Pilot Trial of CenteringPregnancy With Mindfulness Skills
13. Februar 2020 aktualisiert von: University of California, San Francisco
Integrative Stress Reduction for Maternal-Child Health
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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
49
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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California
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San Francisco, California, Vereinigte Staaten, 94115
- University of California, San Francisco
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Weiblich
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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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.
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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.
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.
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Aktiver Komparator: 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.
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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preterm birth
Zeitfenster: post-birth
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gestational age at birth and risk of preterm birth (<37 weeks)
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post-birth
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birth weight
Zeitfenster: post-birth
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birth weight in grams, birth weight to gestational age ratio, and risk of low birth weight (<2500 grams)
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post-birth
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postpartum depression
Zeitfenster: post-birth
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incidence of self-reported postpartum depression
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post-birth
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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change in and level of perceived stress
Zeitfenster: second trimester, third trimester, post-birth
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self-report of perceived life stress
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second trimester, third trimester, post-birth
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change in and type(s) of coping
Zeitfenster: second trimester, third trimester, post-birth
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self-report of coping with salient stressful aspects of pregnancy and parenting
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second trimester, third trimester, post-birth
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change in and level of mindfulness
Zeitfenster: second trimester, third trimester, post-birth
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self-report of mindfulness of daily experiences
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second trimester, third trimester, post-birth
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change in and level of positive and negative emotion
Zeitfenster: second trimester, third trimester, post-birth
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self-report of intensity and frequency of positive and negative affect
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second trimester, third trimester, post-birth
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change in and level of pregnancy-related anxiety
Zeitfenster: second trimester, third trimester
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self-report of pregnancy-related anxiety
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second trimester, third trimester
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change in and level of depressive mood
Zeitfenster: second trimester, third trimester
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self-report of depressive mood
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second trimester, third trimester
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change in and levels of salivary cortisol
Zeitfenster: second trimester, third trimester
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waking, 30-minutes post-waking, and bed-time salivary cortisol
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second trimester, third trimester
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change in and level of adrenocorticotropic hormone (ACTH)
Zeitfenster: second trimester, third trimester
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adrenocorticotropic hormone (ACTH) assayed from blood plasma
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second trimester, third trimester
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change in and levels of corticotropin releasing hormone (CRH)
Zeitfenster: second trimester, third trimester
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corticotropin releasing hormone (CRH) assayed from blood plasma
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second trimester, third trimester
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change in and levels of blood pressure
Zeitfenster: second trimester, third trimester
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diastolic and systolic blood pressure
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second trimester, third trimester
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Larissa G Duncan, PhD, University of California, San Francisco
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Januar 2011
Primärer Abschluss (Tatsächlich)
3. Mai 2017
Studienabschluss (Tatsächlich)
3. Mai 2017
Studienanmeldedaten
Zuerst eingereicht
18. Juli 2012
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
18. Juli 2012
Zuerst gepostet (Schätzen)
20. Juli 2012
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
17. Februar 2020
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
13. Februar 2020
Zuletzt verifiziert
1. Februar 2020
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- K01AT005270 (US NIH Stipendium/Vertrag)
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