NCT03278392

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 11, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

November 17, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2021

Completed
Last Updated

May 13, 2021

Status Verified

May 1, 2021

Enrollment Period

2.5 years

First QC Date

September 6, 2017

Last Update Submit

May 11, 2021

Conditions

Pregnancy RelatedStress, PsychologicalGlucose Intolerance During Pregnancy

Keywords

pregnancymetabolismstressemotional statedietglycemic response

Outcome Measures

Primary Outcomes (1)

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

    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.

    2 hours

Secondary Outcomes (2)

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

    2 hours

  • Physiological stress response to the psychosocial challenge task

    2 hours

Study Arms (2)

Psychosocial challenge task

EXPERIMENTAL

Participants will be assigned to complete the Trier Social Stress Test (TSST) immediately after consuming a standardized breakfast drink

Behavioral: Trier Social Stress Test

Placebo challenge task

SHAM COMPARATOR

Participants will be assigned to complete the placebo non-stress task immediately after consuming a standardized breakfast drink

Behavioral: Placebo Non-stress task

Interventions

Trier Social Stress TestBEHAVIORAL

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).

Psychosocial challenge task
Placebo Non-stress taskBEHAVIORAL

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.

Placebo challenge task

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-40 years
  • Hispanic ethnicity
  • English and/or Spanish speaking
  • Multiparous
  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCI Medical Center, University of California, Irvine

Orange, California, 92868, United States

Location

Related Publications (1)

  • Lindsay KL, Buss C, Wadhwa PD, Entringer S. The Interplay between Maternal Nutrition and Stress during Pregnancy: Issues and Considerations. Ann Nutr Metab. 2017;70(3):191-200. doi: 10.1159/000457136. Epub 2017 Mar 17.

    PMID: 28301838BACKGROUND

MeSH Terms

Conditions

Stress, Psychological

Interventions

Psychological Tests

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

  • Karen L Lindsay

    UC Irvine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 6, 2017

First Posted

September 11, 2017

Study Start

November 17, 2017

Primary Completion

May 1, 2020

Study Completion

May 10, 2021

Last Updated

May 13, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)