Clinical trial NCT00608088: Evaluation of a Community Health Nurse/Peer Counselor Program to Help Low-Income Women Breastfeed Longer
Official title: Support for Low-Income Breastfeeding: Cost and Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breastfeeding Rates
Keywords: Breast feeding
breastfeeding
randomized clinical trial
poverty
Lead sponsor: National Institute of Nursing Research (NINR)
Sponsor class: NIH
First posted: 2008-02-06
Enrollment: 328
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This research was done to better understand how new mothers who are breastfeeding feel and the questions they have. We wanted to use ways to help new mothers to breastfeed successfully. We compared a new approach (home visits and telephone calls) to the usual care given at Johns Hopkins Hospital with strong support to new mothers from nurses, and a peer counselor (another mother with breastfeeding experience).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Breastfeeding Rates
timeFrame: March 2003 - August 2006
measure: Breastfeeding duration
timeFrame: March 2003 - August 2006
Secondary outcomes:
measure: Cost Implications of a Nurse/Peer Councelor Program
timeFrame: March 2003 - August 2006
measure: Infant indicies related to cost
timeFrame: March 2003 - August 2006
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University; York College of Pennsylvania
name: Linda C Pugh, PhD, RNC, FAAN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Milligan, R., Low, G., Spatz, D., Brooks, L., Serwint, J., & Pugh, L.C. (2004). Offering breastfeeding mothers advice on contraception. Contemporary Obstetrics & Gynecology, 49.