MAMA Tot - Healthy Weight Parallel Study
East Carolina University · NCT06598098
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–40 · Women only
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 268
- US sites recruiting
- 1
- Study start
- October 18, 2021
- Record last updated
- September 11, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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. This study 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.
Being studied: Exercise Modes
Conditions: Pregnancy Related
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Age: 18 to 40 years old
- BMI 18.5 to 24.4
- Pregnancy: Singleton; ≤ 16 weeks gestation
- Clearance by Obstetric provider for exercise
Exclusion Criteria
- Age: ≤ 17.9 or ≥ 41 years of age
- 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
Recruiting US locations
East Carolina University
Greenville, NC 27834
Site contact: Linda E May, MS, PhD · 252-737-7072 · mayl@ecu.edu
Study contacts (from the official record)
- Linda E May, MS, PhD · 252-737-7072 · mayl@ecu.edu
- Jameta Edwards · 252-737-7156 · edwardsja@ecu.edu
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