Effect of Breastfeeding Education and Support Provided to Male Partners on Optimal Breastfeeding Practice in Hadiya Zone, Southern Ethiopia: A Cluster-Randomized Controlled Trial
Breastfeeding Education and Support
Estudio de Investigación en servicios de salud
Resumen
Fecha de inicio: 14 de julio de 2022
Fecha en la que se inscribió al primer participante.Optimal breastfeeding practices are essential for child survival, growth, development, and for the health of mothers. Globally, optimal breastfeeding practices are still low: less than 42% of new-borns begin breastfeeding in the first hour after birth, 41% of infants less than 6 months of age are exclusively breastfed and only 45% of mothers continue breastfeeding for at least two years. It's estimated that 823,000 deaths of children could be prevented every year through optimal breastfeeding practices. However, breastfeeding practices are not optimal in Ethiopia. Male partners have an important but often neglected role in the promotion of breastfeeding practices and currently, participants are not targeted in breastfeeding education provided by health care providers. The effect of breastfeeding interventions delivered to male partners on optimal breastfeeding has not been studied in the Ethiopian context. The aim of this study is to evaluate the effect of breastfeeding education and support provided to male partners on optimal breastfeeding practice in Hadiya Zone, southern Ethiopia. A cluster-randomized controlled trial will be conducted. The intervention will be provided to the mothers and male partners by trained village health workers . The male partners in the intervention group will receive breastfeeding education and support, but participants in the control group will receive routine care. The breastfeeding education and support intervention package is comprised of four components: 1) Paternal and maternal group education, 2) providing specific take-home print materials, 3) Telephone call counseling and 4) Individual home visit. A total of 408 couples in third trimester pregnancy will be recruited to either the intervention group (204) or a control group (204) from 16 clusters. Clusters will be Kebeles (lowest administrative unit). Randomization will be conducted at the cluster level.Study assessors will be masked. Data analysis will be conducted by STATA version 14.0 using an Intention-To-Treat Approach. Generalized Estimating Equation (GEE) model will be used to determine the effect of the intervention on optimal breastfeeding practice. P values < 0.05 will be used to declare statistical significance. The duration of the intervention is six months.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 408 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Investigación en Servicios de Salud
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 15 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Criterios
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación