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| ID | Type | Description | Link |
|---|---|---|---|
| R-2026-1101-006 | Registry Identifier | SIRELCIS |
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| Name | Class |
|---|---|
| Tropical Disease Research Centre | UNKNOWN |
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This randomized controlled trial aims to evaluate the effect of a self-efficacy-based educational intervention on exclusive breastfeeding among primigravid women attending a primary care center in Mexico. Participants in the intervention group will receive four weekly educational sessions focused on breastfeeding knowledge, self-efficacy, problem-solving skills, and emotional support during the third trimester of pregnancy. The control group will receive standard prenatal care. Breastfeeding self-efficacy and exclusive breastfeeding rates will be evaluated during postpartum follow-up at 1 and 3 months after delivery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Educational Intervention Group | Experimental | 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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| Control Group | No Intervention | Participants will receive standard prenatal care routinely provided at the family medicine unit without the additional breastfeeding educational intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breastfeeding Self-Efficacy Educational Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Exclusive Breastfeeding Rate at 3 Months Postpartum | Proportion of mothers who maintain exclusive breastfeeding at 3 months postpartum after receiving an educational intervention based on breastfeeding self-efficacy. | 3 months postpartum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guadalupe Aguilar Hernández, MD | Contact | +527442298212 | guadalupe.aguilarhe@imss.gob.mx |
| Name | Affiliation | Role |
|---|---|---|
| Guadalupe Aguilar Hernández, MD | INSTITUTO MEXICANO DEL SEGURO SOCIAL, UNIDAD DE MEDICINA FAMILIAR NO. 9 | Principal Investigator |
| Sergio Paredes Solis, MD | Centro de Investigación de Enfermedades Tropicales, Universidad Autonoma de Guerrero |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidad de Medicina Familiar No. 9 | Acapulco de Juárez | Guerrero | 39300 | Mexico |
Individual participant data will not be publicly available due to institutional privacy and confidentiality policies.
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Participants will be randomly assigned to either an educational intervention group based on breastfeeding self-efficacy or a control group receiving standard prenatal care. Both groups will be followed during pregnancy and evaluated at 1 and 3 months postpartum.
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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