Telephone Support Intervention to Improve Breastfeeding

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00717496
First received: July 15, 2008
Last updated: January 4, 2013
Last verified: July 2008
  Purpose

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.


Condition Intervention
Breastfeeding
Other: Telephone Support Intervention to Improve Breastfeeding

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Telephone Support Intervention to Improve Breastfeeding Rates in Low-Income Women

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Breastfeeding at 3 months and at 6 months [ Time Frame: 3 months and six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Exclusively breastfeeding at 3 months and at 6 months [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Maternal satisfaction: 4-point Likert scale of satisfaction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Maternal confidence among breastfeeding mothers: Breastfeeding Self-Efficacy Short Form, 14-item scale scored 1-5, with range of scores from 14-70 [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]
  • Reasons for stopping breastfeeding—descriptive data [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Utilization outcomes: number of preventive care visits; number of acute visits for illness to clinic; number of emergency room visits; number of hospitalizations [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Descriptive data regarding problems encountered, unmet needs, areas of strength and weakness of intervention and ways it could be improved. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 339
Study Start Date: April 2005
Study Completion Date: August 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
No Intervention: 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.

Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717496

Locations
United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80207
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Allison Kempe, MD, MPH University of Colorado, Denver
  More Information

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

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00717496     History of Changes
Other Study ID Numbers: 04-0893, 04-0893
Study First Received: July 15, 2008
Last Updated: January 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Breastfeeding
Telephone Support
Latino

ClinicalTrials.gov processed this record on October 21, 2014