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Completed

NCT Number: NCT01474096

Implementation Strategy for a Breastfeeding Guideline in Primary Care

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gerencia Atención Primaria, Madrid

Madrid, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

implementation strategy of Breastfeeding

Other

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

Other names: breastfeeding, clinical practice guideline, primary health care

Primary outcomes

  1. proportion of patients with breastfeeding completed at 6 months

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Gerencia de Atención Primaria, Madrid

Other Gov

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 18, 2011
Registry last updated
Apr 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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