Telephone Support From Primary Care for Breastfeeding Mothers

Study Overview
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Brief Summary
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The investigators will conduct a telephone-based support to breastfeeding women with healthy newborns to improve breastfeeding outcomes.

Detailed Description
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The World Health Organization recommends exclusive breastfeeding to infants until 6 months of age in order to achieve optimum growth. The proportion of exclusive breastfeeding mothers at 6 months is only 24.7 in Spain. The investigators believe it is important to increase the proportion of breastfeeding mothers in their population. Therefore, the investigators have developed a telephonic support protocol for mothers. The intervention will be performed by pediatric nurses in Primary Care. The main aim of this study is to evaluate in a randomized controlled trial the effectiveness of telephone-based breastfeeding support in exclusive breastfeeding. The secondary aim is to evaluate the effectiveness of the telephonic support in any breastfeeding. The investigators hypothesis is that this intervention will increase exclusive breastfeeding and any breastfeeding rates. The study will be carried out in Cornellà, a semi-urban area near Barcelona. Participants will include breastfeeding women who have full-term healthy infants. Mothers will be recruited upon their first arrival to Primary Care from hospital. Eligible mothers who consent to participate will be randomized into either the intervention group or the control group. The latter will receive standard postpartum care. The former will receive standard postpartum care, plus a weekly telephone call during the first two months and every 2 weeks thereafter between the second and the sixth month. The pediatric nurse responsible for monitoring the standard care of each and every patient will be the one responsible for contacting them via telephone. Therefore, the study is not blinded. The evolution of exclusive breastfeeding will be compared to artificial or supplemented feeding at 1, 2, 4 and 6 months. The effect of the intervention on breastfeeding supplemented with formula will also be valued. Classification into breastfeeding categories is based on 24-hour dietary recall.

Official Title
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Telephone Support From Primary Care to Breastfeeding Mothers: A Randomized and Multicenter Clinical Trial

Conditions
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Breast Feeding

Intervention / Treatment
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* Behavioral: Telephone support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mothers with healthy newborns 37 weeks gestation or greater Exclusive breastfeeding or any breastfeeding when arrive at Primary Care Exclusion Criteria: Infant or mother admitted in ICU Twin pregnancy Major congenital malformation of babies Mothers age <= 18 Inability to understand Spanish/Catalan Mothers who don't have a telephone Mothers who don't give her consent

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>These mothers and their babies will receive Primary Care standard care (office visits at 1, 2, 4 and 6 months) plus the telephone support | Behavioral: Telephone support<br>* Telephone support intervention to improve breastfeeding rates. The intervention will consist in weekly calls during the first two months and every two weeks between the second and the sixth month. The intervention will be done by pediatric nurses and we have developed a protocol of important issues to deal depending on the age of the baby.<br>|
| No Intervention: No intervention<br>Standard care (office visits at 1, 2, 4 and 6 months) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of exclusive breastfeeding | Exclusive breastfeeding at 6 months. (time frame: 6 months) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of exclusive breastfeeding | Exclusive Breastfeeding at 4 months. (time frame: 4 months) | 4 months | 
| Rate of exclusive breastfeeding | Exclusive breastfeeding at 2 months. (time frame: 2 months) | 2 months | 
| Rate of exclusive breastfeeding | Exclusive breastfeeding at 1 month. (time frame: 1 month) | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Feeding, Telephone, Education, Primary Health Care