Clinical trial Recruiting at 1 site Interventional Ages 18 and up Women only

Effectiveness of a Counseling Program to Support Exclusive Breastfeeding

Official title: Effectiveness of a Counseling Program on Exclusive Breastfeeding Rates in a Primary Care Center in A Coruña.Randomized Controlled Clinical Trial

Run by Fundación Pública Galega de Investigación Biomédica INIBIC · NCT07309510 · Data updated 2026-11-12

A counseling program is tested to see if it helps new mothers in a primary care setting breastfeed exclusively for six months.

Quick facts

Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment160 (estimated)
SponsorFundación Pública Galega de Investigación Biomédica INIBIC
Academic / other
Locations1 site (A Coruña, Galicia)
StatusRecruiting
StartedFebruary 1, 2026
Main results expectedAugust 2027
Study endsJanuary 2028
Registry record updatedSeptember 16, 2026
Trial IDNCT07309510 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Mothers of healthy, full-term newborns who plan to breastfeed, deliver at the study site, and speak Spanish or Galician.

Probably not a fit

Maters who do not plan to breastfeed, have contraindications to breastfeeding, or whose infants have conditions incompatible with exclusive breastfeeding.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot randomized study compares usual care to enhanced breastfeeding counseling for healthy, full-term newborns and their mothers in a community clinic. The goal is to see whether structured guidance improves exclusive breastfeeding rates at six months. The trial is conducted in a pediatric nursing clinic at a Coruña health center, enrolling mothers who plan to breastfeed and deliver at the study site. Eligibility includes fluency in Spanish or Galician and intention to breastfeed, with several maternal and infant exclusions noted. The primary outcome is exclusive breastfeeding rate at six months, analyzed within a real-world primary care context.

Why it matters

Potential benefit: If successful, the program could improve exclusive breastfeeding rates and related infant health outcomes in the community.

How similar studies have gone: Previous evidence supports breastfeeding support programs in community settings, though this specific randomized pilot in primary care is novel in its exact design.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Mothers who express a desire to breastfeed during a follow-up consultation with the Obstetric and Gynecological Nursing or Physician specialist at 36 weeks of gestation.
* Mothers who plan to give birth at HMI of CHUAC, referred from the C.S. Ventorrillo.
* Women who are fluent in Spanish or Galician.

Exclusion Criteria:

* Maternal age under 18 years - Maternal use of drugs or medication that prevent breastfeeding .
* Maternal infection with HIV or Human T-cell Leukemia Virus.
* Mothers of newborns with cow's milk protein allergy, galactosemia, or congenital primary lactase deficiency.
* Participate in other clinical trials.

Where it's running

  • Centro de Salud de O Ventorrillo
    A Coruña, Galicia, Spain
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.