Background
Feeding newborns: The benefits of breast-feeding
Recommendations regarding the promotion of breast-feeding
Prevalence of breast-feeding in developed countries: Associated factors
Strategies to foment breast-feeding
Methods/design
Objectives
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To compare the effectiveness of an educational group intervention in primary healthcare with usual care to increase the proportion of mother-child pairs that use PBF up to six months of age.
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To describe women’s adherence and degree of satisfaction with the educational group intervention.
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To describe the reasons for abandonment of breast-feeding in both study groups. To describe the reasons of breastfeeding abandonment in both study groups.
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To explore the predictive factors of maintenance EBF at six months of age.
Design of the study
Subjects of the study
Inclusion criteria
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Minimum of 2 years working as a professional in PHC.
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Have no intention of transferring during the study period.
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Provide healthcare to the infant population within their daily healthcare workload.
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Sign the researcher agreement.
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Mothers of full-term newborns and that use EBF ≥ 18 years of age at the selection visit
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Full-term newborns (≥ 37 weeks of gestation), with a birth weight > 2.5 kg and with the newborn’s age ≤ 4 weeks.
Exclusion criteria
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Those that reject participation in the study.
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Clinical conditions of the mother that contraindicate breast-feeding: active tuberculosis, active chicken pox, active Herpes lesions on breasts, Chagas disease; human immunodeficiency virus (HIV); human T-lymphotropic virus (HTLV) I and II; substance abuse; mother in treatment with radioactive isotopes or chemotherapy or antimetabolite drugs.
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Clinical conditions of the child that complicate or impede breast-feeding, orofacial malformations.
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Clinical conditions of the child that contraindicate breast-feeding: classic galactosemia (galactose-1-phosphate uridyltransferase deficiency) in newborns.
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Infants that have been initiated on complementary feeding.
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Women that do not consent to participating in the study.
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Impossibility of the mother to come to the visits proposed for the conduction of the study.
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Difficulties with the language that impede or complicate communication between the mother and the healthcare professionals.
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Women that are participating in another research study during the study period.
Sample size
Randomisation
Masking
Intervention
Visit | Randomisation:2 months before visit 1 | Trainig: 1–2 months before visit 1 | Visit 1: < 1 month after birth | Visit 2: 2 months after birth | Visit 3: 3 months after birth | Visit 4: 4 months after birth | Visit 5: 5 months after birth | Visit 6: 6 months after birth |
---|---|---|---|---|---|---|---|---|
Study procedures | ||||||||
Randomisation |
X
| |||||||
Professional training |
X
| |||||||
Informed consent |
X
| |||||||
Recruitment |
X
| |||||||
Demographics |
X
| |||||||
Telephone contact |
X
|
X
|
X
|
X
|
X
| |||
Interventions | ||||||||
Standard practice |
X
|
X
|
X
| |||||
PROLACT intervention |
X
|
X
|
X
| |||||
Outcomes measures | ||||||||
EBF |
X
|
X
|
X
|
X
|
X
|
X
| ||
PBF |
X
|
X
|
X
|
X
|
X
|
X
| ||
CF |
X
|
X
|
X
|
X
|
X
|
X
| ||
Reasons for abandoning breastfeeding |
X
|
X
|
X
|
X
|
X
|
X
| ||
Acceptability of intervention |
X
| |||||||
Adherence |
X
|
X
|
X
| |||||
Satisfaction |
X
|
Control group (usual care)
Intervention group (educational group intervention)
Variables
Outcome variables
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Type of feeding at six months (categorical: EBF, PBF, CF).
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Duration of EBF (days) = (Date of abandonment EBF – Date of birth of infant).
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Reasons for abandonment of BF (semi-structured questionnaire created for the study).
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Number of group education sessions to which the dyad attends. Adequate adherence is considered as attendance to at least 85% of the planned sessions.
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Degree of satisfaction with the educational group intervention (measurement instrument: SERVQUAL).
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For the professional: age (years), sex, breastfeeding training received.
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For the mother: age (years); education level (low – primary studies only; medium - high school completed, technical training or other non-university studies completed; high - university level education completed); income level; nationality; working situation of the mother (if she works outside the home and the number of hours per working day/ days per week); living situation with partner; obstetric history (pregnancies/abortions/live births); type of birth (vaginal/caesarean; single/multiple); Previous breastfeeding experience; peso(kg); size(cm); smoker (yes/no).
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For the newborn: single foetus (YES/NO); sex; birth-weight (grams); discharged from hospital with mother (YES/NO); APGAR test, separation from the mother during hospital stay (YES/NO); breast-fed during first hours after birth (YES/NO).
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Regarding breast-feeding: intention to breast-feed (only mother’s milk/only formula/both/I don’t know); received support for breast-feeding during pregnancy (YES/NO); received support for breast-feeding in the hospital (assessment of the attention received in the hospital regarding breast-feeding using the BFHI test); family support measured using the Apgar family test [34]; if breast-feeding took place in the first 30 min.; self-efficacy in breast-feeding measured using the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) (test validated in Spain with a global score of 0 to 100); cracks or mastitis in the first 8 days; schedule limitation of feedings.