Pilot Trial of CenteringPregnancy With Mindfulness Skills

University of California San Francisco (UCSF)

Status: Completed

Conditions: Postpartum Depression; Low Birth Weight; Premature Birth

Treatments: Behavioral: CenteringPregnancy; Behavioral: CenteringPregnancy with Mindfulness Skills

Study type: Interventional

Funder types: Other

Identifiers

NCT01646463

K01AT005270

Details and patient eligibility

About

In the U.S., rates of preterm birth and low birth weight have increased over the past 30 years. Poor birth outcomes are especially high among racial/ethnic minority populations. Maternal stress is an important factor that can lead to negative birth outcomes. Thus, programs that reduce stress during pregnancy could improve birth outcomes. Initial pilot work tested a mindfulness-based approach to stress reduction during pregnancy. Women in the pilot study had lower stress and improved coping after the program. For the current study, mindfulness is added to an existing prenatal healthcare program called CenteringPregnancy (CP). CP provides prenatal care through 10 group sessions. This study compares CP with a version of CP infused with mindfulness skills training. Effects of the two versions of CP on psychological stress and coping, stress hormones, and birth outcomes will be tested. Data will be collected from participants three times: twice during pregnancy and once after birth. Medical records will provide data on birth outcomes and other health factors. The study will provide initial information about a mind-body program to reduce stress and improve birth outcomes. Data from the study will inform the development of an R01 proposal for a larger study. The study will also help advance the long term goal of reducing health disparities.

Enrollment: 49 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age 18 and over
• enrolled to receive group-based prenatal healthcare from the San Francisco General Hospital (SFGH) Outpatient Midwifery Clinic CenteringPregnancy program

Exclusion criteria

• ineligible for CenteringPregnancy due to the need for individualized prenatal care
• Type 2 diabetes
• HIV
• seizure disorder
• serious mental health disorder
• substance abuse or medical condition that would lead to inability to adhere to intervention guidelines
• not fluent in English or Spanish
• previous formal training in meditation, yoga, or other mind-body practice
• previous participation in CenteringPregnancy

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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49 participants in 2 patient groups

CenteringPregnancy with Mindfulness Skills

Experimental group

Description:

CenteringPregnancy with Mindfulness Skills is the standard CenteringPregnancy prenatal healthcare intervention combined with mindfulness meditation and mindful movement/yoga applied to pregnancy, childbirth, and parenting.

Treatment:

Behavioral: CenteringPregnancy with Mindfulness Skills

Behavioral: CenteringPregnancy

CenteringPregnancy

Active Comparator group

Description:

CenteringPregnancy is group-based prenatal healthcare delivered according to the guidelines of the American College of Obstetrics and Gynecology. It includes assessment, support, and health education delivered in a healthcare empowerment framework.

Treatment:

Behavioral: CenteringPregnancy