Enhanced Neonatal Health and Neonatal Cardiac Effect Developmentally (ENHANCED)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03517293|
Recruitment Status : Recruiting
First Posted : May 7, 2018
Last Update Posted : July 23, 2020
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|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.|
|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|
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
- Offspring Heart Development Measures [ Time Frame: 36 week gestational age ]Heart Rate
- Offspring Heart Development Measures [ Time Frame: One-month after birth ]Heart Rate
- Offspring Adipose Development Measures [ Time Frame: 36 week gestational age ]body fat
- Offspring Adipose Development Measures [ Time Frame: One-month after birth ]body fat
- Offspring Body Development Measures [ Time Frame: One-month after birth ]Lean Mass %
- Offspring neuromotor outomces [ Time Frame: One-month after birth ]Neuromotor scores on PDMS-2 test
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
|Contact: Linda E May, MS, PhDfirstname.lastname@example.org|
|Contact: Devon Kuehn, MD||KUEHND@ECU.EDU|
|Principal Investigator:||Linda E May, MS, PhD||East Carolina University|