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
  Purpose

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.


Condition Intervention
Breastfeeding
Other: implementation strategy of Breastfeeding

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effectiveness of Implementation Strategy for a Breastfeeding Guideline in Primary Care: Cluster Randomised Trial

Resource links provided by NLM:


Further study details as provided by Gerencia de Atención Primaria, Madrid:

Primary Outcome Measures:
  • 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


Enrollment: 208
Study Start Date: January 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01474096

Locations
Spain
Gerencia Atención Primaria, Madrid
Madrid, Spain
Sponsors and Collaborators
Gerencia de Atención Primaria, Madrid
Investigators
Principal Investigator: Susana Martin, Nurse Gerencia Atención Primaria. Madrid
  More Information

No publications provided by Gerencia de Atención Primaria, Madrid

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Esperanza Escortell, Epidemiologist Researcher, Gerencia de Atención Primaria, Madrid
ClinicalTrials.gov Identifier: NCT01474096     History of Changes
Other Study ID Numbers: 08/90680
Study First Received: November 4, 2011
Last Updated: April 3, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Gerencia de Atención Primaria, Madrid:
clinical practice guideline-primary health care

ClinicalTrials.gov processed this record on August 26, 2014