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Completed

NCT Number: NCT04430439

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).

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Key information

Conditions

Pregnancy Related Behavior Behavioral Symptoms Emotional Stress Glucose Intolerance During Pregnancy Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Insulin Resistance Insulin Sensitivity/Resistance Metabolic Diseases Nutritional and Metabolic Diseases Postprandial Hyperglycemia Stress, Psychological

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Irvine, Irvine, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychosocial Stress

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

Behavioral

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

Primary outcomes

  1. Postprandial Glycemic Response With Stress Exposure

    Time frame: 2 weeks

    Glycemic response (area-under-the-curve of glucose) to the assigned meal type during the visit with the psychosocial stress task (TSST)

  2. Postprandial Glycemic Response Without Stress Exposure

    Time frame: 2 weeks

    Glycemic response (glucose area-under-the-curve) to the assigned meal type during the visit with the non-stress control condition

Secondary outcomes

  1. Postprandial Insulin Response With Stress Exposure

    Time frame: 2 weeks

    Insulin response (area-under-the-curve) to the assigned meal type during the visit with the standardized stress task

  2. Postprandial Insulin Response Without Stress Exposure

    Time frame: 2 weeks

    Insulin response (area-under-the-curve) to the assigned meal type during the visit with the non-stress control condition

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

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

Registry information

Official study title

Postprandial Response to Emotion-Diet Interactions in Pregnancy

Acronym: PREDIP

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 12, 2020
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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