<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/NCT03010644</url>
  </required_header>
  <id_info>
    <org_study_id>2016B0034</org_study_id>
    <nct_id>NCT03010644</nct_id>
  </id_info>
  <brief_title>Summer Weight and Environmental Assessment Trial</brief_title>
  <acronym>SWEAT</acronym>
  <official_title>Summer Weight and Environmental Assessment Trial (SWEAT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>USDA North Central - Nutrition Education Center of Excellence</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ohio State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The consequences of childhood obesity are devastating, affecting the physical and mental&#xD;
      health of children. Disadvantaged school-age children are at risk for unhealthy gains in BMI&#xD;
      during the summer months and there is a dearth of information regarding the causal health&#xD;
      behaviors and environmental factors. The overall objective of this application is to provide&#xD;
      an in depth examination of key dietary and physical activity behaviors as well as the food,&#xD;
      physical activity, and social environments of low-income, racial/ethnic school-age children.&#xD;
      To achieve this goal, an observational study utilizing a multi-state prospective cohort&#xD;
      design will be conducted with the goal of examining the weight gain trajectory among a&#xD;
      racially and ethnically diverse convenience sample of disadvantaged school-age children who&#xD;
      routinely attend structured programming during the summer months and those who don't&#xD;
      participate in structured programming. In addition, a subset of these children will be&#xD;
      evaluated to learn their daily health behaviors, as well as their food, physical activity,&#xD;
      and social environments during the summer. Identification of determinants of program&#xD;
      participation and factors that may enhance the beneficial effects of program participation&#xD;
      will also occur. A social ecological framework approach will guide the research. This study&#xD;
      can be expected to have a significant positive impact by providing information on the factors&#xD;
      that protect disadvantaged children from unhealthy weight gain during the summer which can be&#xD;
      used by stakeholders at the local, state, and federal level to reform current policy that&#xD;
      will increase child participation in health promoting programming during the summer window of&#xD;
      risk.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">November 30, 2018</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>Change in BMI</measure>
    <time_frame>Baseline (beginning of summer), T1 (5 weeks), T2 (10 weeks), T3 (22 weeks)</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">152</enrollment>
  <condition>Childhood Obesity</condition>
  <arm_group>
    <arm_group_label>Underserved school-aged children</arm_group_label>
    <description>Underserved school-aged children at risk for obesity</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>n/a - observational study</intervention_name>
    <description>n/a - observational study</description>
    <arm_group_label>Underserved school-aged children</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Racially and ethnically diverse convenience sample of disadvantaged school-age children&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  School-aged children (rising kindergartners through rising 5th graders) attending&#xD;
             schools in the target neighborhoods.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Purdue University</name>
      <address>
        <city>West Lafayette</city>
        <state>Indiana</state>
        <zip>47907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>March 11, 2019</last_update_submitted>
  <last_update_submitted_qc>March 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Carolyn Gunther</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pediatric Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03010644
org study id: 2016B0034
nct id: NCT03010644
lead sponsor: 
collaborator: 
has dmc: No
The consequences of childhood obesity are devastating, affecting the physical and mental
      health of children. Disadvantaged school-age children are at risk for unhealthy gains in BMI
      during the summer months and there is a dearth of information regarding the causal health
      behaviors and environmental factors. The overall objective of this application is to provide
      an in depth examination of key dietary and physical activity behaviors as well as the food,
      physical activity, and social environments of low-income, racial/ethnic school-age children.
      To achieve this goal, an observational study utilizing a multi-state prospective cohort
      design will be conducted with the goal of examining the weight gain trajectory among a
      racially and ethnically diverse convenience sample of disadvantaged school-age children who
      routinely attend structured programming during the summer months and those who don't
      participate in structured programming. In addition, a subset of these children will be
      evaluated to learn their daily health behaviors, as well as their food, physical activity,
      and social environments during the summer. Identification of determinants of program
      participation and factors that may enhance the beneficial effects of program participation
      will also occur. A social ecological framework approach will guide the research. This study
      can be expected to have a significant positive impact by providing information on the factors
      that protect disadvantaged children from unhealthy weight gain during the summer which can be
      used by stakeholders at the local, state, and federal level to reform current policy that
      will increase child participation in health promoting programming during the summer window of
      risk.
observational model: Cohort
time perspective: Prospective
measure: Change in BMI
time frame: Baseline (beginning of summer), T1 (5 weeks), T2 (10 weeks), T3 (22 weeks)
arm group label: Underserved school-aged children
description: Underserved school-aged children at risk for obesity
intervention type: Other
intervention name: n/a - observational study
description: n/a - observational study
arm group label: Underserved school-aged children
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 4 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Carolyn Gunther
investigator title: Assistant Professor
mesh term: Pediatric Obesity
sharing ipd: No