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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Obesity; Pregnancy Related; Cardiovascular Risk Factor
• Intervention / Treatment: Behavioral: Stretching Exercise Intervention

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 Type: Interventional
• Enrollment (Anticipated): 306
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • The University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prenatal Heart Smart 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.	Behavioral: Stretching Exercise Intervention; Sequential static stretching of the large skeletal muscle group 5 days per week. Each skeletal group is stretched for 20 seconds for 3 repetitions.
No Intervention: Usual Care (Control); 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?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Anticipated): May 31, 2025
• Study Completion (Anticipated): July 1, 2025

Study Registration Dates

• First Submitted: February 21, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (Actual): March 2, 2020

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 18-3091; 1R01NR017944-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No