Pilot Trial of CenteringPregnancy With Mindfulness Skills
13 febbraio 2020 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
49
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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California
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San Francisco, California, Stati Uniti, 94115
- University of California, San Francisco
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Femmina
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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preterm birth
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: post-birth
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incidence of self-reported postpartum depression
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post-birth
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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change in and level of perceived stress
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Larissa G Duncan, PhD, University of California, San Francisco
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 gennaio 2011
Completamento primario (Effettivo)
3 maggio 2017
Completamento dello studio (Effettivo)
3 maggio 2017
Date di iscrizione allo studio
Primo inviato
18 luglio 2012
Primo inviato che soddisfa i criteri di controllo qualità
18 luglio 2012
Primo Inserito (Stima)
20 luglio 2012
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
17 febbraio 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
13 febbraio 2020
Ultimo verificato
1 febbraio 2020
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- K01AT005270 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .