Emotion-Diet Interactions in Pregnancy

NCT ID: NCT04430439

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-11
• Study Completion Date: 2024-02-28

Brief Summary

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).

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.

Conditions

Pregnancy Related; Stress, Psychological; Glucose Intolerance During Pregnancy; Emotional Stress; Postprandial Hyperglycemia; Insulin Sensitivity/Resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Psychosocial stress

Participants will complete the Trier Social Stress Test (TSST) immediately following consumption of their assigned meal type (low or high GI).

Group Type: EXPERIMENTAL

Psychosocial stress

Intervention Type: BEHAVIORAL

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.

Control non-stress

Participants will complete a non-stress relaxed task immediately following consumption of their assigned meal type (low or high GI).

Group Type: ACTIVE_COMPARATOR

Control non-stress

Intervention Type: BEHAVIORAL

Participants will have a relaxed 15 minute conversation with a familiar research team member.

Interventions

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.

Intervention Type: BEHAVIORAL

Control non-stress

Participants will have a relaxed 15 minute conversation with a familiar research team member.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Karen Lindsay

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of California, Irvine

Irvine, California, United States

UCI Medical Center, University of California, Irvine

Orange, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

R00HD096109

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20205914

Identifier Type: -

Identifier Source: org_study_id