Clinical trial

Pregnancy Exercise Mode Effect on Childhood Obesity

Recruiting now · Not applicable · 1 countries · Registry ID NCT04805502

Recruiting nowNot applicableInterventional

What this 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 45 Years

SexFemale

Healthy volunteersAccepted

ConditionPregnancy, Overweight and Obesity

Full registry 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

Treatments and study arms

Exercise Modes

Behavioral

Moderate intensity aerobic exercise, moderate intensity resistance exercise, moderate intensity combination exercise

Primary outcomes

1 month Infant non-HDL1 month

non-HDL measured from venipuncture

6 month Infant non-HDL6 months

non-HDL measured from venipuncture

12 month Infant non-HDL12 months

non-HDL measured from venipuncture

1 month Infant BMI z-score1 month

BMI normalized

6 month Infant BMI z-score6 months

BMI normalized

12 month Infant BMI z-score12 months

BMI normalized

Enrollment (8-13wks) Maternal fasting non-HDLenrollment (~8-13 wks gestation)

non-HDL measured from venipuncture

36wk Maternal fasting non-HDL36 weeks gestation

non-HDL measured from venipuncture

Study locations

1 locations were listed when this page was built. The first 40 are shown.

East Carolina University🇺🇸 Greenville, North Carolina, United States

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Linda E May, MS, PhDContact

Email · Call 2527377072

James DeVente, MDContact