<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/NCT02229552</url>
  </required_header>
  <id_info>
    <org_study_id>1102924-1-61250</org_study_id>
    <nct_id>NCT02229552</nct_id>
  </id_info>
  <brief_title>Habituation to Food as a Risk Factor for Pediatric Obesity</brief_title>
  <official_title>Habituation to Food as a Risk Factor for Pediatric Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>State University of New York at Buffalo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>State University of New York at Buffalo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is designed to assess habituation of behavioral responding for food as risk factors&#xD;
      for increases in Standardized Body Mass Index (zBMI) over two years in non-overweight&#xD;
      children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cross sectional data have shown slower habituation is related to greater energy intake, and&#xD;
      habituation is slower for overweight/obese compared to leaner youth, but it is not known&#xD;
      whether this is a result of being overweight, or whether slower habituation is a risk factor&#xD;
      for weight gain. The goal of this application is to study individual differences in&#xD;
      behavioral (responding for food) habituation as risk factors for alterations in zBMI and body&#xD;
      fat over a two year period in 200, 8 to 12 year-old non-overweight children. This project&#xD;
      will provide the first test of the hypothesis that slow habituation to food is a risk factor&#xD;
      for increases in zBMI in non-overweight youth.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Children completed measurements of body weight, habituation to food, questionnaires and cognitive assessments in a repeated assessment prospective study.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in zBMI</measure>
    <time_frame>2 years</time_frame>
    <description>To assess the rate of habituation of behavioral responding to savory, sweet and salty foods as independent or interactive risk factors for zBMI trajectories, with the hypothesis that the rate of habituation of behavioral responding for food predicts zBMI trajectories over time, controlling for child gender, parental education, parental BMI, physical activity, ethnicity, the reinforcing value of food and eating in the absence of hunger.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">237</enrollment>
  <condition>Obesity in Children</condition>
  <arm_group>
    <arm_group_label>Baseline Cohort</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Children completed body weight and other measures at baseline, 1-year follow up and 2-year follow up measurement periods.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standardized Assessments</intervention_name>
    <description>Children were asked to attend appointments without consuming study foods 24 hours previously, as habituation measurements are sensitive to recent consumption. Children were provided access to snack prior to completing questionnaires or cognitive assessments. Habituation to food, questionnaires and cognitive assessments were re-measured at 1-year and 2-year follow up.</description>
    <arm_group_label>Baseline Cohort</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  8-12 years of age&#xD;
&#xD;
          -  Participants will include children who are at the 50th BMI percentile and less than&#xD;
             the 85th BMI percentile (BMI = kg/m2) at baseline. We will also include children who&#xD;
             are below the 50th percentile, but have at least one biological parent with a current&#xD;
             BMI ≥ 25 kg/m2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Food allergies or special diets: Youth should have no dietary restrictions that could&#xD;
             interfere with these experiments, including food allergies or religious or ethnic&#xD;
             practices that limit food choice or medical conditions which alter nutritional status&#xD;
             or intestinal absorption (e.g. inflammatory bowel disease).&#xD;
&#xD;
          -  Activity restrictions: Children who have activity restrictions due to medical or&#xD;
             physical problems, such as uncontrolled exercise induced asthma or a disability&#xD;
             requiring wheelchair use will not participate.&#xD;
&#xD;
          -  Psychopathology, medications or sickness: Children should have no psychopathology&#xD;
             (e.g. childhood schizophrenia) or developmental disabilities that would limit&#xD;
             participation. Children will also be excluded if they are taking medications that&#xD;
             could affect their level of activity or appetite (e.g. methylphenidate).&#xD;
&#xD;
          -  Moderate or greater liking of study foods. Children must report at least a moderate&#xD;
             liking ( 3 or greater on a 5-point Likert-type scale) of the foods used in these&#xD;
             studies and be willing to consume them.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leonard Epstein, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University at Buffalo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University at Buffalo</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://medicine.buffalo.edu/departments/pediatrics/divisions/behavioral-medicine.html</url>
    <description>UB Division of Behavioral Medicine Website</description>
  </link>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <results_first_submitted>June 24, 2019</results_first_submitted>
  <results_first_submitted_qc>October 1, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 26, 2020</results_first_posted>
  <last_update_submitted>October 1, 2020</last_update_submitted>
  <last_update_submitted_qc>October 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>State University of New York at Buffalo</investigator_affiliation>
    <investigator_full_name>Leonard Epstein</investigator_full_name>
    <investigator_title>Principal Investigator</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>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Baseline Cohort</title>
          <description>All children completed the same baseline measures</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Baseline</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="237"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="231"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>1-year Follow up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="231"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="206"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>2-Year Follow up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="231">All baseline participants were eligible for year 2 follow up, regardless of completion of year 1.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="205"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Baseline Cohort</title>
          <description>All children completed measures of habituation to food, questionnaires and cognitive assessments at baseline and 1-year and 2-year follow up periods.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="231"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10.45" spread="1.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="120"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="215"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="170"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>Centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="142.89" spread="11.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>pounds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="78.33" spread="18.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17.15" spread="1.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Composition</title>
          <units>Percent body fat</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.52" spread="5.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>zBMI</title>
          <description>The BMI Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean, based on age and sex. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. A lower z-score indicates less obesity, with numbers between -1.0 and +1.0 indicating normal weight and numbers greater than 1.0 indicating an overweight status.</description>
          <units>z-score BMI</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="-0.039" spread="0.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in zBMI</title>
        <description>To assess the rate of habituation of behavioral responding to savory, sweet and salty foods as independent or interactive risk factors for zBMI trajectories, with the hypothesis that the rate of habituation of behavioral responding for food predicts zBMI trajectories over time, controlling for child gender, parental education, parental BMI, physical activity, ethnicity, the reinforcing value of food and eating in the absence of hunger.</description>
        <time_frame>2 years</time_frame>
        <population>205 children completed baseline, year one height and weight measures and year two follow up height and weight measures</population>
        <group_list>
          <group group_id="O1">
            <title>Baseline Cohort</title>
            <description>All children completed the same baseline measures</description>
          </group>
        </group_list>
        <measure>
          <title>Change in zBMI</title>
          <description>To assess the rate of habituation of behavioral responding to savory, sweet and salty foods as independent or interactive risk factors for zBMI trajectories, with the hypothesis that the rate of habituation of behavioral responding for food predicts zBMI trajectories over time, controlling for child gender, parental education, parental BMI, physical activity, ethnicity, the reinforcing value of food and eating in the absence of hunger.</description>
          <population>205 children completed baseline, year one height and weight measures and year two follow up height and weight measures</population>
          <units>z-score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="205"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Measures</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.048" spread="0.744"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1-year follow up measures</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.013" spread="0.759"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2-year follow up measures</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.011" spread="0.807"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Repeated measures analysis of variance with zbmi for each year as the repeated dependent measure.</non_inferiority_desc>
            <p_value>0.051</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>3.00</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 years</time_frame>
      <desc>Only participation-related adverse events were collected.</desc>
      <group_list>
        <group group_id="E1">
          <title>Baseline Cohort</title>
          <description>All children completed the same baseline measures</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="237"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="237"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="237"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Leonard H Epstein</name_or_title>
      <organization>SUNY Buffalo</organization>
      <phone>716-826-3400</phone>
      <email>ckk@buffalo.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02229552
org study id: 1102924-1-61250
nct id: NCT02229552
lead sponsor: 
has dmc: Yes
The study is designed to assess habituation of behavioral responding for food as risk factors
      for increases in Standardized Body Mass Index (zBMI) over two years in non-overweight
      children.
Cross sectional data have shown slower habituation is related to greater energy intake, and
      habituation is slower for overweight/obese compared to leaner youth, but it is not known
      whether this is a result of being overweight, or whether slower habituation is a risk factor
      for weight gain. The goal of this application is to study individual differences in
      behavioral (responding for food) habituation as risk factors for alterations in zBMI and body
      fat over a two year period in 200, 8 to 12 year-old non-overweight children. This project
      will provide the first test of the hypothesis that slow habituation to food is a risk factor
      for increases in zBMI in non-overweight youth.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Children completed measurements of body weight, habituation to food, questionnaires and cognitive assessments in a repeated assessment prospective study.
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in zBMI
time frame: 2 years
description: To assess the rate of habituation of behavioral responding to savory, sweet and salty foods as independent or interactive risk factors for zBMI trajectories, with the hypothesis that the rate of habituation of behavioral responding for food predicts zBMI trajectories over time, controlling for child gender, parental education, parental BMI, physical activity, ethnicity, the reinforcing value of food and eating in the absence of hunger.
arm group label: Baseline Cohort
arm group type: Other
description: Children completed body weight and other measures at baseline, 1-year follow up and 2-year follow up measurement periods.
intervention type: Other
intervention name: Standardized Assessments
description: Children were asked to attend appointments without consuming study foods 24 hours previously, as habituation measurements are sensitive to recent consumption. Children were provided access to snack prior to completing questionnaires or cognitive assessments. Habituation to food, questionnaires and cognitive assessments were re-measured at 1-year and 2-year follow up.
arm group label: Baseline Cohort
criteria: 
gender: All
minimum age: 8 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Leonard Epstein, Ph.D.
role: Principal Investigator
affiliation: University at Buffalo
facility: 
country: United States
url: http://medicine.buffalo.edu/departments/pediatrics/divisions/behavioral-medicine.html
description: UB Division of Behavioral Medicine Website
responsible party type: Principal Investigator
investigator affiliation: State University of New York at Buffalo
investigator full name: Leonard Epstein
investigator title: Principal Investigator
mesh term: Obesity
mesh term: Pediatric Obesity
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 