Abstract
BackgroundThe World Health Organization leads a global strategy to promote the initiation and maintenance of breast-feeding.Existing literature shows that education and supportive interventions, both for breast-feeding mothers as well as for healthcare professionals, can increase the proportion of women that use exclusive breast-feeding, however, more evidence is needed on the effectiveness of group interventions.MethodsThis study involves a community-based cluster randomised trial conducted at Primary Healthcare Centres in the Community of Madrid (Spain). The project aims to evaluate the effectiveness of an educational group intervention performed by primary healthcare professionals in increasing the proportion of mother-infant pairs using exclusive breastfeeding at six months compared to routine practice.The number of patients required will be 432 (216 in each arm). All mother-infant pairs using exclusive breastfeeding that seek care or information at healthcare centres will be included, as long as the infant is not older than four weeks, and the mother has used exclusive breastfeeding in the last 24 h and who gives consent to participate.The main response variable is mother-infant pairs using exclusive breast-feeding at six months.Main effectiveness will be analysed by comparing the proportion of mother-infant pairs using exclusive breast-feeding at six months between the intervention group and the control group. All statistical tests will be performed with intention-to-treat. The estimation will be adjusted using an explanatory logistic regression model. A survival analysis will be used to compare the two groups using the log-rank test to assess the effect of the intervention on the duration of breastfeeding. The control of potential confounding variables will be performed through the construction of Cox regression models.DiscussionWe must implement strategies with scientific evidence to improve the percentage of exclusive breast-feeding at six months in our environment as established by the WHO. Group education is an instrument used by professionals in Primary Care that favours the acquisition of skills and modification of already-acquired behaviour, all making it a potential method of choice to improve rates of exclusive breast-feeding in this period.Trial registrationThe trial was registered with ClinicalTrials.gov under code number NCT01869920 (Date of registration: June 3, 2013).
Highlights
The World Health Organization leads a global strategy to promote the initiation and maintenance of breast-feeding
The World Health Organization (WHO) defines three types of breast-feeding [2]: exclusive breast feeding (EBF), when the infants receive only breast milk, accepting the use of rehydration salts, drops, syrups, vitamins, minerals or medicines; predominant breast-feeding (PBF), when water or water-based liquids and/or fruit juices are added to that included in EBF; and complementary feeding (CF), when any solid or liquid foods, including formula and non-human milk, are added
The primary objective of this study is to evaluate the effectiveness of an educational group intervention in primary healthcare, compared to habitual practice in increasing the proportion of mother-child pairs that use EBF up to six months of age
Summary
The World Health Organization leads a global strategy to promote the initiation and maintenance of breast-feeding. Feeding newborns: The benefits of breast-feeding Breast-feeding is the natural way to feed newborns, and human milk is the best-adapted food for their nutritional needs. The World Health Organization (WHO) defines three types of breast-feeding [2]: exclusive breast feeding (EBF), when the infants receive only breast milk, accepting the use of rehydration salts, drops, syrups, vitamins, minerals or medicines; predominant breast-feeding (PBF), when water or water-based liquids and/or fruit juices are added to that included in EBF; and complementary feeding (CF), when any solid or liquid foods, including formula and non-human milk, are added. On the short-term it favours uterine involution, weight loss, decreased risk of uterine haemorrhaging, anaemia, hypertension and post-partum depression. On the longterm it acts as a protective factor against the risk of osteoporosis and breast and ovary cancer [4]
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