Effectiveness of a Counseling Program on Exclusive Breastfeeding Rates in a Primary Care Center
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: breastfeeding counseling.
- Who it may be relevant to
- Registry conditions: Growth & Development, Breastfeeding Satisfaction, Breastfeeding Consultancy Training, Breastfeeding Duration. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of a Counseling Program on Exclusive Breastfeeding Rates in a Primary Care Center in A Coruña.Randomized Controlled Clinical Trial
Overview
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.
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 r
Primary outcome measures
- Rate of exclusive breastfeeding at 6 months of age of the newborn [Time frame: From birth up to 6 months of the infant's life]
Secondary outcome measures (12)
- Number of participants with exclusive breastfeeding at 15 days, one month, and three months of the newborn's life. [Time frame: At 15 days, one month, and three months of the newborn's life.]
- Number of participants with recovery to birth weight [Time frame: At 15 days and one month of age]
- Grams of daily weight gain [Time frame: At 15 days, 1 month, 2 months, 4 months and 6 months of the infant's life]
- Age of introduction of complementary feeding [Time frame: From birth to 6 months of age]
- Number of Hospital admissions by the newborn [Time frame: From birth to 6 months of age]
- Number of emergency department visits by the newborn [Time frame: From birth to 6 months of age]
- Number of visits by the pediatric nurse specialist [Time frame: Until completion of the study (6 months after birth)]
- Number of visits to the specialist nurse in Obstetric-Gynecological Nursing [Time frame: Until completion of the study (6 months after birth)]
- Days after birth of cessation of breastfeeding [Time frame: Until completion of the study (6 months after birth)]
- Reasons reasons given by the mother in an interview for breastfeeding abandonment [Time frame: 6 months after birth or when the mother abandons the study]
- Score on the validated scale of impact of support networks in breastfeeding [Time frame: 6 months after birth or when the mother abandons the study]
- Score of Maternal Breastfeeding Evaluation Scale (MBFES-E) [Time frame: 6 months after birth or when the mother abandons the study]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Spain · 1 center
- Centro de Salud de O Ventorrillo — A Coruña
Identifiers
NCT: NCT07309510 · 2025/235 · 2025/235