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

NCT07309510 | Not Yet Recruiting

• 1 other identifier: 2025/235
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

Breastfeeding; Infant; Human Milk; Health Education; Primary Health Care; Postpartum Period

Outcome Measures

Primary Outcomes (1)

• Rate of exclusive breastfeeding at 6 months of age of the newborn

  The practice of feeding the infant exclusively with breast milk from 0 to 5 months (without giving any other food or drink, not even water). Nursing by a wet nurse, feeding with expressed breast milk, and feeding with breast milk from donors are also considered breastfeeding.

  From birth up to 6 months of the infant's life

Secondary Outcomes (12)

• Number of participants with exclusive breastfeeding at 15 days, one month, and three months of the newborn's life.

  At 15 days, one month, and three months of the newborn's life.

• Number of participants with recovery to birth weight

  At 15 days and one month of age

• Grams of daily weight gain

  At 15 days, 1 month, 2 months, 4 months and 6 months of the infant's life

• Age of introduction of complementary feeding

  From birth to 6 months of age

• Number of Hospital admissions by the newborn

  From birth to 6 months of age

Study Arms (2)

Conventional care

NO INTERVENTION

Conventional care within the Child Health Program (SERGAS) The health program includes 5 appointments with the Pediatric Specialist doctor and the Pediatric Specialist nurse in the first 6 months of life. These appointments will take place at 7-15 days, at 1 month, at 2 months, at 4 months, and at 6 months of age.

breastfeeding counseling

EXPERIMENTAL

Behavioral: breastfeeding counseling

Interventions

breastfeeding counseling BEHAVIORAL

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.

breastfeeding counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mothers who express a desire to breastfeed during a follow-up consultation with the Obstetric and Gynecological Nursing 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion Profesor Novoa Santos: lead

Study Sites (1)

Centro de Salud de O Ventorrillo

A Coruña, Galicia, Spain

Location

MeSH Terms

Conditions

Breast Feeding; Health Education

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Yolanda Sánchez Suárez

  Servicio Gallego de Salud

  PRINCIPAL INVESTIGATOR

• Carmen Neri Fernández Pombo, PhD

  Servicio Gallego de Salud. Instituto de Investigación Biomédica de A Coruña.

  PRINCIPAL INVESTIGATOR

• Javier Muñíz García, PhD

  Universidade de A Coruña

  STUDY DIRECTOR

Central Study Contacts

Yolanda suarez Sánchez Suárez

CONTACT

+34 687211163; yolanda.sanchez.suarez2@sergas.es

Carmen Neri Fernández Pombo, PhD

CONTACT

carmen.neri.fernandez.pombo@col.udc.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse specialist in Pediatric Nursing

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 30, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)