MAMA Tot - Healthy Weight Parallel Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 268
- 试验地点
- 2
- 主要终点
- 1 month Infant non-HDL
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: 18 to 40 years old
- •BMI 18.5 to 24.4
- •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 (Behavioral)
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 (Behavioral)
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 (Behavioral)
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
1 month Infant non-HDL
时间窗: 1 month
non-HDL measures from venipuncture
6 month Infant non-HDL
时间窗: 6 months
non-HDL measures from venipuncture
12 month Infant non-HDL
时间窗: 12 months
non-HDL measures 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
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: 36wks gestation
non-HDL measured from venipuncture
1 month Maternal fasting non-HDL
时间窗: 1 month postpartum
non-HDL measured from venipuncture
6 month Maternal fasting non-HDL
时间窗: 6 months postpartum
non-HDL measured from venipuncture
Adverse Pregnancy Outcomes
时间窗: At delivery
Presence or absence of Adverse Pregnancy outcomes (preterm birth, gestational diabetes \[GDM\], preeclampsia, hypertension)
12 month Maternal fasting non-HDL
时间窗: 12 months postpartum
non-HDL measured from venipuncture
次要结局
- 12 month Postpartum Maternal Resting Blood Pressure(12 months postpartum)
- Maternal Gestational Weight Gain (GWG)(At delivery)
- 16wk Maternal Body Fat %(16wks gestation)
- 1 month infant Resting Heart Rate(1 month)
- 6 month infant Resting Heart Rate(6 months)
- 12 month infant Resting Heart Rate(12 months)
- 1 month infant Resting Blood Pressure(1 month)
- 6 month infant Resting Blood Pressure(6 months)
- 12 month infant Resting Blood Pressure(12 months)
- 1 month infant Body Fat %(1 month)
- 6 month infant Body Fat %(6 months)
- 12 month infant Body Fat %(12 months)
- 1 month infant % Muscle Mass(1 month)
- 6 month infant % Muscle Mass(6 months)
- 12 month infant % Muscle Mass(12 months)
- 1 month Infant Resting Energy Expenditure (REE)(1 month)
- 6 month Infant Resting Energy Expenditure (REE)(6 months)
- 12 month Infant Resting Energy Expenditure (REE)(12 months)
- 1 month Infant Neuromotor Assessment(1 month)
- 6 month Infant Neuromotor Assessment(6 months)
- 12 month Infant Neuromotor Assessment(12 months)
- 1 month Infant Veggie Meter(1 month)
- 6 month Infant Veggie Meter(6 months)
- 12 month Infant Veggie Meter(12 months)
- 1 month Infant Blood Biomarkers (CRP)(1 month)
- 6 month Infant Blood Biomarkers (CRP)(6 months)
- 12 month Infant Blood Biomarkers (CRP)(12 months)
- 1 month Infant Blood Biomarkers (IL6)(1 month)
- 6 month Infant Blood Biomarkers (IL6)(6 months)
- 12 month Infant Blood Biomarkers (IL6)(12 months)
- 1 month Infant Blood Biomarkers (adiponectin)(1 month)
- 6 month Infant Blood Biomarkers (adiponectin)(6 months)
- 12 month Infant Blood Biomarkers (adiponectin)(12 months)
- 1 month Infant Metabolomics(1 month)
- 6 month Infant Metabolomics(6 months)
- 12 month Infant Metabolomics(12 months)
- 16wk Maternal Resting Heart Rate(16wks gestation)
- 36wk Maternal Resting Heart Rate(36wks gestation)
- 1 month Postpartum Maternal Resting Heart Rate(1 month postpartum)
- 6 month Postpartum Maternal Resting Heart Rate(6 months postpartum)
- 12 month Postpartum Maternal Resting Heart Rate(12 months postpartum)
- 16wk Maternal Resting Blood Pressure(16wks gestation)
- 36wk Maternal Resting Blood Pressure(36wks gestation)
- 1 month Postpartum Maternal Resting Blood Pressure(1 month postpartum)
- 6 month Postpartum Maternal Resting Blood Pressure(6 months postpartum)
- 36wk Maternal Body Fat %(36wks gestation)
- 1 month Postpartum Maternal Body Fat %(1 month postpartum)
- 6 month Postpartum Maternal Body Fat %(6 months postpartum)
- 12 month Postpartum Maternal Body Fat %(12 months postpartum)
- 16wk Maternal Biomarkers (CRP)(16wks gestation)
- 36wk Maternal Biomarkers (CRP)(36wks gestation)
- 1 month Postpartum Maternal Biomarkers (CRP)(1 month postpartum)
- 6 month Postpartum Maternal Biomarkers (CRP)(6 months postpartum)
- 12 month Postpartum Maternal Biomarkers (CRP)(12 months postpartum)
- 16wk Maternal Biomarkers (IL6)(16wks gestation)
- 36wk Maternal Biomarkers (IL6)(36wks gestation)
- 1 month Postpartum Maternal Biomarkers (IL6)(1 month postpartum)
- 6 month Postpartum Maternal Biomarkers (IL6)(6 months postpartum)
- 12 month Postpartum Maternal Biomarkers (IL6)(12 months postpartum)
- 16wks Maternal Biomarkers (adiponectin)(16wks gestation)
- 36wks Maternal Biomarkers (adiponectin)(36wks gestation)
- 1 month postpartum Maternal Biomarkers (adiponectin)(1 month postpartum)
- 6 month postpartum Maternal Biomarkers (adiponectin)(6 months postpartum)
- 12 month postpartum Maternal Biomarkers (adiponectin)(12 months postpartum)
- 16wks Maternal Biomarkers (cortisol)(16wks gestation)
- 36wks Maternal Biomarkers (cortisol)(36wks gestation)
- 1 month Postpartum Maternal Biomarkers (cortisol)(1 month postpartum)
- 6 month Postpartum Maternal Biomarkers (cortisol)(6 months postpartum)
- 12 month Postpartum Maternal Biomarkers (cortisol)(12 months postpartum)
研究者
Linda May
Associate Professor; Dept. Chair
East Carolina University