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BreastfeedingCRIAANCT03944642

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

A study testing Breastfeeding support in people with Breastfeeding and Self Efficacy, run by Pontificia Universidad Catolica de Chile at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Breastfeeding, Self Efficacy
What is being tested?
Breastfeeding support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
4 sitesin 2 countries
Study dates
9 Aug 2019to 30 Nov 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

Chile3 sites

  • Escuela de Enfermeria Pontificia Universidad Catolica de Chile

    Santiago, 7820436

  • Centro de Salud Familiar ANCORA San Alberto Hurtado

    Santiago, 8181297

  • Centro de Salud Familiar ANCORA Juan Pablo II

    Santiago, 8831695

Other trials in Chile

Spain1 site

  • Facultad de Enfermeria Universidad de Navarra

    Pamplona, 31008

Other trials in Spain

About this study

Official title: Breastfeeding as a Health-promoting Behavior: 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.

Read the 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.

Being tested
Breastfeeding support
Keywords
Complex Intervention, Pilot Study, Breastfeeding Support
Medical subject headings
Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Breastfeeding supportBehavioural

    Also called CRIAA Program

    Breastfeeding self-efficacy enhancing through professional support

Study groups in NCT03944642
Study groupRoleWhat they receive
InterventionExperimentalParticipants 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.
Receives: Behavioral: Breastfeeding support
Standard CareNo interventionThis group will receive the standard pre and postnatal regular care, for mother and child. Professionals who provide direct care will maintain their usual attention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At five points: week 28 - 40 pregnancy (T1); and 10 days (T2); 2 months (T3); 4 months (T4); and 6 months (T5) after birth

  2. 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

    Measured: 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)

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

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

    Measured: Baseline

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

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

    Measured: Baseline

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

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

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

  4. Acceptability of the intervention by mothers

    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

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

  5. Acceptability of the intervention by professionals

    Explored by semi-structured interviews and focus group with professionals

    Measured: 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)

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

    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)

    Measured: At five points: week 28 - 40 pregnancy (T1); and 10 days (T2); 2 months (T3); 4 months (T4); and 6 months (T5) after birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2019
  2. Study start9 Aug 2019
  3. Primary completion30 Nov 2020
  4. Study completion30 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03944642
Sponsor's protocol ID
PIEM04-19
Acronym
CRIAA
Status last verified
Jan 2021
First submitted
3 May 2019
Last updated
27 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 37461904

  • 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.

    PubMed 33058232

Questions about this trial

What is this clinical trial studying?

A study testing Breastfeeding support in people with Breastfeeding and Self Efficacy, run by Pontificia Universidad Catolica de Chile at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Chile, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03944642, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.

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