Exclusive Breastfeeding
Conditions
Keywords
breastfeeding, education, intervention
Brief summary
Hypothesis: An educational intervention increases the proportion of mother-infant pairs using exclusive breastfeeding
Detailed description
Objective: Evaluate the effectiveness of an educational group intervention performed by primary healthcare professionals in terms of increasing the proportion of mother-infant pairs using exclusive breastfeeding at six months compared to routine practice. Design: cluster randomized trial. Setting: Multicentre. Primary Care Health Centres (PCHC). Madrid. Subjects: mother-infant pairs using exclusive breastfeeding who come for any query to the health centre, as long as the infant is not older than four weeks and who consent to participate in the study. Sample size: N= 432 (216 in each arm). Randomisation: Unit of randomization: primary healthcare centres. Analysis unit: mother-infant pairs, recruitment to consecutive sampling. Intervention: Educational group intervention in the treatment group and the usual intervention in the control group. Variables: Main response variable: mother-infant pairs using exclusive breastfeeding (EBF) at six months. Secondary variables: type of breastfeeding at 6 months, duration of EBF, reasons for ceasing breastfeeding, satisfaction with the intervention (SERVQUAL). Prognostic variables: infant, mother and professional. Data Analysis: Analysis of main effectiveness by intention to treat, comparing the proportion of mother-infant pairs using EBF at six months in both groups. The estimation adjusted using an explanatory logistics regression model. To assess the effect of the educational group intervention on the duration of the various type of breastfeeding, a survival analysis will be used comparing the two groups using the log-rank test. The control of potential confounding variables will be performed by the construction of various Cox regression models.
Interventions
Education on breastfeeding
Usual care
Sponsors
Study design
Eligibility
Inclusion criteria
* Female 18 years old or older, * mother-infant pairs using exclusive breastfeeding, * Signed Informed Consent
Exclusion criteria
* Any medical conditions that prevents breastfeeding * infant should be not older than four weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exclusive breastfeeding (EBF) | six months | Evaluate the presence of EBF 6 months after educational intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Type of breastfeeding and duration of EBF | Six months | EBF or not exclusive breastfeeding and duration in months |
| breastfeeding ceasing | During follow-up | Reasons for breastfeeding ceasing |
Countries
Spain