The CRIAA Program complex intervention in primary care to support women and their families in breastfeeding: Study protocol for a pilot trial
Date
2020-07
Type:
Article
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Abstract
Aim: To report a pilot study protocol to assess the feasibility of a complex intervention, in the primary healthcare context, to support women and their families in
breastfeeding.
Design: A pilot/feasibility trial with control and intervention groups.
Methods: The study will be conducted in two primary healthcare centres with 40
childbearing women (20 control group; 20 intervention group), with their partner/
meaningful person and their respective healthcare professionals. Intervention group
participants will receive the intervention: (a) in a breastfeeding workshop during their
third trimester of pregnancy; and (b) via virtual breastfeeding support for six months
postpartum. Health professionals will be trained to deliver the intervention. The
control group will receive standard care in the outpatient clinic. The pilot will help
determine the intervention's feasibility. Data collected pre-intervention, 10-days
postpartum and two-, four-, and six-months postpartum will provide estimates of
the intervention's preliminary effects on self-efficacy and main outcomes. Research
Ethics Committee approval was obtained in April 2019.
Discussion: Breastfeeding support is a complex reality influenced by multiple factors.
Therefore, approaches to breastfeeding are also, requiring interventions that address
its multidimensional nature, including all actors involved. The proposed intervention
will be applied by an interdisciplinary professional health team, allowing for its incorporation into standard practice and its perpetual maintenance.
Impact: The study will produce an original, comprehensive, complex intervention
addressing contextual, and organizational factors to promote breastfeeding support
using an interdisciplinary and family-based approach; breastfeeding self-efficacy is
the core concept. The program evaluation and feasibility study will permit exploration of the integration of the intervention's novel aspects into the daily work of professionals and reveal how to better use existing resources in a full-scale clinical trial.
Trial registration: ClinicalTrials.gov ID: NCT03944642.
Description
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Citation
Journal of Advanced Nursing, 2020, vol.76:3641–3653
Keywords
Breastfeeding self-efficacy, Breastfeeding support, Complex intervention, Midwives, Nursing, Pilot study, Primary health care