Telephone Support Intervention to Improve Breastfeeding

Breastfeeding Clinical Trial

Official title:

Telephone Support Intervention to Improve Breastfeeding Rates in Low-Income Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00717496
• Other study ID #: 04-0893
• Secondary ID: 04-0893
• Status: Completed
• Phase: N/A
• First received: July 15, 2008
• Last updated: January 4, 2013
• Start date: April 2005
• Est. completion date: August 2006

Study information

• Verified date: July 2008
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This randomized controlled trial will evaluate an innovative telephone-based breastfeeding education and promotion intervention that will be implemented in a low-income, predominately Latina population. The trial will assess the impact of the intervention on duration of breastfeeding and exclusivity of breastfeeding at 1, 2, 3 and 6 months post-partum.

Description:

This randomized controlled trial will evaluate an innovative telephone-based breastfeeding education and promotion intervention that will be implemented in a low-income, predominately Latina population. The intervention was developed in association with national breastfeeding experts, local public health department and WIC personnel and community leaders. Additionally, it will also be informed by focus groups that are currently being conducted in the community with a particular emphasis on cultural barriers to breastfeeding in Latina populations. The intervention consists of scripted education and support protocols delivered by telephone daily, in English and Spanish, by a trained nurse over the first two weeks after delivery and will be funded by the Division of General Pediatrics. In the evaluation mothers will be randomized during the first 24 hours after delivering a healthy baby to the intervention arm or to usual post-partum care. The trial will assess the impact of the intervention on duration of breastfeeding and exclusivity of breastfeeding at 1, 2, 3 and 6 months post-partum. In addition, it will assess cost-effectiveness of the intervention and secondary and process-of-care outcomes related to maternal satisfaction with feeding, confidence with breastfeeding and utilization of health services.

The specific aims of this project are:

• To evaluate in a randomized controlled trial the effect of a telephone-based breastfeeding support and education intervention compared to usual post-partum care on a) the duration of breastfeeding at 1, 2, 3 and 6 months and b) the exclusivity of breastfeeding at 1, 2, 3 and 6 months in low-income, primarily Latina women.

• To evaluate the cost-effectiveness of the telephone-based intervention compared to usual care

• To compare secondary outcomes for mothers in the intervention versus control groups such as maternal satisfaction and confidence with feeding, reasons for discontinuing breastfeeding and utilization of acute, preventive health care services and hospitalizations

• To better understand unmet needs in women who breastfeed and how well the intervention addressed these needs by conducting qualitative interviews

The major hypotheses are:

1. a) Proactive telephone contact in the early postpartum period using scripted protocols will increase breastfeeding rates in low-income women from a current baseline of 30% to 45% at 3 months and from 20% to 35% at 6 months.

b) Proactive telephone contact in the early postpartum period using scripted protocols will increase exclusivity from a current baseline of 15% at 3 months to 30% and from 10% at 6 months to 25% compared to the usual care group.

2. The telephone-based intervention will be cost-effective compared with routine care with use of formula.

3. The telephone-based intervention will be associated with higher levels of maternal satisfaction overall.

4. Confidence with breastfeeding will be higher in breastfeeding mothers in the intervention group compared to breastfeeding mothers in the usual care group.

5. Compliance with scheduled preventive visits will be higher in the intervention group and use of acute health services, including clinic and emergency room visits will be lower in the intervention group compared to the usual care group. Hospitalizations will not differ significantly between the groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 339
• Est. completion date: August 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• First time mother

• Mother 18 years old or older

• 37 weeks gestation or greater at delivery

• Intent to breastfeed

Exclusion Criteria:

• mother's primary language is something other than English or Spanish

• mother has medical complications that interfere with her instituting breastfeeding or require her to stay in the hospital for >72 hours

• infant has a medical problem that requires admission to the intensive care nursery or requires hospitalization for >72 hours

• mother expresses a strong desire to formula feed

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Breastfeeding

Intervention

Other:
• Telephone Support Intervention to Improve Breastfeeding
The intervention will consist of outreach telephone calls daily by bilingual trained nursing staff for the first 2 weeks postpartum using the scripted protocols developed for this program. Both groups will receive a small bag with reading materials, illustrations of breastfeeding positions and latch, hand breast pump, and lanolin cream. The intervention nurse will ask the mothers on their initial intake call for the best time to call each day to minimize time needed to reach the mother.

Locations

Country	Name	City	State
United States	Denver Health Medical Center	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

References & Publications (12)

Breastfeeding and the use of human milk. American Academy of Pediatrics. Work Group on Breastfeeding. Pediatrics. 1997 Dec;100(6):1035-9. — View Citation

Dennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short form. J Obstet Gynecol Neonatal Nurs. 2003 Nov-Dec;32(6):734-44. — View Citation

Forste R, Weiss J, Lippincott E. The decision to breastfeed in the United States: does race matter? Pediatrics. 2001 Aug;108(2):291-6. — View Citation

Guise JM, Palda V, Westhoff C, Chan BK, Helfand M, Lieu TA; U.S. Preventive Services Task Force. The effectiveness of primary care-based interventions to promote breastfeeding: systematic evidence review and meta-analysis for the US Preventive Services Task Force. Ann Fam Med. 2003 Jul-Aug;1(2):70-8. Review. — View Citation

Li R, Grummer-Strawn L. Racial and ethnic disparities in breastfeeding among United States infants: Third National Health and Nutrition Examination Survey, 1988-1994. Birth. 2002 Dec;29(4):251-7. — View Citation

Libbus MK. Breastfeeding attitudes in a sample of Spanish-speaking Hispanic American women. J Hum Lact. 2000 Aug;16(3):216-20. — View Citation

Loughlin HH, Clapp-Channing NE, Gehlbach SH, Pollard JC, McCutchen TM. Early termination of breast-feeding: identifying those at risk. Pediatrics. 1985 Mar;75(3):508-13. — View Citation

Milligan RA, Pugh LC, Bronner YL, Spatz DL, Brown LP. Breastfeeding duration among low income women. J Midwifery Womens Health. 2000 May-Jun;45(3):246-52. Review. — View Citation

Taveras EM, Capra AM, Braveman PA, Jensvold NG, Escobar GJ, Lieu TA. Clinician support and psychosocial risk factors associated with breastfeeding discontinuation. Pediatrics. 2003 Jul;112(1 Pt 1):108-15. — View Citation

U.S. Department of Health and Human Services. Healthy People 2010. 2000:47-8.

Wood SP, Sasonoff KM, Beal JA. Breast-feeding attitudes and practices of Latino women: a descriptive study. J Am Acad Nurse Pract. 1998 Jun;10(6):253-60. — View Citation

Zimmerman DR, Guttman N. "Breast is best": knowledge among low-income mothers is not enough. J Hum Lact. 2001 Feb;17(1):14-9. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breastfeeding at 3 months and at 6 months		3 months and six months	No
Secondary	Exclusively breastfeeding at 3 months and at 6 months		3 months and 6 months	No
Secondary	Cost analysis: costs of training, costs of nurse for intervention, costs associated with intervention, cost of formula from WIC, time spent breastfeeding and time spent getting formula, acute care utilization associated with breastfeeding problems		6 months	No
Secondary	Maternal satisfaction: 4-point Likert scale of satisfaction		6 months	No
Secondary	Maternal confidence among breastfeeding mothers: Breastfeeding Self-Efficacy Short Form, 14-item scale scored 1-5, with range of scores from 14-70		3 months and 6 months	No
Secondary	Reasons for stopping breastfeeding—descriptive data		6 months	No
Secondary	Utilization outcomes: number of preventive care visits; number of acute visits for illness to clinic; number of emergency room visits; number of hospitalizations		6 months	No
Secondary	Descriptive data regarding problems encountered, unmet needs, areas of strength and weakness of intervention and ways it could be improved.		6 months	No