NCT01474096

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 18, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 9, 2015

Status Verified

April 1, 2015

Enrollment Period

2.9 years

First QC Date

November 4, 2011

Last Update Submit

April 8, 2015

Conditions

Keywords

clinical practice guideline-primary health care

Outcome Measures

Primary Outcomes (1)

  • proportion of patients with breastfeeding completed at 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

Study Arms (2)

implementation strategy

EXPERIMENTAL

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

Conventional intervention

NO INTERVENTION

Interventions

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

Also known as: breastfeeding, clinical practice guideline, primary health care
implementation strategy

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Breastfeeding Contraindications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gerencia Atención Primaria, Madrid

Madrid, Madrid, Spain

Location

Related Publications (2)

  • Gavine A, Shinwell SC, Buchanan P, Farre A, Wade A, Lynn F, Marshall J, Cumming SE, Dare S, McFadden A. Support for healthy breastfeeding mothers with healthy term babies. Cochrane Database Syst Rev. 2022 Oct 25;10(10):CD001141. doi: 10.1002/14651858.CD001141.pub6.

  • Martin-Iglesias S, del-Cura-Gonzalez I, Sanz-Cuesta T, Arana-Canedo Arguelles C, Rumayor-Zarzuelo M, Alvarez-de la Riva M, Lloret-Saez Bravo AM, Fernandez-Arroyo RM, Arejula-Torres JL, Aguado-Arroyo O, Gongora-Maldonado F, Garcia-Corraliza M, Sandoval-Encinas N, Tomico-delRio M, Cornejo-Gutierrez AM. Effectiveness of an implementation strategy for a breastfeeding guideline in Primary Care: cluster randomised trial. BMC Fam Pract. 2011 Dec 30;12:144. doi: 10.1186/1471-2296-12-144.

MeSH Terms

Conditions

Breast Feeding

Interventions

LactationPrimary Health Care

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Reproductive Physiological PhenomenaReproductive and Urinary Physiological PhenomenaPostpartum PeriodComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Susana Martin, Nurse

    Gerencia Atención Primaria. Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

November 4, 2011

First Posted

November 18, 2011

Study Start

January 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

April 9, 2015

Record last verified: 2015-04

Locations