Effectiveness of a Counseling Program on Exclusive Breastfeeding Rates in a Primary Care Center (ALM-AP)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Growth & Development; Breastfeeding, Exclusive; Breastfeeding Rate; Breastfeeding Outcomes; Breastfeeding Duration; Breastfeeding After Discharge From Hospital Following Childbirth, Yes/no; Breastfeeding Attitude; Breastfeeding Support System; Breastfeeding Consultancy Training; Breastfeeding Satisfaction
• Intervention / Treatment: Behavioral: breastfeeding counseling

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yolanda suarez Sánchez Suárez; Phone Number: +34 687211163; Email: yolanda.sanchez.suarez2@sergas.es
• Study Contact Backup: Name: Carmen Neri Fernández Pombo, PhD; Email: carmen.neri.fernandez.pombo@col.udc.es

Study Locations

• Spain
  • Galicia
    • A Coruña, Galicia, Spain
      • Centro de Salud de O Ventorrillo
      • Contact: Yolanda Sánchez Suárez; Phone Number: 981178000; Email: yolanda.sanchez.suarez2@sergas.es
      • Principal Investigator: Yolanda Sánchez Suárez
      • Sub-Investigator: Úrsula Nieto Caamaño
      • Sub-Investigator: Julia Varas Merino
      • Sub-Investigator: Tania Súarez Lavandeira

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Conventional care; 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.
Experimental: breastfeeding counseling	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with exclusive breastfeeding at 15 days, one month, and three months of the newborn's life.	Defined as the practice of feeding the infant exclusively with breast milk (without giving any other food or drink, not even water). Breastfeeding by a wet nurse, feeding with expressed breast milk, and feeding with donor breast milk are also considered breastfeeding.	At 15 days, one month, and three months of the newborn's life.
Number of participants with recovery to birth weight	The infant regains the weight with which they were born	At 15 days and one month of age
Grams of daily weight gain	Grams of weight gained per day since the previous weight check.	At 15 days, 1 month, 2 months, 4 months and 6 months of the infant's life
Age of introduction of complementary feeding	Age of the infant at which complementary feeding is started in both study groups.	From birth to 6 months of age
Number of Hospital admissions by the newborn	Hospital admissions by the newborn in both study groups.	From birth to 6 months of age
Number of emergency department visits by the newborn	number and reason for emergency department visits by the newborn in both study groups.	From birth to 6 months of age
Number of visits by the pediatric nurse specialist	Number and reason for visits by the pediatric nurse specialist in both study groups.	Until completion of the study (6 months after birth)
Number of visits to the specialist nurse in Obstetric-Gynecological Nursing	Number of visits to the specialist nurse in Obstetric-Gynecological Nursing	Until completion of the study (6 months after birth)
Days after birth of cessation of breastfeeding	Days of the infant's life when the last breastfeeding is administered	Until completion of the study (6 months after birth)
Reasons reasons given by the mother in an interview for breastfeeding abandonment	Reasons for breastfeeding discontinuation among the study groups.	6 months after birth or when the mother abandons the study
Score on the validated scale of impact of support networks in breastfeeding	Score on the validated scale of impact of support networks in breastfeeding Validated scale of the impact of support networks on breastfeeding. Composed of 12 items, self-administered. Mothers must indicate their level of agreement or disagreement with the statements using a 5-point Likert scale. The maximum score is 60 points and the minimum is 12 points. A higher score indicates a greater degree of satisfaction or perceived quality among users of breastfeeding support services.	6 months after birth or when the mother abandons the study
Score of Maternal Breastfeeding Evaluation Scale (MBFES-E)	Score on the Spanish version of the Maternal Breastfeeding Evaluation Scale (MBFES-E). A 5-point Likert-type scale is used in which the participant rates their level of agreement with the item statement (1: strongly disagree to 5: strongly agree). The final score on the scale will range from 30 to 150 and is interpreted such that a higher score indicates greater satisfaction with the breastfeeding experience.	6 months after birth or when the mother abandons the study

Collaborators and Investigators

• Sponsor: Fundacion Profesor Novoa Santos
• Investigators: Principal Investigator: 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.; Study Director: Javier Muñíz García, PhD, Universidade de A Coruña

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Estimated): December 30, 2025

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Primary Health Care; Infant; Health Education; Breastfeeding; Human Milk; Postpartum Period
• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Feeding Behavior; Patient Compliance; Patient Acceptance of Health Care; Adherence Interventions; Medication Adherence; Breast Feeding; Health Education
• Other Study ID Numbers: 2025/235 (Other Identifier: Comité de Ética de la Investigación de A Coruña- Ferrol)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No