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

Fundacion Profesor Novoa Santos

Status: Not yet enrolling

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

Treatments: Behavioral: breastfeeding counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT07309510

2025/235 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Conventional care

No Intervention group

Description:

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 group

Treatment:

Behavioral: breastfeeding counseling