<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/NCT03751813</url>
  </required_header>
  <id_info>
    <org_study_id>Baby BLISS</org_study_id>
    <nct_id>NCT03751813</nct_id>
  </id_info>
  <brief_title>Baby Bump Lifestyle Intervention Supplement Study</brief_title>
  <acronym>Baby BLISS</acronym>
  <official_title>Baby Bump Lifestyle Intervention Supplement 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 study is to examine how natural supplements can mediate the&#xD;
      effects of stress on fetal development during pregnancy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    IRB had concerns about study; terminated&#xD;
  </why_stopped>
  <start_date type="Actual">March 21, 2019</start_date>
  <completion_date type="Actual">November 30, 2019</completion_date>
  <primary_completion_date type="Actual">November 30, 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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>lower blood stress markers via venous draw</measure>
    <time_frame>9 months</time_frame>
    <description>We hypothesize that the addition of nutrients during gestation will decrease the levels of stress hormones/reactants in pregnant women who are at high risk for stressful pregnancies.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Gestational Diabetes</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo supplement</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Supplement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>actual supplement</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Supplement</intervention_name>
    <description>Supplement will be given to this group to take daily for 8 weeks</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Supplement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant woman presenting to her first obstetrical visit for this pregnancy&#xD;
&#xD;
          -  Must be in the first trimester (&lt;13 weeks)&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  High-stress levels as measured by the Perceived Stress Level Questionnaire&#xD;
&#xD;
          -  Must be a single pregnancy (e.g. not twins, triplets, etc.)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes (types 1 and 2)&#xD;
&#xD;
          -  Diagnosis of gestational diabetes in prior pregnancy&#xD;
&#xD;
          -  Hyperemesis gravidarum or severe morning sickness that interferes with supplement&#xD;
             intake&#xD;
&#xD;
          -  Major medical illnesses including but not limited to: malabsorption syndromes&#xD;
             (Celiac's disease, Crohn's, Ulcerative Colitis), Systemic Lupus Erythematosus and&#xD;
             other major autoimmune conditions&#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>
  <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>February 2020</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>February 18, 2020</last_update_submitted>
  <last_update_submitted_qc>February 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2020</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>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/NCT03751813
org study id: Baby BLISS
nct id: NCT03751813
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overall purpose of this study is to examine how natural supplements can mediate the
      effects of stress on fetal development during pregnancy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: lower blood stress markers via venous draw
time frame: 9 months
description: We hypothesize that the addition of nutrients during gestation will decrease the levels of stress hormones/reactants in pregnant women who are at high risk for stressful pregnancies.
arm group label: Placebo
arm group type: Placebo Comparator
description: placebo supplement
arm group label: Supplement
arm group type: Experimental
description: actual supplement
intervention type: Dietary Supplement
intervention name: Supplement
description: Supplement will be given to this group to take daily for 8 weeks
arm group label: Placebo
arm group label: Supplement
criteria: 
gender: Female
gender based: Yes
gender description: female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
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: No