Pregnancy Related
Conditions
Keywords
exercise modes, exercise intervention
Brief summary
The overall objective of this proposal is to conduct a longitudinal prospective study of healthy 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 268 healthy pregnant women randomized to an exercise intervention (aerobic exercise, resistance exercise, aerobic and resistance exercise) 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 aerobic and resistance exercise and resistance exercise training during pregnancy will, in healthy weight BMI (HW) women, improve maternal and offspring cardiometabolic outcomes to a greater extent than AE alone. This study will test this hypothesis with two specific aims: Aim 1. Determine the influence of different exercise modes during HW pregnancy on infant cardiometabolic health and growth trajectories. Hypothesis: AE, RE, and AERE by HW 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, non-HDL, and C-Reactive Protein (CRP); increased insulin sensitivity) compared to infants of HW 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 HW pregnancy on improving maternal cardiometabolic health outcomes. Hypothesis: AE, RE, and AERE by HW 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 to 36 weeks gestation) and overall pregnancy outcomes (e.g. lower incidence of gestational diabetes, pre-eclampsia, hypertension during gestation) compared to HW 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 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 may be at increased risk of poor outcomes. 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
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
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 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Age: 18 to 40 years old * BMI 18.5 to 24.4 * 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
| Measure | Time frame | Description |
|---|---|---|
| 1 month Infant non-HDL | 1 month | non-HDL measures from venipuncture |
| 6 month Infant non-HDL | 6 months | non-HDL measures from venipuncture |
| 12 month Infant non-HDL | 12 months | non-HDL measures from venipuncture |
| 1 month infant BMI z-score | 1 month | BMI normalized |
| 6 month infant BMI z-score | 6 months | BMI normalized |
| 12 month infant BMI z-score | 12 months | BMI normalized |
| Enrollment (8-13wks) Maternal fasting non-HDL | enrollment (~8-13 wks gestation) | non-HDL measured from venipuncture |
| 36wk Maternal fasting non-HDL | 36wks gestation | non-HDL measured from venipuncture |
| 1 month Maternal fasting non-HDL | 1 month postpartum | non-HDL measured from venipuncture |
| 6 month Maternal fasting non-HDL | 6 months postpartum | non-HDL measured from venipuncture |
| Adverse Pregnancy Outcomes | At delivery | Presence or absence of Adverse Pregnancy outcomes (preterm birth, gestational diabetes \[GDM\], preeclampsia, hypertension) |
| 12 month Maternal fasting non-HDL | 12 months postpartum | non-HDL measured from venipuncture |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1 month infant Resting Heart Rate | 1 month | resting HR |
| 6 month infant Resting Heart Rate | 6 months | resting HR |
| 12 month infant Resting Heart Rate | 12 months | resting HR |
| 1 month infant Resting Blood Pressure | 1 month | resting BP |
| 6 month infant Resting Blood Pressure | 6 months | resting BP |
| 12 month infant Resting Blood Pressure | 12 months | resting BP |
| 1 month infant Body Fat % | 1 month | body fat % from skinfolds |
| 6 month infant Body Fat % | 6 months | body fat % from skinfolds |
| 12 month infant Body Fat % | 12 months | body fat % from skinfolds |
| 1 month infant % Muscle Mass | 1 month | muscle mass % from skinfolds |
| 6 month infant % Muscle Mass | 6 months | muscle mass % from skinfolds |
| 12 month infant % Muscle Mass | 12 months | muscle mass % from skinfolds |
| 1 month Infant Resting Energy Expenditure (REE) | 1 month | resting REE |
| 6 month Infant Resting Energy Expenditure (REE) | 6 months | resting REE |
| 12 month Infant Resting Energy Expenditure (REE) | 12 months | resting REE |
| 1 month Infant Neuromotor Assessment | 1 month | Peabody Developmental Motor Scale (1st - 99th percentile) - the higher the percentile the better |
| 6 month Infant Neuromotor Assessment | 6 months | Peabody Developmental Motor Scale (1st - 99th percentile) - the higher the percentile the better |
| 12 month Infant Neuromotor Assessment | 12 months | Peabody Developmental Motor Scale (1st - 99th percentile) - the higher the percentile the better |
| 1 month Infant Veggie Meter | 1 month | Raman Spectroscopy-Skin Carotenoid assessments |
| 6 month Infant Veggie Meter | 6 months | Raman Spectroscopy-Skin Carotenoid assessments |
| 12 month Infant Veggie Meter | 12 months | Raman Spectroscopy-Skin Carotenoid assessments |
| 1 month Infant Blood Biomarkers (CRP) | 1 month | Multiplex analyses of inflammatory markers (CRP) |
| 6 month Infant Blood Biomarkers (CRP) | 6 months | Multiplex analyses of inflammatory markers (CRP) |
| 12 month Infant Blood Biomarkers (CRP) | 12 months | Multiplex analyses of inflammatory markers (CRP) |
| 1 month Infant Blood Biomarkers (IL6) | 1 month | Multiplex analyses of inflammatory markers (IL6) |
| 6 month Infant Blood Biomarkers (IL6) | 6 months | Multiplex analyses of inflammatory markers (IL6) |
| 12 month Infant Blood Biomarkers (IL6) | 12 months | Multiplex analyses of inflammatory markers (IL6) |
| 1 month Infant Blood Biomarkers (adiponectin) | 1 month | Multiplex analyses of inflammatory markers (adiponectin) |
| 6 month Infant Blood Biomarkers (adiponectin) | 6 months | Multiplex analyses of inflammatory markers (adiponectin) |
| 12 month Infant Blood Biomarkers (adiponectin) | 12 months | Multiplex analyses of inflammatory markers (adiponectin) |
| 1 month Infant Metabolomics | 1 month | Metabolomic pathway analysis of significantly different blood metabolites based on p-value less than or equal to 0.05 |
| 6 month Infant Metabolomics | 6 months | Metabolomic pathway analysis of significantly different blood metabolites based on p-value less than or equal to 0.05 |
| 12 month Infant Metabolomics | 12 months | Metabolomic pathway analysis of significantly different blood metabolites based on p-value less than or equal to 0.05 |
| 16wk Maternal Resting Heart Rate | 16wks gestation | resting HR |
| 36wk Maternal Resting Heart Rate | 36wks gestation | resting HR |
| 1 month Postpartum Maternal Resting Heart Rate | 1 month postpartum | resting HR |
| 6 month Postpartum Maternal Resting Heart Rate | 6 months postpartum | resting HR |
| 12 month Postpartum Maternal Resting Heart Rate | 12 months postpartum | resting HR |
| 16wk Maternal Resting Blood Pressure | 16wks gestation | resting BP |
| 36wk Maternal Resting Blood Pressure | 36wks gestation | resting BP |
| 1 month Postpartum Maternal Resting Blood Pressure | 1 month postpartum | resting BP |
| 6 month Postpartum Maternal Resting Blood Pressure | 6 months postpartum | resting BP |
| 12 month Postpartum Maternal Resting Blood Pressure | 12 months postpartum | resting BP |
| Maternal Gestational Weight Gain (GWG) | At delivery | Gestational Weight Gain |
| 16wk Maternal Body Fat % | 16wks gestation | estimated body fat % |
| 36wk Maternal Body Fat % | 36wks gestation | estimated body fat % |
| 1 month Postpartum Maternal Body Fat % | 1 month postpartum | estimated body fat % |
| 6 month Postpartum Maternal Body Fat % | 6 months postpartum | estimated body fat % |
| 12 month Postpartum Maternal Body Fat % | 12 months postpartum | estimated body fat % |
| 16wk Maternal Biomarkers (CRP) | 16wks gestation | Multiplex analyses of inflammatory markers (CRP) |
| 36wk Maternal Biomarkers (CRP) | 36wks gestation | Multiplex analyses of inflammatory markers (CRP) |
| 1 month Postpartum Maternal Biomarkers (CRP) | 1 month postpartum | Multiplex analyses of inflammatory markers (CRP) |
| 6 month Postpartum Maternal Biomarkers (CRP) | 6 months postpartum | Multiplex analyses of inflammatory markers (CRP) |
| 12 month Postpartum Maternal Biomarkers (CRP) | 12 months postpartum | Multiplex analyses of inflammatory markers (CRP) |
| 16wk Maternal Biomarkers (IL6) | 16wks gestation | Multiplex analyses of inflammatory markers (IL6) |
| 36wk Maternal Biomarkers (IL6) | 36wks gestation | Multiplex analyses of inflammatory markers (IL6) |
| 1 month Postpartum Maternal Biomarkers (IL6) | 1 month postpartum | Multiplex analyses of inflammatory markers (IL6) |
| 6 month Postpartum Maternal Biomarkers (IL6) | 6 months postpartum | Multiplex analyses of inflammatory markers (IL6) |
| 12 month Postpartum Maternal Biomarkers (IL6) | 12 months postpartum | Multiplex analyses of inflammatory markers (IL6) |
| 16wks Maternal Biomarkers (adiponectin) | 16wks gestation | Multiplex analyses of inflammatory markers (adiponectin) |
| 36wks Maternal Biomarkers (adiponectin) | 36wks gestation | Multiplex analyses of inflammatory markers (adiponectin) |
| 1 month postpartum Maternal Biomarkers (adiponectin) | 1 month postpartum | Multiplex analyses of inflammatory markers (adiponectin) |
| 6 month postpartum Maternal Biomarkers (adiponectin) | 6 months postpartum | Multiplex analyses of inflammatory markers (adiponectin) |
| 12 month postpartum Maternal Biomarkers (adiponectin) | 12 months postpartum | Multiplex analyses of inflammatory markers (adiponectin) |
| 16wks Maternal Biomarkers (cortisol) | 16wks gestation | Multiplex analyses of inflammatory markers (cortisol) |
| 36wks Maternal Biomarkers (cortisol) | 36wks gestation | Multiplex analyses of inflammatory markers (cortisol) |
| 1 month Postpartum Maternal Biomarkers (cortisol) | 1 month postpartum | Multiplex analyses of inflammatory markers (cortisol) |
| 6 month Postpartum Maternal Biomarkers (cortisol) | 6 months postpartum | Multiplex analyses of inflammatory markers (cortisol) |
| 12 month Postpartum Maternal Biomarkers (cortisol) | 12 months postpartum | Multiplex analyses of inflammatory markers (cortisol) |
Countries
United States
Contacts
CONTACTLinda E May, MS, PhD
CONTACTJameta Edwards
PRINCIPAL_INVESTIGATORLinda May, MS, PhD
East Carolina University
Outcome results
None listed