Centering Pregnancy Care + Yoga for Diverse Pregnant Women

NCT ID: NCT02873481

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-12-31

Brief Summary

This is a pilot longitudinal mixed-methods study of pregnant women (n=20) who participate in CPC+Y at the VCU Health System Nelson Clinic or the Virginia Department of Health Richmond Health District's prenatal clinic (RHD) during their pregnancies. This pilot project will provide the necessary preliminary data to fuel an appropriately powered randomized controlled trial to evaluate the effects of CPC+Y in controlling weight gain, enhancing stress resilience, and improving maternal-child outcomes among overweight/obese diverse women. Because increasing physical activity has been found to have important mental health effects and maternal-child outcomes, it stands to reason that this innovative intervention has the potential to impact the way prenatal care is delivered in high risk populations.

Conditions

Pregnancy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Yoga (CPC+Y)

Women in Centering Pregnancy Care (CPC) will receive the intervention which is a 30 minute yoga sessions during each of the 2-hour CPC meetings (CPC+Y)

Group Type: EXPERIMENTAL

Centering Pregnancy Care plus Yoga (CPC+Y)

Intervention Type: BEHAVIORAL

Gentle prenatal yoga for 30 minutes at the end of the Centering Pregnancy Care session

Comparison (CPC alone)

To strengthen our ability to examine causal relationships between the intervention and outcomes, we will use longitudinal comparison group data contributed from deidentified archival data from an existing IRB-approved study (PI: Masho) which includes pregnant women who participated in the CPC model of care alone (without the yoga component) and were followed throughout their pregnancies using numerous measures identical to those in the proposed study, including weight/BMI, depressive symptoms, anxiety, and stress.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Centering Pregnancy Care plus Yoga (CPC+Y)

Gentle prenatal yoga for 30 minutes at the end of the Centering Pregnancy Care session

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• pregnant women age 18 years or older
• currently participating in CPC at the VCU Health System Nelson Clinic or Richmond Health District

Exclusion Criteria

• current physical conditions preventing participation in physical activity (ACOG guidelines: restrictive lung disease, hemodynamically significant heart disease, incompetent cervix, multiple gestation at risk of premature labor, persistent 2nd or 3rd trimester bleeding, placenta previa after 26 weeks gestation, premature labor, ruptured membranes, preeclampsia, severe anemia)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sigma Theta Tau International Honor Society of Nursing

OTHER

Sponsor Role: collaborator

Southern Nursing Research Society

UNKNOWN

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Patricia Anne Kinser

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patricia Kinser, PhD

Role: PRINCIPAL_INVESTIGATOR

VCU

Locations

Virginia Commonwealth University School of Nursing

Richmond, Virginia, United States

Countries

United States

Other Identifiers

HM20005136

Identifier Type: -

Identifier Source: org_study_id