Pregnancy Exercise Mode Effect on Childhood Obesity
Effect of Exercise Modality During Pregnancy on Childhood Obesity Risk
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 45 Years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests exercise that raises your heart rate, strength training, or both during pregnancy, compared with no exercise. It is for pregnant women who are overweight or have obesity and looks at heart health, body fat, and blood sugar in mothers and babies. Babies will be checked at 1, 6, and 12 months old.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 18 to 40 years old.
- Your BMI is 25 or higher. BMI is a measure of weight compared with height.
- You are pregnant with one baby and are no more than 16 weeks pregnant.
- Your pregnancy care provider says it is safe for you to exercise.
Who can't join
- You are under 18 or 41 or older, or your BMI is below 25.
- You are pregnant with more than one baby.
- Your pregnancy care provider does not approve exercise.
- You cannot or do not want to agree to join the study.
- You cannot communicate with the study team, even with an interpreter.
- You have certain health conditions, such as HIV/AIDS, cancer, type 1 or type 2 diabetes, untreated high blood pressure, or thyroid problems.
- You use tobacco, alcohol, recreational drugs, or medicines such as blood pressure pills or insulin.
- You cannot provide a phone number or email address.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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
Study sites (1)
NC
- East Carolina University · Greenville, NC 27834Linda E May, MS, PhD · Study contact · 2527377072 · mayl@ecu.eduJames DeVente, MD · Study contact · deventeja@ecu.eduMore trials in Greenville