Open Access Study protocol

Effectiveness of an implementation strategy for a breastfeeding guideline in Primary Care: cluster randomised trial

Susana Martín-Iglesias1*, Isabel del-Cura-González2, Teresa Sanz-Cuesta2, Celina Arana-Cañedo_Argüelles3, Mercedes Rumayor-Zarzuelo4, Marta Álvarez-de la Riva5, Ana M Lloret-Sáez_Bravo6, Rosa M Férnandez-Arroyo7, José L Aréjula-Torres8, Óscar Aguado-Arroyo9, Francisco Góngora-Maldonado10, Manuela García-Corraliza11, Nazareth Sandoval-Encinas12, Margarita Tomico-delRío12 and Ana M Cornejo-Gutiérrez13

Author Affiliations

1 Dirección Asistencial Sur Atención Primaria, Servicio Madrileño de Salud, (Avenida Juan de la Cierva, s/n), Getafe, (28902). Spain

2 Unidad de Apoyo a la Investigación Gerencia Atención Primaria, Servicio Madrileño de Salud, (Calle Espronceda, 24), Madrid, (28003), Spain

3 Centro de Salud Mª Ángeles López Gómez, Servicio Madrileño de Salud, (Calle María Ángeles López Gómez, 2), Leganés, (28915), Spain

4 Hospital Clínico San Carlos, Servicio Madrileño de Salud, (Calle Profesor Martín Lagos, s/n), Madrid, (28040), Spain

5 Centro de Salud Mendiguchía Carriche, Servicio Madrileño de Salud, (Plaza Comunidad de Madrid, s/n), Leganés, (28914), Spain

6 Centro de Salud Huerta de los Frailes, Servicio Madrileño de Salud, (Avenida de los Pinos, 30), Leganés, (28914), Spain

7 Centro de Salud Jaime Vera, Servicio Madrileño de Salud, (Avenida Europa, 1), Leganés, (28915), Spain

8 Dirección Técnica de Sistemas de Información Gerencia Atención Primaria, Servicio Madrileño de Salud, (Calle O'Donnell, 55), Madrid, (28009), Spain

9 Centro de Salud Francia, Servicio Madrileño de Salud, (Calle Francia, 38), Fuenlabrada, (28943), Spain

10 Consultorio Local Moraleja de Enmedio, Servicio Madrileño de Salud, (Calle La Fuente, s/n), Moraleja de En medio, (28950), Spain

11 Centro de Salud Alicante, Servicio Madrileño de Salud, (Calle Alicante, s/n), Fuenlabrada, (28945), Spain

12 Centro de Salud Humanes, Servicio Madrileño de Salud, (Calle Ferrocarril, s/n), Humanes, (28970), Spain

13 Hospital Universitario Ramón y Cajal, Servicio Madrileño de Salud, (Carretera de Colmenar Viejo, km. 9,100), Madrid, (28034), Spain

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BMC Family Practice 2011, 12:144  doi:10.1186/1471-2296-12-144

Published: 30 December 2011



The protection and promotion of breastfeeding is considered a priority in Europe where only 22% of infants less than 6 months old are exclusively breastfed. In Spain this percentage reaches 24.8% but in our city it falls to 18.26%. Various studies emphasise that the improvement of these results should be based upon the training of health professionals. Following the recommendations of a breastfeeding guide can modify the practice of health professionals and improve results with respect to exclusively or predominatly breastfed children at 6 months of age.


This study involves a community based cluster randomized trial in primary healthcare centres in Leganés (Madrid, Spain). The project aims to determine whether the use of an implementation strategy (including training session, information distribution, opinion leader) of a breastfeeding guideline in primary care is more effective than usual diffusion.

The number of patients required will be 240 (120 in each arm). It will be included all the mothers of infants born during the study period (6 months) who come to the health centre on the first visit of the child care programme and who give their consent to participate. The main outcome variable is the exclusive o predominant breastfeeding at 6 moths of age..

Main effectiveness will be analyzed by comparing the percentage of infants with exclusive or predominant breastfeeding at 6 months between the intervention group and the control group. All statistical tests will be performed with intention to treat. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis.


Strategies need to be found which facilitate the giving of effective advice on breastfeeding by professionals and which provide support to women during the breastfeeding period. By applying the guide's recommendations, clinical variability can be reduced and the care received by patients can be improved.

Trial registration

The trial was registered with, number NCT01474096