Telephone Support Intervention to Improve Breastfeeding

NCT00717496 | Completed

• 1 other identifier: 04-0893
• Study Type: interventional
• Target: 339
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breastfeeding

Keywords

Breastfeeding; Telephone Support; Latino

Outcome Measures

Primary Outcomes (1)

• Breastfeeding at 3 months and at 6 months

  3 months and six months

Secondary Outcomes (7)

• Exclusively breastfeeding at 3 months and at 6 months

  3 months and 6 months

• 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

• Maternal satisfaction: 4-point Likert scale of satisfaction

  6 months

• 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

• Reasons for stopping breastfeeding-descriptive data

  6 months

Study Arms (2)

A

EXPERIMENTAL

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.

Other: Telephone Support Intervention to Improve Breastfeeding

B

NO INTERVENTION

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.

Interventions

Telephone Support Intervention to Improve Breastfeeding OTHER

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.

A

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First time mother
• Mother 18 years old or older
• weeks gestation or greater at delivery
• Intent to breastfeed

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Denver Health Medical Center

Denver, Colorado, 80207, United States

Location

Related Publications (14)

• 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.

  PMID: 9411381 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 11847846 BACKGROUND

• 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.

  PMID: 11483790 BACKGROUND

• 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.

  PMID: 12431264 BACKGROUND

• 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.

  PMID: 3975119 BACKGROUND

• 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.

  PMID: 12837875 BACKGROUND

• 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.

  PMID: 11153155 BACKGROUND

• 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.

  PMID: 10907334 BACKGROUND

• 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.

  PMID: 9801560 BACKGROUND

• 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.

  PMID: 15040435 BACKGROUND

• 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.

  PMID: 14649593 BACKGROUND

• 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.

  PMID: 36282618 DERIVED

• 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.

  PMID: 20129478 DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Allison Kempe, MD, MPH

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2008
• First Posted: July 17, 2008
• Study Start: April 1, 2005
• Primary Completion: May 1, 2006
• Study Completion: August 1, 2006
• Last Updated: January 8, 2013

Record last verified: 2008-07

Locations

US (1)