Effectiveness of an Educational Intervention to Maintain Exclusive Breastfeeding
NCT ID: NCT01869920
Last Updated: 2017-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
434 participants
INTERVENTIONAL
2015-02-28
2017-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Implementation Strategy for a Breastfeeding Guideline in Primary Care
NCT01474096
Effectiveness of a Counseling Program on Exclusive Breastfeeding Rates in a Primary Care Center
NCT07309510
Efficacy of an Educational Intervention in Exclusive Breastfeeding
NCT04655846
Synergy, Self-efficacy, Breastfeeding and Care (SInergia, Autoeficacia, Lactancia y Cuidados)
NCT03019484
Antenatal Educational Intervention for Improvement of Breastfeeding
NCT00270192
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Sample size: N= 432 (216 in each arm). Randomisation: Unit of randomization: primary healthcare centres.
Analysis unit: mother-infant pairs, recruitment to consecutive sampling. Intervention: Educational group intervention in the treatment group and the usual intervention in the control group.
Variables: Main response variable: mother-infant pairs using exclusive breastfeeding (EBF) at six months. Secondary variables: type of breastfeeding at 6 months, duration of EBF, reasons for ceasing breastfeeding, satisfaction with the intervention (SERVQUAL). Prognostic variables: infant, mother and professional.
Data Analysis: Analysis of main effectiveness by intention to treat, comparing the proportion of mother-infant pairs using EBF at six months in both groups. The estimation adjusted using an explanatory logistics regression model. To assess the effect of the educational group intervention on the duration of the various type of breastfeeding, a survival analysis will be used comparing the two groups using the log-rank test. The control of potential confounding variables will be performed by the construction of various Cox regression models.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
intervention group
Intervention group receive a training education on breastfeeding. Education training is provided by an expert group from General Direction of Primary Care
Intervention group
Education on breastfeeding
Controll group
Usual care
Usual care
Usual care
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Intervention group
Education on breastfeeding
Usual care
Usual care
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* mother-infant pairs using exclusive breastfeeding,
* Signed Informed Consent
Exclusion Criteria
* infant should be not older than four weeks
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gerencia de Atención Primaria, Madrid
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Susana Martín Iglesias
Nurse
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
María J Santamaría, Nurse
Role: PRINCIPAL_INVESTIGATOR
Gerencia de Atención Primaria, Madrid
Susana Martín, Nurse
Role: PRINCIPAL_INVESTIGATOR
Gerencia de Atención Primaria, Madrid
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Gerencia de Atencion Primaria
Madrid, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Santamaria-Martin MJ, Martin-Iglesias S, Schwarz C, Rico-Blazquez M, Portocarrero-Nunez JA, Diez-Izquierdo L, Llamosas-Falcon L, Rodriguez-Barrientos R, Del-Cura-Gonzalez I; Grupo PROLACT. Effectiveness of a group educational intervention - prolact - in primary care to promote exclusive breastfeeding: a cluster randomized clinical trial. BMC Pregnancy Childbirth. 2022 Feb 16;22(1):132. doi: 10.1186/s12884-022-04394-8.
Martin-Iglesias S, Santamaria-Martin MJ, Alonso-Alvarez A, Rico-Blazquez M, Del Cura-Gonzalez I, Rodriguez-Barrientosn R, Barbera-Martin A, Sanz-Cuesta T, Isabel Coghen-Vigueras M, de Antonio-Ramirez I, Durand-Rincon I, Garrido-Rodriguez F, Geijo-Rincon MJ, Mielgo-Salvador R, Morales-Montalva MS, Reviriego-Gutierrez MA, Rivero-Garrido C, Ruiz-Calabria M, Santamaria-Mechano MP, Santiago-Fernandez R, Sillero-Quintana MI, Soto-Almendro B, Terol-Claramonte M, Villa-Arranz M. Effectiveness of an educational group intervention in primary healthcare for continued exclusive breast-feeding: PROLACT study. BMC Pregnancy Childbirth. 2018 Feb 26;18(1):59. doi: 10.1186/s12884-018-1679-3.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PI12/02609_PI12/02020
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.