Telephone Support Intervention to Improve Breastfeeding
NCT ID: NCT00717496
Last Updated: 2013-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
339 participants
INTERVENTIONAL
2005-04-30
2006-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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A
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. This group 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.
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.
B
Mothers assigned to the control group will receive usual care. This group will also receive a small bag with reading materials, illustrations of breastfeeding positions and latch, hand breast pump, and lanolin cream.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Mother 18 years old or older
* 37 weeks gestation or greater at delivery
* Intent to breastfeed
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Centers for Disease Control and Prevention
FED
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Allison Kempe, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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Denver Health Medical Center
Denver, Colorado, United States
Countries
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References
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Breastfeeding and the use of human milk. American Academy of Pediatrics. Work Group on Breastfeeding. Pediatrics. 1997 Dec;100(6):1035-9. doi: 10.1542/peds.100.6.1035.
U.S. Department of Health and Human Services. Healthy People 2010. 2000:47-8.
Zimmerman DR, Guttman N. "Breast is best": knowledge among low-income mothers is not enough. J Hum Lact. 2001 Feb;17(1):14-9. doi: 10.1177/089033440101700104.
Forste R, Weiss J, Lippincott E. The decision to breastfeed in the United States: does race matter? Pediatrics. 2001 Aug;108(2):291-6. doi: 10.1542/peds.108.2.291.
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. doi: 10.1046/j.1523-536x.2002.00199.x.
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.
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. doi: 10.1542/peds.112.1.108.
Libbus MK. Breastfeeding attitudes in a sample of Spanish-speaking Hispanic American women. J Hum Lact. 2000 Aug;16(3):216-20. doi: 10.1177/089033440001600306.
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. doi: 10.1016/s1526-9523(00)00018-0.
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. doi: 10.1111/j.1745-7599.1998.tb00502.x. No abstract available.
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. doi: 10.1370/afm.56.
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. doi: 10.1177/0884217503258459.
Gavine A, Shinwell SC, Buchanan P, Farre A, Wade A, Lynn F, Marshall J, Cumming SE, Dare S, McFadden A. Support for healthy breastfeeding mothers with healthy term babies. Cochrane Database Syst Rev. 2022 Oct 25;10(10):CD001141. doi: 10.1002/14651858.CD001141.pub6.
Bunik M, Shobe P, O'Connor ME, Beaty B, Langendoerfer S, Crane L, Kempe A. Are 2 weeks of daily breastfeeding support insufficient to overcome the influences of formula? Acad Pediatr. 2010 Jan-Feb;10(1):21-8. doi: 10.1016/j.acap.2009.09.014.
Other Identifiers
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04-0893
Identifier Type: -
Identifier Source: secondary_id
04-0893
Identifier Type: -
Identifier Source: org_study_id
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