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

Not Applicable

Active, not recruiting

• Conditions: Obesity; Pregnancy Related; Cardiovascular Risk Factor
• Interventions: Behavioral: Stretching Exercise Intervention

• Registration Number: NCT04291560
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2020-02-21
• Study First Submitted QC: 2020-02-27
• Study Start: 2020-03-01
• Study First Posted: 2020-03-02
• Status Verified: 2024-06
• Last Update Submitted: 2024-07-12
• Last Update Posted: 2024-07-16
• Primary Completion: 2024-10-11
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 224

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prenatal Heart Smart Intervention	Stretching Exercise Intervention	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.

Primary Outcome Measures

Name	Time	Method
Change in arterial stiffness assessed by SphygmoCor XCEL from baseline (27 gestational weeks) to 32 gestational weeks	Baseline 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.
Change in high frequency of heart rate variability from baseline (27 gestational weeks) to 32 gestational weeks	Baseline 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.
Change in diastolic blood pressure from baseline (27 gestational weeks) to 32 gestational weeks	Baseline 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.
Change in high frequency of heart rate variability from baseline (27 gestational weeks) to 37 gestational weeks	Baseline 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.
Change in arterial stiffness assessed by SphygmoCor XCEL from baseline (27 gestational weeks) to 37 gestational weeks	Baseline 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.
Change in diastolic blood pressure from baseline (27 gestational weeks) to 37 gestational weeks	Baseline 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.
Change in sympatho-vagal balance projection period (PEP) for sympathetic activity from baseline (27 gestational weeks) to 32 gestational weeks	Baseline 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.
Change in systolic blood pressure from baseline (27 gestational weeks) to 37 gestational weeks	Baseline 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.
Change in sympatho-vagal balance projection period (PEP) for sympathetic from baseline (27 gestational weeks) to 37 gestational weeks	Baseline 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.
Change in systolic blood pressure from baseline (27 gestational weeks) to 32 gestational weeks	Baseline 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.

Secondary Outcome Measures

Name	Time	Method
Onset of eclampsia anytime between baseline (27 weeks gestation) and the end of pregnancy	From baseline (27 weeks gestation) through 8 weeks following delivery	Presence of eclampsia anytime between baseline (27 weeks gestation) and the end of pregnancy in the electronic medical record.
Child being large for gestational age at the end of pregnancy	From baseline (27 weeks gestation) through 8 weeks following delivery	Presence of the child being large for gestational age in the electronic medical record.
Onset of pregnancy induced hypertension anytime between baseline (27 weeks gestation) and the end of pregnancy	From baseline (27 weeks gestation) through 8 weeks following delivery	Presence of pregnancy induced hypertension anytime between baseline (27 weeks gestation) and the end of pregnancy in the electronic medical record.
Onset of preeclampsia anytime between baseline (27 weeks gestation) and the end of pregnancy	From baseline (27 weeks gestation) through 8 weeks following delivery	Presence of preeclampsia anytime between baseline (27 weeks gestation) and the end of pregnancy in the electronic medical record.
Onset of gestational diabetes anytime between baseline (27 weeks) and the end of pregnancy	From baseline (27 weeks gestation) through 8 weeks following delivery	Presence of gestational diabetes anytime between baseline (27 weeks gestation) and the end of pregnancy in the electronic medical record.
Composite Score of Fetal/Neonatal Outcomes at the End of Pregnancy.	From baseline (27 weeks gestation) through 8 weeks following delivery	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.
Neonatal intensive care unit admission at the end of pregnancy	From baseline (27 weeks gestation) through 8 weeks following delivery	Presence of a neonatal intensive care unit admission in the electronic medical record.
Composite score of Maternal Outcomes at the End of Pregnancy.	From baseline (27 weeks gestation) through 8 weeks following delivery	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.
Intrauterine death at end of pregnancy	From baseline (27 weeks gestation) through 8 weeks following delivery	Presence of an intrauterine death in the electronic medical record.
Preterm delivery at end of pregnancy	From baseline (27 weeks gestation) through 8 weeks following delivery	Presence of preterm delivery in the electronic medical record.
Elective or emergency cesarean section at end of pregnancy	From baseline (27 weeks gestation) through 8 weeks following delivery	Presence of an elective or emergency cesarean section in the electronic medical record.
Child being small for gestational age at the end of pregnancy	From baseline (27 weeks gestation) through 8 weeks following delivery	Presence of the child being small for gestational age in the electronic medical record.

Trial Locations

Locations (1)

The University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States