Menu
Not yet recruiting NCT07593716

Effect of a Self-Efficacy-Based Educational Intervention on Breastfeending in Primigravid Women: A Randomized Controlled Trial

No phase Interventional Exclusive Breastfeeding Breastfeeding Self-Efficacy Pregnancy Maternal Health Education

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Breastfeeding Self-Efficacy Educational Program.
Who it may be relevant to
Registry conditions: Exclusive Breastfeeding, Breastfeeding Self-Efficacy, Pregnancy, Maternal Health Education. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Mexico
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of a Self-Efficacy-Based Educational Intervention on Exclusive Breastfeeding in Primigravid Women Attending a Primary Care Center: A Randomized Controlled Trial

Overview

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.

Detailed description

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.

Interventions

  • Behavioral Breastfeeding Self-Efficacy Educational Program
    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.

Primary outcome measures

  • Exclusive Breastfeeding Rate at 3 Months Postpartum [Time frame: 3 months postpartum]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Mexico · 1 center
  • Unidad de Medicina Familiar No. 9 — Acapulco de Juárez

Identifiers

NCT: NCT07593716 · IMSS-UMF-BSES-2026 · R-2026-1101-006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗