Pregnancy Exercise Mode Effect on Childhood Obesity
East Carolina University · NCT04805502
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 18–45 · Women only
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 300
- US sites recruiting
- 1
- Study start
- October 18, 2021
- Record last updated
- June 4, 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 overweight/obese (OW/OB) pregnant women and their offspring to determine which prenatal exercise mode will have the greatest impact on maternal and infant cardiometabolic health. This information may lead to clinical practice recommendations that improve childhood health. This randomized controlled trial will recruit 284 OW/OB pregnant women randomized to an exercise intervention (aerobic (AE), resistance (RE), or aerobic+resistance exercise (AERE)) or to no exercise; their infants will be measured at 1, 6, and 12 months of age. This design will test our central hypothesis that AERE and RE training during pregnancy will improve maternal and offspring cardiometabolic outcomes to a greater extent than AE alone. This hypothesis will be tested with two specific aims:
Aim 1. Determine the influence of different exercise modes during OW/OB pregnancy on infant cardiometabolic health and growth trajectories. Hypothesis: AE, RE, and AERE by OW/OB 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 [HR], non-HDL, and C-Reactive Protein (CRP); increased insulin sensitivity) compared to infants of OW/OB 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 OW/OB pregnancy on improving maternal cardiometabolic health outcomes. Hypothesis: AE, RE, and AERE by OW/OB pregnant women will improve both maternal cardiometabolic health measures (e.g. decreased BMI z-score, non-HDL, % body fat, HR, weight gain) across pregnancy (16-36 weeks' gestation) and overall pregnancy outcomes (e.g. lower incidence of gestational diabetes, pre-eclampsia, hypertension during gestation) compared to OW/OB 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 study will be the first to provide an understanding of the influence of maternal exercise modes on the cardiometabolic health and growth trajectories of offspring who are at increased risk due to maternal OW/OB. This work will have a significant impact on reducing the cycle of OB, potentially providing the earliest and most efficacious intervention to decrease or prevent OB in the next generation.
Being studied: Exercise Modes
Conditions: Pregnancy; Overweight and Obesity
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 between ≥ 25
- 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 · 2527377072 · mayl@ecu.edu
Study contacts (from the official record)
- Linda E May, MS, PhD · 2527377072 · mayl@ecu.edu
- Jameta Edwards · 2527377156 · edwardsja@ecu.edu
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