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| Sponsored by: |
National Institute of Nursing Research (NINR) |
|---|---|
| Information provided by: | National Institute of Nursing Research (NINR) |
| ClinicalTrials.gov Identifier: | NCT00608088 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Breastfeeding Rates |
Behavioral: Usual Care Behavioral: Community Health Nurse/Peer Councelor Team |
Phase III |
| Study Type: | Interventional |
| Study Design: | Health Services Research, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Support for Low-Income Breastfeeding: Cost and Outcomes |
| Enrollment: | 328 |
| Study Start Date: | March 2003 |
| Study Completion Date: | August 2006 |
| Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Usual Care
|
Behavioral: Usual Care
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.
|
|
2: Active Comparator
Health Nurse/Peer Councelor Intervention
|
Behavioral: Community Health Nurse/Peer Councelor Team
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. |
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| Ages Eligible for Study: | 12 Years to 44 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States | |
| Principal Investigator: | Linda C Pugh, PhD, RNC, FAAN | Johns Hopkins University; York College of Pennsylvania |
More Information
| Responsible Party: | Johns Hopkins University School of Nursing ( Gayle G. Page RN, DNSc, FAAN ) |
| Study ID Numbers: | FWA 0006088, NIH/NINR - R01 RN007675 |
| Study First Received: | January 24, 2008 |
| Last Updated: | January 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00608088 History of Changes |
| Health Authority: | United States: Federal Government; United States: Institutional Review Board |
|
Breast feeding breastfeeding randomized clinical trial poverty |
