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Pregnancy Exercise Mode Effect on Childhood Obesity

Effect of Exercise Modality During Pregnancy on Childhood Obesity Risk

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04805502
Enrollment
300
Registered
2021-03-18
Start date
2021-10-18
Completion date
2027-08-30
Last updated
2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity, Pregnancy

Keywords

exercise modes, exercise intervention

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALExercise Modes

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

Sponsors

East Carolina University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Masking description

those performing measurements on participants will be blinded to group allocation.

Intervention model description

PRegnant women will be randomized to one of four groups: aerobic exercise, resistance exercise, combination (aerobic + resistance), or control (no exercise). All exercise participants will be prescribed exercise that meets guidelines of the American College of Obstetricians and Gynecologists (ACOG), American College of Sports Medicine (ACSM), and the American Heart Association (AHA); 150 minutes per week, moderate intensity (60-80% aerobic capacity, Rating of Perceived Exertion, rating of perceived exertion (RPE), 12-15) per week. These limits are the same as those that generated previous positive findings for our preliminary data.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
1 month Infant non-HDL1 monthnon-HDL measured from venipuncture
6 month Infant non-HDL6 monthsnon-HDL measured from venipuncture
12 month Infant non-HDL12 monthsnon-HDL measured from venipuncture
1 month Infant BMI z-score1 monthBMI normalized
6 month Infant BMI z-score6 monthsBMI normalized
12 month Infant BMI z-score12 monthsBMI normalized
Enrollment (8-13wks) Maternal fasting non-HDLenrollment (~8-13 wks gestation)non-HDL measured from venipuncture
36wk Maternal fasting non-HDL36 weeks gestationnon-HDL measured from venipuncture
1 month postpartum Maternal fasting non-HDL1 month postpartumnon-HDL measured from venipuncture
6 months postpartum Maternal fasting non-HDL6 months postpartumnon-HDL measured from venipuncture
Adverse Pregnancy OutcomesAt DeliveryPresence or absence of Adverse Pregnancy outcomes (preterm birth, gestational diabetes \[GDM\], preeclampsia, hypertension)

Secondary

MeasureTime frameDescription
1 month Infant Resting Heart Rate1 monthresting HR
6 month Infant Resting Heart Rate6 monthsresting HR
12 month Infant Resting Heart Rate12 monthsresting HR
1 month Infant Resting Blood Pressure1 monthresting BP
6 month Infant Resting Blood Pressure6 monthsresting BP
12 month Infant Resting Blood Pressure12 monthsresting BP
1 month Infant Body Fat %1 monthestimated body fat % from skinfolds
6 month Infant Body Fat %6 monthsestimated body fat % from skinfolds
12 month Infant Body Fat %12 monthsestimated body fat % from skinfolds
1 month Infant % Muscle Mass1 monthsestimated muscle mass % from skinfolds
6 month Infant % Muscle Mass6 monthsestimated muscle mass % from skinfolds
12 month Infant % Muscle Mass12 monthsestimated muscle mass % from skinfolds
1 month Infant Resting Energy Expenditure (REE)1 monthsestimated REE
6 month Infant Resting Energy Expenditure (REE)6 monthsestimated resting energy expenditure
12 month Infant Resting Energy Expenditure (REE)12 monthsestimated resting energy expenditure
1 month Infant Neuromotor Assessment1 monthsPeabody Developmental Motor Scale (1st - 99th percentile) - the higher the percentile the better
6 month Infant Neuromotor Assessment6 monthsPeabody Developmental Motor Scale (1st - 99th percentile) - the higher the percentile the better
12 month Infant Neuromotor Assessment12 monthsPeabody Developmental Motor Scale (1st - 99th percentile) - the higher the percentile the better
1 month Infant Veggie Meter1 monthRaman Spectroscopy-Skin Carotenoid assessments
6 month Infant Veggie Meter6 monthsRaman spectroscopy-Skin Carotenoid assessments
12 month Infant Veggie Meter12 monthsRaman spectroscopy-Skin Carotenoid assessments
1 month Infant Blood Biomarkers (CRP)1 monthMultiplex analyses of inflammatory markers (CRP)
6 month Infant Blood Biomarkers (CRP)6 monthsMultiplex analyses of inflammatory markers (CRP)
12 month Infant Blood Biomarkers (CRP)12 monthsMultiplex analyses of inflammatory markers (CRP)
1 month Infant Blood Biomarkers (IL6)1 monthMultiplex analyses of inflammatory markers (IL6)
6 month Infant Blood Biomarkers (IL6)6 monthsMultiplex analyses of inflammatory markers (IL6)
12 month Infant Blood Biomarkers (IL6)12 monthsMultiplex analyses of inflammatory markers (IL6)
1 month Infant Blood Biomarkers (adiponectin)1 monthMultiplex analyses of inflammatory markers (adiponectin)
6 month Infant Blood Biomarkers (adiponectin)6 monthMultiplex analyses of inflammatory markers (adiponectin)
12 month Infant Blood Biomarkers (adiponectin)12 monthsMultiplex analyses of inflammatory markers (adiponectin)
1 month Infant Metabolomics1 monthMetabolomic pathway analysis of significantly different blood metabolites based on p-value less than or equal to 0.05
6 month Infant Metabolomics6 monthsMetabolomic pathway analysis of significantly different blood metabolites based on p-value less than or equal to 0.05
12 months Infant Metabolomics12 monthsMetabolomic pathway analysis of significantly different blood metabolites based on p-value less than or equal to 0.05
16wk Maternal Resting Heart Rate16 gestationresting HR
36wk Maternal Resting Heart Rate36 weeks gestationresting HR
1 month postpartum Maternal Resting Heart Rate1 month postpartumresting HR
6 month postpartum Maternal Resting Heart Rate6 months postpartumresting HR
16wk Maternal Resting Blood Pressure16 weeks gestationresting BP
36wk Maternal Resting Blood Pressure36 weeks gestationresting BP
1 month postpartum Maternal Resting Blood Pressure1 month postpartumresting BP
6 month postpartum Maternal Resting Blood Pressure6 months postpartumresting BP
Maternal Gestational Weight Gain (GWG)at deliveryGestational Weight Gain
16wk Maternal Body Fat%16 weeks gestationEstimated body fat %
36wk Maternal Body Fat%36 weeks gestationEstimated body fat %
1 month Postpartum Maternal Body Fat%1 month postpartumEstimated body fat %
6 month Postpartum Maternal Body Fat%6 months postpartumEstimated body fat %
16wk Maternal Biomarkers (CRP)16 weeks gestationMultiplex analyses of inflammatory markers (CRP)
36wk Maternal Biomarkers (CRP)36 weeks gestationMultiplex analyses of inflammatory markers (CRP)
1 month postpartum Maternal Biomarkers (CRP)1 month postpartumMultiplex analyses of inflammatory markers (CRP)
6 month Postpartum Maternal Biomarkers (CRP)6 months postpartumMultiplex analyses of inflammatory markers (CRP)
16wk Maternal Biomarkers (IL6)16 weeks gestationMultiplex analyses of inflammatory markers (IL6)
36wk Maternal Biomarkers (IL6)36 weeks gestationMultiplex analyses of inflammatory markers (IL6)
1 month Postpartum Maternal Biomarkers (IL6)1 month postpartumMultiplex analyses of inflammatory markers (IL6)
6 month Postpartum Maternal Biomarkers (IL6)6 months postpartumMultiplex analyses of inflammatory markers (IL6)
16wk Maternal Biomarkers (adiponectin)16 weeks gestationMultiplex analyses of inflammatory markers (adiponectin)
36wk Maternal Biomarkers (adiponectin)36 weeks gestationMultiplex analyses of inflammatory markers (adiponectin)
1 month Postpartum Maternal Biomarkers (adiponectin)1 month postpartumMultiplex analyses of inflammatory markers (adiponectin)
6 month Postpartum Maternal Biomarkers (adiponectin)6 months postpartumMultiplex analyses of inflammatory markers (adiponectin)
16wk Maternal Biomarkers (cortisol)16 weeks gestationMultiplex analyses of inflammatory markers (cortisol)
36wk Maternal Biomarkers (cortisol)36 weeks gestationMultiplex analyses of inflammatory markers (cortisol)
1 month Postpartum Maternal Biomarkers (cortisol)1 month postpartumMultiplex analyses of inflammatory markers (cortisol)
6 month Postpartum Maternal Biomarkers (cortisol)6 months postpartumMultiplex analyses of inflammatory markers (cortisol)

Countries

United States

Contacts

CONTACTLinda E May, MS, PhD
mayl@ecu.edu2527377072
CONTACTJameta Edwards
edwardsja@ecu.edu2527377156
PRINCIPAL_INVESTIGATORLinda E May, PhD

PI

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026