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Maternal Emotions and Diet in Pregnancy (PEDIMet)

Primary Purpose

Pregnancy Related, Stress, Psychological, Glucose Intolerance During Pregnancy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trier Social Stress Test
Placebo Non-stress task
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pregnancy Related focused on measuring pregnancy, metabolism, stress, emotional state, diet, glycemic response

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts 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

Sites / Locations

  • UCI Medical Center, University of California, Irvine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Psychosocial challenge task

Placebo challenge task

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Difference in the triglyceride response to the standardized meal +/- psychosocial challenge task
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.
Physiological stress response to the psychosocial challenge task
Area under the curve of salivary cortisol following exposure to the psychosocial challenge task

Full Information

First Posted
September 6, 2017
Last Updated
May 11, 2021
Sponsor
University of California, Irvine
Collaborators
University of California, San Francisco, University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT03278392
Brief Title
Maternal Emotions and Diet in Pregnancy
Acronym
PEDIMet
Official Title
Prenatal Emotion-Diet Interactions and the Metabolic Response
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
November 17, 2017 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
May 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
Collaborators
University of California, San Francisco, University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related, Stress, Psychological, Glucose Intolerance During Pregnancy
Keywords
pregnancy, metabolism, stress, emotional state, diet, glycemic response

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Psychosocial challenge task
Arm Type
Experimental
Arm Description
Participants will be assigned to complete the Trier Social Stress Test (TSST) immediately after consuming a standardized breakfast drink
Arm Title
Placebo challenge task
Arm Type
Sham Comparator
Arm Description
Participants will be assigned to complete the placebo non-stress task immediately after consuming a standardized breakfast drink
Intervention Type
Behavioral
Intervention Name(s)
Trier Social Stress Test
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Placebo Non-stress task
Intervention Description
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 Outcome Measure Information:
Title
Difference in the glycemic response to the standardized meal +/- psychosocial challenge task
Description
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.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Difference in the triglyceride response to the standardized meal +/- psychosocial challenge task
Description
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.
Time Frame
2 hours
Title
Physiological stress response to the psychosocial challenge task
Description
Area under the curve of salivary cortisol following exposure to the psychosocial challenge task
Time Frame
2 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen L Lindsay
Organizational Affiliation
UC Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCI Medical Center, University of California, Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28301838
Citation
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.
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Maternal Emotions and Diet in Pregnancy

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