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

NCT03944642 | Completed

• 1 other identifier: PIEM04-19
• Study Type: interventional
• Target: 44
• Locations: 2 countries
• Sites: 4

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.

Conditions

Breastfeeding; Self Efficacy

Keywords

Complex Intervention; Pilot Study; Breastfeeding Support

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Proportion of participants mothers/mothers invited to participate (Feasibility)

  Baseline

• Duration in minutes of the breastfeeding workshop (Feasibility)

  Baseline

• 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

• 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)

Other Outcomes (1)

• Breastfeeding percentage

  At four times: 10 days (T1), 2 months (T2), 4 months (T3), and 6 months (T4)

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Breastfeeding support

Standard Care

NO INTERVENTION

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.

Interventions

Breastfeeding support BEHAVIORAL

Breastfeeding self-efficacy enhancing through professional support

Also known as: CRIAA Program

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being in physiological pregnancy in the third trimester
• Speak Spanish
• Give informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead
• University of Navarra: collaborator

Study Sites (4)

Escuela de Enfermeria Pontificia Universidad Catolica de Chile

Santiago, 7820436, Chile

Location

Centro de Salud Familiar ANCORA San Alberto Hurtado

Santiago, 8181297, Chile

Location

Centro de Salud Familiar ANCORA Juan Pablo II

Santiago, 8831695, Chile

Location

Facultad de Enfermeria Universidad de Navarra

Pamplona, 31008, Spain

Location

Related Publications (2)

• Lucchini-Raies C, Marquez-Doren F, Perez JC, Campos S, Beca P, Lopez-Dicastillo O. A complex intervention to support breastfeeding: A feasibility and acceptability study. Int J Nurs Pract. 2023 Dec;29(6):e13184. doi: 10.1111/ijn.13184. Epub 2023 Jul 18.

  PMID: 37461904 DERIVED

• 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.

  PMID: 33058232 DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Camila Lucchini-Raies, MSc,BSc,RN

  Profesor Asociado Escuela de Enfermeria Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 9, 2019
• Study Start: August 9, 2019
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

ES (1); CL (3)