Pilot Trial of CenteringPregnancy With Mindfulness Skills

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Larissa G. Duncan, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01646463
First received: July 18, 2012
Last updated: March 1, 2013
Last verified: March 2013
  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:


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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014