Pilot Trial of CenteringPregnancy With Mindfulness Skills

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Integrative Stress Reduction for Maternal-Child Health

Conditions
-----------------
Premature Birth, Low Birth Weight, Postpartum Depression

Intervention / Treatment
-----------------
* Behavioral: CenteringPregnancy
* Behavioral: CenteringPregnancy with Mindfulness Skills


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CenteringPregnancy with Mindfulness Skills<br>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<br>* 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.<br>Behavioral: CenteringPregnancy with Mindfulness Skills<br>* 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.<br>|
| Active Comparator: CenteringPregnancy<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preterm birth | gestational age at birth and risk of preterm birth (<37 weeks) | post-birth | 
| birth weight | birth weight in grams, birth weight to gestational age ratio, and risk of low birth weight (<2500 grams) | post-birth | 
| postpartum depression | incidence of self-reported postpartum depression | post-birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in and level of perceived stress | self-report of perceived life stress | second trimester, third trimester, post-birth | 
| change in and type(s) of coping | self-report of coping with salient stressful aspects of pregnancy and parenting | second trimester, third trimester, post-birth | 
| change in and level of mindfulness | self-report of mindfulness of daily experiences | second trimester, third trimester, post-birth | 
| change in and level of positive and negative emotion | self-report of intensity and frequency of positive and negative affect | second trimester, third trimester, post-birth | 
| change in and level of pregnancy-related anxiety | self-report of pregnancy-related anxiety | second trimester, third trimester | 
| change in and level of depressive mood | self-report of depressive mood | second trimester, third trimester | 
| change in and levels of salivary cortisol | waking, 30-minutes post-waking, and bed-time salivary cortisol | second trimester, third trimester | 
| change in and level of adrenocorticotropic hormone (ACTH) | adrenocorticotropic hormone (ACTH) assayed from blood plasma | second trimester, third trimester | 
| change in and levels of corticotropin releasing hormone (CRH) | corticotropin releasing hormone (CRH) assayed from blood plasma | second trimester, third trimester | 
| change in and levels of blood pressure | diastolic and systolic blood pressure | second trimester, third trimester | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mindfulness, stress, coping, emotion, depression, group medical visits, prenatal healthcare, preterm birth, birth weight, postpartum depression, cortisol, neuroendocrine function, blood pressure, health disparities