Implementation Strategy for a Breastfeeding Guideline in Primary Care

Not Applicable

Completed

• Conditions: Breastfeeding
• Interventions: Other: implementation strategy of Breastfeeding

• Registration Number: NCT01474096
• Lead Sponsor: Gerencia de Atención Primaria, Madrid

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2011-11-04
• Study First Submitted QC: 2011-11-17
• Study First Posted: 2011-11-18
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-08
• Last Update Posted: 2015-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 208

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
implementation strategy	implementation strategy of Breastfeeding	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.

Primary Outcome Measures

Name	Time	Method
proportion of patients with breastfeeding completed at 6 months	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

Trial Locations

Locations (1)

Gerencia Atención Primaria, Madrid; 🇪🇸 Madrid, Spain