An interventional study of Breastfeeding Self-Efficacy Educational Program in Exclusive Breastfeeding, Breastfeeding Self-Efficacy and Pregnancy, sponsored by Instituto Mexicano del Seguro Social. Not yet recruiting at 1 site in Mexico. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by Instituto Mexicano del Seguro Social · Not applicable, Interventional, and Prevention
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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.
1,082 studies on the registry are indexed under Breast Feeding; 218 are open to participants now.
This study's planned enrollment of 160 is above the median of 100 across 845 interventional studies indexed under Breast Feeding.
Browse Breast Feeding studies →Instituto Mexicano del Seguro Social is the lead sponsor of 126 studies on the registry; 21 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Breastfeeding Self-Efficacy Educational Program
Participants will receive standard prenatal care routinely provided at the family medicine unit without the additional breastfeeding educational intervention.
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.
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.
Time frame: 3 months postpartum
Plan to share: No — Individual participant data will not be publicly available due to institutional privacy and confidentiality policies.
No publications or documents are linked to this record.
Start is estimated for May 2026; primary completion for Jun 2027, 13 months later.
Of 504 non-industry interventional studies with no phase under Breast Feeding, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 13 months is close to that.
Counting every sponsor, half of 512 studies reached it within 12 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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