<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/NCT03749889</url>
  </required_header>
  <id_info>
    <org_study_id>00002745</org_study_id>
    <nct_id>NCT03749889</nct_id>
  </id_info>
  <brief_title>Low Carb vs Normal Carb in Pregnancy</brief_title>
  <official_title>Bump to Baby Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>State University of New York at Buffalo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>State University of New York at Buffalo</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 overall purpose of this intervention study is to examine whether low-carbohydrate dietary&#xD;
      intervention will prevent the development of gestational diabetes mellitus (GDM) in high-risk&#xD;
      pregnant women. The results of this study should help further our understanding of how&#xD;
      pregnant women can help prevent gestational diabetes mellitus. We hypothesize that a lower&#xD;
      carbohydrate diet will prevent the development of GDM.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Unable to provide OBGYN to assist with study for IRB approval&#xD;
  </why_stopped>
  <start_date type="Actual">September 4, 2018</start_date>
  <completion_date type="Actual">August 5, 2019</completion_date>
  <primary_completion_date type="Actual">August 5, 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Birth Outcome Questionnaire</measure>
    <time_frame>24 months</time_frame>
    <description>Upon delivery of the baby, a birth outcome questionnaire will be collected which includes questions about the delivery and birth of the baby and a question about gestational diabetes. The answer to gestational diabetes or not will be the measure for the outcome.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Gestational Diabetes</condition>
  <arm_group>
    <arm_group_label>100 g carbs</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100 grams of carbohydrate allowance for the day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MyPlate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Carbohydrate suggestions based on standard MyPlate. 45-65% kcal intake from carbs.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>100 g carbs</intervention_name>
    <description>Participants will be assigned a diet of 100g carbs max for the day</description>
    <arm_group_label>100 g carbs</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MyPlate</intervention_name>
    <description>40-65% of daily intake is from carbohydrates</description>
    <arm_group_label>MyPlate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 - 40 years old&#xD;
&#xD;
          -  BMI &gt; 30 and/or history of gestational diabetes mellitus&#xD;
&#xD;
          -  Currently in first trimester of pregnancy with single fetus (e.g. not twins, triplets,&#xD;
             etc.)&#xD;
&#xD;
          -  Newborns of current participants&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes (types 1 and 2)&#xD;
&#xD;
          -  History of major chronic disease or blood clotting disorders (e.g., cancer, heart&#xD;
             disease, kidney disease, hypertension)&#xD;
&#xD;
          -  Known fetal anomaly&#xD;
&#xD;
          -  History of eating disorders&#xD;
&#xD;
          -  Current use of medications that affect appetite or insulin secretion/sensitivity (e.g.&#xD;
             stimulants)&#xD;
&#xD;
          -  Current use of illegal substances, antipsychotic or opioid substitution medications,&#xD;
             alcohol, or tobacco&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kai Ling Kong, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>SUNY Buffalo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SUNY Buffalo</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 28, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>September 17, 2019</last_update_submitted>
  <last_update_submitted_qc>September 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>State University of New York at Buffalo</investigator_affiliation>
    <investigator_full_name>Kai Ling Kong</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03749889
org study id: 00002745
nct id: NCT03749889
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overall purpose of this intervention study is to examine whether low-carbohydrate dietary
      intervention will prevent the development of gestational diabetes mellitus (GDM) in high-risk
      pregnant women. The results of this study should help further our understanding of how
      pregnant women can help prevent gestational diabetes mellitus. We hypothesize that a lower
      carbohydrate diet will prevent the development of GDM.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Birth Outcome Questionnaire
time frame: 24 months
description: Upon delivery of the baby, a birth outcome questionnaire will be collected which includes questions about the delivery and birth of the baby and a question about gestational diabetes. The answer to gestational diabetes or not will be the measure for the outcome.
arm group label: 100 g carbs
arm group type: Experimental
description: 100 grams of carbohydrate allowance for the day
arm group label: MyPlate
arm group type: Active Comparator
description: Carbohydrate suggestions based on standard MyPlate. 45-65% kcal intake from carbs.
intervention type: Other
intervention name: 100 g carbs
description: Participants will be assigned a diet of 100g carbs max for the day
arm group label: 100 g carbs
intervention type: Other
intervention name: MyPlate
description: 40-65% of daily intake is from carbohydrates
arm group label: MyPlate
criteria: 
gender: Female
gender based: Yes
gender description: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kai Ling Kong, PhD
role: Principal Investigator
affiliation: SUNY Buffalo
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: State University of New York at Buffalo
investigator full name: Kai Ling Kong
investigator title: Principal Investigator
mesh term: Diabetes, Gestational
sharing ipd: Undecided