Effect of Mobile-Based Counselling on Breastfeeding in Spain: A Randomized Controlled Trial Protocol (COMLACT Study)
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Otros documentos de la autoría: Mena Tudela, Desirée; Soriano-Vidal, Francisco Javier; Vila Candel, Rafael; QUESADA, JOSE ANTONIO; Aguilar, Laia; Franco Antonio, Cristina
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Mostrar el registro completo del ítemcomunitat-uji-handle:10234/9
comunitat-uji-handle2:10234/36084
comunitat-uji-handle3:10234/36085
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Título
Effect of Mobile-Based Counselling on Breastfeeding in Spain: A Randomized Controlled Trial Protocol (COMLACT Study)Autoría
Fecha de publicación
2023Editor
MDPIISSN
2227-9032Cita bibliográfica
Mena-Tudela, D.; Soriano-Vidal, F.J.; Vila-Candel, R.; Quesada, J.A.; Aguilar, L.; Franco-Antonio, C. Effect of Mobile-Based Counselling on Breastfeeding in Spain: A Randomized Controlled Trial Protocol (COMLACT Study). Healthcare 2023, 11, 1434. https:// doi.org/10.3390/healthcare11101434Tipo de documento
info:eu-repo/semantics/articleVersión
info:eu-repo/semantics/publishedVersionPalabras clave / Materias
Resumen
Purpose: The primary aim of this study is to determine the influence of an intervention in
women based on a free mobile application (LactApp®, Barcelona, Spain) in maintaining breastfeeding
(BF) up to 6 months ... [+]
Purpose: The primary aim of this study is to determine the influence of an intervention in
women based on a free mobile application (LactApp®, Barcelona, Spain) in maintaining breastfeeding
(BF) up to 6 months postpartum. The secondary aim is to assess the effect of health literacy (HL)
on breastfeeding duration. Methods: A multicenter, randomized controlled clinical trial of parallel
groups will be carried out. Women will be randomly assigned to each of the parallel groups. In
the control group, usual clinical practice will be followed from the third trimester of pregnancy to
promote BF. In the intervention group, and in addition to usual clinical practice, the women will use a
free mobile application (LactApp®) from the third trimester to 6 months postpartum. The type of BF
at birth, at 15 days and at 3 and 6 months postpartum and the causes of cessation of BF in both groups
will be monitored. The hypothesis will be tested using inferential analysis, considering an alpha of
5%. The study protocol was approved by the Clinical Research Ethics Committee of Hospital de la
Ribera (Alzira, Valencia, Spain) in February 2021. A per protocol analysis and an intention-to-treat
analysis will be performed. Discussion: This study will identify the influence of a mobile application
on improving BF rates. If the application proves effective, we will have a tool with free information
available to any user at any time of day, which may be complemented by normal clinical practice and
be integrated into our health care system. Trial registration: ClinicalTrials.gov ID: NCT05432700. [-]
Publicado en
Healthcare 2023, 11, 1434.Entidad financiadora
FISABIO
Código del proyecto o subvención
UGP-20-245
Derechos de acceso
info:eu-repo/semantics/openAccess
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