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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Guadalupe Aguilar Hernández, MD
- Numéro de téléphone: +527442298212
- E-mail: guadalupe.aguilarhe@imss.gob.mx
Lieux d'étude
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Guerrero
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Acapulco de Juárez, Guerrero, Mexique, 39300
- Unidad de Medicina Familiar No. 9
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Contact:
- Guadalupe Aguilar Hernández, MD
- Numéro de téléphone: +52 7442298212
- E-mail: guadalupe.aguilarhe@imss.gob.mx
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Chercheur principal:
- Guadalupe Aguilar Hernández, MD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Aucune intervention: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Exclusive Breastfeeding Rate at 3 Months Postpartum
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Guadalupe Aguilar Hernández, MD, INSTITUTO MEXICANO DEL SEGURO SOCIAL, UNIDAD DE MEDICINA FAMILIAR NO. 9
- Directeur d'études: Sergio Paredes Solis, MD, Centro de Investigación de Enfermedades Tropicales, Universidad Autonoma de Guerrero
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IMSS-UMF-BSES-2026
- R-2026-1101-006 (Identificateur de registre: SIRELCIS)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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