Trial Outcomes & Findings for Promoting Stretching Exercise to Reduce Cardiovascular Health Risk in Late Pregnant Women With Obesity (NCT NCT04291560)

NCT ID: NCT04291560

Last Updated: 2025-11-19

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 224 participants
• Primary outcome timeframe: Baseline (approximately 27 gestational weeks) to approximately 10 weeks after baseline (approximately 37 gestational weeks)
• Results posted on: 2025-11-19

Participant Flow

224 participants consented during early pregnancy. After consenting, participants underwent a run-in period until reaching approximately 27 weeks gestation, at which point a baseline visit was scheduled. 108 participants completed this baseline visit, and thus were randomized to one of the study arms.

Participant milestones

Measure	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. 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.	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.
Overall Study STARTED	53	55
Overall Study COMPLETED	53	55
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Prenatal Heart Smart Intervention n=53 Participants 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. 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.	Usual Care (Control) n=55 Participants 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.	Total n=108 Participants Total of all reporting groups
Age, Continuous	32.8 years STANDARD_DEVIATION 3.7	31.0 years STANDARD_DEVIATION 5.7 • n=4 Participants	31.9 years STANDARD_DEVIATION 4.9 • n=8 Participants
Sex: Female, Male Female	53 Participants	55 Participants n=4 Participants	108 Participants n=8 Participants
Sex: Female, Male Male	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants	6 Participants n=4 Participants	17 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants	44 Participants n=4 Participants	85 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants	5 Participants n=4 Participants	6 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	1 Participants n=4 Participants	2 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants	1 Participants n=4 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	22 Participants	19 Participants n=4 Participants	41 Participants n=8 Participants
Race (NIH/OMB) White	24 Participants	27 Participants n=4 Participants	51 Participants n=8 Participants
Race (NIH/OMB) More than one race	2 Participants	5 Participants n=4 Participants	7 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants	2 Participants n=4 Participants	6 Participants n=8 Participants
Region of Enrollment United States	53 Participants	55 Participants n=4 Participants	108 Participants n=8 Participants

PRIMARY outcome

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

Population: Only includes participants who completed blood pressure measures at their 32 week follow-up visit.

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.

Outcome measures

Measure	Prenatal Heart Smart Intervention n=33 Participants 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. 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.	Usual Care (Control) n=39 Participants 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.
Change in Systolic Blood Pressure From Baseline (27 Gestational Weeks) to 32 Gestational Weeks	0.73 mmHg Standard Deviation 8.21	-1.56 mmHg Standard Deviation 8.34

PRIMARY outcome

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

Population: Only includes participants who completed blood pressure measures at their 37 week follow-up visit.

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.

Outcome measures

Measure	Prenatal Heart Smart Intervention n=28 Participants 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. 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.	Usual Care (Control) n=28 Participants 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.
Change in Systolic Blood Pressure From Baseline (27 Gestational Weeks) to 37 Gestational Weeks	3.14 mmHg Standard Deviation 8.02	6.23 mmHg Standard Deviation 10.07

PRIMARY outcome

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

Population: Only includes participants who completed blood pressure measures at their 32 week follow-up visit.

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.

Outcome measures

Measure	Prenatal Heart Smart Intervention n=33 Participants 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. 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.	Usual Care (Control) n=39 Participants 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.
Change in Diastolic Blood Pressure From Baseline (27 Gestational Weeks) to 32 Gestational Weeks	0.41 mmHg Standard Deviation 7.75	1.42 mmHg Standard Deviation 5.28

PRIMARY outcome

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

Population: Only includes participants who completed blood pressure measures at their 37 week follow-up visit.

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.

Outcome measures

Measure	Prenatal Heart Smart Intervention n=28 Participants 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. 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.	Usual Care (Control) n=28 Participants 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.
Change in Diastolic Blood Pressure From Baseline (27 Gestational Weeks) to 37 Gestational Weeks	4.52 mmHg Standard Deviation 7.08	7.63 mmHg Standard Deviation 7.27

PRIMARY outcome

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

Population: This variable required cardiac impedance data, which were not collected from any participants. PEP was initially proposed as a measure of autonomic function; however, we were already collecting high-frequency (HF) heart rate variability, a more well-established indicator of autonomic function. Adding another measure was deemed an unnecessary burden on participants, so it was removed from the protocol.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

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

Population: This variable required cardiac impedance data, which were not collected from any participants. PEP was initially proposed as a measure of autonomic function; however, we were already collecting high-frequency (HF) heart rate variability, a more well-established indicator of autonomic function. Adding another measure was deemed an unnecessary burden on participants, so it was removed from the protocol.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

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

Population: Only includes participants who completed heart rate variability measures at their 32 week follow-up visit.

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

Outcome measures

Measure	Prenatal Heart Smart Intervention n=30 Participants 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. 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.	Usual Care (Control) n=41 Participants 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.
Change in High Frequency of Heart Rate Variability From Baseline (27 Gestational Weeks) to 32 Gestational Weeks	-0.13 log(ms^2/Hz) Standard Deviation 1.42	-0.03 log(ms^2/Hz) Standard Deviation 1.48

PRIMARY outcome

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

Population: Only includes participants who completed heart rate variability measures at their 37 week follow-up visit.

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

Outcome measures

Measure	Prenatal Heart Smart Intervention n=27 Participants 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. 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.	Usual Care (Control) n=25 Participants 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.
Change in High Frequency of Heart Rate Variability From Baseline (27 Gestational Weeks) to 37 Gestational Weeks	-0.42 log(ms^2/Hz) Standard Deviation 1.02	-0.37 log(ms^2/Hz) Standard Deviation 1.27

PRIMARY outcome

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

Population: Only includes participants who completed PWV measures at their 32 week follow-up visit.

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

Outcome measures

Measure	Prenatal Heart Smart Intervention n=27 Participants 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. 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.	Usual Care (Control) n=34 Participants 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.
Change in Arterial Stiffness Assessed by SphygmoCor XCEL From Baseline (27 Gestational Weeks) to 32 Gestational Weeks	0.20 m/s Standard Deviation 1.81	0.19 m/s Standard Deviation 0.78

PRIMARY outcome

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

Population: Only includes participants who completed PWV measures at their 37 week follow-up visit.

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

Outcome measures

Measure	Prenatal Heart Smart Intervention n=24 Participants 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. 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.	Usual Care (Control) n=22 Participants 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.
Change in Arterial Stiffness Assessed by SphygmoCor XCEL From Baseline (27 Gestational Weeks) to 37 Gestational Weeks	0.07 m/s Standard Deviation 1.34	0.59 m/s Standard Deviation 0.99

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Prenatal Heart Smart Intervention n=53 Participants 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. 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.	Usual Care (Control) n=55 Participants 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.
Onset of Preeclampsia Anytime Between Baseline (27 Weeks Gestation) and the End of Pregnancy	4 Participants	7 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Prenatal Heart Smart Intervention n=53 Participants 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. 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.	Usual Care (Control) n=55 Participants 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.
Onset of Eclampsia Anytime Between Baseline (27 Weeks Gestation) and the End of Pregnancy	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Prenatal Heart Smart Intervention n=53 Participants 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. 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.	Usual Care (Control) n=55 Participants 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.
Onset of Pregnancy Induced Hypertension Anytime Between Baseline (27 Weeks Gestation) and the End of Pregnancy	15 Participants	21 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Prenatal Heart Smart Intervention n=53 Participants 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. 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.	Usual Care (Control) n=55 Participants 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.
Onset of Gestational Diabetes Anytime Between Baseline (27 Weeks) and the End of Pregnancy	6 Participants	6 Participants

SECONDARY outcome

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

Population: Only includes babies delivered within the hospital system to which the study team had record access, or where the mother provided basic delivery information to the study team post-delivery.

Presence of preterm delivery in the electronic medical record.

Outcome measures

Measure	Prenatal Heart Smart Intervention n=51 Participants 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. 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.	Usual Care (Control) n=54 Participants 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.
Preterm Delivery at End of Pregnancy	3 Participants	2 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Prenatal Heart Smart Intervention n=53 Participants 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. 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.	Usual Care (Control) n=55 Participants 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.
Elective or Emergency Cesarean Section at End of Pregnancy	18 Participants	18 Participants

SECONDARY outcome

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

Population: Only includes babies delivered within the hospital system to which the study team had record access, or where the mother provided basic delivery information to the study team post-delivery.

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.

Outcome measures

Measure	Prenatal Heart Smart Intervention n=51 Participants 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. 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.	Usual Care (Control) n=54 Participants 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.
Composite Score of Maternal Outcomes at the End of Pregnancy	0.90 score on a scale Standard Deviation 1.12	1.00 score on a scale Standard Deviation 1.05

SECONDARY outcome

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

Population: Only includes babies delivered within the hospital system to which the study team had record access.

Presence of an intrauterine death in the electronic medical record.

Outcome measures

Measure	Prenatal Heart Smart Intervention n=50 Participants 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. 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.	Usual Care (Control) n=53 Participants 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.
Intrauterine Death at End of Pregnancy	0 Participants	0 Participants

SECONDARY outcome

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

Population: Only includes babies delivered within the hospital system to which the study team had record access.

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

Outcome measures

Measure	Prenatal Heart Smart Intervention n=50 Participants 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. 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.	Usual Care (Control) n=53 Participants 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.
Child Being Small for Gestational Age at the End of Pregnancy	2 Participants	5 Participants

SECONDARY outcome

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

Population: Only includes babies delivered within the hospital system to which the study team had record access.

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

Outcome measures

Measure	Prenatal Heart Smart Intervention n=50 Participants 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. 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.	Usual Care (Control) n=53 Participants 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.
Child Being Large for Gestational Age at the End of Pregnancy	7 Participants	11 Participants

SECONDARY outcome

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

Population: Only includes babies delivered within the hospital system to which the study team had record access.

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

Outcome measures

Measure	Prenatal Heart Smart Intervention n=50 Participants 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. 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.	Usual Care (Control) n=53 Participants 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.
Neonatal Intensive Care Unit Admission at the End of Pregnancy	1 Participants	1 Participants

SECONDARY outcome

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

Population: Only includes babies delivered within the hospital system to which the study team had record access.

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.

Outcome measures

Measure	Prenatal Heart Smart Intervention n=50 Participants 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. 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.	Usual Care (Control) n=53 Participants 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.
Composite Score of Fetal/Neonatal Outcomes at the End of Pregnancy.	0.20 score on a scale Standard Deviation 0.40	0.32 score on a scale Standard Deviation 0.47

Adverse Events

Prenatal Heart Smart Intervention

Serious events: 5 serious events

Other events: 35 other events

Deaths: 0 deaths

Usual Care (Control)

Serious events: 8 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Measure	Prenatal Heart Smart Intervention n=53 participants at risk 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. 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.	Usual Care (Control) n=55 participants at risk 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.
Pregnancy, puerperium and perinatal conditions Preeclampsia	7.5% 4/53 • Number of events 4 • From the time of randomization (about 27 weeks gestation) through 8 weeks after delivery, an approximate total of 21 weeks.	12.7% 7/55 • Number of events 7 • From the time of randomization (about 27 weeks gestation) through 8 weeks after delivery, an approximate total of 21 weeks.
Infections and infestations Hospitalization for Urinary Tract Infection	1.9% 1/53 • Number of events 1 • From the time of randomization (about 27 weeks gestation) through 8 weeks after delivery, an approximate total of 21 weeks.	0.00% 0/55 • From the time of randomization (about 27 weeks gestation) through 8 weeks after delivery, an approximate total of 21 weeks.
Congenital, familial and genetic disorders Fetal abnormality (abdominal mass) detected via ultrasound	0.00% 0/53 • From the time of randomization (about 27 weeks gestation) through 8 weeks after delivery, an approximate total of 21 weeks.	1.8% 1/55 • Number of events 1 • From the time of randomization (about 27 weeks gestation) through 8 weeks after delivery, an approximate total of 21 weeks.

Other adverse events

Measure	Prenatal Heart Smart Intervention n=53 participants at risk 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. 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.	Usual Care (Control) n=55 participants at risk 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.
Cardiac disorders Shortness of breath while exercising	5.7% 3/53 • Number of events 3 • From the time of randomization (about 27 weeks gestation) through 8 weeks after delivery, an approximate total of 21 weeks.	5.5% 3/55 • Number of events 6 • From the time of randomization (about 27 weeks gestation) through 8 weeks after delivery, an approximate total of 21 weeks.
Cardiac disorders Dizziness while exercising	11.3% 6/53 • Number of events 6 • From the time of randomization (about 27 weeks gestation) through 8 weeks after delivery, an approximate total of 21 weeks.	3.6% 2/55 • Number of events 2 • From the time of randomization (about 27 weeks gestation) through 8 weeks after delivery, an approximate total of 21 weeks.
Respiratory, thoracic and mediastinal disorders Reported contracting respiratory virus (cold, flu, RSV, or Covid)	13.2% 7/53 • Number of events 8 • From the time of randomization (about 27 weeks gestation) through 8 weeks after delivery, an approximate total of 21 weeks.	5.5% 3/55 • Number of events 3 • From the time of randomization (about 27 weeks gestation) through 8 weeks after delivery, an approximate total of 21 weeks.
Gastrointestinal disorders Gastrointestinal virus	5.7% 3/53 • Number of events 3 • From the time of randomization (about 27 weeks gestation) through 8 weeks after delivery, an approximate total of 21 weeks.	1.8% 1/55 • Number of events 1 • From the time of randomization (about 27 weeks gestation) through 8 weeks after delivery, an approximate total of 21 weeks.
Pregnancy, puerperium and perinatal conditions Pregnancy-related pain or soreness	11.3% 6/53 • Number of events 7 • From the time of randomization (about 27 weeks gestation) through 8 weeks after delivery, an approximate total of 21 weeks.	10.9% 6/55 • Number of events 6 • From the time of randomization (about 27 weeks gestation) through 8 weeks after delivery, an approximate total of 21 weeks.
Pregnancy, puerperium and perinatal conditions Delivery via Caesarean section	34.0% 18/53 • Number of events 18 • From the time of randomization (about 27 weeks gestation) through 8 weeks after delivery, an approximate total of 21 weeks.	32.7% 18/55 • Number of events 18 • From the time of randomization (about 27 weeks gestation) through 8 weeks after delivery, an approximate total of 21 weeks.
Pregnancy, puerperium and perinatal conditions Gestational hypertension	28.3% 15/53 • Number of events 15 • From the time of randomization (about 27 weeks gestation) through 8 weeks after delivery, an approximate total of 21 weeks.	38.2% 21/55 • Number of events 21 • From the time of randomization (about 27 weeks gestation) through 8 weeks after delivery, an approximate total of 21 weeks.
Pregnancy, puerperium and perinatal conditions Gestational diabetes	11.3% 6/53 • Number of events 6 • From the time of randomization (about 27 weeks gestation) through 8 weeks after delivery, an approximate total of 21 weeks.	10.9% 6/55 • Number of events 6 • From the time of randomization (about 27 weeks gestation) through 8 weeks after delivery, an approximate total of 21 weeks.

Additional Information

Jamie Crandell, PhD

University of North Carolina at Chapel Hill

Phone: 919-966-5803

Email: jcrandell@unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place