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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. We 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerobic Exercise (AE) | Experimental | 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, RPE, 12-15) per week. These limits are the same as those that generated previous positive findings for our preliminary data. The AE group will exercise on aerobic machines (i.e. treadmill, elliptical, bicycle) for all of their sessions. |
|
| Resistance Exercise (RE) | Experimental | 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, RPE, 12-15) per week. These limits are the same as those that generated previous positive findings for our preliminary data. The RE group will perform 12-15 repetitions of 10-12 resistance exercises in a circuit, for 3 sets with rest period of 30-60 seconds between sets as needed.[100] Seated isokinetic exercise using Cybex machines will target all major muscle groups. Light dumbbells and resistance bands will be used if the participant is unable to lift the minimal load on Cybex machines. Core exercises will be performed at the end of the session (i.e. seated side bends). |
|
| Combination Exercise (AERE) | Experimental | 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, RPE, 12-15) per week. These limits are the same as those that generated previous positive findings for our preliminary data. The AERE group will switch between AE exercise and RE; for this group, RE exercises will consist of 1 set of 12-15 repetitions of 4 resistance exercises, then 5 minutes of AE, then repeated repeat with different exercises.[106-108] The investigators will also calculate the metabolic minutes per week (METmin/wk) of all participants in order to account for potential differences in energy expenditure based on activity, though the dose of 150 min/wk at moderate intensity is held constant between exercise groups. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Modes | Behavioral | Moderate intensity aerobic exercise, moderate intensity resistance exercise, moderate intensity combination exercise |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1 month Infant non-HDL | non-HDL measures from venipuncture | 1 month |
| 6 month Infant non-HDL | non-HDL measures from venipuncture | 6 months |
| 12 month Infant non-HDL | non-HDL measures from venipuncture | 12 months |
| 1 month infant BMI z-score | BMI normalized | 1 month |
| 6 month infant BMI z-score | BMI normalized | 6 months |
| 12 month infant BMI z-score | BMI normalized | 12 months |
| Enrollment (8-13wks) Maternal fasting non-HDL | non-HDL measured from venipuncture | enrollment (~8-13 wks gestation) |
| 36wk Maternal fasting non-HDL | non-HDL measured from venipuncture | 36wks gestation |
| 1 month Maternal fasting non-HDL | non-HDL measured from venipuncture |
| Measure | Description | Time Frame |
|---|---|---|
| 1 month infant Resting Heart Rate | resting HR | 1 month |
| 6 month infant Resting Heart Rate | resting HR | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linda E May, MS, PhD | Contact | 252-737-7072 | mayl@ecu.edu | |
| Jameta Edwards | Contact | 252-737-7156 | edwardsja@ecu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Linda May, MS, PhD | East Carolina University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Carolina University | Recruiting | Greenville | North Carolina | 27834 | United States |
de-identified data can be shared upon request to researchers
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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.
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| Control (no exercise) | No Intervention | The Control group will participate in weekly sessions that focus on stretching, breathing, and healthy lifestyle. |
| 1 month postpartum |
| 6 month Maternal fasting non-HDL | non-HDL measured from venipuncture | 6 months postpartum |
| Adverse Pregnancy Outcomes | Presence or absence of Adverse Pregnancy outcomes (preterm birth, gestational diabetes [GDM], preeclampsia, hypertension) | At delivery |
| 12 month Maternal fasting non-HDL | non-HDL measured from venipuncture | 12 months postpartum |
| 12 month infant Resting Heart Rate | resting HR | 12 months |
| 1 month infant Resting Blood Pressure | resting BP | 1 month |
| 6 month infant Resting Blood Pressure | resting BP | 6 months |
| 12 month infant Resting Blood Pressure | resting BP | 12 months |
| 1 month infant Body Fat % | body fat % from skinfolds | 1 month |
| 6 month infant Body Fat % | body fat % from skinfolds | 6 months |
| 12 month infant Body Fat % | body fat % from skinfolds | 12 months |
| 1 month infant % Muscle Mass | muscle mass % from skinfolds | 1 month |
| 6 month infant % Muscle Mass | muscle mass % from skinfolds | 6 months |
| 12 month infant % Muscle Mass | muscle mass % from skinfolds | 12 months |
| 1 month Infant Resting Energy Expenditure (REE) | resting REE | 1 month |
| 6 month Infant Resting Energy Expenditure (REE) | resting REE | 6 months |
| 12 month Infant Resting Energy Expenditure (REE) | resting REE | 12 months |
| 1 month Infant Neuromotor Assessment | Peabody Developmental Motor Scale (1st - 99th percentile) - the higher the percentile the better | 1 month |
| 6 month Infant Neuromotor Assessment | Peabody Developmental Motor Scale (1st - 99th percentile) - the higher the percentile the better | 6 months |
| 12 month Infant Neuromotor Assessment | Peabody Developmental Motor Scale (1st - 99th percentile) - the higher the percentile the better | 12 months |
| 1 month Infant Veggie Meter | Raman Spectroscopy-Skin Carotenoid assessments | 1 month |
| 6 month Infant Veggie Meter | Raman Spectroscopy-Skin Carotenoid assessments | 6 months |
| 12 month Infant Veggie Meter | Raman Spectroscopy-Skin Carotenoid assessments | 12 months |
| 1 month Infant Blood Biomarkers (CRP) | Multiplex analyses of inflammatory markers (CRP) | 1 month |
| 6 month Infant Blood Biomarkers (CRP) | Multiplex analyses of inflammatory markers (CRP) | 6 months |
| 12 month Infant Blood Biomarkers (CRP) | Multiplex analyses of inflammatory markers (CRP) | 12 months |
| 1 month Infant Blood Biomarkers (IL6) | Multiplex analyses of inflammatory markers (IL6) | 1 month |
| 6 month Infant Blood Biomarkers (IL6) | Multiplex analyses of inflammatory markers (IL6) | 6 months |
| 12 month Infant Blood Biomarkers (IL6) | Multiplex analyses of inflammatory markers (IL6) | 12 months |
| 1 month Infant Blood Biomarkers (adiponectin) | Multiplex analyses of inflammatory markers (adiponectin) | 1 month |
| 6 month Infant Blood Biomarkers (adiponectin) | Multiplex analyses of inflammatory markers (adiponectin) | 6 months |
| 12 month Infant Blood Biomarkers (adiponectin) | Multiplex analyses of inflammatory markers (adiponectin) | 12 months |
| 1 month Infant Metabolomics | Metabolomic pathway analysis of significantly different blood metabolites based on p-value less than or equal to 0.05 | 1 month |
| 6 month Infant Metabolomics | Metabolomic pathway analysis of significantly different blood metabolites based on p-value less than or equal to 0.05 | 6 months |
| 12 month Infant Metabolomics | Metabolomic pathway analysis of significantly different blood metabolites based on p-value less than or equal to 0.05 | 12 months |
| 16wk Maternal Resting Heart Rate | resting HR | 16wks gestation |
| 36wk Maternal Resting Heart Rate | resting HR | 36wks gestation |
| 1 month Postpartum Maternal Resting Heart Rate | resting HR | 1 month postpartum |
| 6 month Postpartum Maternal Resting Heart Rate | resting HR | 6 months postpartum |
| 12 month Postpartum Maternal Resting Heart Rate | resting HR | 12 months postpartum |
| 16wk Maternal Resting Blood Pressure | resting BP | 16wks gestation |
| 36wk Maternal Resting Blood Pressure | resting BP | 36wks gestation |
| 1 month Postpartum Maternal Resting Blood Pressure | resting BP | 1 month postpartum |
| 6 month Postpartum Maternal Resting Blood Pressure | resting BP | 6 months postpartum |
| 12 month Postpartum Maternal Resting Blood Pressure | resting BP | 12 months postpartum |
| Maternal Gestational Weight Gain (GWG) | Gestational Weight Gain | At delivery |
| 16wk Maternal Body Fat % | estimated body fat % | 16wks gestation |
| 36wk Maternal Body Fat % | estimated body fat % | 36wks gestation |
| 1 month Postpartum Maternal Body Fat % | estimated body fat % | 1 month postpartum |
| 6 month Postpartum Maternal Body Fat % | estimated body fat % | 6 months postpartum |
| 12 month Postpartum Maternal Body Fat % | estimated body fat % | 12 months postpartum |
| 16wk Maternal Biomarkers (CRP) | Multiplex analyses of inflammatory markers (CRP) | 16wks gestation |
| 36wk Maternal Biomarkers (CRP) | Multiplex analyses of inflammatory markers (CRP) | 36wks gestation |
| 1 month Postpartum Maternal Biomarkers (CRP) | Multiplex analyses of inflammatory markers (CRP) | 1 month postpartum |
| 6 month Postpartum Maternal Biomarkers (CRP) | Multiplex analyses of inflammatory markers (CRP) | 6 months postpartum |
| 12 month Postpartum Maternal Biomarkers (CRP) | Multiplex analyses of inflammatory markers (CRP) | 12 months postpartum |
| 16wk Maternal Biomarkers (IL6) | Multiplex analyses of inflammatory markers (IL6) | 16wks gestation |
| 36wk Maternal Biomarkers (IL6) | Multiplex analyses of inflammatory markers (IL6) | 36wks gestation |
| 1 month Postpartum Maternal Biomarkers (IL6) | Multiplex analyses of inflammatory markers (IL6) | 1 month postpartum |
| 6 month Postpartum Maternal Biomarkers (IL6) | Multiplex analyses of inflammatory markers (IL6) | 6 months postpartum |
| 12 month Postpartum Maternal Biomarkers (IL6) | Multiplex analyses of inflammatory markers (IL6) | 12 months postpartum |
| 16wks Maternal Biomarkers (adiponectin) | Multiplex analyses of inflammatory markers (adiponectin) | 16wks gestation |
| 36wks Maternal Biomarkers (adiponectin) | Multiplex analyses of inflammatory markers (adiponectin) | 36wks gestation |
| 1 month postpartum Maternal Biomarkers (adiponectin) | Multiplex analyses of inflammatory markers (adiponectin) | 1 month postpartum |
| 6 month postpartum Maternal Biomarkers (adiponectin) | Multiplex analyses of inflammatory markers (adiponectin) | 6 months postpartum |
| 12 month postpartum Maternal Biomarkers (adiponectin) | Multiplex analyses of inflammatory markers (adiponectin) | 12 months postpartum |
| 16wks Maternal Biomarkers (cortisol) | Multiplex analyses of inflammatory markers (cortisol) | 16wks gestation |
| 36wks Maternal Biomarkers (cortisol) | Multiplex analyses of inflammatory markers (cortisol) | 36wks gestation |
| 1 month Postpartum Maternal Biomarkers (cortisol) | Multiplex analyses of inflammatory markers (cortisol) | 1 month postpartum |
| 6 month Postpartum Maternal Biomarkers (cortisol) | Multiplex analyses of inflammatory markers (cortisol) | 6 months postpartum |
| 12 month Postpartum Maternal Biomarkers (cortisol) | Multiplex analyses of inflammatory markers (cortisol) | 12 months postpartum |