Study Results
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Basic Information
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RECRUITING
NA
268 participants
INTERVENTIONAL
2021-10-18
2027-08-30
Brief Summary
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Aim 1. Determine the influence of different exercise modes during HW pregnancy on infant cardiometabolic health and growth trajectories. Hypothesis: AE, RE, and AERE by HW pregnant women will improve offspring neuromotor and cardiometabolic measures at 1, 6, and 12 months postpartum (e.g. decreased % body fat, BMI z-score, heart rate, non-HDL, and C-Reactive Protein (CRP); increased insulin sensitivity) compared to infants of HW pregnant women that do not exercise; AERE and RE will have the greatest impact on improving infant measures.
Aim 2. Determine the most effective exercise mode in HW pregnancy on improving maternal cardiometabolic health outcomes. Hypothesis: AE, RE, and AERE by HW pregnant women will improve both maternal cardiometabolic health measures (e.g. decreased BMI z-score, non-HDL, % body fat, HR, weight gain) across pregnancy (16 to 36 weeks gestation) and overall pregnancy outcomes (e.g. lower incidence of gestational diabetes, pre-eclampsia, hypertension during gestation) compared to HW pregnant women that do not exercise; AERE and RE will have the greatest impact on improving maternal health measures, with the AERE group having the highest compliance.
The proposed innovative study will be the first to provide a critical understanding of the influence of antenatal exercise modes upon the cardiometabolic health and growth trajectories of offspring who may be at increased risk of poor outcomes. This work will have a significant impact on reducing the cycle of OB and CVD, potentially providing the earliest and most efficacious intervention to attenuate or prevent OB and CVD in the next generation.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Aerobic Exercise (AE)
All exercise participants will be prescribed exercise that meets guidelines of the American College of Obstetricians and Gynecologists (ACOG), American College of Sports Medicine (ACSM), and the American Heart Association (AHA); 150 minutes per week, moderate intensity (60-80% aerobic capacity, Rating of Perceived Exertion, RPE, 12-15) per week. These limits are the same as those that generated previous positive findings for our preliminary data. The AE group will exercise on aerobic machines (i.e. treadmill, elliptical, bicycle) for all of their sessions.
Exercise Modes
Moderate intensity aerobic exercise, moderate intensity resistance exercise, moderate intensity combination exercise
Resistance Exercise (RE)
All exercise participants will be prescribed exercise that meets guidelines of the American College of Obstetricians and Gynecologists (ACOG), American College of Sports Medicine (ACSM), and the American Heart Association (AHA); 150 minutes per week, moderate intensity (60-80% aerobic capacity, Rating of Perceived Exertion, RPE, 12-15) per week. These limits are the same as those that generated previous positive findings for our preliminary data. The RE group will perform 12-15 repetitions of 10-12 resistance exercises in a circuit, for 3 sets with rest period of 30-60 seconds between sets as needed.\[100\] Seated isokinetic exercise using Cybex machines will target all major muscle groups. Light dumbbells and resistance bands will be used if the participant is unable to lift the minimal load on Cybex machines. Core exercises will be performed at the end of the session (i.e. seated side bends).
Exercise Modes
Moderate intensity aerobic exercise, moderate intensity resistance exercise, moderate intensity combination exercise
Combination Exercise (AERE)
All exercise participants will be prescribed exercise that meets guidelines of the American College of Obstetricians and Gynecologists (ACOG), American College of Sports Medicine (ACSM), and the American Heart Association (AHA); 150 minutes per week, moderate intensity (60-80% aerobic capacity, Rating of Perceived Exertion, RPE, 12-15) per week. These limits are the same as those that generated previous positive findings for our preliminary data. The AERE group will switch between AE exercise and RE; for this group, RE exercises will consist of 1 set of 12-15 repetitions of 4 resistance exercises, then 5 minutes of AE, then repeated repeat with different exercises.\[106-108\] The investigators will also calculate the metabolic minutes per week (METmin/wk) of all participants in order to account for potential differences in energy expenditure based on activity, though the dose of 150 min/wk at moderate intensity is held constant between exercise groups.
Exercise Modes
Moderate intensity aerobic exercise, moderate intensity resistance exercise, moderate intensity combination exercise
Control (no exercise)
The Control group will participate in weekly sessions that focus on stretching, breathing, and healthy lifestyle.
No interventions assigned to this group
Interventions
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Exercise Modes
Moderate intensity aerobic exercise, moderate intensity resistance exercise, moderate intensity combination exercise
Eligibility Criteria
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Inclusion Criteria
* BMI 18.5 to 24.4
* Pregnancy: Singleton; ≤ 16 weeks gestation
* Clearance by Obstetric provider for exercise
Exclusion Criteria
* BMI ≥25
* Multi fetal pregnancy
* Obstetric Provider does not provide clearance for exercise
* Unable or Unwilling to provide consent
* Inability to communicate with members of study team, despite use of interpreter
* Medical Conditions (e,g. HIV/Aids, Cancer, Type 1 or 2 Diabetes, Untreated Hypertension, Thyroid Disorders)
* Use of tobacco products, alcohol, recreational drugs, or medications (oral hypertensive, insulin)
* Unable to provide phone or email contact
18 Years
40 Years
FEMALE
Yes
Sponsors
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East Carolina University
OTHER
Responsible Party
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Linda May
Associate Professor; Dept. Chair
Principal Investigators
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Linda May, MS, PhD
Role: PRINCIPAL_INVESTIGATOR
East Carolina University
Locations
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East Carolina University
Greenville, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Linda E May, MS, PhD
Role: backup
Other Identifiers
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20-002367
Identifier Type: -
Identifier Source: org_study_id
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