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Completed

NCT Number: NCT03278392

Maternal Emotions and Diet in Pregnancy

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

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UCI Medical Center, University of California, Irvine

Orange, California, 92868, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Trier Social Stress Test

Behavioral

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).

Placebo Non-stress task

Behavioral

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.

Primary outcomes

  1. Difference in the glycemic response to the standardized meal +/- psychosocial challenge task

    Time frame: 2 hours

    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.

Secondary outcomes

  1. Difference in the triglyceride response to the standardized meal +/- psychosocial challenge task

    Time frame: 2 hours

    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. Physiological stress response to the psychosocial challenge task

    Time frame: 2 hours

    Area under the curve of salivary cortisol following exposure to the psychosocial challenge task

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

  • University of California, Davis
  • University of California, San Francisco

Registry information

Official study title

Prenatal Emotion-Diet Interactions and the Metabolic Response

Acronym: PEDIMet

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Sep 11, 2017
Registry last updated
May 13, 2021

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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