Maternal Emotions and Diet in Pregnancy (PEDIMet)

Prenatal Emotion-Diet Interactions and the Metabolic Response

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

Study Overview

• Status: Completed
• Conditions: Stress, Psychological; Pregnancy Related; Glucose Intolerance During Pregnancy
• Intervention / Treatment: Behavioral: Trier Social Stress Test; Behavioral: Placebo Non-stress task

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • UCI Medical Center, University of California, Irvine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

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

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: University of California, Davis; University of California, San Francisco
• Investigators: Principal Investigator: Karen L Lindsay, UC Irvine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2017
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): May 10, 2021

Study Registration Dates

• First Submitted: September 6, 2017
• First Submitted That Met QC Criteria: September 8, 2017
• First Posted (Actual): September 11, 2017

Study Record Updates

• Last Update Posted (Actual): May 13, 2021
• Last Update Submitted That Met QC Criteria: May 11, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: pregnancy; stress; diet; metabolism; glycemic response; emotional state
• Additional Relevant MeSH Terms: Behavioral Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Stress, Psychological; Glucose Intolerance
• Other Study ID Numbers: UCI 2017-3803

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No