Implementation Strategy for a Breastfeeding Guideline in Primary Care
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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 |
- 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:
|
| 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 |
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| Spain | |
| Gerencia Atención Primaria, Madrid | |
| Madrid, Spain | |
| 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 June 18, 2013