N/A
N=108
Promoting Stretching Exercise to Reduce Cardiovascular Health Risk in Late Pregnant Women With Obesity
Pregnancy Related · Cardiovascular Risk Factor · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT04291560 ↗Enrolled (actual)
108
Serious AEs
12.0%
Results posted
Nov 2025
Primary outcome: Primary: Change in Systolic Blood Pressure From Baseline (27 Gestational Weeks) to 32 Gestational Weeks — 0.73; -1.56 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Stretching Exercise Intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Systolic Blood Pressure From Baseline (27 Gestational Weeks) to 32 Gestational Weeks |
0.73; -1.56 | — |
| PRIMARY Change in Systolic Blood Pressure From Baseline (27 Gestational Weeks) to 37 Gestational Weeks |
3.14; 6.23 | — |
| PRIMARY Change in Diastolic Blood Pressure From Baseline (27 Gestational Weeks) to 32 Gestational Weeks |
0.41; 1.42 | — |
| PRIMARY Change in Diastolic Blood Pressure From Baseline (27 Gestational Weeks) to 37 Gestational Weeks |
4.52; 7.63 | — |
| PRIMARY Change in Sympatho-vagal Balance Projection Period (PEP) for Sympathetic Activity From Baseline (27 Gestational Weeks) to 32 Gestational Weeks |
— | — |
| PRIMARY Change in Sympatho-vagal Balance Projection Period (PEP) for Sympathetic From Baseline (27 Gestational Weeks) to 37 Gestational Weeks |
— | — |
| PRIMARY Change in High Frequency of Heart Rate Variability From Baseline (27 Gestational Weeks) to 32 Gestational Weeks |
-0.13; -0.03 | — |
| PRIMARY Change in High Frequency of Heart Rate Variability From Baseline (27 Gestational Weeks) to 37 Gestational Weeks |
-0.42; -0.37 | — |
| PRIMARY Change in Arterial Stiffness Assessed by SphygmoCor XCEL From Baseline (27 Gestational Weeks) to 32 Gestational Weeks |
0.20; 0.19 | — |
| PRIMARY Change in Arterial Stiffness Assessed by SphygmoCor XCEL From Baseline (27 Gestational Weeks) to 37 Gestational Weeks |
0.07; 0.59 | — |
| SECONDARY Onset of Preeclampsia Anytime Between Baseline (27 Weeks Gestation) and the End of Pregnancy |
4; 7 | — |
| SECONDARY Onset of Eclampsia Anytime Between Baseline (27 Weeks Gestation) and the End of Pregnancy |
0; 0 | — |
| SECONDARY Onset of Pregnancy Induced Hypertension Anytime Between Baseline (27 Weeks Gestation) and the End of Pregnancy |
15; 21 | — |
| SECONDARY Onset of Gestational Diabetes Anytime Between Baseline (27 Weeks) and the End of Pregnancy |
6; 6 | — |
| SECONDARY Preterm Delivery at End of Pregnancy |
3; 2 | — |
| SECONDARY Elective or Emergency Cesarean Section at End of Pregnancy |
18; 18 | — |
| SECONDARY Composite Score of Maternal Outcomes at the End of Pregnancy |
0.90; 1.00 | — |
| SECONDARY Intrauterine Death at End of Pregnancy |
0; 0 | — |
| SECONDARY Child Being Small for Gestational Age at the End of Pregnancy |
2; 5 | — |
| SECONDARY Child Being Large for Gestational Age at the End of Pregnancy |
7; 11 | — |
| SECONDARY Neonatal Intensive Care Unit Admission at the End of Pregnancy |
1; 1 | — |
| SECONDARY Composite Score of Fetal/Neonatal Outcomes at the End of Pregnancy. |
0.20; 0.32 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04291560). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.