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Not yet recruitingNCT07593716PROMILACTUpdated May 18, 2026

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

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

Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Exclusive Breastfeeding
  • Breastfeeding Self-Efficacy
  • Pregnancy
  • Maternal Health Education

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Keywords

  • Breastfeeding
  • Primigravid Women
  • Educational Intervention
  • Randomized Controlled Trial
  • BSES-SF
  • Primary Care
  • Mexico
03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
160 participants (estimated)

Study arms

  • Experimental
    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.

    Behavioral: Breastfeeding Self-Efficacy Educational Program

  • No intervention
    Control Group

    Participants will receive standard prenatal care routinely provided at the family medicine unit without the additional breastfeeding educational intervention.

Interventions

  • BehavioralBreastfeeding 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.

05

What researchers measure

Primary outcomes

  1. 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

06

Study locations

1 site
  • Unidad de Medicina Familiar No. 9
    Acapulco de Juárez, Guerrero 39300, Mexico
07

References and documents

Individual participant data

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.

08

Registry details

Key details

Study ID
NCT07593716
Lead sponsor
Instituto Mexicano del Seguro Social
Collaborators
Tropical Disease Research Centre
Responsible party
Guadalupe Aguilar Hernández (Family Medicine Specialist, Instituto Mexicano del Seguro Social) — Principal investigator
First posted
May 18, 2026
Start date
May 2026 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
May 18, 2026

Study contacts

Guadalupe Aguilar Hernández, MD
Contact
guadalupe.aguilarhe@imss.gob.mx
+527442298212
Guadalupe Aguilar Hernández, MD
principal investigator · INSTITUTO MEXICANO DEL SEGURO SOCIAL, UNIDAD DE MEDICINA FAMILIAR NO. 9
Sergio Paredes Solis, MD
study director · Centro de Investigación de Enfermedades Tropicales, Universidad Autonoma de Guerrero

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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