East Carolina University
Greenville, North Carolina, 27834, United States
Location status: Recruiting
Location contact
James DeVente, MD
CONTACT
Linda E May, MS, PhD
CONTACT
NCT Number: NCT04805502
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.
Interested in participating?
Request Info18 year–45 year
Female
Interventional
Not applicable
Greenville, North Carolina, 27834, United States
Location status: Recruiting
James DeVente, MD
CONTACT
Linda E May, MS, PhD
CONTACT
Many public health initiatives in the United States, including Healthy People 2020, have goals that include reducing obesity (OB), metabolic dysfunction, and risk of cardiovascular disease (CVD). Studies such as the Bogalusa project have now demonstrated that overweightness (OW), beginning as early as age five, is predictive of adult CVD. In fact, the onset of OW/OB and CVD may begin in the intrauterine period, and infant birth weight and weight gain are strongly related to OB in childhood and beyond. OW/OB mothers and their offspring exhibit increased morbidity and mortality; the American College of Obstetricians and Gynecologists (ACOG) has developed guidelines geared toward reducing maternal OW/OB through exercise. However, few studies have focused on how such exercise interventions during pregnancy impact short and long-term child health outcomes. Furthermore, little is known regarding the influence of different modes of antenatal exercise upon maternal and offspring health outcomes.
The long-term goal of this study is to attenuate child- and adulthood OB and CVD risk by identifying the most effective and easily implemented maternal exercise interventions. The investigators have shown that maternal aerobic exercise (AE) in women of all BMIs favorably impacts maternal cholesterol and LDL levels, which are predictive of infant weight. Furthermore, maternal AE is associated with decreased fetal abdominal circumference (AC), lower body fat percentage at one month, and improved infant neuromotor skills. Our preliminary data for pregnant women of all BMIs suggests that resistance exercise (RE) confers similar benefits to infants at one month as compared to AE, plus improvements such as decreased BMI z-scores, increased metabolomic signatures for glucose use, and decreased metabolites of inflammatory pathways. The most striking finding from this preliminary work is that adding RE to AE improved outcomes for both mothers and infants. Thus, the COMBINATION of aerobic and resistance exercise (AERE) not only had better maternal and one month infant outcomes (versus AE alone), but AERE groups had the best compliance. The positive changes were most pronounced in the infants of OW/OB women. A more comprehensive, longitudinal study geared toward OW/OB mothers is needed to confirm our preliminary work and to assess the persistence of exercise impacts through the infants' first year of life.
The overall objective of this proposal is to conduct a longitudinal prospective study of OW/OB 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 284 OW/OB pregnant women randomized to an exercise intervention (AE, RE, AERE) 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 AERE and RE exercise training during pregnancy will, in OW/OB women, improve maternal and offspring cardiometabolic outcomes to a greater extent than AE alone. The investigators will test this hypothesis 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 BMI z-score, body fat %, non-HDL, heart rate, 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, body fat %, HR, non-HDL, weight gain) across pregnancy (~13 to ~40 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 with improved health outcomes.
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 are at increased risk due to maternal OW/OB. 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Moderate intensity aerobic exercise, moderate intensity resistance exercise, moderate intensity combination exercise
Time frame: 1 month
non-HDL measured from venipuncture
Time frame: 6 months
non-HDL measured from venipuncture
Time frame: 12 months
non-HDL measured from venipuncture
Time frame: 1 month
BMI normalized
Time frame: 6 months
BMI normalized
Time frame: 12 months
BMI normalized
Time frame: enrollment (~8-13 wks gestation)
non-HDL measured from venipuncture
Time frame: 36 weeks gestation
non-HDL measured from venipuncture
Time frame: 1 month postpartum
non-HDL measured from venipuncture
Time frame: 6 months postpartum
non-HDL measured from venipuncture
Time frame: At Delivery
Presence or absence of Adverse Pregnancy outcomes (preterm birth, gestational diabetes [GDM], preeclampsia, hypertension)
Time frame: 1 month
resting HR
Time frame: 6 months
resting HR
Time frame: 12 months
resting HR
Time frame: 1 month
resting BP
Time frame: 6 months
resting BP
Time frame: 12 months
resting BP
Time frame: 1 month
estimated body fat % from skinfolds
Time frame: 6 months
estimated body fat % from skinfolds
Time frame: 12 months
estimated body fat % from skinfolds
Time frame: 1 months
estimated muscle mass % from skinfolds
Time frame: 6 months
estimated muscle mass % from skinfolds
Time frame: 12 months
estimated muscle mass % from skinfolds
Time frame: 1 months
estimated REE
Time frame: 6 months
estimated resting energy expenditure
Time frame: 12 months
estimated resting energy expenditure
Time frame: 1 months
Peabody Developmental Motor Scale (1st - 99th percentile) - the higher the percentile the better
Time frame: 6 months
Peabody Developmental Motor Scale (1st - 99th percentile) - the higher the percentile the better
Time frame: 12 months
Peabody Developmental Motor Scale (1st - 99th percentile) - the higher the percentile the better
Time frame: 1 month
Raman Spectroscopy-Skin Carotenoid assessments
Time frame: 6 months
Raman spectroscopy-Skin Carotenoid assessments
Time frame: 12 months
Raman spectroscopy-Skin Carotenoid assessments
Time frame: 1 month
Multiplex analyses of inflammatory markers (CRP)
Time frame: 6 months
Multiplex analyses of inflammatory markers (CRP)
Time frame: 12 months
Multiplex analyses of inflammatory markers (CRP)
Time frame: 1 month
Multiplex analyses of inflammatory markers (IL6)
Time frame: 6 months
Multiplex analyses of inflammatory markers (IL6)
Time frame: 12 months
Multiplex analyses of inflammatory markers (IL6)
Time frame: 1 month
Multiplex analyses of inflammatory markers (adiponectin)
Time frame: 6 month
Multiplex analyses of inflammatory markers (adiponectin)
Time frame: 12 months
Multiplex analyses of inflammatory markers (adiponectin)
Time frame: 1 month
Metabolomic pathway analysis of significantly different blood metabolites based on p-value less than or equal to 0.05
Time frame: 6 months
Metabolomic pathway analysis of significantly different blood metabolites based on p-value less than or equal to 0.05
Time frame: 12 months
Metabolomic pathway analysis of significantly different blood metabolites based on p-value less than or equal to 0.05
Time frame: 16 gestation
resting HR
Time frame: 36 weeks gestation
resting HR
Time frame: 1 month postpartum
resting HR
Time frame: 6 months postpartum
resting HR
Time frame: 16 weeks gestation
resting BP
Time frame: 36 weeks gestation
resting BP
Time frame: 1 month postpartum
resting BP
Time frame: 6 months postpartum
resting BP
Time frame: at delivery
Gestational Weight Gain
Time frame: 16 weeks gestation
Estimated body fat %
Time frame: 36 weeks gestation
Estimated body fat %
Time frame: 1 month postpartum
Estimated body fat %
Time frame: 6 months postpartum
Estimated body fat %
Time frame: 16 weeks gestation
Multiplex analyses of inflammatory markers (CRP)
Time frame: 36 weeks gestation
Multiplex analyses of inflammatory markers (CRP)
Time frame: 1 month postpartum
Multiplex analyses of inflammatory markers (CRP)
Time frame: 6 months postpartum
Multiplex analyses of inflammatory markers (CRP)
Time frame: 16 weeks gestation
Multiplex analyses of inflammatory markers (IL6)
Time frame: 36 weeks gestation
Multiplex analyses of inflammatory markers (IL6)
Time frame: 1 month postpartum
Multiplex analyses of inflammatory markers (IL6)
Time frame: 6 months postpartum
Multiplex analyses of inflammatory markers (IL6)
Time frame: 16 weeks gestation
Multiplex analyses of inflammatory markers (adiponectin)
Time frame: 36 weeks gestation
Multiplex analyses of inflammatory markers (adiponectin)
Time frame: 1 month postpartum
Multiplex analyses of inflammatory markers (adiponectin)
Time frame: 6 months postpartum
Multiplex analyses of inflammatory markers (adiponectin)
Time frame: 16 weeks gestation
Multiplex analyses of inflammatory markers (cortisol)
Time frame: 36 weeks gestation
Multiplex analyses of inflammatory markers (cortisol)
Time frame: 1 month postpartum
Multiplex analyses of inflammatory markers (cortisol)
Time frame: 6 months postpartum
Multiplex analyses of inflammatory markers (cortisol)
Contact information is provided by the study sponsor or research team.
Jameta Edwards
CONTACT
Linda E May, MS, PhD
CONTACT
East Carolina University
Other
Effect of Exercise Modality During Pregnancy on Childhood Obesity Risk
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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