Condition or disease | Intervention/treatment | Phase |
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Breastfeeding Self Efficacy | Behavioral: Breastfeeding support | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 44 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Masking Description: | The allocation was done by outpatient clinic to avoid contamination bias. Participants of the outpatient clinic A will receive the CRIAA Program (intervention group) and participants of the outpatient clinic B will receive the standard care (control group) |
Primary Purpose: | Supportive Care |
Official Title: | Breastfeeding as a Health-promoting Behavior: Design and Piloting of a Complex Intervention to Support Breastfeeding Self-efficacy: CRIAA Program |
Actual Study Start Date : | August 9, 2019 |
Actual Primary Completion Date : | November 30, 2020 |
Actual Study Completion Date : | November 30, 2020 |
Arm | Intervention/treatment |
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Experimental: Intervention
Participants will receive the standard prenatal care and invited to participate of a breastfeeding workshop during the third trimester of pregnancy, with active and intentional participation of the pregnant woman and her partner/relative; based on adult education methodology. In addition, women participants will have continuous support during their breastfeeding process, up to 6 months of the child's life, through a virtual support group (whats-app), where they will receive messages that promote their self-efficacy in relation to their ability to breastfeed and may ask questions that are related to breastfeeding. Professionals in this group will be train before delivering the intervention.
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Behavioral: Breastfeeding support
Breastfeeding self-efficacy enhancing through professional support
Other Name: CRIAA Program
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No Intervention: Standard Care
This group will receive the standard pre and postnatal regular care, for mother and child. Professionals who provide direct care will maintain their usual attention.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Chile | |
Escuela de Enfermeria Pontificia Universidad Catolica de Chile | |
Santiago, Chile, 7820436 | |
Centro de Salud Familiar ANCORA San Alberto Hurtado | |
Santiago, Chile, 8181297 | |
Centro de Salud Familiar ANCORA Juan Pablo II | |
Santiago, Chile, 8831695 | |
Spain | |
Facultad de Enfermeria Universidad de Navarra | |
Pamplona, Spain, 31008 |
Principal Investigator: | Camila Lucchini-Raies, MSc,BSc,RN | Profesor Asociado Escuela de Enfermeria Pontificia Universidad Catolica de Chile |
Tracking Information | |||||
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First Submitted Date ICMJE | May 3, 2019 | ||||
First Posted Date ICMJE | May 9, 2019 | ||||
Last Update Posted Date | January 27, 2021 | ||||
Actual Study Start Date ICMJE | August 9, 2019 | ||||
Actual Primary Completion Date | November 30, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures |
Breastfeeding percentage [ Time Frame: At four times: 10 days (T1), 2 months (T2), 4 months (T3), and 6 months (T4) ] Percentage of children with exclusive breastfeeding
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Original Other Pre-specified Outcome Measures | Same as current | ||||
Descriptive Information | |||||
Brief Title ICMJE | Design and Piloting of a Complex Intervention to Support Breastfeeding Self-efficacy (CRIAA Program) | ||||
Official Title ICMJE | Breastfeeding as a Health-promoting Behavior: Design and Piloting of a Complex Intervention to Support Breastfeeding Self-efficacy: CRIAA Program | ||||
Brief Summary | The aim of the study is to design and pilot the effect of a complex intervention to support mothers' breastfeeding self-efficacy and professional self-efficacy to support breastfeeding families, considering breastfeeding as a health promoting behavior. Specific objectives are the evaluation of feasibility and acceptability of the intervention, and estimate the preliminary effect on maternal and professional self-efficacy. | ||||
Detailed Description | Breastfeeding is the optimal feeding during early childhood. However, the prevalence of exclusive breastfeeding is not as expected. The evidence of effectiveness of interventions designed to support breastfeeding is not conclusive. Breastfeeding is a complex experience, influenced by numerous factors, as self-efficacy, that require interdisciplinary approaches.The aim of the study is to design and pilot the effect of a complex intervention to support mothers' breastfeeding self-efficacy and professional self-efficacy to support breastfeeding families, considering breastfeeding as a health promoting behavior. The project will be done in two stages a) design of the intervention and b) experimental pilot trial with control and intervention groups, for evaluation of feasibility, acceptability of the intervention and preliminary estimate of its effect on maternal and professional self-efficacy. The project will be carry out in two public outpatient clinics (Centro de Salud Familiar Alberto Hurtado y Centro de Salud Familiar Juan Pablo II) in Santiago, Chile. Participants will be breastfeeding women and their partner/family member; and health professionals who provide care to mother and child. Intervention group will receive a breastfeeding workshop during the third trimester of pregnancy and on-line breastfeeding support during the first 6 months postpartum. Health professionals will be train to deliver the intervention.Control group will receive the standard care as provided in the outpatient clinic. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Masking Description: The allocation was done by outpatient clinic to avoid contamination bias. Participants of the outpatient clinic A will receive the CRIAA Program (intervention group) and participants of the outpatient clinic B will receive the standard care (control group) Primary Purpose: Supportive Care
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Condition ICMJE |
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Intervention ICMJE | Behavioral: Breastfeeding support
Breastfeeding self-efficacy enhancing through professional support
Other Name: CRIAA Program
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Study Arms ICMJE |
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Publications * | Lucchini-Raies C, Marquez-Doren F, Beca P, Perez JC, Campos S, Lopez-Dicastillo O. The CRIAA Program complex intervention in primary care to support women and their families in breastfeeding: Study protocol for a pilot trial. J Adv Nurs. 2020 Dec;76(12):3641-3653. doi: 10.1111/jan.14534. Epub 2020 Oct 15. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
44 | ||||
Original Estimated Enrollment ICMJE |
40 | ||||
Actual Study Completion Date ICMJE | November 30, 2020 | ||||
Actual Primary Completion Date | November 30, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Chile, Spain | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03944642 | ||||
Other Study ID Numbers ICMJE | PIEM04-19 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Camila Lucchini, Pontificia Universidad Catolica de Chile | ||||
Study Sponsor ICMJE | Pontificia Universidad Catolica de Chile | ||||
Collaborators ICMJE | University of Navarra | ||||
Investigators ICMJE |
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PRS Account | Pontificia Universidad Catolica de Chile | ||||
Verification Date | January 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |