<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/NCT02217462</url>
  </required_header>
  <id_info>
    <org_study_id>HHSN275201300015C</org_study_id>
    <nct_id>NCT02217462</nct_id>
  </id_info>
  <brief_title>Pregnancy Eating Attributes Study</brief_title>
  <acronym>PEAS</acronym>
  <official_title>Diet, Obesity, and Weight Change in Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Emmes Company, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this observational cohort study is to examine the role of &quot;food&#xD;
      reward&quot; in maternal diet and weight change during pregnancy and postpartum. The study will&#xD;
      further examine the importance of food reward in the context of behavioral control and other&#xD;
      related aspects of eating behavior, as well as weight-related biomedical, psychosocial and&#xD;
      behavioral factors including genetics, physical activity, stress, sleep and depression. Four&#xD;
      hundred and fifty women of varying baseline weight status will be enrolled early in pregnancy&#xD;
      (before 12 weeks postpartum) and followed until 1 year postpartum. Assessments will occur at&#xD;
      baseline (&lt;12 weeks postpartum), during pregnancy at 13-18 weeks gestation, 16-22 weeks, and&#xD;
      28-32 weeks, and postpartum at 4-6 weeks, 6 months, 9 months and 12 months. Measures will&#xD;
      include assessments of food reward and related constructs, dietary intake, other health&#xD;
      behaviors, and anthropometrics. Clinical data and biological specimens will be obtained.&#xD;
      Infant anthropometrics and feeding practices will also be assessed. Primary exposures include&#xD;
      aspects of food reward and behavioral control, which will be assessed in multiple ways to&#xD;
      maximize information and utility. Primary outcomes include gestational weight gain,&#xD;
      postpartum weight retention and dietary quality.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">June 2018</completion_date>
  <primary_completion_date type="Actual">June 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>Body weight</measure>
    <time_frame>&lt;12 weeks pregnancy; 16-22 weeks pregnancy; 28-32 weeks pregnancy; delivery; 4-6 weeks postpartum; 6 months postpartum; 1 year postpartum</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Dietary intake</measure>
    <time_frame>&lt;12 weeks pregnancy; 16-22 weeks pregnancy; 28-32 weeks pregnancy; 4-6 weeks postpartum; 6 months postpartum; 1 year postpartum</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">458</enrollment>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>Pregnant women</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum Plasma White and red blood cells Urine Stool&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        PEAS is a prospective observational study of N=450 women without evidence of psychiatric or&#xD;
        eating disorders, recruited in early pregnancy (≤12 weeks), targeting N=150 in each weight&#xD;
        status group: normal weight (BMI 18.5-24.9), overweight (BMI 25-29.9) and obese (BMI &gt;=30).&#xD;
        Women will be followed through pregnancy and until 1 year postpartum, along with their&#xD;
        infants from birth to 1 year, with collection of blood, stool, and urine specimens,&#xD;
        previous and current medical information, dietary intake and eating behaviors,&#xD;
        anthropometrics, and demographic information.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female confirmed pregnant &lt;12 weeks at screening&#xD;
&#xD;
          -  Uncomplicated singleton pregnancy anticipated&#xD;
&#xD;
          -  Age &gt;=18 and &lt;45 at screening&#xD;
&#xD;
          -  Willingness to undergo study procedures and provide informed consent for her&#xD;
             participation and assent for the baby's participation&#xD;
&#xD;
          -  BMI &gt;=18.5 (to qualify as normal: 18.5-24.9; overweight 25-29.9; or obese : &gt;=30)&#xD;
&#xD;
          -  Able to complete self-reported assessments in English&#xD;
&#xD;
          -  Access to Internet with email to complete self-reported assessments&#xD;
&#xD;
          -  Plan to deliver at UNC Hospital&#xD;
&#xD;
          -  Plan to remain in the area for 1 year following delivery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-existing diabetes (type 1 or type 2)&#xD;
&#xD;
          -  Multiple pregnancy&#xD;
&#xD;
          -  Participant-reported eating disorder&#xD;
&#xD;
          -  Any fetal anomaly requiring surgery with hospital admission following delivery (e.g.&#xD;
             NTDs, gastroschisis, cardiac defects, Trisomy 21)&#xD;
&#xD;
          -  Any medical condition contraindicating participation in the study such as chronic&#xD;
             illnesses or use of medication that could affect diet or weight e.g. cancer, HIV,&#xD;
             active renal disease, MI in the last 6 months, chronic steroid use, thyroid disease&#xD;
             requiring medication, or autoimmune disease (rheumatoid arthritis, lupus,&#xD;
             antiphospholipid antibody syndrome, scleroderma)&#xD;
&#xD;
          -  Psychosocial condition contraindicating participation in the study such as bipolar,&#xD;
             schizophrenia, major affective disorder, substance abuse.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>44 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tonja R. Nansel, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UNC Hospitals Obstetrics Clinic; Timberlylne Obstetrics &amp; Gynecology Clinic</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27514</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>February 26, 2020</last_update_submitted>
  <last_update_submitted_qc>February 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pregnancy</keyword>
  <keyword>gestational weight gain</keyword>
  <keyword>dietary intake</keyword>
  <keyword>food reward</keyword>
  <!-- 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/NCT02217462
org study id: HHSN275201300015C
nct id: NCT02217462
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The primary purpose of this observational cohort study is to examine the role of "food
      reward" in maternal diet and weight change during pregnancy and postpartum. The study will
      further examine the importance of food reward in the context of behavioral control and other
      related aspects of eating behavior, as well as weight-related biomedical, psychosocial and
      behavioral factors including genetics, physical activity, stress, sleep and depression. Four
      hundred and fifty women of varying baseline weight status will be enrolled early in pregnancy
      (before 12 weeks postpartum) and followed until 1 year postpartum. Assessments will occur at
      baseline (<12 weeks postpartum), during pregnancy at 13-18 weeks gestation, 16-22 weeks, and
      28-32 weeks, and postpartum at 4-6 weeks, 6 months, 9 months and 12 months. Measures will
      include assessments of food reward and related constructs, dietary intake, other health
      behaviors, and anthropometrics. Clinical data and biological specimens will be obtained.
      Infant anthropometrics and feeding practices will also be assessed. Primary exposures include
      aspects of food reward and behavioral control, which will be assessed in multiple ways to
      maximize information and utility. Primary outcomes include gestational weight gain,
      postpartum weight retention and dietary quality.
observational model: Cohort
time perspective: Prospective
measure: Body weight
time frame: <12 weeks pregnancy; 16-22 weeks pregnancy; 28-32 weeks pregnancy; delivery; 4-6 weeks postpartum; 6 months postpartum; 1 year postpartum
measure: Dietary intake
time frame: <12 weeks pregnancy; 16-22 weeks pregnancy; 28-32 weeks pregnancy; 4-6 weeks postpartum; 6 months postpartum; 1 year postpartum
arm group label: Pregnant women
Serum Plasma White and red blood cells Urine Stool
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 44 Years
healthy volunteers: No
last name: Tonja R. Nansel, PhD
role: Principal Investigator
affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
facility: 
country: United States
responsible party type: Sponsor