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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-09

Study Completion Date

2020-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breastfeeding Self Efficacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

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)

Study Groups

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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.

Group Type EXPERIMENTAL

Breastfeeding support

Intervention Type BEHAVIORAL

Breastfeeding self-efficacy enhancing through professional support

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Breastfeeding support

Breastfeeding self-efficacy enhancing through professional support

Intervention Type BEHAVIORAL

Other Intervention Names

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CRIAA Program

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes