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

NCT ID: NCT04291560

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2024-12-20

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

Conditions

Pregnancy Related; Cardiovascular Risk Factor; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Stretching Exercise Intervention

Intervention Type: BEHAVIORAL

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

SeonAe Yeo, PhD, FAAN

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan: Original version

View Document

Document Type: Study Protocol and Statistical Analysis Plan: Revised version to remove Cardiac Impedance measures

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01NR017944-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18-3091

Identifier Type: -

Identifier Source: org_study_id