- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00608088
Evaluation of a Community Health Nurse/Peer Counselor Program to Help Low-Income Women Breastfeed Longer
Support for Low-Income Breastfeeding: Cost and Outcomes
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Healthy People 2010 included the goal of increasing breastfeeding duration to 6 months for 50% of all mothers. Other professional and national health organizations and the Health and Human Services Blueprint for Action on Breastfeeding recommend that women breastfeed exclusively for six months. Increasing breastfeeding among low-income women is a priority, as disparities exist. Only 20.1% of low-income women (on WIC) breastfeed for six months compared to 40.7 % of more affluent women. Consistent, comprehensive, culturally sensitive breastfeeding support increases duration of breastfeeding, thus offering well-documented health benefits often specifically appropriate for low-income women. Breastfeeding relates to lower formula cost, lower health care costs, and breastfeeding may be less time consuming. These cost savings can potentially offset costs of breastfeeding promotion. Facilitating breastfeeding among low-income women includes comprehensive and culturally relevant support in the hospital, during the first week postpartum, and periodic support in the mother's home. Nearly 35% of low-income women stop breastfeeding within eight days of delivery. Repeated contact with supportive persons such as peer counselors and nurses, affects the duration and exclusivity of breastfeeding practice after the immediate postpartum period. However, support for low-income women has been neglected and not made available because of generally unsubstantiated claims that it is not cost effective. The breastfeeding intervention used an enhanced traditional community health nurse/peer counselor home visit, which is no longer usual care for contemporary community health nursing practice, along with in-hospital and telephone support. The overall hypothesis was the intervention group will have improved breastfeeding outcomes and will demonstrate a net cost savings over usual care.
The consent form explained the purpose of the study; the actual number of visits and telephone calls (if randomized into the intervention group) and the data collecttion procedures. There were no identified risks for those enrolled in the study. Incentives included $105 if the participant completed each data point.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Maryland
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Baltimore, Maryland, Stati Uniti
- Johns Hopkins University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- breastfeeding
- low-income (WIC eligible)
- English speaking
- telephone available (includes pager or close family member)
- full-term singleton birth, with no cranio-facial abnormalities
- neonate was admitted to the normal newborn nursery (not the NICU)
- negative drug screen for mother and infant.
Exclusion Criteria:
- inability to meet the above criteria
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: 1
Solita cura
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The usual care group will received standard care from the Johns Hopkins Hospital lactation consultant and nurses, which may have included a visit in the hospital by the lactation consultant if mothers delivered Monday through Friday.
The lactation consultant was also available by request.
A "warm-line" was also standard.
This was a telephone line that was connected to an answering machine; the lactation consultant checked this line once daily (Monday through Friday) and returned calls.
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Comparatore attivo: 2
Health Nurse/Peer Councelor Intervention
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Visits by a community health nurse/peer counselor team during the first six postpartum months. Based on prior research and experience, the team was developed to provide culturally relevant support and health-care education to low-income mothers, who were a high percentage of African American women. The goals of this team were to 1) increase the duration of breastfeeding while emphasizing ways to decrease fatigue, and decrease breast discomfort; 2) strengthen maternal competence with breastfeeding and commitment to breastfeeding; 3) provide parent education about the infant regarding breastfeeding; 4) provide/find social support needed for continued breastfeeding; and 5) foster linkages to community services that will facilitate the maintenance of breastfeeding. The specific activities of the CHN/peer counselor team included hospital visitation after enrollment, home visiting during the first postpartum month, and telephone support throughout the first six postpartum months. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Breastfeeding Rates
Lasso di tempo: March 2003 - August 2006
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March 2003 - August 2006
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Breastfeeding duration
Lasso di tempo: March 2003 - August 2006
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March 2003 - August 2006
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Cost Implications of a Nurse/Peer Councelor Program
Lasso di tempo: March 2003 - August 2006
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March 2003 - August 2006
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Infant indicies related to cost
Lasso di tempo: March 2003 - August 2006
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March 2003 - August 2006
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Linda C Pugh, PhD, RNC, FAAN, Johns Hopkins University; York College of Pennsylvania
Pubblicazioni e link utili
Pubblicazioni generali
- Frick KD, Milligan RA, White KM, Serwint JR, Pugh LC. Nurse-supported breastfeeding promotion: a framework for economic evaluation. Nurs Econ. 2005 Jul-Aug;23(4):165-72, 206, 147.
- Wilson PR, Pugh LC. Promoting nutrition in breastfeeding women. J Obstet Gynecol Neonatal Nurs. 2005 Jan-Feb;34(1):120-4. doi: 10.1177/0884217504272806.
- Milligan, R., Low, G., Spatz, D., Brooks, L., Serwint, J., & Pugh, L.C. (2004). Offering breastfeeding mothers advice on contraception. Contemporary Obstetrics & Gynecology, 49.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- FWA 0006088
- NIH/NINR - R01 RN007675
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 .