Implementation Strategy for a Breastfeeding Guideline in Primary Care

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Esperanza Escortell, Gerencia de Atención Primaria, Madrid
ClinicalTrials.gov Identifier:
NCT01474096
First received: November 4, 2011
Last updated: April 3, 2013
Last verified: April 2013

November 4, 2011
April 3, 2013
January 2010
December 2012   (final data collection date for primary outcome measure)
proportion of patients with breastfeeding completed at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Analysis of main effectiveness will be done, comparing the proportion of patients with breastfeeding completed at 6 months in the two study groups
Same as current
Complete list of historical versions of study NCT01474096 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Implementation Strategy for a Breastfeeding Guideline in Primary Care
Effectiveness of Implementation Strategy for a Breastfeeding Guideline in Primary Care: Cluster Randomised Trial

The purpose of this study is to determine whether an implementation strategy for a breastfeeding guide is more effective than the usual practice (simple circulation of the guide) in terms of increasing the percentage of children receiving exclusive or preferential breastfeeding at 6 months age.

Protection and promotion of breastfeeding is considered a priority in Europe where only 22% of children 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 falls upon the training of health professionals. Following the recommendations of a breastfeeding guide can modify professional practice and improve results with respect to patients.

Aim:to determine whether an implementation strategy for a breastfeeding guide is more effective than the usual practice (simple circulation of the guide) in terms of increasing the percentage of children receiving exclusive or preferential breastfeeding at 6 months age.

Method/Design: The present work involves a community, clinical trial, randomised by clusters in Primary Health Care Centres in Madrid Region (Spain). The project aims at determining whether the use of implementation strategy (including training session, information distribution, an opinion leader) of Breastfeeding CPG in primary care is more effective than the usual practice of mere circulation.

Number of patients required will be 240 (n=120 in the intervention group and control group), all mothers of children born during the study period (6 months), who come to the health centre on the first visit of child attention programme and give their consent to participate.

The main outcome variable is age at which breastfeeding ceases; secondary outcome variables include sex, age, educational level.

Analysis of main effectiveness will be done, comparing the proportion of patients with breastfeeding completed at 6 months in the two study groups. 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Breastfeeding
Other: implementation strategy of Breastfeeding
implementation strategy (including training session, information distribution, an opinion leader) of Breastfeeding
Other Names:
  • breastfeeding
  • clinical practice guideline
  • primary health care
  • Experimental: implementation strategy
    determining whether the use of implementation strategy (including training session, information distribution, an opinion leader) of Breastfeeding CPG in primary care is more effective than the usual practice of mere circulation.
    Intervention: Other: implementation strategy of Breastfeeding
  • No Intervention: Conventional intervention
Martín-Iglesias S, del-Cura-González I, Sanz-Cuesta T, Arana-Cañedo Argüelles C, Rumayor-Zarzuelo M, Alvarez-de la Riva M, Lloret-Sáez Bravo AM, Férnandez-Arroyo RM, Aréjula-Torres JL, Aguado-Arroyo Ó, Góngora-Maldonado F, García-Corraliza M, Sandoval-Encinas N, Tomico-delRío M, Cornejo-Gutiérrez AM. Effectiveness of an implementation strategy for a breastfeeding guideline in Primary Care: cluster randomised trial. BMC Fam Pract. 2011 Dec 30;12:144. doi: 10.1186/1471-2296-12-144.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
208
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Mothers of children born during the study period (6 months)
  • Mothers who come to the health centre on 1st visit (child attention programme)
  • Mothers who give their consent to participate.

Exclusion Criteria:

  • Breastfeeding Contraindications
Female
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01474096
08/90680
Yes
Esperanza Escortell, Gerencia de Atención Primaria, Madrid
Gerencia de Atención Primaria, Madrid
Not Provided
Principal Investigator: Susana Martin, Nurse Gerencia Atención Primaria. Madrid
Gerencia de Atención Primaria, Madrid
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP