Promoting Stretching Exercise to Reduce Cardiovascular Health Risk in Late Pregnant Women With Obesity

Study Overview
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Brief Summary
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The purpose of this trial is to determine whether a stretching intervention is superior to a usual care control condition (moderate/vigorous activity 30 minutes daily, 5 days per week) for pregnant women from 27 to 37 gestational weeks.

Detailed Description
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Although being sedentary can lead to excess risk for maternal and child mortality and morbidity, most pregnant women reduce their physical activity and only 8% meet the recommendations in the 3rd trimester. In a prior randomized control trial, it was found that fewer women who stretched developed preeclampsia than did women who walked (3/60 stretchers vs. 10/64 walkers, p=.05). In this study, participants will either receive a stretching intervention

Official Title
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Promoting Stretching Exercise to Reduce Cardiovascular Health Risk in Late Pregnant Women With Obesity

Conditions
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Pregnancy Related, Cardiovascular Risk Factor, Obesity

Intervention / Treatment
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* Behavioral: Stretching Exercise Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant at less than 24 weeks gestation Singleton pregnancy BMI ≥ 30 kg/m^2 at their first prenatal care visit English or Spanish speaking Exclusion Criteria: Women who expect or are scheduled to deliver prior to 37 weeks gestation Women who expect to move from the area during their participation in the study Women who are unable to exercise for 30 or more minutes 3 times per week

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A parallel design will be used, with an equal allocation of 306 obese pregnant women to the two groups: stretching exercise and enhanced usual care.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prenatal Heart Smart Intervention<br>This group will have usual care completed and supportive calls from a facilitator to discuss adherence to the home exercise. In addition, the group will complete a sequential static stretching exercise 5 days per week for 10 weeks. The stretching exercise consists of 20 seconds of stretching, for 3 repetitions per muscle group. | Behavioral: Stretching Exercise Intervention<br>* Sequential static stretching of the large skeletal muscle group 5 days per week. Each skeletal group is stretched for 20 seconds for 3 repetitions.<br>|
| No Intervention: Usual Care (Control)<br>This group will have usual care completed and supportive calls from a facilitator to discuss adherence to the home exercise. In addition, this group will complete moderate-intensity walking 5 days per week for 10 weeks in accordance to usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in systolic blood pressure from baseline (27 gestational weeks) to 32 gestational weeks | Average systolic blood pressure measurement between two measurements, assessed at baseline (27 gestational weeks) and 32 gestational weeks. Three total measurements will be taken, the first will be removed and the second two averaged. | Baseline to 32 gestational weeks | 
| Change in systolic blood pressure from baseline (27 gestational weeks) to 37 gestational weeks | Average systolic blood pressure measurement between two measurements, assessed at baseline (27 gestational weeks) and 37 gestational weeks. Three total measurements will be taken, the first will be removed and the second two averaged. | Baseline to 37 gestational weeks | 
| Change in diastolic blood pressure from baseline (27 gestational weeks) to 32 gestational weeks | Average diastolic blood pressure measurement between two measurements, assessed at baseline (27 gestational weeks) and 32 gestational weeks. Three total measurements will be taken, the first will be removed and the second two averaged. | Baseline to 32 gestational weeks | 
| Change in diastolic blood pressure from baseline (27 gestational weeks) to 37 gestational weeks | Average diastolic blood pressure measurement between two measurements, assessed at baseline (27 gestational weeks) and 37 gestational weeks. Three total measurements will be taken, the first will be removed and the second two averaged. | Baseline to 37 gestational weeks | 
| Change in sympatho-vagal balance projection period (PEP) for sympathetic activity from baseline (27 gestational weeks) to 32 gestational weeks | he time in milliseconds from the ECG R point (left ventricular depolarization) and the B-point on the Dz/dt wave form (opening of the aortic valve), assessed at baseline (27 gestational weeks) and 32 gestational weeks. | Baseline to 32 gestational weeks | 
| Change in sympatho-vagal balance projection period (PEP) for sympathetic from baseline (27 gestational weeks) to 37 gestational weeks | The time in milliseconds from the ECG R point (left ventricular depolarization) and the B-point on the Dz/dt wave form (opening of the aortic valve), assessed at baseline (27 gestational weeks) and 37 gestational weeks. | Baseline to 37 gestational weeks | 
| Change in high frequency of heart rate variability from baseline (27 gestational weeks) to 32 gestational weeks | High frequency of heart rate variability (reported in absolute value, m^2/Hz) from an electrocardiogram, assessed at baseline (27 gestational weeks) and 32 gestational weeks. | Baseline to 32 gestational weeks | 
| Change in high frequency of heart rate variability from baseline (27 gestational weeks) to 37 gestational weeks | High frequency of heart rate variability (reported in absolute value, m^2/Hz) from an electrocardiogram, assessed at baseline (27 gestational weeks) and 37 gestational weeks. | Baseline to 37 gestational weeks | 
| Change in arterial stiffness assessed by SphygmoCor XCEL from baseline (27 gestational weeks) to 32 gestational weeks | Carotid-femoral pulse wave velocity is a measure of arterial stiffness reported in m/s. Lower values reflect less arterial stiffness. | Baseline to 32 gestational weeks | 
| Change in arterial stiffness assessed by SphygmoCor XCEL from baseline (27 gestational weeks) to 37 gestational weeks | Carotid-femoral pulse wave velocity is a measure of arterial stiffness reported in m/s. Lower values reflect less arterial stiffness. | Baseline to 37 gestational weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of preeclampsia anytime between baseline (27 weeks gestation) and the end of pregnancy | Presence of preeclampsia anytime between baseline (27 weeks gestation) and the end of pregnancy in the electronic medical record. | From baseline (27 weeks gestation) through delivery | 
| Onset of eclampsia anytime between baseline (27 weeks gestation) and the end of pregnancy | Presence of eclampsia anytime between baseline (27 weeks gestation) and the end of pregnancy in the electronic medical record. | From baseline (27 weeks gestation) through delivery | 
| Onset of pregnancy induced hypertension anytime between baseline (27 weeks gestation) and the end of pregnancy | Presence of pregnancy induced hypertension anytime between baseline (27 weeks gestation) and the end of pregnancy in the electronic medical record. | From baseline (27 weeks gestation) through delivery | 
| Onset of gestational diabetes anytime between baseline (27 weeks) and the end of pregnancy | Presence of gestational diabetes anytime between baseline (27 weeks gestation) and the end of pregnancy in the electronic medical record. | From baseline (27 weeks gestation) through delivery | 
| Preterm delivery at end of pregnancy | Presence of preterm delivery in the electronic medical record. | From baseline (27 weeks gestation) through delivery | 
| Elective or emergency cesarean section at end of pregnancy | Presence of an elective or emergency cesarean section in the electronic medical record. | From baseline (27 weeks gestation) through delivery | 
| Composite score of Maternal Outcomes at the End of Pregnancy. | The composite score of maternal outcomes (onset of preeclampsia, eclampsia pregnancy induced hypertension, gestational diabetes, preterm delivery, and elective or emergency cesarean section) is obtained at the end of pregnancy. Scores range from 0-6, with higher scores indicating a less healthy pregnancy. | From baseline (27 weeks gestation) through delivery | 
| Intrauterine death at end of pregnancy | Presence of an intrauterine death in the electronic medical record. | From baseline (27 weeks gestation) through delivery | 
| Child being small for gestational age at the end of pregnancy | Presence of the child being small for gestational age in the electronic medical record. | From baseline (27 weeks gestation) through delivery | 
| Child being large for gestational age at the end of pregnancy | Presence of the child being large for gestational age in the electronic medical record. | From baseline (27 weeks gestation) through delivery | 
| Neonatal intensive care unit admission at the end of pregnancy | Presence of a neonatal intensive care unit admission in the electronic medical record. | From baseline (27 weeks gestation) through delivery | 
| Composite Score of Fetal/Neonatal Outcomes at the End of Pregnancy. | The composite score of fetal/neonatal outcomes (intrauterine death, child being small, child being large, neonatal intensive care admission) is obtained at the end of pregnancy. Scores range from 0-4, with higher scores indicating a less healthy fetus/neonate. | From baseline (27 weeks gestation) through delivery |