Study Results
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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COMPLETED
NA
38 participants
INTERVENTIONAL
2017-11-17
2021-05-10
Brief Summary
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Detailed Description
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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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Study Design
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NON_RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
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
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).
Placebo challenge task
Participants will be assigned to complete the placebo non-stress task immediately after consuming a standardized breakfast drink
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.
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).
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* \>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
18 Years
40 Years
FEMALE
Yes
Sponsors
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University of California, San Francisco
OTHER
University of California, Davis
OTHER
University of California, Irvine
OTHER
Responsible Party
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Karen Lindsay
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
Countries
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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.
Other Identifiers
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UCI 2017-3803
Identifier Type: -
Identifier Source: org_study_id
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