<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/NCT03278392</url>
  </required_header>
  <id_info>
    <org_study_id>UCI 2017-3803</org_study_id>
    <nct_id>NCT03278392</nct_id>
  </id_info>
  <brief_title>Maternal Emotions and Diet in Pregnancy</brief_title>
  <acronym>PEDIMet</acronym>
  <official_title>Prenatal Emotion-Diet Interactions and the Metabolic Response</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Irvine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Irvine</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 seeks to understand how a mother's emotional state in pregnancy influences her&#xD;
      biological response to food intake.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this research study is to understand how a mother's emotional state in&#xD;
      pregnancy influences her biological response to food intake. Natural variation in emotional&#xD;
      and mental state is frequently experienced in daily life, including during pregnancy. While&#xD;
      the investigators understand that a healthy diet is important in pregnancy for maintaining&#xD;
      blood sugar levels and other metabolic factors within normal ranges for optimal development&#xD;
      of the baby, less consideration is given to the health effects of a mother's mental state&#xD;
      during pregnancy. It may even be possible that, regardless of what a woman eats or drinks,&#xD;
      the way her body responds to food may differ according to her emotional or mental state.&#xD;
&#xD;
      This research is particularly interested in understanding how the combination of maternal&#xD;
      emotional state and diet influence metabolism in pregnancy. Thus, the aim of this study is to&#xD;
      test whether and how an individual's emotional response to a mental challenge of varying&#xD;
      complexity during pregnancy modifies the body's metabolic response to a standard breakfast.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 17, 2017</start_date>
  <completion_date type="Actual">May 10, 2021</completion_date>
  <primary_completion_date type="Actual">May 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in the glycemic response to the standardized meal +/- psychosocial challenge task</measure>
    <time_frame>2 hours</time_frame>
    <description>Glycemic response (area-under-the-curve of glucose) to the standardized breakfast drink following exposure to either the psychosocial challenge (TSST) or non-challenge (placebo-TSST) task.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in the triglyceride response to the standardized meal +/- psychosocial challenge task</measure>
    <time_frame>2 hours</time_frame>
    <description>Area under the curve of blood triglycerides to the standardized breakfast drink following exposure to either the psychosocial challenge (TSST) or non-challenge (placebo-TSST) task.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physiological stress response to the psychosocial challenge task</measure>
    <time_frame>2 hours</time_frame>
    <description>Area under the curve of salivary cortisol following exposure to the psychosocial challenge task</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Pregnancy Related</condition>
  <condition>Stress, Psychological</condition>
  <condition>Glucose Intolerance During Pregnancy</condition>
  <arm_group>
    <arm_group_label>Psychosocial challenge task</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be assigned to complete the Trier Social Stress Test (TSST) immediately after consuming a standardized breakfast drink</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo challenge task</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants will be assigned to complete the placebo non-stress task immediately after consuming a standardized breakfast drink</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Trier Social Stress Test</intervention_name>
    <description>Task instructions provided to subject (5mins), subject prepares speech on their strengths and weaknesses (5 mins), subject delivers speech before a stern evaluative committee while being video-taped (5 mins), subject completes a mental arithmetic challenge task before the evaluative committee with critiques if errors are made (5mins).</description>
    <arm_group_label>Psychosocial challenge task</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Placebo Non-stress task</intervention_name>
    <description>Subject engages in a friendly conversation about a neutral or happy topic (e.g. recent holiday, favorite past-times) for 15 minutes with a familiar research staff member.</description>
    <arm_group_label>Placebo challenge task</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-40 years&#xD;
&#xD;
          -  Hispanic ethnicity&#xD;
&#xD;
          -  English and/or Spanish speaking&#xD;
&#xD;
          -  Multiparous&#xD;
&#xD;
          -  28-30 week's gestation&#xD;
&#xD;
          -  Pre-pregnancy BMI 25.0-34.9 kg/m2&#xD;
&#xD;
          -  Singleton, intrauterine pregnancy&#xD;
&#xD;
          -  Non-smoker&#xD;
&#xD;
          -  Non-diabetic and negative result on routine prenatal glucose challenge test (GCT)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI &lt;25.0 or ≥35.0 kg/m2&#xD;
&#xD;
          -  &gt;30 week's gestation&#xD;
&#xD;
          -  multiple pregnancy&#xD;
&#xD;
          -  nulliparous&#xD;
&#xD;
          -  present/prior obstetric risk conditions (hypertension, preeclampsia, infections,&#xD;
             placental abnormalities)&#xD;
&#xD;
          -  current smoker&#xD;
&#xD;
          -  current psychiatric disorders or undergoing treatment/taking psychiatric medications&#xD;
&#xD;
          -  Use of systemic/frequent corticosteroids or thyroid meds&#xD;
&#xD;
          -  Diabetic or presence of other metabolic or neuroendocrine disorders&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karen L Lindsay</last_name>
    <role>Principal Investigator</role>
    <affiliation>UC Irvine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCI Medical Center, University of California, Irvine</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Lindsay KL, Buss C, Wadhwa PD, Entringer S. The Interplay between Maternal Nutrition and Stress during Pregnancy: Issues and Considerations. Ann Nutr Metab. 2017;70(3):191-200. doi: 10.1159/000457136. Epub 2017 Mar 17.</citation>
    <PMID>28301838</PMID>
  </reference>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>May 11, 2021</last_update_submitted>
  <last_update_submitted_qc>May 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Irvine</investigator_affiliation>
    <investigator_full_name>Karen Lindsay</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>pregnancy</keyword>
  <keyword>metabolism</keyword>
  <keyword>stress</keyword>
  <keyword>emotional state</keyword>
  <keyword>diet</keyword>
  <keyword>glycemic response</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glucose Intolerance</mesh_term>
    <mesh_term>Stress, Psychological</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/NCT03278392
org study id: UCI 2017-3803
nct id: NCT03278392
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study seeks to understand how a mother's emotional state in pregnancy influences her
      biological response to food intake.
The purpose of this research study is to understand how a mother's emotional state in
      pregnancy influences her biological response to food intake. Natural variation in emotional
      and mental state is frequently experienced in daily life, including during pregnancy. While
      the investigators understand that a healthy diet is important in pregnancy for maintaining
      blood sugar levels and other metabolic factors within normal ranges for optimal development
      of the baby, less consideration is given to the health effects of a mother's mental state
      during pregnancy. It may even be possible that, regardless of what a woman eats or drinks,
      the way her body responds to food may differ according to her emotional or mental state.

      This research is particularly interested in understanding how the combination of maternal
      emotional state and diet influence metabolism in pregnancy. Thus, the aim of this study is to
      test whether and how an individual's emotional response to a mental challenge of varying
      complexity during pregnancy modifies the body's metabolic response to a standard breakfast.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Difference in the glycemic response to the standardized meal +/- psychosocial challenge task
time frame: 2 hours
description: Glycemic response (area-under-the-curve of glucose) to the standardized breakfast drink following exposure to either the psychosocial challenge (TSST) or non-challenge (placebo-TSST) task.
measure: Difference in the triglyceride response to the standardized meal +/- psychosocial challenge task
time frame: 2 hours
description: Area under the curve of blood triglycerides to the standardized breakfast drink following exposure to either the psychosocial challenge (TSST) or non-challenge (placebo-TSST) task.
measure: Physiological stress response to the psychosocial challenge task
time frame: 2 hours
description: Area under the curve of salivary cortisol following exposure to the psychosocial challenge task
arm group label: Psychosocial challenge task
arm group type: Experimental
description: Participants will be assigned to complete the Trier Social Stress Test (TSST) immediately after consuming a standardized breakfast drink
arm group label: Placebo challenge task
arm group type: Sham Comparator
description: Participants will be assigned to complete the placebo non-stress task immediately after consuming a standardized breakfast drink
intervention type: Behavioral
intervention name: Trier Social Stress Test
description: Task instructions provided to subject (5mins), subject prepares speech on their strengths and weaknesses (5 mins), subject delivers speech before a stern evaluative committee while being video-taped (5 mins), subject completes a mental arithmetic challenge task before the evaluative committee with critiques if errors are made (5mins).
arm group label: Psychosocial challenge task
intervention type: Behavioral
intervention name: Placebo Non-stress task
description: Subject engages in a friendly conversation about a neutral or happy topic (e.g. recent holiday, favorite past-times) for 15 minutes with a familiar research staff member.
arm group label: Placebo challenge task
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Karen L Lindsay
role: Principal Investigator
affiliation: UC Irvine
facility: 
country: United States
citation: Lindsay KL, Buss C, Wadhwa PD, Entringer S. The Interplay between Maternal Nutrition and Stress during Pregnancy: Issues and Considerations. Ann Nutr Metab. 2017;70(3):191-200. doi: 10.1159/000457136. Epub 2017 Mar 17.
PMID: 28301838
responsible party type: Principal Investigator
investigator affiliation: University of California, Irvine
investigator full name: Karen Lindsay
investigator title: Principal Investigator
mesh term: Glucose Intolerance
mesh term: Stress, Psychological
sharing ipd: No