Actively Recruiting
MAMA Tot - Healthy Weight Parallel Study
Led by East Carolina University · Updated on 2024-09-19
268
Participants Needed
1
Research Sites
306 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The overall objective of this proposal is to conduct a longitudinal prospective study of healthy pregnant women and their offspring to determine which antenatal maternal exercise mode(s) will have the greatest impact on maternal and infant cardiometabolic health. This information may lead to modified clinical practice recommendations that improve health in childhood and possibly beyond. This randomized controlled trial will recruit 268 healthy pregnant women randomized to an exercise intervention (aerobic exercise, resistance exercise, aerobic and resistance exercise) or to no exercise (usual care); their infants will be measured at 1, 6, and 12 months of age. This rigorous design will test our central hypothesis that aerobic and resistance exercise and resistance exercise training during pregnancy will, in healthy weight BMI (HW) women, improve maternal and offspring cardiometabolic outcomes to a greater extent than AE alone. We will test this hypothesis with two specific aims: 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.
CONDITIONS
Official Title
MAMA Tot - Healthy Weight Parallel Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 40 years old
- Body mass index (BMI) between 18.5 and 24.4
- Singleton pregnancy at 16 weeks gestation or less
- Clearance from obstetric provider to exercise during pregnancy
You will not qualify if you...
- Younger than 18 or older than 40 years of age
- BMI of 25 or higher
- Multiple fetus pregnancy (twins or more)
- No clearance from obstetric provider to exercise
- Unable or unwilling to provide consent
- Inability to communicate with study team even with interpreter
- Medical conditions such as HIV/AIDS, cancer, type 1 or 2 diabetes, untreated hypertension, thyroid disorders
- Use of tobacco, alcohol, recreational drugs, or certain medications like oral hypertensives or insulin
- Unable to provide phone or email contact
AI-Screening
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Trial Site Locations
Total: 1 location
1
East Carolina University
Greenville, North Carolina, United States, 27834
Actively Recruiting
Research Team
L
Linda E May, MS, PhD
CONTACT
J
Jameta Edwards
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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