Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-01-04 @ 2:57 AM
Study NCT ID:
NCT03278392
Status:
COMPLETED
Last Update Posted:
2021-05-13
First Post:
2017-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maternal Emotions and Diet in Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013315', 'term': 'Stress, Psychological'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011581', 'term': 'Psychological Tests'}], 'ancestors': [{'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-11', 'studyFirstSubmitDate': '2017-09-06', 'studyFirstSubmitQcDate': '2017-09-08', 'lastUpdatePostDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in the glycemic response to the standardized meal +/- psychosocial challenge task', 'timeFrame': '2 hours', '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.'}], 'secondaryOutcomes': [{'measure': 'Difference in the triglyceride response to the standardized meal +/- psychosocial challenge task', 'timeFrame': '2 hours', '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.'}, {'measure': 'Physiological stress response to the psychosocial challenge task', 'timeFrame': '2 hours', 'description': 'Area under the curve of salivary cortisol following exposure to the psychosocial challenge task'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pregnancy', 'metabolism', 'stress', 'emotional state', 'diet', 'glycemic response'], 'conditions': ['Pregnancy Related', 'Stress, Psychological', 'Glucose Intolerance During Pregnancy']}, 'referencesModule': {'references': [{'pmid': '28301838', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': "This study seeks to understand how a mother's emotional state in pregnancy influences her biological response to food intake.", 'detailedDescription': "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.\n\nThis 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18-40 years\n* Hispanic ethnicity\n* English and/or Spanish speaking\n* Multiparous\n* 28-30 week's gestation\n* Pre-pregnancy BMI 25.0-34.9 kg/m2\n* Singleton, intrauterine pregnancy\n* Non-smoker\n* Non-diabetic and negative result on routine prenatal glucose challenge test (GCT)\n\nExclusion Criteria:\n\n* BMI \\<25.0 or ≥35.0 kg/m2\n* \\>30 week's gestation\n* multiple pregnancy\n* nulliparous\n* present/prior obstetric risk conditions (hypertension, preeclampsia, infections, placental abnormalities)\n* current smoker\n* current psychiatric disorders or undergoing treatment/taking psychiatric medications\n* Use of systemic/frequent corticosteroids or thyroid meds\n* Diabetic or presence of other metabolic or neuroendocrine disorders"}, 'identificationModule': {'nctId': 'NCT03278392', 'acronym': 'PEDIMet', 'briefTitle': 'Maternal Emotions and Diet in Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Prenatal Emotion-Diet Interactions and the Metabolic Response', 'orgStudyIdInfo': {'id': 'UCI 2017-3803'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Psychosocial challenge task', 'description': 'Participants will be assigned to complete the Trier Social Stress Test (TSST) immediately after consuming a standardized breakfast drink', 'interventionNames': ['Behavioral: Trier Social Stress Test']}, {'type': 'SHAM_COMPARATOR', 'label': 'Placebo challenge task', 'description': 'Participants will be assigned to complete the placebo non-stress task immediately after consuming a standardized breakfast drink', 'interventionNames': ['Behavioral: Placebo Non-stress task']}], 'interventions': [{'name': 'Trier Social Stress Test', 'type': 'BEHAVIORAL', '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).', 'armGroupLabels': ['Psychosocial challenge task']}, {'name': 'Placebo Non-stress task', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Placebo challenge task']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'UCI Medical Center, University of California, Irvine', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}], 'overallOfficials': [{'name': 'Karen L Lindsay', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UC Irvine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, San Francisco', 'class': 'OTHER'}, {'name': 'University of California, Davis', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Karen Lindsay', 'investigatorAffiliation': 'University of California, Irvine'}}}}