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

NCT04291560 | Completed Results DMC

• 2 other identifiers: 18-30911R01NR017944-01A1
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Cardiovascular Risk Factor; Obesity

Outcome Measures

Primary Outcomes (10)

• 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 (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.

  Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 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 (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.

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

  Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 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 (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.

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

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

  Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 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 (approximately 27 gestational weeks) to approximately 10 weeks after baseline (approximately 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 (log(ms\^2/Hz)) from an electrocardiogram, assessed at baseline (27 gestational weeks) and 32 gestational weeks.

  Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 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 (log(ms\^2/Hz)) from an electrocardiogram, assessed at baseline (27 gestational weeks) and 37 gestational weeks.

  Baseline (approximately 27 gestational weeks) to approximately 10 weeks after baseline (approximately 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 (PWV) is a measure of arterial stiffness reported in m/s. Lower values reflect less arterial stiffness.

  Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 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 (PWV) is a measure of arterial stiffness reported in m/s. Lower values reflect less arterial stiffness.

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

Secondary Outcomes (12)

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

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

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

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

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

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

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

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

• Preterm Delivery at End of Pregnancy

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

Study Arms (2)

Prenatal Heart Smart Intervention

EXPERIMENTAL

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

Usual Care (Control)

NO INTERVENTION

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.

Interventions

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.

Prenatal Heart Smart Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant at less than 24 weeks gestation
• Singleton pregnancy
• BMI ≥ 30 kg/m\^2 at their first prenatal care visit
• English or Spanish speaking

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jamie Crandell, PhD
• Organization: University of North Carolina at Chapel Hill

jcrandell@unc.edu

919-966-5803

Study Officials

• SeonAe Yeo, PhD, FAAN

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Masking will not be completed in this trial.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: March 2, 2020
• Study Start: March 1, 2020
• Primary Completion: October 23, 2024
• Study Completion: December 20, 2024
• Last Updated: November 19, 2025
• Results First Posted: November 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)