Petal Petersen Williams, Isabelle L Lange, Jodilee Erasmus, Lesley-Ann Erasmus-Claassen, Maham Saleem, Lisa Sophie Reigl, Meike Wolf, Stefan Schaub, Christoph Buck, Abhijit Nadkarni, Daniela C Fuhr
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引用次数: 0
Abstract
Background: South Africa has the highest global prevalence of foetal alcohol spectrum disorders (FASD). Despite guidelines for FASD prevention, there are no community-based psychological interventions to reduce alcohol use during pregnancy. Through formative research, a culturally adapted intervention, the Mommy and Baby Wellness Programme, was developed to address the needs of pregnant women in the setting. The aim of the feasibility trial is to refine the trial methods before conducting a full-scale trial, and explore the feasibility of programme delivery, the acceptability of session content, and participants' perceptions of its effectiveness.
Methods and analysis: A parallel-arm, single-blind, individually randomised feasibility trial will be conducted. Forty pregnant women (≥ 18 years) screening positive for hazardous alcohol use (AUDIT score ≥ 8) and confirming past-month alcohol consumption will be randomised 1:1 to receive either the Mommy and Baby Wellness Programme or enhanced usual care. Women will be assessed at baseline and again three months after randomisation. The study uses an embedded mixed-methods design, in which a parallel quantitative feasibility trial is complemented by qualitative interviews with participants and community health workers. Quantitative indicators of trial feasibility, acceptability and implementation (e.g. recruitment, retention, adherence and completeness of outcome data) will be summarised descriptively, and qualitative data will be used in an explanatory role to help interpret these findings and refine trial procedures and intervention delivery. Ethical approval has been obtained from the South African Medical Research Council (SAMRC) and the Technical University of Munich Health Research Ethics Committees. All participants will provide informed consent. Study data will be securely managed using Research Electronic Data Capture software hosted on SAMRC servers.
Discussion: The pilot trial of the Mommy and Baby Wellness Programme provides initial evidence on the feasibility and acceptability of a community health worker-delivered psychological intervention to reduce alcohol use among pregnant women in South Africa. Findings will inform the design of a future definitive trial and guide adaptation of recruitment, retention, and counselling strategies for a highly stigmatised population. Insights from the process evaluation will refine approaches to participant engagement and fidelity monitoring, supporting culturally responsive and sustainable implementation. If feasible, the intervention could contribute to improved maternal and child health outcomes and reducing alcohol-related harm in resource-limited settings.
Trial registration: ClinicalTrials.gov ID NCT06853873. Retrospectively registered: 2025-02-25 https://www.
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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