Maternal Emotions and Diet in Pregnancy

Study Overview
=================
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.

Official Title
-----------------
Prenatal Emotion-Diet Interactions and the Metabolic Response

Conditions
-----------------
Pregnancy Related, Stress, Psychological, Glucose Intolerance During Pregnancy

Intervention / Treatment
-----------------
* Behavioral: Trier Social Stress Test
* Behavioral: Placebo Non-stress task


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychosocial challenge task<br>Participants will be assigned to complete the Trier Social Stress Test (TSST) immediately after consuming a standardized breakfast drink | Behavioral: Trier Social Stress Test<br>* 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).<br>|
| Sham Comparator: Placebo challenge task<br>Participants will be assigned to complete the placebo non-stress task immediately after consuming a standardized breakfast drink | Behavioral: Placebo Non-stress task<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Physiological stress response to the psychosocial challenge task | Area under the curve of salivary cortisol following exposure to the psychosocial challenge task | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pregnancy, metabolism, stress, emotional state, diet, glycemic response