Clinical trial NCT01869920: Effectiveness of an Educational Intervention to Maintain Exclusive Breastfeeding
Official title: Effectiveness of an Educational Group Intervention in Primary Care to Maintain Exclusive Breastfeeding. Cluster Randomised Clinical Trial. PROLACT Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exclusive Breastfeeding
Keywords: breastfeeding
education
intervention
Lead sponsor: Gerencia de Atención Primaria, Madrid
Sponsor class: OTHER_GOV
First posted: 2013-06-05
Enrollment: 434
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Exclusive breastfeeding (EBF)
timeFrame: six months
Secondary outcomes:
measure: Type of breastfeeding and duration of EBF
timeFrame: Six months
measure: breastfeeding ceasing
timeFrame: During follow-up
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Gerencia de Atencion Primaria
Study officials:
affiliation: Gerencia de Atención Primaria, Madrid
name: María J Santamaría, Nurse
role: PRINCIPAL_INVESTIGATOR
affiliation: Gerencia de Atención Primaria, Madrid
name: Susana Martín, Nurse
role: PRINCIPAL_INVESTIGATOR
References:
citation: Santamaria-Martin MJ, Martin-Iglesias S, Schwarz C, Rico-Blazquez M, Portocarrero-Nunez JA, Diez-Izquierdo L, Llamosas-Falcon L, Rodriguez-Barrientos R, Del-Cura-Gonzalez I; Grupo PROLACT. Effectiveness of a group educational intervention - prolact - in primary care to promote exclusive breastfeeding: a cluster randomized clinical trial. BMC Pregnancy Childbirth. 2022 Feb 16;22(1):132. doi: 10.1186/s12884-022-04394-8.
citation: Martin-Iglesias S, Santamaria-Martin MJ, Alonso-Alvarez A, Rico-Blazquez M, Del Cura-Gonzalez I, Rodriguez-Barrientosn R, Barbera-Martin A, Sanz-Cuesta T, Isabel Coghen-Vigueras M, de Antonio-Ramirez I, Durand-Rincon I, Garrido-Rodriguez F, Geijo-Rincon MJ, Mielgo-Salvador R, Morales-Montalva MS, Reviriego-Gutierrez MA, Rivero-Garrido C, Ruiz-Calabria M, Santamaria-Mechano MP, Santiago-Fernandez R, Sillero-Quintana MI, Soto-Almendro B, Terol-Claramonte M, Villa-Arranz M. Effectiveness of an educational group intervention in primary healthcare for continued exclusive breast-feeding: PROLACT study. BMC Pregnancy Childbirth. 2018 Feb 26;18(1):59. doi: 10.1186/s12884-018-1679-3.