Effect of Exercise Modality During Pregnancy on Childhood Obesity Risk
概览
- 阶段
- 不适用
- 干预措施
- Exercise Modes
- 疾病 / 适应症
- Pregnancy
- 发起方
- East Carolina University
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- 6 months postpartum Maternal fasting non-HDL
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
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.
详细描述
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.
研究者
Linda May
Associate Professor; Interim Dept. Chair
East Carolina University
入排标准
入选标准
- •Age: 18 to 40 years old
- •BMI between ≥ 25
- •Pregnancy: Singleton; ≤ 16 weeks gestation
- •Clearance by Obstetric provider for exercise
排除标准
- •Age: ≤ 17.9 or ≥ 41 years of age
- •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
研究组 & 干预措施
Aerobic Exercise (AE)
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.
干预措施: Exercise Modes
Resistance Exercise (RE)
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).
干预措施: Exercise Modes
Combination Exercise (AERE)
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.
干预措施: Exercise Modes
Control (no exercise)
The Control group will participate in weekly sessions that focus on stretching, breathing, and healthy lifestyle.
结局指标
主要结局
6 months postpartum Maternal fasting non-HDL
时间窗: 6 months postpartum
non-HDL measured from venipuncture
6 month Infant non-HDL
时间窗: 6 months
non-HDL measured from venipuncture
1 month Infant BMI z-score
时间窗: 1 month
BMI normalized
6 month Infant BMI z-score
时间窗: 6 months
BMI normalized
12 month Infant BMI z-score
时间窗: 12 months
BMI normalized
Adverse Pregnancy Outcomes
时间窗: At Delivery
Presence or absence of Adverse Pregnancy outcomes (preterm birth, gestational diabetes \[GDM\], preeclampsia, hypertension)
1 month Infant non-HDL
时间窗: 1 month
non-HDL measured from venipuncture
12 month Infant non-HDL
时间窗: 12 months
non-HDL measured from venipuncture
Enrollment (8-13wks) Maternal fasting non-HDL
时间窗: enrollment (~8-13 wks gestation)
non-HDL measured from venipuncture
36wk Maternal fasting non-HDL
时间窗: 36 weeks gestation
non-HDL measured from venipuncture
1 month postpartum Maternal fasting non-HDL
时间窗: 1 month postpartum
non-HDL measured from venipuncture
次要结局
- 1 month Infant Resting Blood Pressure(1 month)
- 12 month Infant Body Fat %(12 months)
- 1 month Infant Resting Heart Rate(1 month)
- 6 month Infant Body Fat %(6 months)
- 6 month Infant Resting Heart Rate(6 months)
- 6 month Infant Resting Blood Pressure(6 months)
- 1 month Infant Resting Energy Expenditure (REE)(1 months)
- 6 month Postpartum Maternal Biomarkers (IL6)(6 months postpartum)
- 6 month Postpartum Maternal Biomarkers (adiponectin)(6 months postpartum)
- 6 month Infant % Muscle Mass(6 months)
- 1 month Infant Neuromotor Assessment(1 months)
- 6 month Infant Veggie Meter(6 months)
- 6 month Infant Blood Biomarkers (CRP)(6 months)
- 6 month Infant Blood Biomarkers (IL6)(6 months)
- 6 month Infant Blood Biomarkers (adiponectin)(6 month)
- 36wk Maternal Resting Heart Rate(36 weeks gestation)
- 1 month postpartum Maternal Biomarkers (CRP)(1 month postpartum)
- 12 month Infant Resting Heart Rate(12 months)
- 12 month Infant Resting Blood Pressure(12 months)
- 1 month Infant Body Fat %(1 month)
- 12 month Infant % Muscle Mass(12 months)
- 6 month Infant Resting Energy Expenditure (REE)(6 months)
- 1 month Infant Veggie Meter(1 month)
- 1 month Infant Blood Biomarkers (IL6)(1 month)
- 6 month postpartum Maternal Resting Heart Rate(6 months postpartum)
- 36wk Maternal Resting Blood Pressure(36 weeks gestation)
- 1 month Postpartum Maternal Body Fat%(1 month postpartum)
- 12 month Infant Resting Energy Expenditure (REE)(12 months)
- 6 month Infant Neuromotor Assessment(6 months)
- 12 month Infant Blood Biomarkers (CRP)(12 months)
- 1 month Infant Blood Biomarkers (adiponectin)(1 month)
- 12 month Infant Blood Biomarkers (adiponectin)(12 months)
- 1 month Infant Metabolomics(1 month)
- 12 months Infant Metabolomics(12 months)
- 16wk Maternal Resting Blood Pressure(16 weeks gestation)
- 1 month postpartum Maternal Resting Blood Pressure(1 month postpartum)
- Maternal Gestational Weight Gain (GWG)(at delivery)
- 1 month Infant % Muscle Mass(1 months)
- 12 month Infant Neuromotor Assessment(12 months)
- 12 month Infant Veggie Meter(12 months)
- 1 month Infant Blood Biomarkers (CRP)(1 month)
- 6 month Infant Metabolomics(6 months)
- 16wk Maternal Resting Heart Rate(16 gestation)
- 6 month Postpartum Maternal Body Fat%(6 months postpartum)
- 16wk Maternal Biomarkers (IL6)(16 weeks gestation)
- 1 month Postpartum Maternal Biomarkers (adiponectin)(1 month postpartum)
- 12 month Infant Blood Biomarkers (IL6)(12 months)
- 1 month postpartum Maternal Resting Heart Rate(1 month postpartum)
- 6 month postpartum Maternal Resting Blood Pressure(6 months postpartum)
- 16wk Maternal Body Fat%(16 weeks gestation)
- 16wk Maternal Biomarkers (CRP)(16 weeks gestation)
- 36wk Maternal Biomarkers (CRP)(36 weeks gestation)
- 16wk Maternal Biomarkers (cortisol)(16 weeks gestation)
- 36wk Maternal Body Fat%(36 weeks gestation)
- 1 month Postpartum Maternal Biomarkers (IL6)(1 month postpartum)
- 16wk Maternal Biomarkers (adiponectin)(16 weeks gestation)
- 6 month Postpartum Maternal Biomarkers (CRP)(6 months postpartum)
- 36wk Maternal Biomarkers (IL6)(36 weeks gestation)
- 36wk Maternal Biomarkers (cortisol)(36 weeks gestation)
- 1 month Postpartum Maternal Biomarkers (cortisol)(1 month postpartum)
- 6 month Postpartum Maternal Biomarkers (cortisol)(6 months postpartum)
- 36wk Maternal Biomarkers (adiponectin)(36 weeks gestation)