Emotion-Diet Interactions in Pregnancy (PREDIP)

Postprandial Response to Emotion-Diet Interactions in Pregnancy

This study will investigate how maternal emotional state following a controlled stress exposure in pregnancy influences blood glucose and insulin levels after eating a standardized meal, and whether the effects of emotional state on blood glucose and insulin is different after eating a healthy meal (low GI) compared to a less healthy meal (high GI).

Study Overview

• Status: Completed
• Conditions: Stress, Psychological; Pregnancy Related; Insulin Sensitivity/Resistance; Emotional Stress; Postprandial Hyperglycemia; Glucose Intolerance During Pregnancy
• Intervention / Treatment: Behavioral: Psychosocial stress; Behavioral: Control non-stress

Detailed Description

Maternal glucose-insulin homeostasis in pregnancy represents one of the most important physiological processes for maternal and child health outcomes. Although maternal diet is a key regulator of this process, its effects vary widely across individuals. Maternal stress could represent a moderator of considerable importance in this regard, yet little is known about the effects of stress on glycemic control in pregnancy and whether the effects of stress may vary as a function of diet quality. This project will investigate the effects of acute psychosocial stress exposure on the postprandial metabolic response to a meal of varying glycemic index (GI) among women with overweight/obesity in mid-pregnancy.

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92617
      • University of California, Irvine
    • 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

Description

Inclusion Criteria:

• English and/or Spanish speaking
• 18-22 week's gestation
• Pre-pregnancy BMI 25.0-39.9 kg/m2
• Singleton, intrauterine pregnancy
• Non-smoker
• Non-diabetic and normal result on a random peripheral blood glucose test at the screening visit (<200 mg/dl)

Exclusion Criteria:

• Non-fluency in English or Spanish
• BMI <25.0 or ≥40.0 kg/m2
• >22 week's gestation
• multiple pregnancy
• current smoker
• present/prior obstetric conditions (preeclampsia, infections, placental abnormalities, uterine anomalies, congenital malformations, fetal chromosomal abnormalities)
• presence of any conditions that may dysregulate neuroendocrine, metabolic or cardiovascular function, such as diabetes, hepatic, renal, or autoimmune disorders
• current psychiatric disorders or undergoing treatment/taking psychiatric medications
• use of systemic/frequent corticosteroids or thyroid, lipid-lowering or anti-diabetic medications
• gestational diabetes mellitus or raised glucose result detected on the screening visit
• unwilling to eat the standard breakfast meal at each laboratory visit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Psychosocial stress; Participants will complete the Trier Social Stress Test (TSST) immediately following consumption of their assigned meal type (low or high GI).	Behavioral: Psychosocial stress; The TSST is a 15 minute standardized lab-based challenge task that involves speech preparation, speech delivery while being evaluated by strangers and video taped, and complex mental arithmetic with critiques if errors are made.
Active Comparator: Control non-stress; Participants will complete a non-stress relaxed task immediately following consumption of their assigned meal type (low or high GI).	Behavioral: Control non-stress; Participants will have a relaxed 15 minute conversation with a familiar research team member.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial Glycemic Response With Stress Exposure	Glycemic response (area-under-the-curve of glucose) to the assigned meal type during the visit with the psychosocial stress task (TSST)	2 weeks
Postprandial Glycemic Response Without Stress Exposure	Glycemic response (glucose area-under-the-curve) to the assigned meal type during the visit with the non-stress control condition	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial Insulin Response With Stress Exposure	Insulin response (area-under-the-curve) to the assigned meal type during the visit with the standardized stress task	2 weeks
Postprandial Insulin Response Without Stress Exposure	Insulin response (area-under-the-curve) to the assigned meal type during the visit with the non-stress control condition	2 weeks

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2021
• Primary Completion (Actual): February 14, 2024
• Study Completion (Actual): February 28, 2024

Study Registration Dates

• First Submitted: June 10, 2020
• First Submitted That Met QC Criteria: June 10, 2020
• First Posted (Actual): June 12, 2020

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 15, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Behavioral Symptoms; Glucose Metabolism Disorders; Hyperinsulinism; Hyperglycemia; Insulin Resistance; Stress, Psychological; Glucose Intolerance
• Other Study ID Numbers: 20205914; R00HD096109 (U.S. NIH Grant/Contract)

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
• product manufactured in and exported from the U.S.: No