Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2026-02-20 @ 3:33 PM
Study NCT ID:
NCT01869920
Status:
COMPLETED
Last Update Posted:
2017-08-22
First Post:
2013-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of an Educational Intervention to Maintain Exclusive Breastfeeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 434}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-21', 'studyFirstSubmitDate': '2013-06-03', 'studyFirstSubmitQcDate': '2013-06-04', 'lastUpdatePostDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exclusive breastfeeding (EBF)', 'timeFrame': 'six months', 'description': 'Evaluate the presence of EBF 6 months after educational intervention.'}], 'secondaryOutcomes': [{'measure': 'Type of breastfeeding and duration of EBF', 'timeFrame': 'Six months', 'description': 'EBF or not exclusive breastfeeding and duration in months'}, {'measure': 'breastfeeding ceasing', 'timeFrame': 'During follow-up', 'description': 'Reasons for breastfeeding ceasing'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['breastfeeding', 'education', 'intervention'], 'conditions': ['Exclusive Breastfeeding']}, 'referencesModule': {'references': [{'pmid': '35172775', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '29482516', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Hypothesis: An educational intervention increases the proportion of mother-infant pairs using exclusive breastfeeding', 'detailedDescription': 'Objective: Evaluate the effectiveness of an educational group intervention performed by primary healthcare professionals in terms of increasing the proportion of mother-infant pairs using exclusive breastfeeding at six months compared to routine practice. Design: cluster randomized trial. Setting: Multicentre. Primary Care Health Centres (PCHC). Madrid. Subjects: mother-infant pairs using exclusive breastfeeding who come for any query to the health centre, as long as the infant is not older than four weeks and who consent to participate in the study.\n\nSample size: N= 432 (216 in each arm). Randomisation: Unit of randomization: primary healthcare centres.\n\nAnalysis unit: mother-infant pairs, recruitment to consecutive sampling. Intervention: Educational group intervention in the treatment group and the usual intervention in the control group.\n\nVariables: 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.\n\nData 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female 18 years old or older,\n* mother-infant pairs using exclusive breastfeeding,\n* Signed Informed Consent\n\nExclusion Criteria:\n\n* Any medical conditions that prevents breastfeeding\n* infant should be not older than four weeks'}, 'identificationModule': {'nctId': 'NCT01869920', 'acronym': 'PROLACT', 'briefTitle': 'Effectiveness of an Educational Intervention to Maintain Exclusive Breastfeeding', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Gerencia de Atención Primaria, Madrid'}, 'officialTitle': 'Effectiveness of an Educational Group Intervention in Primary Care to Maintain Exclusive Breastfeeding. Cluster Randomised Clinical Trial. PROLACT Study.', 'orgStudyIdInfo': {'id': 'PI12/02609_PI12/02020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention group', 'description': 'Intervention group receive a training education on breastfeeding. Education training is provided by an expert group from General Direction of Primary Care', 'interventionNames': ['Behavioral: Intervention group']}, {'type': 'OTHER', 'label': 'Controll group', 'description': 'Usual care', 'interventionNames': ['Behavioral: Usual care']}], 'interventions': [{'name': 'Intervention group', 'type': 'BEHAVIORAL', 'description': 'Education on breastfeeding', 'armGroupLabels': ['intervention group']}, {'name': 'Usual care', 'type': 'BEHAVIORAL', 'description': 'Usual care', 'armGroupLabels': ['Controll group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Madrid', 'country': 'Spain', 'facility': 'Gerencia de Atencion Primaria', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'María J Santamaría, Nurse', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gerencia de Atención Primaria, Madrid'}, {'name': 'Susana Martín, Nurse', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gerencia de Atención Primaria, Madrid'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gerencia de Atención Primaria, Madrid', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nurse', 'investigatorFullName': 'Susana Martín Iglesias', 'investigatorAffiliation': 'Gerencia de Atención Primaria, Madrid'}}}}