Maternal Emotions and Diet in Pregnancy

Not Applicable

Completed

• Conditions: Pregnancy Related; Glucose Intolerance During Pregnancy; Stress, Psychological
• Interventions: Behavioral: Placebo Non-stress task; Behavioral: Trier Social Stress Test

• Registration Number: NCT03278392
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2017-09-06
• Study First Submitted QC: 2017-09-08
• Study First Posted: 2017-09-11
• Study Start: 2017-11-17
• Primary Completion: 2020-05-01
• Status Verified: 2021-05
• Study Completion: 2021-05-10
• Last Update Submitted: 2021-05-11
• Last Update Posted: 2021-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo challenge task	Placebo Non-stress task	Participants will be assigned to complete the placebo non-stress task immediately after consuming a standardized breakfast drink
Psychosocial challenge task	Trier Social Stress Test	Participants will be assigned to complete the Trier Social Stress Test (TSST) immediately after consuming a standardized breakfast drink

Primary Outcome Measures

Name	Time	Method
Difference in the glycemic response to the standardized meal +/- psychosocial challenge task	2 hours	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.

Secondary Outcome Measures

Name	Time	Method
Difference in the triglyceride response to the standardized meal +/- psychosocial challenge task	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	2 hours	Area under the curve of salivary cortisol following exposure to the psychosocial challenge task

Trial Locations

Locations (1)

UCI Medical Center, University of California, Irvine; 🇺🇸 Orange, California, United States