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Effectiveness of an Educational Intervention to Maintain Exclusive Breastfeeding

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01869920
Acronym
PROLACT
Enrollment
434
Registered
2013-06-05
Start date
2015-02-28
Completion date
2017-06-30
Last updated
2017-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exclusive Breastfeeding

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

BEHAVIORALIntervention group

Education on breastfeeding

BEHAVIORALUsual care

Usual care

Sponsors

Gerencia de Atención Primaria, Madrid
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

MeasureTime frameDescription
Exclusive breastfeeding (EBF)six monthsEvaluate the presence of EBF 6 months after educational intervention.

Secondary

MeasureTime frameDescription
Type of breastfeeding and duration of EBFSix monthsEBF or not exclusive breastfeeding and duration in months
breastfeeding ceasingDuring follow-upReasons for breastfeeding ceasing

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026