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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

Tracking Information
First Submitted Date  ICMJE February 13, 2018
First Posted Date  ICMJE May 7, 2018
Last Update Posted Date July 23, 2020
Actual Study Start Date  ICMJE July 1, 2015
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2019)
  • Offspring Heart Development Measures [ Time Frame: 36 week gestational age ]
    Heart Rate
  • Offspring Heart Development Measures [ Time Frame: One-month after birth ]
    Heart Rate
Original Primary Outcome Measures  ICMJE
 (submitted: April 24, 2018)
Offspring Heart Development Measures [ Time Frame: One-month after birth ]
Heart Rate
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2019)
  • 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 %
Original Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2018)
  • Offspring Adipose Development Measures [ Time Frame: One-month after birth ]
    body fat
  • Offspring Body Development Measures [ Time Frame: One-month after birth ]
    Lean Mass %
Current Other Pre-specified Outcome Measures
 (submitted: April 24, 2018)
Offspring neuromotor outomces [ Time Frame: One-month after birth ]
Neuromotor scores on PDMS-2 test
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Enhanced Neonatal Health and Neonatal Cardiac Effect Developmentally
Official Title  ICMJE Enhanced Neonatal Health and Neonatal Cardiac Effect Developmentally
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Physical Exercise
Intervention  ICMJE Behavioral: Aerobic Exercise training
Study Arms  ICMJE
  • Experimental: Aerobic Exercise Intervention
    Aerobic Exercise training 50 minutes of moderate intensity exercise, 3 times per week from ~16-40 weeks of pregnancy
    Intervention: Behavioral: Aerobic Exercise training
  • No Intervention: Control
    usual daily activities - not exercise, not elevating heart rate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 24, 2018)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2021
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Since this is a pregnancy study, all participants are female.
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Linda E May, MS, PhD 252-737-7072 mayl@ecu.edu
Contact: Devon Kuehn, MD KUEHND@ECU.EDU
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03517293
Other Study ID Numbers  ICMJE 12-002524
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Linda May, East Carolina University
Study Sponsor  ICMJE East Carolina University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Linda E May, MS, PhD East Carolina University
PRS Account East Carolina University
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP