Effectiveness of a Counseling Program on Exclusive Breastfeeding Rates in a Primary Care Center

NCT07309510 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-01-08

No results posted yet for this study

Summary

Introduction: Evidence supports that exclusive breastfeeding (EBF) is the most beneficial method of infant feeding up to 6 months of age. The practice confers numerous advantages for the infant and the mother. Many breasfeeding are abandoned early due difficulties experienced after dischargue and after returning to work. Development specific early breastfeeding support programs in the community is necessary to avoid unwanted abandonment.

Objective: To analyse the differences in BF rates at six month of birth in healthy full-term newborns between the study groups.

Methodology: Pilot study of a randomised clinical trial carried out in a Paediatric Nursing clinic at the Ventorrillo Health Centre in A Coruña. The study population will be mothers of healthy full-term newborns who wish to give BF at the time of delivery and whose reference health centre is the one of the study. The mother- newborn dyads in the control group (CG) will receive the usual care described in the child health Program of the Galician Health Service, and the dyads included in the intervention group (IG) will also receive specific advice on breastfeeding during the first 6 months of life. A study sample of 80 participants is estimated for each group. The study will be approved by the Research Ethics Committee of A Coruña-Ferrol. The variables under study will be collected in a data collection notebook for later statistical analysis. A significant value of p \< 0.05 being considered.

Conditions

  • Growth & Development
  • Breastfeeding Satisfaction
  • Breastfeeding Consultancy Training
  • Breastfeeding Duration
  • Breastfeeding After Discharge From Hospital Following Childbirth, Yes/no
  • Breastfeeding, Exclusive
  • Breastfeeding Attitude
  • Breastfeeding Support System
  • Breastfeeding Rate
  • Breastfeeding Outcomes

Interventions

BEHAVIORAL

breastfeeding counseling

The intervention group will receive, in addition to the indicated conventional care, 4 scheduled breastfeeding counseling appointments, the first of which will take place within the first 72 hours after hospital discharge following birth. As part of the breastfeeding counseling, the Latch scale will be used to observe and assess breastfeeding sessions, the breastfeeding self-efficacy scale-short (BSES-SF) to evaluate breastfeeding self-efficacy, the Visual Analogue Scale (VAS) to evaluate pain related to breastfeeding, and the breastfeeding clinical record form from the World Health Organization (WHO). Training will be provided to the mother and family on pre-selected breastfeeding topics. Mothers will be able to contact the IP nurse by phone daily on demand from 10 a.m. to 3 p.m.

Sponsors & Collaborators

  • Fundacion Profesor Novoa Santos

    lead OTHER

Principal Investigators

  • Yolanda Sánchez Suárez · Servicio Gallego de Salud

  • Carmen Neri Fernández Pombo, PhD · Servicio Gallego de Salud. Instituto de Investigación Biomédica de A Coruña.

  • Javier Muñíz García, PhD · Universidade de A Coruña

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2026-08-31
Completion
2027-01-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07309510 on ClinicalTrials.gov