Stretching Exercises for Pregnancy and Obesity

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Preterm delivery, Moving, Inability to exercise

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 10 weeks

224 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

SeonAe Yeo, PhD, FAAN

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for pregnant women with obesity, carrying one baby and less than 24 weeks into their pregnancy. They should have a BMI of 30 or higher at their first prenatal visit and must speak English or Spanish. It's not for those who plan to give birth before 37 weeks, move away during the study, or can't exercise regularly.

Inclusion Criteria

Pregnant at less than 24 weeks gestation

BMI ≥ 30 kg/m^2 at their first prenatal care visit

You are pregnant with only one baby.

Exclusion Criteria

Women who expect or are scheduled to deliver prior to 37 weeks gestation

I cannot exercise for 30 minutes or more three times a week.

Women who expect to move from the area during their participation in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a stretching intervention or usual care with moderate-intensity walking for 10 weeks

10 weeks

5 days per week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including the onset of preeclampsia, hypertension, and other maternal and fetal outcomes

8 weeks following delivery

What Are the Treatments Tested in This Trial?

Interventions

• Stretching Exercise Intervention

Trial Overview The trial is testing if stretching exercises are better than the usual care (moderate to vigorous activity for 30 minutes daily, five days a week) in reducing cardiovascular risks in obese pregnant women between their 27th and 37th gestational weeks.

How Is the Trial Designed?

Group I: Prenatal Heart Smart Intervention Experimental Treatment 1 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.

Group II: Usual Care (Control) Active Control 1 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.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+