Effectiveness of an Educational Intervention to Maintain Exclusive Breastfeeding

Not Applicable

Completed

• Conditions: Exclusive Breastfeeding
• Interventions: Behavioral: Intervention group; Behavioral: Usual care

• Registration Number: NCT01869920
• Lead Sponsor: Gerencia de Atención Primaria, Madrid

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.

Study Timeline

• Study First Submitted: 2013-06-03
• Study First Submitted QC: 2013-06-04
• Study First Posted: 2013-06-05
• Study Start: 2015-02
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-21
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 434

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	Intervention group	Intervention group receive a training education on breastfeeding. Education training is provided by an expert group from General Direction of Primary Care
Controll group	Usual care	Usual care

Primary Outcome Measures

Name	Time	Method
Exclusive breastfeeding (EBF)	six months	Evaluate the presence of EBF 6 months after educational intervention.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Gerencia de Atencion Primaria; 🇪🇸 Madrid, Spain