Breastfeeding RatesPhase 3NCT00608088
Evaluation of a Community Health Nurse/Peer Counselor Program to Help Low-Income Women Breastfeed Longer
A Phase 3 study testing Community Health Nurse/Peer Councelor Team in people with Breastfeeding Rates, run by National Institute of Nursing Research (NINR) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding Rates
- What is being tested?
- Community Health Nurse/Peer Councelor Team
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Aug 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 44 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- inability to meet the above criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Breastfeeding Rates
- Being tested
- Usual Care, Community Health Nurse/Peer Councelor Team
- Keywords
- Breast feeding, breastfeeding, randomized clinical trial, poverty
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareBehavioural
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.
Community Health Nurse/Peer Councelor TeamBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Usual Care Receives: Behavioral: Usual Care |
| 2 | Active comparator | Health Nurse/Peer Councelor Intervention Receives: Behavioral: Community Health Nurse/Peer Councelor Team |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Rates
Measured: March 2003 - August 2006
Breastfeeding duration
Measured: March 2003 - August 2006
Secondary outcomes (2)
Cost Implications of a Nurse/Peer Councelor Program
Measured: March 2003 - August 2006
Infant indicies related to cost
Measured: March 2003 - August 2006
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startMar 2003
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breastfeeding RatesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Nursing Research (NINR)
- Sponsor type
- US National Institutes of Health
- Investigators
- Linda C Pugh, PhD, RNC, FAAN, Principal investigator, Johns Hopkins University; York College of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00608088
- Sponsor's protocol ID
- FWA 0006088
- Other IDs
- NIH/NINR - R01 RN007675
- Status last verified
- Jan 2008
- First submitted
- 24 Jan 2008
- Last updated
- 6 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16189981Wilson PR, Pugh LC. Promoting nutrition in breastfeeding women. J Obstet Gynecol Neonatal Nurs. 2005 Jan-Feb;34(1):120-4. doi: 10.1177/0884217504272806.
PubMed 15673655Milligan, R., Low, G., Spatz, D., Brooks, L., Serwint, J., & Pugh, L.C. (2004). Offering breastfeeding mothers advice on contraception. Contemporary Obstetrics & Gynecology, 49.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Support for Low-Income Breastfeeding: Cost and Outcomes
- ClinicalTrials.gov ID
- NCT00608088
- Acronym / sponsor ID
- FWA 0006088
- Conditions
- Breastfeeding Rates
- Keywords
- Breast feeding, breastfeeding, randomized clinical trial, poverty
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- National Institute of Nursing Research (NINR)US National Institutes of Health
- Study start
- Mar 2003
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 6 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Usual CareUsual Care |
| 2 | Active comparator | Behavioral: Community Health Nurse/Peer Councelor TeamHealth Nurse/Peer Councelor Intervention |
Who may qualify
- Ages
- 12 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- breastfeeding
- low-income (WIC eligible)
- English speaking
- telephone available (includes pager or close family member)
- full-term singleton birth, with no cranio-facial abnormalities
Key exclusion criteria (1 listed)
- inability to meet the above criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual CareThe 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. | Behavioural | 1 |
| Community Health Nurse/Peer Councelor TeamVisits 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. | Behavioural | 2 |
Primary outcome
Breastfeeding Rates
Time frame: March 2003 - August 2006
Breastfeeding duration
Time frame: March 2003 - August 2006
2 secondary outcomes
Cost Implications of a Nurse/Peer Councelor Program
Time frame: March 2003 - August 2006
Infant indicies related to cost
Time frame: March 2003 - August 2006
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2008.
- Results publication: PubMed 16189981Frick 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.
- Results publication: PubMed 15673655Wilson PR, Pugh LC. Promoting nutrition in breastfeeding women. J Obstet Gynecol Neonatal Nurs. 2005 Jan-Feb;34(1):120-4. doi: 10.1177/0884217504272806.
- Results publicationMilligan, R., Low, G., Spatz, D., Brooks, L., Serwint, J., & Pugh, L.C. (2004). Offering breastfeeding mothers advice on contraception. Contemporary Obstetrics & Gynecology, 49.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda C Pugh, PhD, RNC, FAAN principal investigator
Johns Hopkins University; York College of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Community Health Nurse/Peer Councelor Team in people with Breastfeeding Rates, run by National Institute of Nursing Research (NINR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastfeeding Rates (time frame: March 2003 - August 2006). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00608088, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2008.