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Clinical Trials/NCT03944642
NCT03944642
Completed
Not Applicable

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

Pontificia Universidad Catolica de Chile4 sites in 2 countries44 target enrollmentAugust 9, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breastfeeding
Sponsor
Pontificia Universidad Catolica de Chile
Enrollment
44
Locations
4
Primary Endpoint
Mothers self-efficacy: spanish validated version of Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF)
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 9, 2019
End Date
November 30, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Camila Lucchini

Associate Professor

Pontificia Universidad Catolica de Chile

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)

Outcomes

Primary Outcomes

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

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.

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

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

Secondary Outcomes

  • Proportion of participants mothers/mothers invited to participate (Feasibility)(Baseline)
  • Acceptability of participation in decision making by mothers and their partner/relative(At five points: week 28 - 40 pregnancy (T1); and 10 days (T2); 2 months (T3); 4 months (T4); and 6 months (T5) after birth)
  • Participants recruitment. Participants that complete the intervention/total of participants recruited (Feasibility)(At two times: Baseline (T1) and at the end of the intervention at 6 moths of age of the child (T2))
  • Acceptability of the intervention by mothers(At six months of age of the child, when intervention is over)
  • Duration in minutes of the breastfeeding workshop (Feasibility)(Baseline)
  • Acceptability of the intervention by 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))

Study Sites (4)

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