Status:

COMPLETED

Emotion-Diet Interactions in Pregnancy

Lead Sponsor:

University of California, Irvine

Collaborating Sponsors:

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

Conditions:

Pregnancy Related

Stress, Psychological

Eligibility:

FEMALE

18-40 years

Phase:

NA

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 t...

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 11 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 28 2024

Estimated Enrollment :

113 Patients enrolled

Trial Details

Trial ID

NCT04430439

Start Date

May 11 2021

End Date

February 28 2024

Last Update

August 22 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

University of California, Irvine

Irvine, California, United States, 92617

2

UCI Medical Center, University of California, Irvine

Orange, California, United States, 92868

Emotion-Diet Interactions in Pregnancy | DecenTrialz