<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/NCT03232762</url>
  </required_header>
  <id_info>
    <org_study_id>17-00694</org_study_id>
    <nct_id>NCT03232762</nct_id>
  </id_info>
  <brief_title>Effects of Diet on Pregnancy Outcome and Child Obesity</brief_title>
  <official_title>Effects of Diet on Pregnancy Outcome and Child Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</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>
      The purpose of the study is to compare 3 different diets in pregnancy, equal in calories, and&#xD;
      fats, different in refined grains compared to whole grains as a source of carbohydrates, and&#xD;
      in calories from carbohydrate, compared to protein as a source of calories.The hypothesis is&#xD;
      that there will be differences in the specified outcomes because the proportions of&#xD;
      macronutrients are significant. The primary objective is to detect differences in weight&#xD;
      gain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There will be randomized sequential assignment of pregnant women at the initial clinic visit&#xD;
      to Diet A, a high proportion of calories from refined grains as a carbohydrate source, and&#xD;
      Diet B, a high proportion of calories from whole grains. Random number assignment is&#xD;
      impractical for counseling purposes and blinding not possible. Therefore, randomization by&#xD;
      diet assignment by day of initial visit via random number was chosen. If the random number is&#xD;
      odd Diet A would be selected, if the random number is even Diet B will be selected for that&#xD;
      day.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 3, 2017</start_date>
  <completion_date type="Actual">August 22, 2019</completion_date>
  <primary_completion_date type="Actual">August 22, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Differences in weight gain</measure>
    <time_frame>6 Months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pre-Term Birth Rate</measure>
    <time_frame>6 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal Weight</measure>
    <time_frame>6 Months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">303</enrollment>
  <condition>Pregnancy Related</condition>
  <condition>Diet Modification</condition>
  <condition>Obesity</condition>
  <condition>Hypertension</condition>
  <condition>Pre-Eclampsia</condition>
  <condition>Blood Pressure</condition>
  <condition>Breast Feeding</condition>
  <condition>Birth Weight</condition>
  <arm_group>
    <arm_group_label>Diet A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>high proportion of calories from refined grains as a carbohydrate source</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diet B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>a high proportion of calories from whole grains</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Refined Grains</intervention_name>
    <description>In week one each patient will have a text message or phone call to report on her diet and the information will be recorded as an attempt to assure compliance.</description>
    <arm_group_label>Diet A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Whole Grains</intervention_name>
    <description>In week one each patient will have a text message or phone call to report on her diet and the information will be recorded as an attempt to assure compliance.</description>
    <arm_group_label>Diet B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All normal pregnant patients who will be more than three months from term&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Illness making it a high risk pregnancy&#xD;
&#xD;
          -  Chronic renal disease&#xD;
&#xD;
          -  Malignancy&#xD;
&#xD;
          -  Congestive heart failure&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Hypertension&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>All will be pregnant women</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bruce Young, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York University School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>November 11, 2019</last_update_submitted>
  <last_update_submitted_qc>November 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2019</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>Eclampsia</mesh_term>
    <mesh_term>Pre-Eclampsia</mesh_term>
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Pediatric Obesity</mesh_term>
    <mesh_term>Birth Weight</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/NCT03232762
org study id: 17-00694
nct id: NCT03232762
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to compare 3 different diets in pregnancy, equal in calories, and
      fats, different in refined grains compared to whole grains as a source of carbohydrates, and
      in calories from carbohydrate, compared to protein as a source of calories.The hypothesis is
      that there will be differences in the specified outcomes because the proportions of
      macronutrients are significant. The primary objective is to detect differences in weight
      gain.
There will be randomized sequential assignment of pregnant women at the initial clinic visit
      to Diet A, a high proportion of calories from refined grains as a carbohydrate source, and
      Diet B, a high proportion of calories from whole grains. Random number assignment is
      impractical for counseling purposes and blinding not possible. Therefore, randomization by
      diet assignment by day of initial visit via random number was chosen. If the random number is
      odd Diet A would be selected, if the random number is even Diet B will be selected for that
      day.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Differences in weight gain
time frame: 6 Months
measure: Pre-Term Birth Rate
time frame: 6 Months
measure: Neonatal Weight
time frame: 6 Months
arm group label: Diet A
arm group type: Active Comparator
description: high proportion of calories from refined grains as a carbohydrate source
arm group label: Diet B
arm group type: Active Comparator
description: a high proportion of calories from whole grains
intervention type: Dietary Supplement
intervention name: Refined Grains
description: In week one each patient will have a text message or phone call to report on her diet and the information will be recorded as an attempt to assure compliance.
arm group label: Diet A
intervention type: Dietary Supplement
intervention name: Whole Grains
description: In week one each patient will have a text message or phone call to report on her diet and the information will be recorded as an attempt to assure compliance.
arm group label: Diet B
criteria: 
gender: Female
gender based: Yes
gender description: All will be pregnant women
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bruce Young, MD
role: Principal Investigator
affiliation: NYU Langone Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Eclampsia
mesh term: Pre-Eclampsia
mesh term: Obesity
mesh term: Pediatric Obesity
mesh term: Birth Weight