Telephone Support From Primary Care for Breastfeeding Mothers
1 other identifier
interventional
434
1 country
1
Brief Summary
The investigators will conduct a telephone-based support to breastfeeding women with healthy newborns to improve breastfeeding outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2014
CompletedFirst Posted
Study publicly available on registry
July 10, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedDecember 23, 2014
December 1, 2014
1.4 years
June 29, 2014
December 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of exclusive breastfeeding
Exclusive breastfeeding at 6 months. (time frame: 6 months)
6 months
Secondary Outcomes (3)
Rate of exclusive breastfeeding
4 months
Rate of exclusive breastfeeding
2 months
Rate of exclusive breastfeeding
1 month
Other Outcomes (4)
Rate of non exclusive breastfeeding
6 months
Rate of non exclusive breastfeeding
4 months
Rate of non exclusive breastfeeding
2 months
- +1 more other outcomes
Study Arms (2)
Experimental
EXPERIMENTALThese mothers and their babies will receive Primary Care standard care (office visits at 1, 2, 4 and 6 months) plus the telephone support
No intervention
NO INTERVENTIONStandard care (office visits at 1, 2, 4 and 6 months)
Interventions
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
You may qualify if:
- Mothers with healthy newborns
- weeks gestation or greater
- Exclusive breastfeeding or any breastfeeding when arrive at Primary Care
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jordi Gol i Gurina Foundation
Barcelona, Barcelona, 08007, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Josep Balaguer, Doctor
Jordi Gol i Gorina Foundation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2014
First Posted
July 10, 2014
Study Start
October 1, 2014
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
December 23, 2014
Record last verified: 2014-12