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Maternal Emotions and Diet in Pregnancy (PEDIMet)

University of California Irvine (UCI) logo

University of California Irvine (UCI)

Status

Completed

Conditions

Pregnancy Related
Glucose Intolerance During Pregnancy
Stress, Psychological

Treatments

Behavioral: Placebo Non-stress task
Behavioral: Trier Social Stress Test

Study type

Interventional

Funder types

Other

Identifiers

NCT03278392
UCI 2017-3803

Details and patient eligibility

About

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

Full description

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.

Enrollment

38 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

38 participants in 2 patient groups

Psychosocial challenge task
Experimental group
Description:
Participants will be assigned to complete the Trier Social Stress Test (TSST) immediately after consuming a standardized breakfast drink
Treatment:
Behavioral: Trier Social Stress Test
Placebo challenge task
Sham Comparator group
Description:
Participants will be assigned to complete the placebo non-stress task immediately after consuming a standardized breakfast drink
Treatment:
Behavioral: Placebo Non-stress task

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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