Implementation Strategy for a Breastfeeding Guideline in Primary Care

Breastfeeding Clinical Trial

Official title:

Effectiveness of Implementation Strategy for a Breastfeeding Guideline in Primary Care: Cluster Randomised Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01474096
• Other study ID #: 08/90680
• Status: Completed
• Phase: N/A
• First received: November 4, 2011
• Last updated: April 8, 2015
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: April 2015
• Source: Gerencia de Atención Primaria, Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breastfeeding

Intervention

Other:
• implementation strategy of Breastfeeding
implementation strategy (including training session, information distribution, an opinion leader) of Breastfeeding

Locations

Country	Name	City	State
Spain	Gerencia Atención Primaria, Madrid	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	proportion of patients with breastfeeding completed at 6 months	Analysis of main effectiveness will be done, comparing the proportion of patients with breastfeeding completed at 6 months in the two study groups	6 months	No