Effectiveness of an Educational Intervention to Maintain Exclusive Breastfeeding

Study Overview
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Brief Summary
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Hypothesis: An educational intervention increases the proportion of mother-infant pairs using exclusive breastfeeding

Detailed Description
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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.

Official Title
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Effectiveness of an Educational Group Intervention in Primary Care to Maintain Exclusive Breastfeeding. Cluster Randomised Clinical Trial. PROLACT Study.

Conditions
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Exclusive Breastfeeding

Intervention / Treatment
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* Behavioral: Intervention group
* Behavioral: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>Intervention group receive a training education on breastfeeding. Education training is provided by an expert group from General Direction of Primary Care | Behavioral: Intervention group<br>* Education on breastfeeding<br>|
| Other: Controll group<br>Usual care | Behavioral: Usual care<br>* Usual care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exclusive breastfeeding (EBF) | Evaluate the presence of EBF 6 months after educational intervention. | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of breastfeeding and duration of EBF | EBF or not exclusive breastfeeding and duration in months | Six months | 
| breastfeeding ceasing | Reasons for breastfeeding ceasing | During follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breastfeeding, education, intervention