<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/NCT02265185</url>
  </required_header>
  <id_info>
    <org_study_id>1409-091</org_study_id>
    <nct_id>NCT02265185</nct_id>
  </id_info>
  <brief_title>Measuring the Weight Status, Primary Care Usage and Dietary Intake in the Pediatric Emergency Department</brief_title>
  <official_title>Measuring the Weight Status, Primary Care Usage and Dietary Intake in the Pediatric Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospitals and Clinics of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospitals and Clinics of Minnesota</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Childhood obesity is a major area of concern for health care and public health. Overweight&#xD;
      children are more likely overweight and obese adults. Chronic health problems associated with&#xD;
      adult obesity are now occurring more frequently in children. Because of the associated health&#xD;
      problems and potential for long term struggles with obesity, intervention early in life is&#xD;
      essential for addressing the obesity epidemic. Some intervention work in this area has&#xD;
      focused on the pediatric primary care setting in order to utilize the influence and&#xD;
      credibility of medical providers. Unfortunately, primary care visits are often too short to&#xD;
      spend a significant amount of time on issues of diet, weight and nutrition.&#xD;
&#xD;
      There has been very little work exploring the potential of alternative care settings, such as&#xD;
      the pediatric Emergency Department (ED) in addressing childhood obesity. While provider time&#xD;
      is also limited in the ED, there is often a considerable amount of downtime during emergency&#xD;
      department visits that could be valuable time for patient and parent education. There may&#xD;
      also be an opportunity to reach parents and children in the ED who do not regularly utilize&#xD;
      primary care. In order to explore the possibility of pediatric obesity interventions in&#xD;
      Children's Pediatric Emergency Department, we will need to measure the prevalence of obesity&#xD;
      in the population that utilizes the Children's ED. The height of patients seen in the ED is&#xD;
      not routinely measured, which makes calculating BMI to determine obesity impossible. This&#xD;
      study, establishing the prevalence of obesity in Children's Emergency Department will lay the&#xD;
      groundwork for future work addressing obesity in the ED.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background/Significance Childhood obesity is a well-documented public health crisis. Data&#xD;
      from the most recent National Health and Nutrition Examination survey (NHANES) indicate that&#xD;
      the prevalence of obesity is 8.4% in 2 to 5-year-olds, 17.7% in 6 to 11-year-olds, and 20.5%&#xD;
      in 12 to 19-year-olds (1). Large racial/ethnic disparities in risk for obesity are already&#xD;
      present by the preschool years (2). In 2 to 5-year-olds, 3.5% of non-Hispanic white children&#xD;
      are obese, compared to 11.3% of non-Hispanic black and 16.7% of Hispanic children (1). Many&#xD;
      health problems that were previously associated only with adult obesity are now being seen in&#xD;
      youth, including the metabolic syndrome, type 2 diabetes, and cardiovascular abnormalities&#xD;
      (3). Obesity tracks into adulthood, highlighting the need for early intervention (4).&#xD;
      Overweight children have more chronic conditions, a greater risk of emergency department&#xD;
      visits, and significantly higher costs for common pediatric hospitalizations (5-7).&#xD;
      Successfully addressing the childhood obesity epidemic will require coordinated and&#xD;
      collective efforts across many settings including multiple healthcare settings (8). Obesity&#xD;
      interventions are increasingly being developed that utilize the influential role and&#xD;
      credibility of pediatric primary care providers by integrating interventions into healthcare&#xD;
      settings (9). Unfortunately, primary care visits are often short (average primary visit is&#xD;
      16.4 minutes) and leave little time for addressing obesity in detail, highlighting the need&#xD;
      to also incorporate assessment and treatment in alternative care settings (i.e., emergency&#xD;
      care) (10, 11).&#xD;
&#xD;
      There is little research on what role alternative healthcare setting could play in addressing&#xD;
      childhood obesity. The pediatric ED is currently untapped as a setting for obesity screening,&#xD;
      treatment and prevention (12). Yet, childhood obesity has important implications for&#xD;
      emergency medicine and trauma care, and the pediatric ED may be shouldering a&#xD;
      disproportionate burden of this disease compared to other healthcare settings (13, 14). Not&#xD;
      addressing a patient's obesity in the ED setting is a missed opportunity, especially when&#xD;
      many visits are obesity- related (e.g., asthma, type 2 diabetes, fractures), and weight&#xD;
      reduction in specific subgroups could lead to a decrease in future ED utilization. The&#xD;
      pediatric ED may not seem like an ideal location for addressing childhood obesity but many&#xD;
      visits are for non-emergent/urgent conditions and these types of visits provide a window for&#xD;
      screening and intervention (12,15). Families spend a substantial amount of time in the ED&#xD;
      waiting for laboratory/radiology results and disposition. In 2013, the average length of stay&#xD;
      in the Children's EDs was 155 minutes in Minneapolis and 143 minutes in St. Paul, valuable&#xD;
      time that could be used for obesity screening, education, and connection to external&#xD;
      resources. The pediatric ED has the potential to be an important additional healthcare&#xD;
      setting for obesity screening, education, and linkage to external resources, but much more&#xD;
      research is needed (12,13,16).&#xD;
&#xD;
      Three previous studies have examined obesity rates in the pediatric ED, each finding a higher&#xD;
      prevalence of obesity compared to the general population (12,13,16). Prendergast et al.&#xD;
      conducted a retrospective chart review and found a prevalence of obesity of 29% in a Chicago&#xD;
      pediatric ED, nearly double the national average of 17% (12). The other two studies collected&#xD;
      cross-sectional data from small samples in urban pediatric EDs and found a prevalence of&#xD;
      obesity of 24% (13) and 21.6% (16). Only one study has tested obesity screening in the&#xD;
      pediatric ED (16). Vaughn et al. found that all parents were receptive to obesity screening&#xD;
      and prevention in the ED, regardless of race (16). They also found that only 7.6% of parents&#xD;
      reported that their child's regular physician had counseled them regarding their child's&#xD;
      weight, highlighting the need for obesity screening in additional healthcare settings (16).&#xD;
      These studies indicate that pediatric EDs are seeing a population of patients at high risk&#xD;
      for obesity, many of whom may not be receiving screening or counseling from their regular&#xD;
      physician. Other topics in emergency medicine have received far greater coverage in the&#xD;
      literature, including smoking cessation, injury prevention and substance abuse (13). With the&#xD;
      dramatic increase in pediatric obesity, research on obesity in the pediatric ED is especially&#xD;
      warranted as innovative strategies and collaboration across healthcare settings will be&#xD;
      needed to successfully address this epidemic.&#xD;
&#xD;
      Currently, the prevalence of obesity in patients who utilize the pediatric ED at Children's&#xD;
      Hospitals and Clinics of Minnesota is unknown. Because of time constraints, the height of&#xD;
      patients seen in the pediatric ED are not routinely measured or recorded in the Electronic&#xD;
      Medical Record (EMR). Establishing prevalence of obesity in this population is not possible&#xD;
      without measuring the height of PED patients to determine BMI. Establishing the prevalence in&#xD;
      the population of patients who utilize the pediatric ED will lay the groundwork for future&#xD;
      grant proposals and research in this area.&#xD;
&#xD;
      Research Questions:&#xD;
&#xD;
        1. What is the prevalence of obesity in the Children's ED patient population?&#xD;
&#xD;
        2. What is the association between weight status and ED utilization for injury, asthma and&#xD;
           mental health?&#xD;
&#xD;
      Study Design We will conduct a cross-sectional cohort study of patients aged 2-10 in&#xD;
      Children's ED.&#xD;
&#xD;
      Methods ED research assistants will screen the ED log for patients in the 2-10 age range&#xD;
      triaged level 3-5. Research assistants will randomly determine 1 out of 5 patients to&#xD;
      approach for study enrollment. After the consent process is completed, the research assistant&#xD;
      will measure and record the child's height, and ask the parent to complete a short&#xD;
      questionnaire.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Obesity</measure>
    <time_frame>1 year</time_frame>
    <description>Prevalence in Children's ED will be compared to prevalence in the general pediatric population using previously established national data</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Associations between obesity and primary diagnosis</measure>
    <time_frame>1 year</time_frame>
    <description>We will calculate attributable risk in the exposed population (in the obese) and attributable risk in the population (overall).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">484</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>ED Patients</arm_group_label>
    <description>Children aged 2-10 visiting the Emergency Department.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients (aged 2-10) visiting the Children's EDs, who are triaged level 3-5, when a study&#xD;
        RA is on duty will be eligible for the study. We have selected the 2-10 year old patient&#xD;
        population for this study as the early grade school years are a critical time to intervene&#xD;
        before unhealthy lifestyle habits are established, and this age group provides a unique&#xD;
        window of opportunity in which to utilize parent and child interaction.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Emergency Severity Index (ESI) Triage levels 3-5&#xD;
&#xD;
          2. Patient between 2 and 10 years of age (inclusive)&#xD;
&#xD;
          3. Parent able to consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Transferred patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gretchen Cutler, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospitals and Clinics of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospitals and Clinics of Minnesota</name>
      <address>
        <city>Minneapolis and St. Paul</city>
        <state>Minnesota</state>
        <zip>55404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>October 9, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>November 17, 2015</last_update_submitted>
  <last_update_submitted_qc>November 17, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <!-- 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/NCT02265185
org study id: 1409-091
nct id: NCT02265185
lead sponsor: 
has dmc: No
Childhood obesity is a major area of concern for health care and public health. Overweight
      children are more likely overweight and obese adults. Chronic health problems associated with
      adult obesity are now occurring more frequently in children. Because of the associated health
      problems and potential for long term struggles with obesity, intervention early in life is
      essential for addressing the obesity epidemic. Some intervention work in this area has
      focused on the pediatric primary care setting in order to utilize the influence and
      credibility of medical providers. Unfortunately, primary care visits are often too short to
      spend a significant amount of time on issues of diet, weight and nutrition.

      There has been very little work exploring the potential of alternative care settings, such as
      the pediatric Emergency Department (ED) in addressing childhood obesity. While provider time
      is also limited in the ED, there is often a considerable amount of downtime during emergency
      department visits that could be valuable time for patient and parent education. There may
      also be an opportunity to reach parents and children in the ED who do not regularly utilize
      primary care. In order to explore the possibility of pediatric obesity interventions in
      Children's Pediatric Emergency Department, we will need to measure the prevalence of obesity
      in the population that utilizes the Children's ED. The height of patients seen in the ED is
      not routinely measured, which makes calculating BMI to determine obesity impossible. This
      study, establishing the prevalence of obesity in Children's Emergency Department will lay the
      groundwork for future work addressing obesity in the ED.
Background/Significance Childhood obesity is a well-documented public health crisis. Data
      from the most recent National Health and Nutrition Examination survey (NHANES) indicate that
      the prevalence of obesity is 8.4% in 2 to 5-year-olds, 17.7% in 6 to 11-year-olds, and 20.5%
      in 12 to 19-year-olds (1). Large racial/ethnic disparities in risk for obesity are already
      present by the preschool years (2). In 2 to 5-year-olds, 3.5% of non-Hispanic white children
      are obese, compared to 11.3% of non-Hispanic black and 16.7% of Hispanic children (1). Many
      health problems that were previously associated only with adult obesity are now being seen in
      youth, including the metabolic syndrome, type 2 diabetes, and cardiovascular abnormalities
      (3). Obesity tracks into adulthood, highlighting the need for early intervention (4).
      Overweight children have more chronic conditions, a greater risk of emergency department
      visits, and significantly higher costs for common pediatric hospitalizations (5-7).
      Successfully addressing the childhood obesity epidemic will require coordinated and
      collective efforts across many settings including multiple healthcare settings (8). Obesity
      interventions are increasingly being developed that utilize the influential role and
      credibility of pediatric primary care providers by integrating interventions into healthcare
      settings (9). Unfortunately, primary care visits are often short (average primary visit is
      16.4 minutes) and leave little time for addressing obesity in detail, highlighting the need
      to also incorporate assessment and treatment in alternative care settings (i.e., emergency
      care) (10, 11).

      There is little research on what role alternative healthcare setting could play in addressing
      childhood obesity. The pediatric ED is currently untapped as a setting for obesity screening,
      treatment and prevention (12). Yet, childhood obesity has important implications for
      emergency medicine and trauma care, and the pediatric ED may be shouldering a
      disproportionate burden of this disease compared to other healthcare settings (13, 14). Not
      addressing a patient's obesity in the ED setting is a missed opportunity, especially when
      many visits are obesity- related (e.g., asthma, type 2 diabetes, fractures), and weight
      reduction in specific subgroups could lead to a decrease in future ED utilization. The
      pediatric ED may not seem like an ideal location for addressing childhood obesity but many
      visits are for non-emergent/urgent conditions and these types of visits provide a window for
      screening and intervention (12,15). Families spend a substantial amount of time in the ED
      waiting for laboratory/radiology results and disposition. In 2013, the average length of stay
      in the Children's EDs was 155 minutes in Minneapolis and 143 minutes in St. Paul, valuable
      time that could be used for obesity screening, education, and connection to external
      resources. The pediatric ED has the potential to be an important additional healthcare
      setting for obesity screening, education, and linkage to external resources, but much more
      research is needed (12,13,16).

      Three previous studies have examined obesity rates in the pediatric ED, each finding a higher
      prevalence of obesity compared to the general population (12,13,16). Prendergast et al.
      conducted a retrospective chart review and found a prevalence of obesity of 29% in a Chicago
      pediatric ED, nearly double the national average of 17% (12). The other two studies collected
      cross-sectional data from small samples in urban pediatric EDs and found a prevalence of
      obesity of 24% (13) and 21.6% (16). Only one study has tested obesity screening in the
      pediatric ED (16). Vaughn et al. found that all parents were receptive to obesity screening
      and prevention in the ED, regardless of race (16). They also found that only 7.6% of parents
      reported that their child's regular physician had counseled them regarding their child's
      weight, highlighting the need for obesity screening in additional healthcare settings (16).
      These studies indicate that pediatric EDs are seeing a population of patients at high risk
      for obesity, many of whom may not be receiving screening or counseling from their regular
      physician. Other topics in emergency medicine have received far greater coverage in the
      literature, including smoking cessation, injury prevention and substance abuse (13). With the
      dramatic increase in pediatric obesity, research on obesity in the pediatric ED is especially
      warranted as innovative strategies and collaboration across healthcare settings will be
      needed to successfully address this epidemic.

      Currently, the prevalence of obesity in patients who utilize the pediatric ED at Children's
      Hospitals and Clinics of Minnesota is unknown. Because of time constraints, the height of
      patients seen in the pediatric ED are not routinely measured or recorded in the Electronic
      Medical Record (EMR). Establishing prevalence of obesity in this population is not possible
      without measuring the height of PED patients to determine BMI. Establishing the prevalence in
      the population of patients who utilize the pediatric ED will lay the groundwork for future
      grant proposals and research in this area.

      Research Questions:

        1. What is the prevalence of obesity in the Children's ED patient population?

        2. What is the association between weight status and ED utilization for injury, asthma and
           mental health?

      Study Design We will conduct a cross-sectional cohort study of patients aged 2-10 in
      Children's ED.

      Methods ED research assistants will screen the ED log for patients in the 2-10 age range
      triaged level 3-5. Research assistants will randomly determine 1 out of 5 patients to
      approach for study enrollment. After the consent process is completed, the research assistant
      will measure and record the child's height, and ask the parent to complete a short
      questionnaire.
observational model: Cohort
time perspective: Cross-Sectional
measure: Obesity
time frame: 1 year
description: Prevalence in Children's ED will be compared to prevalence in the general pediatric population using previously established national data
measure: Associations between obesity and primary diagnosis
time frame: 1 year
description: We will calculate attributable risk in the exposed population (in the obese) and attributable risk in the population (overall).
arm group label: ED Patients
description: Children aged 2-10 visiting the Emergency Department.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 10 Years
healthy volunteers: No
last name: Gretchen Cutler, PhD
role: Principal Investigator
affiliation: Children's Hospitals and Clinics of Minnesota
facility: 
country: United States
responsible party type: Sponsor
mesh term: Emergencies