Clinical trial NCT04291560: Promoting Stretching Exercise to Reduce Cardiovascular Health Risk in Late Pregnant Women With Obesity
Official title: Promoting Stretching Exercise to Reduce Cardiovascular Health Risk in Late Pregnant Women With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Cardiovascular Risk Factor
Obesity
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2020-03-02
Enrollment: 224
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in systolic blood pressure from baseline (27 gestational weeks) to 32 gestational weeks
timeFrame: Baseline to 32 gestational weeks
measure: Change in systolic blood pressure from baseline (27 gestational weeks) to 37 gestational weeks
timeFrame: Baseline to 37 gestational weeks
measure: Change in diastolic blood pressure from baseline (27 gestational weeks) to 32 gestational weeks
timeFrame: Baseline to 32 gestational weeks
measure: Change in diastolic blood pressure from baseline (27 gestational weeks) to 37 gestational weeks
timeFrame: Baseline to 37 gestational weeks
measure: Change in sympatho-vagal balance projection period (PEP) for sympathetic activity from baseline (27 gestational weeks) to 32 gestational weeks
timeFrame: Baseline to 32 gestational weeks
measure: Change in sympatho-vagal balance projection period (PEP) for sympathetic from baseline (27 gestational weeks) to 37 gestational weeks
timeFrame: Baseline to 37 gestational weeks
measure: Change in high frequency of heart rate variability from baseline (27 gestational weeks) to 32 gestational weeks
timeFrame: Baseline to 32 gestational weeks
measure: Change in high frequency of heart rate variability from baseline (27 gestational weeks) to 37 gestational weeks
timeFrame: Baseline to 37 gestational weeks
measure: Change in arterial stiffness assessed by SphygmoCor XCEL from baseline (27 gestational weeks) to 32 gestational weeks
timeFrame: Baseline to 32 gestational weeks
measure: Change in arterial stiffness assessed by SphygmoCor XCEL from baseline (27 gestational weeks) to 37 gestational weeks
timeFrame: Baseline to 37 gestational weeks
Secondary outcomes:
measure: Onset of preeclampsia anytime between baseline (27 weeks gestation) and the end of pregnancy
timeFrame: From baseline (27 weeks gestation) through 8 weeks following delivery
measure: Onset of eclampsia anytime between baseline (27 weeks gestation) and the end of pregnancy
timeFrame: From baseline (27 weeks gestation) through 8 weeks following delivery
measure: Onset of pregnancy induced hypertension anytime between baseline (27 weeks gestation) and the end of pregnancy
timeFrame: From baseline (27 weeks gestation) through 8 weeks following delivery
measure: Onset of gestational diabetes anytime between baseline (27 weeks) and the end of pregnancy
timeFrame: From baseline (27 weeks gestation) through 8 weeks following delivery
measure: Preterm delivery at end of pregnancy
timeFrame: From baseline (27 weeks gestation) through 8 weeks following delivery
measure: Elective or emergency cesarean section at end of pregnancy
timeFrame: From baseline (27 weeks gestation) through 8 weeks following delivery
measure: Composite score of Maternal Outcomes at the End of Pregnancy.
timeFrame: From baseline (27 weeks gestation) through 8 weeks following delivery
measure: Intrauterine death at end of pregnancy
timeFrame: From baseline (27 weeks gestation) through 8 weeks following delivery
measure: Child being small for gestational age at the end of pregnancy
timeFrame: From baseline (27 weeks gestation) through 8 weeks following delivery
measure: Child being large for gestational age at the end of pregnancy
timeFrame: From baseline (27 weeks gestation) through 8 weeks following delivery
measure: Neonatal intensive care unit admission at the end of pregnancy
timeFrame: From baseline (27 weeks gestation) through 8 weeks following delivery
measure: Composite Score of Fetal/Neonatal Outcomes at the End of Pregnancy.
timeFrame: From baseline (27 weeks gestation) through 8 weeks following delivery
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: SeonAe Yeo, PhD, FAAN
role: PRINCIPAL_INVESTIGATOR
References: