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Completed

NCT Number: NCT03944642

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

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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Key information

Conditions

Breastfeeding Behavior Breast Feeding Feeding Behavior Self Efficacy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Salud Familiar ANCORA Juan Pablo II, Santiago, Chile

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Breastfeeding support

Behavioral

Breastfeeding self-efficacy enhancing through professional support

Other names: CRIAA Program

Primary outcomes

  1. 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.

  2. 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

  1. Proportion of participants mothers/mothers invited to participate (Feasibility)

    Time frame: Baseline

    Proportion of participants mothers/mothers invited to participate to measure the recruitment process of the CRIAA program

  2. Duration in minutes of the breastfeeding workshop (Feasibility)

    Time frame: Baseline

    Duration in minutes of the breastfeeding workshop (scheduled time v/s time used) to measure the implementation of the CRIAA program

  3. Participants recruitment. Participants that complete the intervention/total of participants recruited (Feasibility)

    Time frame: At two times: Baseline (T1) and at the end of the intervention at 6 moths of age of the child (T2)

    Participants that complete the CRIAA Program/total of participants recruited to measure participant's retention of the CRIAA program

  4. Acceptability of the intervention by mothers

    Time frame: At six months of age of the child, when intervention is over

    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

  5. Acceptability of the intervention by professionals

    Time frame: 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)

    Explored by semi-structured interviews and focus group with professionals

  6. Acceptability of participation in decision making by mothers and their partner/relative

    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 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)

Other outcomes

  1. Breastfeeding percentage

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

    Percentage of children with exclusive breastfeeding

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Collaborators

  • University of Navarra

Registry information

Official study title

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

Acronym: CRIAA

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 9, 2019
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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