Maternal Emotions and Diet in Pregnancy

Pregnancy Related Clinical Trial

— PEDIMet  

Official title:

Prenatal Emotion-Diet Interactions and the Metabolic Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03278392
• Other study ID #: UCI 2017-3803
• Status: Completed
• Phase: N/A
• Start date: November 17, 2017
• Est. completion date: May 10, 2021

Study information

• Verified date: May 2021
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 10, 2021
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• Glucose Intolerance During Pregnancy
• Pregnancy Related
• Stress, Psychological

Intervention

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).
• 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.

Locations

Country	Name	City	State
United States	UCI Medical Center, University of California, Irvine	Orange	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Irvine	University of California, Davis, University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in the glycemic response to the standardized meal +/- psychosocial challenge task	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.	2 hours
Secondary	Difference in the triglyceride response to the standardized meal +/- psychosocial challenge task	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 hours
Secondary	Physiological stress response to the psychosocial challenge task	Area under the curve of salivary cortisol following exposure to the psychosocial challenge task	2 hours