Effectiveness of an Educational Intervention to Maintain Exclusive Breastfeeding

Exclusive Breastfeeding Clinical Trial

— PROLACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01869920
• Other study ID #: PI12/02609_PI12/02020
• Status: Completed
• Phase: N/A
• First received: June 3, 2013
• Last updated: August 21, 2017
• Start date: February 2015
• Est. completion date: June 2017

Study information

• Verified date: August 2017
• Source: Gerencia de Atención Primaria, Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 434
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Exclusive Breastfeeding

Intervention

Behavioral:
• Intervention group
Education on breastfeeding
• Usual care
Usual care

Locations

Country	Name	City	State
Spain	Gerencia de Atencion Primaria	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Gerencia de Atención Primaria, Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exclusive breastfeeding (EBF)	Evaluate the presence of EBF 6 months after educational intervention.	six months
Secondary	Type of breastfeeding and duration of EBF	EBF or not exclusive breastfeeding and duration in months	Six months
Secondary	breastfeeding ceasing	Reasons for breastfeeding ceasing	During follow-up