Enhanced Neonatal Health and Neonatal Cardiac Effect Developmentally

NCT03517293 | Completed

• 1 other identifier: 12-002524
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Exercise

Outcome Measures

Primary Outcomes (2)

• Offspring Heart Development Measures

  Heart Rate

  36 week gestational age

• Offspring Heart Development Measures

  Heart Rate

  One-month after birth

Secondary Outcomes (3)

• Offspring Adipose Development Measures

  36 week gestational age

• Offspring Adipose Development Measures

  One-month after birth

• Offspring Body Development Measures

  One-month after birth

Other Outcomes (1)

• Offspring neuromotor outomces

  One-month after birth

Study Arms (2)

Aerobic Exercise Intervention

EXPERIMENTAL

Aerobic Exercise training 50 minutes of moderate intensity exercise, 3 times per week from \~16-40 weeks of pregnancy

Behavioral: Aerobic Exercise training

Control

NO INTERVENTION

usual daily activities - not exercise, not elevating heart rate

Interventions

Aerobic Exercise training BEHAVIORAL

Aerobic Exercise Intervention

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Since this is a pregnancy study, all participants are female.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• East Carolina University: lead

Study Sites (1)

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Related Publications (1)

• 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.

  PMID: 37259255 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Linda E May, MS, PhD

  East Carolina University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: women were randomly assigned to either aerobic exercise intervention or no exercise.

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: May 7, 2018
• Study Start: July 1, 2015
• Primary Completion: January 30, 2023
• Study Completion: January 30, 2023
• Last Updated: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)