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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

breastfeeding counseling

Group Type EXPERIMENTAL

breastfeeding counseling

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No