Clinical trial NCT03944642: Design and Piloting of a Complex Intervention to Support Breastfeeding Self-efficacy (CRIAA Program)
Official title: Breastfeeding as a Health-promoting Behavior: Design and Piloting of a Complex Intervention to Support Breastfeeding Self-efficacy: CRIAA Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Self Efficacy
Keywords: Complex Intervention
Pilot Study
Breastfeeding Support
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
Collaborators: name: University of Navarra
First posted: 2019-05-09
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Mothers self-efficacy: spanish validated version of Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF)
timeFrame: At five points: week 28 - 40 pregnancy (T1); and 10 days (T2); 2 months (T3); 4 months (T4); and 6 months (T5) after birth
measure: Professionals self-efficacy in relation to their ability to support breastfeeding mothers: APCLA Scale (Professional Self Efficacy for Breastfeeding Care Scale)
timeFrame: 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 outcomes:
measure: Proportion of participants mothers/mothers invited to participate (Feasibility)
timeFrame: Baseline
measure: Duration in minutes of the breastfeeding workshop (Feasibility)
timeFrame: Baseline
measure: Participants recruitment. Participants that complete the intervention/total of participants recruited (Feasibility)
timeFrame: At two times: Baseline (T1) and at the end of the intervention at 6 moths of age of the child (T2)
measure: Acceptability of the intervention by mothers
timeFrame: At six months of age of the child, when intervention is over
measure: Acceptability of the intervention by professionals
timeFrame: 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)
measure: Acceptability of participation in decision making by mothers and their partner/relative
timeFrame: At five points: week 28 - 40 pregnancy (T1); and 10 days (T2); 2 months (T3); 4 months (T4); and 6 months (T5) after birth
Other outcomes:
measure: Breastfeeding percentage
timeFrame: At four times: 10 days (T1), 2 months (T2), 4 months (T3), and 6 months (T4)
Locations:
city: Santiago
country: Chile
facility: Escuela de Enfermeria Pontificia Universidad Catolica de Chile
city: Santiago
country: Chile
facility: Centro de Salud Familiar ANCORA San Alberto Hurtado
city: Santiago
country: Chile
facility: Centro de Salud Familiar ANCORA Juan Pablo II
city: Pamplona
country: Spain
facility: Facultad de Enfermeria Universidad de Navarra
Study officials:
affiliation: Profesor Asociado Escuela de Enfermeria Pontificia Universidad Catolica de Chile
name: Camila Lucchini-Raies, MSc,BSc,RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.