Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 11:37 PM
Study NCT ID:
NCT03517293
Status:
COMPLETED
Last Update Posted:
2023-08-08
First Post:
2018-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Enhanced Neonatal Health and Neonatal Cardiac Effect Developmentally
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Due to the nature of an exercise study, the participant cannot be blinded to the group. However, those assessing outcomes are blinded to group assignment.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'women were randomly assigned to either aerobic exercise intervention or no exercise.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-05', 'studyFirstSubmitDate': '2018-02-13', 'studyFirstSubmitQcDate': '2018-04-24', 'lastUpdatePostDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Offspring neuromotor outomces', 'timeFrame': 'One-month after birth', 'description': 'Neuromotor scores on PDMS-2 test'}], 'primaryOutcomes': [{'measure': 'Offspring Heart Development Measures', 'timeFrame': '36 week gestational age', 'description': 'Heart Rate'}, {'measure': 'Offspring Heart Development Measures', 'timeFrame': 'One-month after birth', 'description': 'Heart Rate'}], 'secondaryOutcomes': [{'measure': 'Offspring Adipose Development Measures', 'timeFrame': '36 week gestational age', 'description': 'body fat'}, {'measure': 'Offspring Adipose Development Measures', 'timeFrame': 'One-month after birth', 'description': 'body fat'}, {'measure': 'Offspring Body Development Measures', 'timeFrame': 'One-month after birth', 'description': 'Lean Mass %'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Physical Exercise']}, 'referencesModule': {'references': [{'pmid': '37259255', 'type': 'DERIVED', 'citation': 'May LE, McDonald S, Stewart C, Newton E, Isler C, Steed D, Sarno LA, Kelley GA, Chasan-Taber L, Kuehn D, Allman-Tucker BR, Strom C, Claiborne A, Fang X. Influence of Supervised Maternal Aerobic Exercise during Pregnancy on 1-Month-Old Neonatal Cardiac Function and Outflow: A Pilot Study. Med Sci Sports Exerc. 2023 Nov 1;55(11):1977-1984. doi: 10.1249/MSS.0000000000003227. Epub 2023 Jun 1.'}]}, 'descriptionModule': {'briefSummary': 'AHA and ACSM recognize lack of exercise is a major risk factor for developing cardiovascular disease (CVD), and other CVD risk factors such as obesity. It is important to note that CVD is the sixth leading cause of death and children are more likely to be undiagnosed due to their age and lack of symptoms. Further, according to the CDC, over one-third of children and adolescents are overweight or obese and at increased risk of CVD. Although many programs for children aim to decrease CVD risks and obesity few, if any, programs begin the intervention during prenatal development. Our preliminary findings suggest that regular maternal exercise improves cardiovascular health (lower heart rate, increased heart rate variability), normalizes body fat composition, and improves nervous system and motor tone even after birth. Norepinephrine is essential for fetal development, influences many tissues (heart, nerve cells, skeletal muscle, and fat cells), and can stimulate growth factors. It is believed that exercise hormones, such as norepinephrine, released during maternal exercise influence these growth factors during development.\n\nThe central hypothesis of this proposal is that regular maternal exercise during pregnancy will improve the health of offspring before and after birth as evidenced by lower resting heart rate, increasing heart rate variability improved neurological maturation, and decreased adiposity. We have three specific aims to test this hypothesis through the Enhanced Neonatal Health and Neonatal Cardiovascular Efficiency Developmentally (ENHANCED) by Mom project (IRB approved #12-002524). Aim 1 will establish the association between maternal exercise during pregnancy and the heart health of offspring before and after birth. Aim 2 will determine the relationship between modes of regular maternal exercise and neonate neurological and muscular maturation as this relates to health of the child after birth. Aim 3 will elucidate the influence of different modes of maternal exercise during pregnancy on fetal and infant body composition as this relates to risk of obesity and CVD disease. These studies will provide novel insight into how different types of maternal exercise during pregnancy influence the overall health of offspring. Furthermore, these findings may have significant implications on the public health as it may provide evidence of pregnancy as the earliest intervention for attenuating cardiovascular disease risk of children.', 'detailedDescription': 'Recent studies have shown alarming increases in some of the major modifiable risk factors for heart disease (cholesterol, blood pressure, adiposity) in young children. We have previously found an association between self-reported exercise during pregnancy and improved heart measures of the fetus and neonate. In addition, a limited number of studies in which exercise was self-reported have demonstrated improved heart and adipose measures in the fetus or neonate with effects that persist into childhood. Previous prenatal exercise intervention studies using a prescribed exercise regimen have demonstrated the feasibility of such an approach; however, these studies have focused on maternal health and pregnancy outcomes such as birth weight. At this point, there is a gap in our understanding as to how carefully controlled, regular maternal aerobic exercise programs may lead to improvements in cardiovascular and adiposity risk factors in utero and in neonates.\n\nThe central hypothesis of this project is that maternal exercise during pregnancy will improve the health of the offspring. Specifically, the objectives of the research proposed in this application are to determine the effects of regular maternal exercise on heart function, adiposity, and neur0motor function of offspring\n\nThe data gathered will be the first documentation, by direct measurement, of the effects of maternal aerobic exercise on selected heart and obesity outcomes during the prenatal and postnatal periods. The potential impact of the proposed research on public health education regarding heart disease and obesity prevention is of public import.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Since this is a pregnancy study, all participants are female.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18 to 35 years BMI between 18.5 - 34.9 Pregnancy: Singleton; between 13-16 weeks gestation (based on ultrasound dating) Health Status: Healthy, no chronic illness that affects fetal growth; Clearance by Obstetric provider (no contraindications to exercise) Communication: fluent in English, available for contact by phone and email\n\nExclusion Criteria:\n\n* Age: ≤ 17.9 or ≥ 35.9 years of age BMI \\<18.49 or \\>35 Pregnancy: expecting multiples; or ≥16 wks. Health Status: Any chronic condition (i.e. diabetes, hypertension, HIV, mental health disorders, etc.) that may affect fetal development Communication: unable to consent in English; No telephone/email contact Taking medicine known to affect fetal development/pregnancy outcomes (i.e. SSRI) Use of tobacco, alcohol, or other recreational drugs No transportation'}, 'identificationModule': {'nctId': 'NCT03517293', 'acronym': 'ENHANCED', 'briefTitle': 'Enhanced Neonatal Health and Neonatal Cardiac Effect Developmentally', 'organization': {'class': 'OTHER', 'fullName': 'East Carolina University'}, 'officialTitle': 'Enhanced Neonatal Health and Neonatal Cardiac Effect Developmentally', 'orgStudyIdInfo': {'id': '12-002524'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aerobic Exercise Intervention', 'description': 'Aerobic Exercise training 50 minutes of moderate intensity exercise, 3 times per week from \\~16-40 weeks of pregnancy', 'interventionNames': ['Behavioral: Aerobic Exercise training']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'usual daily activities - not exercise, not elevating heart rate'}], 'interventions': [{'name': 'Aerobic Exercise training', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Aerobic Exercise Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'East Carolina University', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}], 'overallOfficials': [{'name': 'Linda E May, MS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'East Carolina University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'East Carolina University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Linda May', 'investigatorAffiliation': 'East Carolina University'}}}}