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 : March 25, 2020
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|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|
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.
- 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.
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278392
|Contact: Karen Lindsayfirstname.lastname@example.org|
|United States, California|
|UCI Medical Center, University of California, Irvine||Recruiting|
|Orange, California, United States, 92868|
|Contact: Karen Lindsay, PhD 714-456-8401 email@example.com|
|Principal Investigator:||Karen L Lindsay||UC Irvine|