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Enhanced Neonatal Health and Neonatal Cardiac Effect Developmentally (ENHANCED)

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ClinicalTrials.gov Identifier: NCT03517293
Recruitment Status : Recruiting
First Posted : May 7, 2018
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
Linda May, East Carolina University

Brief Summary:

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.

The 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.


Condition or disease Intervention/treatment Phase
Physical Exercise Behavioral: Aerobic Exercise training Not Applicable

Detailed Description:

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.

The 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

The 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: women were randomly assigned to either aerobic exercise intervention or no exercise.
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Enhanced Neonatal Health and Neonatal Cardiac Effect Developmentally
Actual Study Start Date : July 1, 2015
Actual Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aerobic Exercise Intervention
Aerobic Exercise training 50 minutes of moderate intensity exercise, 3 times per week from ~16-40 weeks of pregnancy
Behavioral: Aerobic Exercise training
No Intervention: Control
usual daily activities - not exercise, not elevating heart rate



Primary Outcome Measures :
  1. Offspring Heart Development Measures [ Time Frame: 36 week gestational age ]
    Heart Rate

  2. Offspring Heart Development Measures [ Time Frame: One-month after birth ]
    Heart Rate


Secondary Outcome Measures :
  1. Offspring Adipose Development Measures [ Time Frame: 36 week gestational age ]
    body fat

  2. Offspring Adipose Development Measures [ Time Frame: One-month after birth ]
    body fat

  3. Offspring Body Development Measures [ Time Frame: One-month after birth ]
    Lean Mass %


Other Outcome Measures:
  1. Offspring neuromotor outomces [ Time Frame: One-month after birth ]
    Neuromotor scores on PDMS-2 test



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Since this is a pregnancy study, all participants are female.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03517293


Contacts
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Contact: Linda E May, MS, PhD 252-737-7072 mayl@ecu.edu
Contact: Devon Kuehn, MD KUEHND@ECU.EDU

Locations
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United States, North Carolina
East Carolina University Recruiting
Greenville, North Carolina, United States, 27834
Contact: Linda E May, MS, PhD    252-737-7072    mayl@ecu.edu   
Contact: Devon Kuehn, MD       kuehnd@ecu.edu   
Sponsors and Collaborators
East Carolina University
Investigators
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Principal Investigator: Linda E May, MS, PhD East Carolina University
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Responsible Party: Linda May, Assistant Professor, East Carolina University
ClinicalTrials.gov Identifier: NCT03517293    
Other Study ID Numbers: 12-002524
First Posted: May 7, 2018    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No