Exclusive BreastfeedingPROMILACTNCT07593716
Effect of a Self-Efficacy-Based Educational Intervention on Breastfeending in Primigravid Women: A Randomized Controlled Trial
A study testing Breastfeeding Self-Efficacy Educational Program in people with Exclusive Breastfeeding and Breastfeeding Self-Efficacy, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Exclusive Breastfeeding, Breastfeeding Self-Efficacy, Pregnancy
- What is being tested?
- Breastfeeding Self-Efficacy Educational Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteMexico
- Study dates
- May 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
Unidad de Medicina Familiar No. 9
Acapulco de Juárez, Guerrero, 39300
Guadalupe Aguilar Hernández, MD, +52 7442298212, guadalupe.aguilarhe@imss.gob.mx
Guadalupe Aguilar Hernández, MD
About this study
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
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.
- Conditions
- Exclusive Breastfeeding, Breastfeeding Self-Efficacy, Pregnancy, Maternal Health Education
- Being tested
- Breastfeeding Self-Efficacy Educational Program
- Keywords
- Breastfeeding, Primigravid Women, Educational Intervention, Randomized Controlled Trial, BSES-SF, Primary Care, Mexico
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breastfeeding Self-Efficacy Educational ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Breastfeeding Self-Efficacy Educational Program |
| Control Group | No intervention | Participants will receive standard prenatal care routinely provided at the family medicine unit without the additional breastfeeding educational intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study startMay 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exclusive BreastfeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Collaborators
- Tropical Disease Research Centre
- Responsible party
- Principal investigator, Guadalupe Aguilar Hernández, Instituto Mexicano del Seguro Social
- Investigators
- Guadalupe Aguilar Hernández, MD, Principal investigator, INSTITUTO MEXICANO DEL SEGURO SOCIAL, UNIDAD DE MEDICINA FAMILIAR NO. 9Sergio Paredes Solis, MD, Study director, Centro de Investigación de Enfermedades Tropicales, Universidad Autonoma de Guerrero
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593716
- Sponsor's protocol ID
- IMSS-UMF-BSES-2026
- Other IDs
- R-2026-1101-006
- Acronym
- PROMILACT
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly available due to institutional privacy and confidentiality policies.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07593716
- Acronym / sponsor ID
- PROMILACT / IMSS-UMF-BSES-2026
- Conditions
- Exclusive Breastfeeding, Breastfeeding Self-Efficacy, Pregnancy, Maternal Health Education
- Keywords
- Breastfeeding, Primigravid Women, Educational Intervention, Randomized Controlled Trial, BSES-SF, Primary Care, Mexico
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Collaborators
- Tropical Disease Research Centre
- Study start
- May 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Educational Intervention Group | Experimental | Behavioral: Breastfeeding Self-Efficacy Educational ProgramParticipants 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. |
| Control Group | No intervention | –Participants will receive standard prenatal care routinely provided at the family medicine unit without the additional breastfeeding educational intervention. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breastfeeding Self-Efficacy Educational ProgramParticipants 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. | Behavioural | Educational Intervention Group |
Primary outcome
Exclusive Breastfeeding Rate at 3 Months 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly available due to institutional privacy and confidentiality policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breastfeeding Self-Efficacy Educational Program in people with Exclusive Breastfeeding and Breastfeeding Self-Efficacy, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guadalupe Aguilar Hernández, MD (+527442298212, guadalupe.aguilarhe@imss.gob.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exclusive Breastfeeding Rate at 3 Months Postpartum (time frame: 3 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.