Effect of a Self-Efficacy-Based Educational Intervention on Breastfeending in Primigravid Women: A Randomized Controlled Trial (PROMILACT)
Effect of a Self-Efficacy-Based Educational Intervention on Exclusive Breastfeeding in Primigravid Women Attending a Primary Care Center: A Randomized Controlled Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Exclusive breastfeeding is recognized as one of the most effective interventions for improving maternal and infant health outcomes. However, breastfeeding rates remain below international recommendations in many settings, particularly among first-time mothers who may experience uncertainty, lack of confidence, and insufficient support during the prenatal and postpartum periods.
Self-efficacy theory suggests that maternal confidence plays a critical role in breastfeeding initiation and maintenance. Educational interventions based on self-efficacy principles may improve breastfeeding behaviors and increase exclusive breastfeeding duration.
This study is a randomized controlled trial conducted in a primary care setting of the Mexican Social Security Institute (IMSS) in Acapulco, Guerrero, Mexico. The study will include primigravid women in the third trimester of pregnancy receiving prenatal care at Unidad de Medicina Familiar No. 9.
Participants assigned to the intervention group will receive a structured educational intervention consisting of four weekly sessions lasting approximately 90 minutes each. The sessions will address breastfeeding physiology, breastfeeding techniques, common breastfeeding difficulties, emotional support, and strategies to improve maternal self-efficacy. The control group will continue receiving standard prenatal care routinely provided by the institution.
The primary outcomes will include breastfeeding self-efficacy and exclusive breastfeeding rates during postpartum follow-up. Secondary outcomes may include breastfeeding knowledge and breastfeeding continuation at different postpartum time points.
Breastfeeding self-efficacy will be evaluated using the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF). Follow-up evaluations will be performed at 1 and 3 months postpartum.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Guadalupe Aguilar Hernández, MD
- Número de teléfono: +527442298212
- Correo electrónico: guadalupe.aguilarhe@imss.gob.mx
Ubicaciones de estudio
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Guerrero
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Acapulco de Juárez, Guerrero, México, 39300
- Unidad de Medicina Familiar No. 9
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Contacto:
- Guadalupe Aguilar Hernández, MD
- Número de teléfono: +52 7442298212
- Correo electrónico: guadalupe.aguilarhe@imss.gob.mx
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Investigador principal:
- Guadalupe Aguilar Hernández, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Pregnant women aged 18 years or older
- Primigravidae in the third trimester of pregnancy
- Receiving prenatal care at UMF No. 9, IMSS
- Ability to attend the educational sessions
- Willingness to participate and sign informed consent
Exclusion Criteria:
- High-risk pregnancy
- Medical conditions contraindicating breastfeeding
- Cognitive impairment or communication difficulties preventing participation
- Previous participation in breastfeeding educational programs
- Failure to complete follow-up evaluations
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Educational Intervention Group
Participants will receive a breastfeeding educational intervention based on self-efficacy theory during the third trimester of pregnancy.
The intervention includes four weekly sessions focused on breastfeeding knowledge, techniques, confidence building, and problem-solving strategies.
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Participants will receive four weekly educational sessions during the third trimester of pregnancy based on breastfeeding self-efficacy theory.
Sessions will include breastfeeding education, practical techniques, confidence building, problem-solving strategies, and support to improve exclusive breastfeeding practices postpartum.
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Sin intervención: Control Group
Participants will receive standard prenatal care routinely provided at the family medicine unit without the additional breastfeeding educational intervention.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Exclusive Breastfeeding Rate at 3 Months Postpartum
Periodo de tiempo: 3 months postpartum
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Proportion of mothers who maintain exclusive breastfeeding at 3 months postpartum after receiving an educational intervention based on breastfeeding self-efficacy.
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3 months postpartum
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Guadalupe Aguilar Hernández, MD, INSTITUTO MEXICANO DEL SEGURO SOCIAL, UNIDAD DE MEDICINA FAMILIAR NO. 9
- Director de estudio: Sergio Paredes Solis, MD, Centro de Investigación de Enfermedades Tropicales, Universidad Autonoma de Guerrero
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IMSS-UMF-BSES-2026
- R-2026-1101-006 (Identificador de registro: SIRELCIS)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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