Maternal Emotions and Diet in Pregnancy

NCT ID: NCT03278392

Last Updated: 2021-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-17

Study Completion Date

2021-05-10

Brief Summary

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

Detailed Description

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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.

Conditions

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Pregnancy Related Stress, Psychological Glucose Intolerance During Pregnancy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Psychosocial challenge task

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

Group Type EXPERIMENTAL

Trier Social Stress Test

Intervention Type 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 challenge task

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

Group Type SHAM_COMPARATOR

Placebo Non-stress task

Intervention Type 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.

Interventions

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Trier Social Stress Test

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

Placebo Non-stress task

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role collaborator

University of California, Davis

OTHER

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Karen Lindsay

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen L Lindsay

Role: PRINCIPAL_INVESTIGATOR

UC Irvine

Locations

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UCI Medical Center, University of California, Irvine

Orange, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 28301838 (View on PubMed)

Other Identifiers

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UCI 2017-3803

Identifier Type: -

Identifier Source: org_study_id

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