 food and activity images while in and out of the fMRI machine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise Intervention/Newsletter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After completion of the initial fMRI session the participant will be randomly assigned to intervention for 3 months and then complete another round of assessments described as above (except for the orientation session).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise Intervention</intervention_name>
    <description>Youth randomized to the active condition will participate in an organized exercise program. During the exercise program, adolescents will participate in a supervised structured exercise (treadmill walking/cycling on stationary bike) on 3 days equivalent to approximately 180 min/week of moderate-intensity exercise. The rationale for this dose of structured exercise is based on national (ADA) and international physical activity recommendations for youth of 60 minutes/day.</description>
    <arm_group_label>Exercise Intervention/Newsletter</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Newsletter</intervention_name>
    <description>Families will receive a monthly newsletter with &quot;parenting tips, sample praise statements, and child-appropriate activities and recipes&quot; identical to what has been used in the work of leaders in the field of pediatric obesity. Previous research suggests that newsletter/mail interventions are well received by participants and are frequently included in federally funded health intervention studies.</description>
    <arm_group_label>Exercise Intervention/Newsletter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Overweight/obese (BMI ≥85th to &lt;99th percentile for age and sex)&#xD;
&#xD;
          -  Weight stable&#xD;
&#xD;
          -  Ages 14-17&#xD;
&#xD;
          -  No meds that may alter metabolism&#xD;
&#xD;
          -  Sedentary (&lt;20 min/day exercise)&#xD;
&#xD;
          -  At risk for T2D, according to American Diabetes Association (ADA) criteria:&#xD;
&#xD;
               -  family history of T2D in first- or second- degree relative&#xD;
&#xD;
               -  Race/ethnicity (Native American, African American, Latino, Asian American,&#xD;
                  Pacific Islander)&#xD;
&#xD;
               -  Signs of insulin resistance&#xD;
&#xD;
               -  Maternal history of diabetes for gestational diabetes during child's gestation&#xD;
&#xD;
          -  Willing to participate in an exercise program&#xD;
&#xD;
          -  Willing to provide permission/assent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI &lt;85th percentile for age and sex&#xD;
&#xD;
          -  Weight not stable&#xD;
&#xD;
          -  Age &lt;14 or &gt;17&#xD;
&#xD;
          -  On meds that may alter metabolism&#xD;
&#xD;
          -  Active (&gt;20 min/day exercise)&#xD;
&#xD;
          -  Not at risk for T2D, according to American Diabetes Association (ADA) criteria (see&#xD;
             above)&#xD;
&#xD;
          -  Not willing to participate in an exercise program&#xD;
&#xD;
          -  Not willing to provide permission/assent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robin Shook, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research Faculty PhD</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Mercy Kansas City</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>July 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>May 12, 2020</last_update_submitted>
  <last_update_submitted_qc>May 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Children's Mercy Hospital Kansas City</investigator_affiliation>
    <investigator_full_name>Robin Shook</investigator_full_name>
    <investigator_title>Research Faculty PhD</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data will be kept private.</ipd_description>
  </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/NCT03783390
org study id: 00000096
nct id: NCT03783390
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The long-term goal is to develop effective, evidence-based lifestyle interventions to prevent
      and treat childhood obesity and related co-morbidities. The short-term goal, and the purpose
      of this application, is to quantify appetite and neural mechanisms of food reward in
      overweight/obese (OW/OB) sedentary youth and to quantify changes following the implementation
      of a physical activity intervention. The central hypothesis is that appetite becomes
      dysregulated at low levels of physical activity via neural reward pathways, and appetite
      control will improve following a long-term exercise intervention. The investigators consider
      this project a pilot study designed to generate data to be used for future external funding
      opportunities, demonstrate collaboration between researchers, and test the feasibility of the
      protocols.
Specific Aim 1: To identify associations between neural, psychological, and hormonal appetite
      control pathways using subjective and objective measures of appetite and neurocognitive
      assessments of reward pre-intervention.

      Hypothesis 1: There will be significant cross-modulation of appetite across neural (brain
      activation), psychological (subjective hunger), and hormonal pathways (satiety biomarkers),
      though the temporal relationship between each in response to feeding is unknown.

      Specific Aim 2: To assess the effectiveness of a physical activity intervention on eating
      behavior in adolescents; OW/OB inactive adolescents will be randomly assigned to a 3-month
      exercise intervention (Exercise +Newsletter), or a control condition (Newsletter).

      Hypothesis 2a: Those exposed to the exercise intervention will have greater improvements
      (compared to control group) in appetite (subjective self-reported hunger and palatability
      responses, and, objectively, satiety and appetite hormones glucose, insulin, ghrelin, and
      leptin, and calories consumed during ad libitum meal).

      Hypothesis 2B. Compared to pre-intervention, OB/OW youth in the exercise group will show
      decreased reward activation in regions of the brain when making decisions about appetizing
      foods compared to post-intervention when hungry and when fed. In self-control regions,
      compared to pre-intervention, the investigators will observe increased activity in both
      hungry and fed conditions.

      At the end of the proposed study, it is the expectation that the investigators will have
      collected important preliminary data regarding how long-term structured exercise acts upon
      appetite and neural mechanisms related to food reward in adolescents. Findings are key not
      only to interventions targeting OW/OB youth, but also to public policy and health
      recommendations for the importance of physical activity in children.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: To assess the effectiveness of a physical activity intervention on eating behavior in adolescents; OW/OB inactive adolescents will be randomly assigned to a 3-month exercise intervention (Exercise +Newsletter), or a control condition (Newsletter).
primary purpose: Health Services Research
masking: None (Open Label)
measure: Assess the effectiveness of a physical activity intervention on eating behavior- subjective responses
time frame: 12 monthts
description: To assess the effectiveness of a physical activity intervention on eating behavior in adolescents; OW/OB inactive adolescents will be randomly assigned to a 3-month exercise intervention (Exercise +Newsletter), or a control condition (Newsletter).
Those exposed to the exercise intervention will have greater improvements (compared to control group) in appetite (subjective self-reported hunger responses).
measure: Assess changes in structural and functional MRI in response to an exercise intervention- prefrontal and hippocampal volume
time frame: 12 months
description: Assess changes in structural and functional MRI pre- to post- intervention in sedentary youth at risk for type 2 diabetes.
Youth randomized to the exercise intervention will exhibit increases in prefrontal and hippocampal volume compared to controls.
measure: Assess changes in structural and functional MRI in response to an exercise intervention- reward and control
time frame: 12 months
description: Assess changes in structural and functional MRI pre- to post- intervention in sedentary youth at risk for type 2 diabetes.
Compared to pre-intervention, youth in the exercise group will show de-creased activation in reward regions (orbitofrontal cortex, ventral striatum) when making food/activity choices; increased activation in control regions (dorsolateral PFC, inferior frontal gyrus) during food/activity choices.
measure: Assess the effectiveness of a physical activity intervention on eating behavior- subjective responses
time frame: 12 monthts
description: To assess the effectiveness of a physical activity intervention on eating behavior in adolescents; OW/OB inactive adolescents will be randomly assigned to a 3-month exercise intervention (Exercise +Newsletter), or a control condition (Newsletter).
Those exposed to the exercise intervention will have greater improvements (compared to control group) in appetite (subjective self-reported hunger responses).
measure: Assess the effectiveness of a physical activity intervention on eating behavior- biological responses
time frame: 12 monthts
description: To assess the effectiveness of a physical activity intervention on eating behavior in adolescents; OW/OB inactive adolescents will be randomly assigned to a 3-month exercise intervention (Exercise +Newsletter), or a control condition (Newsletter).
Those exposed to the exercise intervention will have greater improvements (compared to control group) in appetite hormones ghrelin, and leptin.
arm group label: Orientation
arm group type: No Intervention
description: Informed consent, height, weight, and blood pressure measurement. A link to an online survey the participant and their parent can fill out at home about the participant's medical history will be given.
arm group label: Measurement session Pre/Post Intervention
arm group type: No Intervention
description: Questionnaires completed, blood draws, and fixed and ad lib meals completed to measure appetite and hormones. DXA completed.
arm group label: Home Assessments Pre/Post intervention
arm group type: No Intervention
description: 24-hour dietary recalls. Physical activity measured by monitors (Actigraph, ActivPAL).
arm group label: Physical Activity Session Pre/Post intervention
arm group type: No Intervention
description: DXA, and Fitness testing to measure VO2submax and VO2max. Cognitive assessments will be administered.
arm group label: fMRI Session Pre/Post intervention
arm group type: No Intervention
description: The participant will have an fMRI completed and answer questions related to 60 food and activity images while in and out of the fMRI machine.
arm group label: Exercise Intervention/Newsletter
arm group type: Experimental
description: After completion of the initial fMRI session the participant will be randomly assigned to intervention for 3 months and then complete another round of assessments described as above (except for the orientation session).
intervention type: Behavioral
intervention name: Exercise Intervention
description: Youth randomized to the active condition will participate in an organized exercise program. During the exercise program, adolescents will participate in a supervised structured exercise (treadmill walking/cycling on stationary bike) on 3 days equivalent to approximately 180 min/week of moderate-intensity exercise. The rationale for this dose of structured exercise is based on national (ADA) and international physical activity recommendations for youth of 60 minutes/day.
arm group label: Exercise Intervention/Newsletter
intervention type: Behavioral
intervention name: Newsletter
description: Families will receive a monthly newsletter with "parenting tips, sample praise statements, and child-appropriate activities and recipes" identical to what has been used in the work of leaders in the field of pediatric obesity. Previous research suggests that newsletter/mail interventions are well received by participants and are frequently included in federally funded health intervention studies.
arm group label: Exercise Intervention/Newsletter
criteria: 
gender: All
minimum age: 14 Years
maximum age: 17 Years
healthy volunteers: No
last name: Robin Shook, PhD
role: Principal Investigator
affiliation: Research Faculty PhD
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Children's Mercy Hospital Kansas City
investigator full name: Robin Shook
investigator title: Research Faculty PhD
sharing ipd: No
ipd description: Data will be kept private.