<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/NCT03281850</url>
  </required_header>
  <id_info>
    <org_study_id>206846</org_study_id>
    <nct_id>NCT03281850</nct_id>
  </id_info>
  <brief_title>The GLOWING Study: Growing Life, Optimizing Wellness 2</brief_title>
  <official_title>The GLOWING Study: Growing Life, Optimizing Wellness 2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arkansas Children's Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Arkansas Children's Hospital Research Institute</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>
      This study will help us learn more about how maternal health can influence child health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study follows people who are healthy and less than 36 weeks pregnant to see how the&#xD;
      mother's health can impact their child's growth and development. Up to 300 people including&#xD;
      the mother and their future child will be a part of this study. The study will follow the&#xD;
      child until they are two years of age.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 11, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2024</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Determine energy expenditure in children</measure>
    <time_frame>2 years</time_frame>
    <description>Using stable isotope techniques to determine energy expenditure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determine fat oxidation in children</measure>
    <time_frame>2 years</time_frame>
    <description>Using stable isotope techniques to determine fat oxidation</description>
  </primary_outcome>
  <enrollment type="Actual">212</enrollment>
  <condition>Healthy</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Urine collected&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        A prospective longitudinal cohort of 150 dyads (pregnant women and offspring)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pre-pregnancy BMI 18.5-45&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
          -  at least 18 years of age&#xD;
&#xD;
          -  conceived without assisted fertility treatments&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preexisting medical conditions (e.g. DM, GDM, CRF, HTN, pre-eclampsia or eclampsia,&#xD;
             malignancies, seizure disorder, lupus, serious psychiatric disorders)&#xD;
&#xD;
          -  sexually transmitted diseases&#xD;
&#xD;
          -  medications during pregnancy known to influence fetal growth&#xD;
&#xD;
          -  smoking, alcohol drinking or drug use during pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Arkansas Children's Nutrition Center</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>March 26, 2023</last_update_submitted>
  <last_update_submitted_qc>March 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03281850
org study id: 206846
nct id: NCT03281850
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will help us learn more about how maternal health can influence child health.
This study follows people who are healthy and less than 36 weeks pregnant to see how the
      mother's health can impact their child's growth and development. Up to 300 people including
      the mother and their future child will be a part of this study. The study will follow the
      child until they are two years of age.
observational model: Cohort
time perspective: Prospective
measure: Determine energy expenditure in children
time frame: 2 years
description: Using stable isotope techniques to determine energy expenditure
measure: Determine fat oxidation in children
time frame: 2 years
description: Using stable isotope techniques to determine fat oxidation
Urine collected
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
country: United States
responsible party type: Sponsor