<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/NCT03269253</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 15-1668</org_study_id>
    <nct_id>NCT03269253</nct_id>
  </id_info>
  <brief_title>Maternal Loss of Control Eating</brief_title>
  <official_title>Maternal Loss of Control Eating: a Longitudinal Study of Maternal and Child Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</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 focused on investigating the effects of maternal disordered eating on maternal and&#xD;
      child outcomes as part of a secondary data analysis of the Avon Longitudinal Study of Parents&#xD;
      and Children (ALSPAC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Deidentified and anonymised data already collected as part of the ALSPAC study will be&#xD;
      analysed to investigate the effects of maternal eating on maternal and child outcomes (diet,&#xD;
      eating, weight, metabolic). The Avon Longitudinal Study of Parents and Children (ALSPAC) is a&#xD;
      longitudinal, prospective study designed to examine the effects of environment, genetics and&#xD;
      other factors on health and development.All pregnant women living in the geographical area of&#xD;
      Avon, UK, who were expected to deliver their baby between 1st April 1991 and 31st December&#xD;
      1992, were recruited. 14,541 women were enrolled. Amongst these pregnancies, there were a&#xD;
      total of 14,676 fetuses, resulting in 14,062 live births and 13,798 children who were alive&#xD;
      at 1 year of age and were singletons. The ALSPAC study website contains details of all the&#xD;
      data that is available through a fully searchable data Dictionary&#xD;
      (http://www.bris.ac.uk/alspac/researchers/data-access/data-dictionary/).&#xD;
&#xD;
      Missingness will be assessed and standard data analytical techniques such as MI will be&#xD;
      used.Crude and adjusted logistic, linear, and multinomial regression models will be employed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2016</start_date>
  <completion_date type="Actual">July 20, 2017</completion_date>
  <primary_completion_date type="Actual">July 20, 2017</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>birth weight</measure>
    <time_frame>Day 1</time_frame>
    <description>weight at birth</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BMI</measure>
    <time_frame>average 21 years</time_frame>
    <description>body mass index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Food Frequency Questionnaire (FFQ)</measure>
    <time_frame>average 9 months</time_frame>
    <description>adult dietary patterns - software specific to the FFQ will be used to analyze data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Food Frequency Questionnaire</measure>
    <time_frame>average 21 years</time_frame>
    <description>child dietary patterns- software specific to the FFQ will be used to analyze data.</description>
  </secondary_outcome>
  <enrollment type="Actual">14451</enrollment>
  <condition>Eating Disorder</condition>
  <condition>Obesity</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All pregnant women living in the geographical area of Avon, UK, who were expected to&#xD;
        deliver their baby between 1st April 1991 and 31st December 1992, were recruited. 14,541&#xD;
        women were enrolled. Amongst these pregnancies, there were a total of 14,676 fetuses,&#xD;
        resulting in 14,062 live births and 13,798 children who were alive at 1 year of age and&#xD;
        were singletons.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  multiple pregnancies&#xD;
&#xD;
          -  no questionnaire data at 32 weeks.&#xD;
&#xD;
        eligibility criteria : enrolled in the ALSPAC study; inclusion: all women part of the&#xD;
        ALSPAC study;&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>43 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nadia Micali, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>August 29, 2017</last_update_submitted>
  <last_update_submitted_qc>August 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ALSPAC</keyword>
  <keyword>longitudinal</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Feeding and Eating Disorders</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/NCT03269253
org study id: GCO 15-1668
nct id: NCT03269253
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study focused on investigating the effects of maternal disordered eating on maternal and
      child outcomes as part of a secondary data analysis of the Avon Longitudinal Study of Parents
      and Children (ALSPAC).
Deidentified and anonymised data already collected as part of the ALSPAC study will be
      analysed to investigate the effects of maternal eating on maternal and child outcomes (diet,
      eating, weight, metabolic). The Avon Longitudinal Study of Parents and Children (ALSPAC) is a
      longitudinal, prospective study designed to examine the effects of environment, genetics and
      other factors on health and development.All pregnant women living in the geographical area of
      Avon, UK, who were expected to deliver their baby between 1st April 1991 and 31st December
      1992, were recruited. 14,541 women were enrolled. Amongst these pregnancies, there were a
      total of 14,676 fetuses, resulting in 14,062 live births and 13,798 children who were alive
      at 1 year of age and were singletons. The ALSPAC study website contains details of all the
      data that is available through a fully searchable data Dictionary
      (http://www.bris.ac.uk/alspac/researchers/data-access/data-dictionary/).

      Missingness will be assessed and standard data analytical techniques such as MI will be
      used.Crude and adjusted logistic, linear, and multinomial regression models will be employed.
observational model: Cohort
time perspective: Prospective
measure: birth weight
time frame: Day 1
description: weight at birth
measure: BMI
time frame: average 21 years
description: body mass index
measure: Food Frequency Questionnaire (FFQ)
time frame: average 9 months
description: adult dietary patterns - software specific to the FFQ will be used to analyze data.
measure: Food Frequency Questionnaire
time frame: average 21 years
description: child dietary patterns- software specific to the FFQ will be used to analyze data.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 16 Years
maximum age: 43 Years
healthy volunteers: No
last name: Nadia Micali, MD, PhD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
facility: 
country: United States
responsible party type: Sponsor
mesh term: Feeding and Eating Disorders
sharing ipd: No