Pilot Trial of CenteringPregnancy With Mindfulness Skills - Full Text View

Purpose

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.

Condition	Intervention	Phase
Premature Birth Low Birth Weight Postpartum Depression	Behavioral: CenteringPregnancy Behavioral: CenteringPregnancy with Mindfulness Skills	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Integrative Stress Reduction for Maternal-Child Health

Resource links provided by NLM:

MedlinePlus related topics: Birth Weight Depression Postpartum Care Postpartum Depression Prenatal Care

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

preterm birth [ Time Frame: post-birth ] [ Designated as safety issue: No ]
gestational age at birth and risk of preterm birth (<37 weeks)
birth weight [ Time Frame: post-birth ] [ Designated as safety issue: No ]
birth weight in grams, birth weight to gestational age ratio, and risk of low birth weight (<2500 grams)
postpartum depression [ Time Frame: post-birth ] [ Designated as safety issue: No ]
incidence of self-reported postpartum depression

Secondary Outcome Measures:

change in and level of perceived stress [ Time Frame: second trimester, third trimester, post-birth ] [ Designated as safety issue: No ]
self-report of perceived life stress
change in and type(s) of coping [ Time Frame: second trimester, third trimester, post-birth ] [ Designated as safety issue: No ]
self-report of coping with salient stressful aspects of pregnancy and parenting
change in and level of mindfulness [ Time Frame: second trimester, third trimester, post-birth ] [ Designated as safety issue: No ]
self-report of mindfulness of daily experiences
change in and level of positive and negative emotion [ Time Frame: second trimester, third trimester, post-birth ] [ Designated as safety issue: No ]
self-report of intensity and frequency of positive and negative affect
change in and level of pregnancy-related anxiety [ Time Frame: second trimester, third trimester ] [ Designated as safety issue: No ]
self-report of pregnancy-related anxiety
change in and level of depressive mood [ Time Frame: second trimester, third trimester ] [ Designated as safety issue: No ]
self-report of depressive mood
change in and levels of salivary cortisol [ Time Frame: second trimester, third trimester ] [ Designated as safety issue: No ]
waking, 30-minutes post-waking, and bed-time salivary cortisol
change in and level of adrenocorticotropic hormone (ACTH) [ Time Frame: second trimester, third trimester ] [ Designated as safety issue: No ]
adrenocorticotropic hormone (ACTH) assayed from blood plasma
change in and levels of corticotropin releasing hormone (CRH) [ Time Frame: second trimester, third trimester ] [ Designated as safety issue: No ]
corticotropin releasing hormone (CRH) assayed from blood plasma
change in and levels of blood pressure [ Time Frame: second trimester, third trimester ] [ Designated as safety issue: No ]
diastolic and systolic blood pressure

Enrollment:	49
Study Start Date:	January 2011
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CenteringPregnancy with Mindfulness Skills 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.	Behavioral: CenteringPregnancy CenteringPregnancy (CP) follows a standardized curriculum for group-based prenatal healthcare offered to groups of 10-12 women with similar due dates. In lieu of receiving a series of individually-delivered prenatal healthcare, participants meet 10 times over the course of pregnancy and early postpartum for 2 hour sessions, essentially pooling their minutes for each prenatal healthcare visit. The visit schedule adheres to the guidelines set forth by ACOG of monthly and then weekly visits close to birth. All sessions of CP include three core components of: (1) physical assessment (including blood pressure, weight, and fundal height assessment), (2) education and skills-building, and (3) support. Content topics for group discussion include nutrition, exercise, relaxation, understanding pregnancy problems, infant care and feeding, postpartum issues including contraception, comfort measures in pregnancy, sexuality and childbearing, abuse issues, parenting, and childbirth preparation. Behavioral: CenteringPregnancy with Mindfulness Skills CenteringPregnancy with Mindfulness Skills contains the CenteringPregnancy (CP) content combined with training in mindfulness meditation and mindful movement/yoga. The mind-body methods have been adapted from those taught in the Mindfulness-Based Childbirth and Parenting (MBCP) course, which is a tailored version of the Mindfulness-Based Stress Reduction program delivered to pregnant women during the perinatal period. These practices include mindfulness meditation of the breath, body, feelings, thoughts, and emotions; body scan meditation; yoga postures practiced with mindful awareness of the body and the physical changes associated with pregnancy; and loving-kindness meditation. In addition, MBCP includes specific exercises in coping with stress, pain, and fear associated with pregnancy, childbirth, and early parenting with a focus on shifting the way participants relate to negative thoughts and emotions and cope with stress.
Active Comparator: CenteringPregnancy 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.	Behavioral: CenteringPregnancy CenteringPregnancy (CP) follows a standardized curriculum for group-based prenatal healthcare offered to groups of 10-12 women with similar due dates. In lieu of receiving a series of individually-delivered prenatal healthcare, participants meet 10 times over the course of pregnancy and early postpartum for 2 hour sessions, essentially pooling their minutes for each prenatal healthcare visit. The visit schedule adheres to the guidelines set forth by ACOG of monthly and then weekly visits close to birth. All sessions of CP include three core components of: (1) physical assessment (including blood pressure, weight, and fundal height assessment), (2) education and skills-building, and (3) support. Content topics for group discussion include nutrition, exercise, relaxation, understanding pregnancy problems, infant care and feeding, postpartum issues including contraception, comfort measures in pregnancy, sexuality and childbearing, abuse issues, parenting, and childbirth preparation.

Arms

Assigned Interventions

Experimental: CenteringPregnancy with Mindfulness Skills

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.

Behavioral: CenteringPregnancy

CenteringPregnancy (CP) follows a standardized curriculum for group-based prenatal healthcare offered to groups of 10-12 women with similar due dates. In lieu of receiving a series of individually-delivered prenatal healthcare, participants meet 10 times over the course of pregnancy and early postpartum for 2 hour sessions, essentially pooling their minutes for each prenatal healthcare visit. The visit schedule adheres to the guidelines set forth by ACOG of monthly and then weekly visits close to birth. All sessions of CP include three core components of: (1) physical assessment (including blood pressure, weight, and fundal height assessment), (2) education and skills-building, and (3) support. Content topics for group discussion include nutrition, exercise, relaxation, understanding pregnancy problems, infant care and feeding, postpartum issues including contraception, comfort measures in pregnancy, sexuality and childbearing, abuse issues, parenting, and childbirth preparation.

Behavioral: CenteringPregnancy with Mindfulness Skills

CenteringPregnancy with Mindfulness Skills contains the CenteringPregnancy (CP) content combined with training in mindfulness meditation and mindful movement/yoga. The mind-body methods have been adapted from those taught in the Mindfulness-Based Childbirth and Parenting (MBCP) course, which is a tailored version of the Mindfulness-Based Stress Reduction program delivered to pregnant women during the perinatal period. These practices include mindfulness meditation of the breath, body, feelings, thoughts, and emotions; body scan meditation; yoga postures practiced with mindful awareness of the body and the physical changes associated with pregnancy; and loving-kindness meditation. In addition, MBCP includes specific exercises in coping with stress, pain, and fear associated with pregnancy, childbirth, and early parenting with a focus on shifting the way participants relate to negative thoughts and emotions and cope with stress.

Active Comparator: CenteringPregnancy

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.

Behavioral: CenteringPregnancy

CenteringPregnancy (CP) follows a standardized curriculum for group-based prenatal healthcare offered to groups of 10-12 women with similar due dates. In lieu of receiving a series of individually-delivered prenatal healthcare, participants meet 10 times over the course of pregnancy and early postpartum for 2 hour sessions, essentially pooling their minutes for each prenatal healthcare visit. The visit schedule adheres to the guidelines set forth by ACOG of monthly and then weekly visits close to birth. All sessions of CP include three core components of: (1) physical assessment (including blood pressure, weight, and fundal height assessment), (2) education and skills-building, and (3) support. Content topics for group discussion include nutrition, exercise, relaxation, understanding pregnancy problems, infant care and feeding, postpartum issues including contraception, comfort measures in pregnancy, sexuality and childbearing, abuse issues, parenting, and childbirth preparation.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01646463

Locations

United States, California
University of California, San Francisco
San Francisco, California, United States, 94115

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator:

Larissa G Duncan, PhD

University of California, San Francisco

More Information

No publications provided

Responsible Party:	Larissa G. Duncan, Assistant Professor, University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT01646463 History of Changes
Other Study ID Numbers:	K01AT005270
Study First Received:	July 18, 2012
Last Updated:	March 1, 2013
Health Authority:	United States: Data and Safety Monitoring Board United States: Institutional Review Board United States: Federal Government

Keywords provided by University of California, San Francisco:

mindfulness
stress
coping
emotion
depression
group medical visits
prenatal healthcare

preterm birth
birth weight
postpartum depression
cortisol
neuroendocrine function
blood pressure
health disparities

Additional relevant MeSH terms:

Birth Weight
Depression
Depressive Disorder
Premature Birth
Depression, Postpartum
Body Weight
Signs and Symptoms

Behavioral Symptoms
Mood Disorders
Mental Disorders
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders

ClinicalTrials.gov processed this record on May 22, 2013