Effectiveness of an Educational Intervention to Maintain Exclusive Breastfeeding
PROLACT
1 other identifier
interventional
434
1 country
1
Brief Summary
Hypothesis: An educational intervention increases the proportion of mother-infant pairs using exclusive breastfeeding
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2015
Typical duration for not_applicable
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 3, 2013
CompletedFirst Posted
Study publicly available on registry
June 5, 2013
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedAugust 22, 2017
August 1, 2017
2.3 years
June 3, 2013
August 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Exclusive breastfeeding (EBF)
Evaluate the presence of EBF 6 months after educational intervention.
six months
Secondary Outcomes (2)
Type of breastfeeding and duration of EBF
Six months
breastfeeding ceasing
During follow-up
Study Arms (2)
intervention group
EXPERIMENTALIntervention group receive a training education on breastfeeding. Education training is provided by an expert group from General Direction of Primary Care
Controll group
OTHERUsual care
Interventions
Eligibility Criteria
You may qualify if:
- Female 18 years old or older,
- mother-infant pairs using exclusive breastfeeding,
- Signed Informed Consent
You may not qualify if:
- Any medical conditions that prevents breastfeeding
- infant should be not older than four weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gerencia de Atencion Primaria
Madrid, Spain
Related Publications (2)
Santamaria-Martin MJ, Martin-Iglesias S, Schwarz C, Rico-Blazquez M, Portocarrero-Nunez JA, Diez-Izquierdo L, Llamosas-Falcon L, Rodriguez-Barrientos R, Del-Cura-Gonzalez I; Grupo PROLACT. Effectiveness of a group educational intervention - prolact - in primary care to promote exclusive breastfeeding: a cluster randomized clinical trial. BMC Pregnancy Childbirth. 2022 Feb 16;22(1):132. doi: 10.1186/s12884-022-04394-8.
PMID: 35172775DERIVEDMartin-Iglesias S, Santamaria-Martin MJ, Alonso-Alvarez A, Rico-Blazquez M, Del Cura-Gonzalez I, Rodriguez-Barrientosn R, Barbera-Martin A, Sanz-Cuesta T, Isabel Coghen-Vigueras M, de Antonio-Ramirez I, Durand-Rincon I, Garrido-Rodriguez F, Geijo-Rincon MJ, Mielgo-Salvador R, Morales-Montalva MS, Reviriego-Gutierrez MA, Rivero-Garrido C, Ruiz-Calabria M, Santamaria-Mechano MP, Santiago-Fernandez R, Sillero-Quintana MI, Soto-Almendro B, Terol-Claramonte M, Villa-Arranz M. Effectiveness of an educational group intervention in primary healthcare for continued exclusive breast-feeding: PROLACT study. BMC Pregnancy Childbirth. 2018 Feb 26;18(1):59. doi: 10.1186/s12884-018-1679-3.
PMID: 29482516DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
María J Santamaría, Nurse
Gerencia de Atención Primaria, Madrid
- PRINCIPAL INVESTIGATOR
Susana Martín, Nurse
Gerencia de Atención Primaria, Madrid
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Nurse
Study Record Dates
First Submitted
June 3, 2013
First Posted
June 5, 2013
Study Start
February 1, 2015
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
August 22, 2017
Record last verified: 2017-08