Unidad de Medicina Familiar No. 9
Acapulco de Juárez, Guerrero, 39300, Mexico
Location contact
Guadalupe Aguilar Hernández, MD
CONTACT
Guadalupe Aguilar Hernández, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07593716
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.
Trial opening soon.
Get Notified18 year–45 year
Female
Interventional
Not applicable
Acapulco de Juárez, Guerrero, 39300, Mexico
Guadalupe Aguilar Hernández, MD
CONTACT
Guadalupe Aguilar Hernández, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 3 months postpartum
Proportion of mothers who maintain exclusive breastfeeding at 3 months postpartum after receiving an educational intervention based on breastfeeding self-efficacy.
Contact information is provided by the study sponsor or research team.
Instituto Mexicano del Seguro Social
Other Gov
Effect of a Self-Efficacy-Based Educational Intervention on Exclusive Breastfeeding in Primigravid Women Attending a Primary Care Center: A Randomized Controlled Trial
Acronym: PROMILACT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06701227
Adherence Interventions, Behavior
Jaboticabal, São Paulo, Brazil
View Trial DetailsNCT05477628
Behavior, Body Weight
View Trial DetailsNCT07341256
Behavior, Breast Feeding
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT06691932
Behavior, Breast Feeding
Rochester, New York, United States
View Trial Details