Telephone Support Intervention to Improve Breastfeeding

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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. The telephone-based intervention will be cost-effective compared with routine care with use of formula. The telephone-based intervention will be associated with higher levels of maternal satisfaction overall. Confidence with breastfeeding will be higher in breastfeeding mothers in the intervention group compared to breastfeeding mothers in the usual care group. 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.

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

Conditions
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Breastfeeding

Intervention / Treatment
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* Other: Telephone Support Intervention to Improve Breastfeeding


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>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<br>* 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.<br>|
| No Intervention: B<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breastfeeding at 3 months and at 6 months |  | 3 months and six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Descriptive data regarding problems encountered, unmet needs, areas of strength and weakness of intervention and ways it could be improved. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breastfeeding, Telephone Support, Latino