- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03944642
Design and Piloting of a Complex Intervention to Support Breastfeeding Self-efficacy (CRIAA Program) (CRIAA)
January 25, 2021 updated by: Camila Lucchini, Pontificia Universidad Catolica de Chile
Breastfeeding as a Health-promoting Behavior: Design and Piloting of a Complex Intervention to Support Breastfeeding Self-efficacy: CRIAA Program
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Santiago, Chile, 7820436
- Escuela de Enfermeria Pontificia Universidad Catolica de Chile
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Santiago, Chile, 8181297
- Centro de Salud Familiar ANCORA San Alberto Hurtado
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Santiago, Chile, 8831695
- Centro de Salud Familiar ANCORA Juan Pablo II
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Pamplona, Spain, 31008
- Facultad de Enfermeria Universidad de Navarra
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Being in physiological pregnancy in the third trimester
- Speak Spanish
- Give informed consent
Exclusion Criteria:
- Pathology during pregnancy that entails difficulties for breastfeeding
- Multiple pregnancy
- Breastfeeding especial situations (cleft lip and palate, congenital heart disease and newborn's hospitalization)
- Preterm birth (at <37 weeks gestation)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / 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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Breastfeeding self-efficacy enhancing through professional support
Other Names:
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mothers self-efficacy: spanish validated version of Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF)
Time Frame: At five points: week 28 - 40 pregnancy (T1); and 10 days (T2); 2 months (T3); 4 months (T4); and 6 months (T5) after birth
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Changes on maternal breastfeeding self-efficacy using the Spanish validated version of Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF).
BSES-SF is a 14 item, unidimensional, self-report instrument developed to measure a mother's confidence in her ability to breastfeed.
All items are presented with a 5-point Likert-type scale where 1 indicates "not at all confident" and 5 indicates "always confident" (scores: minimum 14 and maximum 70).
Higher scores indicate higher levels of breastfeeding self-efficacy.
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At five points: week 28 - 40 pregnancy (T1); and 10 days (T2); 2 months (T3); 4 months (T4); and 6 months (T5) after birth
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Professionals self-efficacy in relation to their ability to support breastfeeding mothers: APCLA Scale (Professional Self Efficacy for Breastfeeding Care Scale)
Time Frame: At three points: before professional training (the same day that the intervention begins) (T1); 3 months (T2) and 6 months (T3) after the beginning of the intervention
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Changes on professional self-efficacy in relation to their ability to support breastfeeding mothers using the Professional Self Efficacy for Breastfeeding Care Scale (Autoeficacia Profesional para los Cuidados en Lactancia, APCLA).
APCLA scale is a 14 item, unidimensional, self-report instrument developed to measure a professional's confidence in her/his ability to support a breastfeeding mother.
All items are presented with a 5-point Likert-type scale where 1 indicates "not at all confident" and 5 indicates "always confident" (scores: minimum 14 and maximum 70).
Higher scores indicate higher levels of breastfeeding support self-efficacy.
This scale was constructed and validated in Spanish based on the Spanish version of BSES-SF
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At three points: before professional training (the same day that the intervention begins) (T1); 3 months (T2) and 6 months (T3) after the beginning of the intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of participants mothers/mothers invited to participate (Feasibility)
Time Frame: Baseline
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Proportion of participants mothers/mothers invited to participate to measure the recruitment process of the CRIAA program
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Baseline
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Duration in minutes of the breastfeeding workshop (Feasibility)
Time Frame: Baseline
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Duration in minutes of the breastfeeding workshop (scheduled time v/s time used) to measure the implementation of the CRIAA program
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Baseline
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Participants recruitment. Participants that complete the intervention/total of participants recruited (Feasibility)
Time Frame: At two times: Baseline (T1) and at the end of the intervention at 6 moths of age of the child (T2)
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Participants that complete the CRIAA Program/total of participants recruited to measure participant's retention of the CRIAA program
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At two times: Baseline (T1) and at the end of the intervention at 6 moths of age of the child (T2)
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Acceptability of the intervention by mothers
Time Frame: At six months of age of the child, when intervention is over
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Explored by semi-structured interviews, without using any scale.
The script of the interviews will contain questions about positive and negative aspects of the program perceived by participant mothers
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At six months of age of the child, when intervention is over
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Acceptability of the intervention by professionals
Time Frame: At two times: Three months post intervention begins by semi-structured interviews (T1) and when study is over, an average of 10 months, by a focus group (T2)
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Explored by semi-structured interviews and focus group with professionals
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At two times: Three months post intervention begins by semi-structured interviews (T1) and when study is over, an average of 10 months, by a focus group (T2)
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Acceptability of participation in decision making by mothers and their partner/relative
Time Frame: At five points: week 28 - 40 pregnancy (T1); and 10 days (T2); 2 months (T3); 4 months (T4); and 6 months (T5) after birth
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Changes on perceived participation in decision making related to the child's type of feeding, using the Spanish validated version of CollaboRate.
It is a short and self-applying generic instrument that allows measuring user participation in a particular health decision (Cronbach's alpha> 0.89).
It consists of three questions with alternative answers with a likert scale of 1 to 7. In this project, both the mothers and the partner /relative will be asked about their participation in the decision to feed the child.
The version that will be used is validated in Chilean population (CollaboRate Chile)
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At five points: week 28 - 40 pregnancy (T1); and 10 days (T2); 2 months (T3); 4 months (T4); and 6 months (T5) after birth
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Breastfeeding percentage
Time Frame: At four times: 10 days (T1), 2 months (T2), 4 months (T3), and 6 months (T4)
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Percentage of children with exclusive breastfeeding
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At four times: 10 days (T1), 2 months (T2), 4 months (T3), and 6 months (T4)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Camila Lucchini-Raies, MSc,BSc,RN, Profesor Asociado Escuela de Enfermería Pontificia Universidad Católica de Chile
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 9, 2019
Primary Completion (ACTUAL)
November 30, 2020
Study Completion (ACTUAL)
November 30, 2020
Study Registration Dates
First Submitted
May 3, 2019
First Submitted That Met QC Criteria
May 8, 2019
First Posted (ACTUAL)
May 9, 2019
Study Record Updates
Last Update Posted (ACTUAL)
January 27, 2021
Last Update Submitted That Met QC Criteria
January 25, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- PIEM04-19
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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