Implementation Strategy for a Breastfeeding Guideline in Primary Care

April 8, 2015 updated by: Susana Martín Iglesias, Gerencia de Atención Primaria, Madrid

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

208

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain
        • Gerencia Atención Primaria, Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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
No Intervention: Conventional intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gerencia de Atención Primaria, Madrid

Investigators

  • Principal Investigator: Susana Martin, Nurse, Gerencia Atención Primaria. Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

November 4, 2011

First Submitted That Met QC Criteria

November 17, 2011

First Posted (Estimate)

November 18, 2011

Study Record Updates

Last Update Posted (Estimate)

April 9, 2015

Last Update Submitted That Met QC Criteria

April 8, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 08/90680

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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