Pilot Trial of CenteringPregnancy With Mindfulness Skills
13. února 2020 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Typ studie
Intervenční
Zápis (Aktuální)
49
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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California
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San Francisco, California, Spojené státy, 94115
- University of California, San Francisco
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Ženský
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Aktivní komparátor: 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.
|
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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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preterm birth
Časové okno: 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
Časové okno: 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
Časové okno: post-birth
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incidence of self-reported postpartum depression
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post-birth
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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change in and level of perceived stress
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Larissa G Duncan, PhD, University of California, San Francisco
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. ledna 2011
Primární dokončení (Aktuální)
3. května 2017
Dokončení studie (Aktuální)
3. května 2017
Termíny zápisu do studia
První předloženo
18. července 2012
První předloženo, které splnilo kritéria kontroly kvality
18. července 2012
První zveřejněno (Odhad)
20. července 2012
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
17. února 2020
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
13. února 2020
Naposledy ověřeno
1. února 2020
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- K01AT005270 (Grant/smlouva NIH USA)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .