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Completed

NCT Number: NCT04291560

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

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.

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Key information

Conditions

Pregnancy Related Body Weight Cardiovascular Risk Factor Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stretching Exercise Intervention

Behavioral

Sequential static stretching of the large skeletal muscle group 5 days per week. Each skeletal group is stretched for 20 seconds for 3 repetitions.

Primary outcomes

  1. Change in Systolic Blood Pressure From Baseline (27 Gestational Weeks) to 32 Gestational Weeks

    Time frame: Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 32 gestational weeks)

    Average systolic blood pressure measurement between two measurements, assessed at baseline (approximately 27 gestational weeks) and approximately 5 weeks after baseline (approximately 32 gestational weeks). Three total measurements will be taken, the first will be removed and the second two averaged.

  2. Change in Systolic Blood Pressure From Baseline (27 Gestational Weeks) to 37 Gestational Weeks

    Time frame: Baseline (approximately 27 gestational weeks) to approximately 10 weeks after baseline (approximately 37 gestational weeks)

    Average systolic blood pressure measurement between two measurements, assessed at baseline (approximately 27 gestational weeks) and approximately 10 weeks after baseline (approximately 37 gestational weeks). Three total measurements will be taken, the first will be removed and the second two averaged.

  3. Change in Diastolic Blood Pressure From Baseline (27 Gestational Weeks) to 32 Gestational Weeks

    Time frame: Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 32 gestational weeks)

    Average diastolic blood pressure measurement between two measurements, assessed at baseline (approximately 27 gestational weeks) and approximately 5 weeks after baseline (approximately 32 gestational weeks) Three total measurements will be taken, the first will be removed and the second two averaged.

  4. Change in Diastolic Blood Pressure From Baseline (27 Gestational Weeks) to 37 Gestational Weeks

    Time frame: Baseline (approximately 27 gestational weeks) to approximately 10 weeks after baseline (approximately 37 gestational weeks)

    Average diastolic blood pressure measurement between two measurements, assessed at baseline (approximately 27 gestational weeks) and approximately 10 weeks after baseline (approximately 32 gestational weeks). Three total measurements will be taken, the first will be removed and the second two averaged.

  5. Change in Sympatho-vagal Balance Projection Period (PEP) for Sympathetic Activity From Baseline (27 Gestational Weeks) to 32 Gestational Weeks

    Time frame: Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 32 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 32 gestational weeks.

  6. Change in Sympatho-vagal Balance Projection Period (PEP) for Sympathetic From Baseline (27 Gestational Weeks) to 37 Gestational Weeks

    Time frame: Baseline (approximately 27 gestational weeks) to approximately 10 weeks after baseline (approximately 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.

  7. Change in High Frequency of Heart Rate Variability From Baseline (27 Gestational Weeks) to 32 Gestational Weeks

    Time frame: Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 32 gestational weeks)

    High frequency of heart rate variability (log(ms^2/Hz)) from an electrocardiogram, assessed at baseline (27 gestational weeks) and 32 gestational weeks.

  8. Change in High Frequency of Heart Rate Variability From Baseline (27 Gestational Weeks) to 37 Gestational Weeks

    Time frame: Baseline (approximately 27 gestational weeks) to approximately 10 weeks after baseline (approximately 37 gestational weeks)

    High frequency of heart rate variability (log(ms^2/Hz)) from an electrocardiogram, assessed at baseline (27 gestational weeks) and 37 gestational weeks.

  9. Change in Arterial Stiffness Assessed by SphygmoCor XCEL From Baseline (27 Gestational Weeks) to 32 Gestational Weeks

    Time frame: Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 32 gestational weeks)

    Carotid-femoral pulse wave velocity (PWV) is a measure of arterial stiffness reported in m/s. Lower values reflect less arterial stiffness.

  10. Change in Arterial Stiffness Assessed by SphygmoCor XCEL From Baseline (27 Gestational Weeks) to 37 Gestational Weeks

    Time frame: Baseline (approximately 27 gestational weeks) to approximately 10 weeks after baseline (approximately 37 gestational weeks)

    Carotid-femoral pulse wave velocity (PWV) is a measure of arterial stiffness reported in m/s. Lower values reflect less arterial stiffness.

Secondary outcomes

  1. Onset of Preeclampsia Anytime Between Baseline (27 Weeks Gestation) and the End of Pregnancy

    Time frame: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks

    Presence of preeclampsia anytime between baseline (27 weeks gestation) and the end of pregnancy in the electronic medical record.

  2. Onset of Eclampsia Anytime Between Baseline (27 Weeks Gestation) and the End of Pregnancy

    Time frame: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks

    Presence of eclampsia anytime between baseline (27 weeks gestation) and the end of pregnancy in the electronic medical record.

  3. Onset of Pregnancy Induced Hypertension Anytime Between Baseline (27 Weeks Gestation) and the End of Pregnancy

    Time frame: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks

    Presence of pregnancy induced hypertension anytime between baseline (27 weeks gestation) and the end of pregnancy in the electronic medical record.

  4. Onset of Gestational Diabetes Anytime Between Baseline (27 Weeks) and the End of Pregnancy

    Time frame: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks

    Presence of gestational diabetes anytime between baseline (27 weeks gestation) and the end of pregnancy in the electronic medical record.

  5. Preterm Delivery at End of Pregnancy

    Time frame: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks

    Presence of preterm delivery in the electronic medical record.

  6. Elective or Emergency Cesarean Section at End of Pregnancy

    Time frame: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks

    Presence of an elective or emergency cesarean section in the electronic medical record.

  7. Composite Score of Maternal Outcomes at the End of Pregnancy

    Time frame: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks

    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.

  8. Intrauterine Death at End of Pregnancy

    Time frame: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks

    Presence of an intrauterine death in the electronic medical record.

  9. Child Being Small for Gestational Age at the End of Pregnancy

    Time frame: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks

    Presence of the child being small for gestational age in the electronic medical record.

  10. Child Being Large for Gestational Age at the End of Pregnancy

    Time frame: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks

    Presence of the child being large for gestational age in the electronic medical record.

  11. Neonatal Intensive Care Unit Admission at the End of Pregnancy

    Time frame: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks

    Presence of a neonatal intensive care unit admission in the electronic medical record.

  12. Composite Score of Fetal/Neonatal Outcomes at the End of Pregnancy.

    Time frame: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Mar 2, 2020
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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