Design and Piloting of a Complex Intervention to Support Breastfeeding Self-efficacy (CRIAA Program)

Breastfeeding Clinical Trial

— CRIAA  

Official title:

Breastfeeding as a Health-promoting Behavior: Design and Piloting of a Complex Intervention to Support Breastfeeding Self-efficacy: CRIAA Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03944642
• Other study ID #: PIEM04-19
• Status: Completed
• Phase: N/A
• Start date: August 9, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: January 2021
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breastfeeding
• Self Efficacy

Intervention

Behavioral:
• Breastfeeding support
Breastfeeding self-efficacy enhancing through professional support

Locations

Country	Name	City	State
Chile	Centro de Salud Familiar ANCORA Juan Pablo II	Santiago
Chile	Centro de Salud Familiar ANCORA San Alberto Hurtado	Santiago
Chile	Escuela de Enfermeria Pontificia Universidad Catolica de Chile	Santiago
Spain	Facultad de Enfermeria Universidad de Navarra	Pamplona

Sponsors (2)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile	University of Navarra

Countries where clinical trial is conducted

Chile,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Breastfeeding percentage	Percentage of children with exclusive breastfeeding	At four times: 10 days (T1), 2 months (T2), 4 months (T3), and 6 months (T4)
Primary	Mothers self-efficacy: spanish validated version of Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF)	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.	At five points: week 28 - 40 pregnancy (T1); and 10 days (T2); 2 months (T3); 4 months (T4); and 6 months (T5) after birth
Primary	Professionals self-efficacy in relation to their ability to support breastfeeding mothers: APCLA Scale (Professional Self Efficacy for Breastfeeding Care Scale)	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	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
Secondary	Proportion of participants mothers/mothers invited to participate (Feasibility)	Proportion of participants mothers/mothers invited to participate to measure the recruitment process of the CRIAA program	Baseline
Secondary	Duration in minutes of the breastfeeding workshop (Feasibility)	Duration in minutes of the breastfeeding workshop (scheduled time v/s time used) to measure the implementation of the CRIAA program	Baseline
Secondary	Participants recruitment. Participants that complete the intervention/total of participants recruited (Feasibility)	Participants that complete the CRIAA Program/total of participants recruited to measure participant's retention of the CRIAA program	At two times: Baseline (T1) and at the end of the intervention at 6 moths of age of the child (T2)
Secondary	Acceptability of the intervention by mothers	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	At six months of age of the child, when intervention is over
Secondary	Acceptability of the intervention by professionals	Explored by semi-structured interviews and focus group with professionals	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)
Secondary	Acceptability of participation in decision making by mothers and their partner/relative	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)	At five points: week 28 - 40 pregnancy (T1); and 10 days (T2); 2 months (T3); 4 months (T4); and 6 months (T5) after birth