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Maternal Emotions and Diet in Pregnancy (PEDIMet)

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ClinicalTrials.gov Identifier: NCT03278392
Recruitment Status : Recruiting
First Posted : September 11, 2017
Last Update Posted : February 5, 2019
Sponsor:
Collaborators:
University of California, San Francisco
University of California, Davis
Information provided by (Responsible Party):
Karen Lindsay, University of California, Irvine

Brief Summary:
This study seeks to understand how a mother's emotional state in pregnancy influences her biological response to food intake.

Condition or disease Intervention/treatment Phase
Pregnancy Related Stress, Psychological Glucose Intolerance During Pregnancy Behavioral: Trier Social Stress Test Behavioral: Placebo Non-stress task Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Prenatal Emotion-Diet Interactions and the Metabolic Response
Actual Study Start Date : November 17, 2017
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2021

Arm Intervention/treatment
Experimental: Psychosocial challenge task
Participants will be assigned to complete the Trier Social Stress Test (TSST) immediately after consuming a standardized breakfast drink
Behavioral: Trier Social Stress Test
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).

Sham Comparator: Placebo challenge task
Participants will be assigned to complete the placebo non-stress task immediately after consuming a standardized breakfast drink
Behavioral: Placebo Non-stress task
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.




Primary Outcome Measures :
  1. Difference in the glycemic response to the standardized meal +/- psychosocial challenge task [ Time Frame: 2 hours ]
    Glycemic response (area-under-the-curve of glucose/insulin ratio) to the standardized breakfast drink following exposure to either the psychosocial challenge (TSST) or non-challenge (placebo-TSST) task.


Secondary Outcome Measures :
  1. Difference in the triglyceride response to the standardized meal +/- psychosocial challenge task [ Time Frame: 2 hours ]
    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.

  2. Physiological stress response to the psychosocial challenge task [ Time Frame: 2 hours ]
    Area under the curve of salivary cortisol following exposure to the psychosocial challenge task



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-40 years
  • Hispanic ethnicity
  • English and/or Spanish speaking
  • Multiparous
  • 28-30 week's gestation
  • Pre-pregnancy BMI 25.0-34.9 kg/m2
  • Singleton, intrauterine pregnancy
  • Non-smoker
  • Non-diabetic and negative result on routine prenatal glucose challenge test (GCT)

Exclusion Criteria:

  • BMI <25.0 or ≥35.0 kg/m2
  • >30 week's gestation
  • multiple pregnancy
  • nulliparous
  • present/prior obstetric risk conditions (hypertension, preeclampsia, infections, placental abnormalities)
  • current smoker
  • current psychiatric disorders or undergoing treatment/taking psychiatric medications
  • Use of systemic/frequent corticosteroids or thyroid meds
  • Diabetic or presence of other metabolic or neuroendocrine disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278392


Contacts
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Contact: Karen Lindsay 714-456-8401 kllindsa@uci.edu

Locations
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United States, California
UCI Medical Center, University of California, Irvine Recruiting
Orange, California, United States, 92868
Contact: Karen Lindsay, PhD    714-456-8401    kllindsa@uci.edu   
Sponsors and Collaborators
University of California, Irvine
University of California, San Francisco
University of California, Davis
Investigators
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Principal Investigator: Karen L Lindsay UC Irvine

Publications:
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Responsible Party: Karen Lindsay, Principal Investigator, University of California, Irvine
ClinicalTrials.gov Identifier: NCT03278392     History of Changes
Other Study ID Numbers: UCI2017-3803
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Karen Lindsay, University of California, Irvine:
pregnancy
metabolism
stress
emotional state
diet
glycemic response

Additional relevant MeSH terms:
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Glucose Intolerance
Stress, Psychological
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Behavioral Symptoms