Telephone Support From Primary Care for Breastfeeding Mothers
NCT ID: NCT02186613
Last Updated: 2014-12-23
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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UNKNOWN
NA
434 participants
INTERVENTIONAL
2014-10-31
2016-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Experimental
These mothers and their babies will receive Primary Care standard care (office visits at 1, 2, 4 and 6 months) plus the telephone support
Telephone support
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.
No intervention
Standard care (office visits at 1, 2, 4 and 6 months)
No interventions assigned to this group
Interventions
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Telephone support
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.
Eligibility Criteria
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Inclusion Criteria
* 37 weeks gestation or greater
* Exclusive breastfeeding or any breastfeeding when arrive at Primary Care
Exclusion Criteria
* 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
18 Years
FEMALE
Yes
Sponsors
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Preventive Services and Health Promotion Research Network
OTHER
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
OTHER
Responsible Party
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Principal Investigators
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Josep Balaguer, Doctor
Role: PRINCIPAL_INVESTIGATOR
Jordi Gol i Gorina Foundation
Locations
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Jordi Gol i Gurina Foundation
Barcelona, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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Josep Balaguer Marinez, Doctor
Role: primary
Other Identifiers
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4R14/015
Identifier Type: -
Identifier Source: org_study_id