Evaluation of a Community Health Nurse/Peer Counselor Program to Help Low-Income Women Breastfeed Longer

Support for Low-Income Breastfeeding: Cost and Outcomes

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).

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

328

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Baltimore, Maryland, United States
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 44 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
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.
Active Comparator: 2
Health Nurse/Peer Councelor Intervention

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Breastfeeding Rates
Time Frame: March 2003 - August 2006
March 2003 - August 2006
Breastfeeding duration
Time Frame: March 2003 - August 2006
March 2003 - August 2006

Secondary Outcome Measures

Outcome Measure
Time Frame
Cost Implications of a Nurse/Peer Councelor Program
Time Frame: March 2003 - August 2006
March 2003 - August 2006
Infant indicies related to cost
Time Frame: March 2003 - August 2006
March 2003 - August 2006

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Linda C Pugh, PhD, RNC, FAAN, Johns Hopkins University; York College of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

January 24, 2008

First Submitted That Met QC Criteria

January 24, 2008

First Posted (Estimate)

February 6, 2008

Study Record Updates

Last Update Posted (Estimate)

February 6, 2008

Last Update Submitted That Met QC Criteria

January 24, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Other Study ID Numbers

  • FWA 0006088
  • NIH/NINR - R01 RN007675

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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