Clinical trial NCT03278392: Maternal Emotions and Diet in Pregnancy
Official title: Prenatal Emotion-Diet Interactions and the Metabolic Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Stress, Psychological
Glucose Intolerance During Pregnancy
Keywords: pregnancy
metabolism
stress
emotional state
diet
glycemic response
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: University of California, Davis
First posted: 2017-09-11
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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

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.

Eligibility 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

Primary outcomes:
measure: Difference in the glycemic response to the standardized meal +/- psychosocial challenge task
timeFrame: 2 hours
Secondary outcomes:
measure: Difference in the triglyceride response to the standardized meal +/- psychosocial challenge task
timeFrame: 2 hours
measure: Physiological stress response to the psychosocial challenge task
timeFrame: 2 hours
Other outcomes:
Locations:
city: Orange
country: United States
facility: UCI Medical Center, University of California, Irvine
state: California
Study officials:
affiliation: UC Irvine
name: Karen L Lindsay
role: PRINCIPAL_INVESTIGATOR
References:
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.