The FirstCPR cluster randomised trial delivered multimodal basic life support (BLS) learning opportunities to community organisations. An a priori process evaluation examined intervention implementation, including participation, reach, uptake and member engagement.
The study used a multimethod process evaluation. Data were collected via semistructured interviews, focus group discussions, participant surveys, study records, web analytics and in-field observations. These sources captured participation patterns and implementation measures (delivery, reach, uptake and engagement: opt-in to digital messages and attendance at training sessions), as well as reasons for refusals and withdrawals. Qualitative data were analysed thematically and organised using the UK Medical Research Council process-evaluation framework. Qualitative and quantitative data were analysed separately and subsequently interpreted collectively to contextualise implementation patterns and identify barriers and enablers that influenced trial successes and failures.
Intervention uptake and engagement varied significantly across organisations, with greater success observed in social and faith-based groups. Of the 82 intervention clusters, 78 (95%) received intervention materials; 74 (90%) engaged in at least one activity and 15 (18%) engaged in all activities. Participation was primarily driven by the organisation’s leadership interest and support in providing BLS training to members, and by the time available to facilitate intervention activities. The presence of a dedicated liaison/champion emerged as the most critical enabler of member engagement and implementation. Feedback recommended concise, simple and culturally tailored modules, with practical components delivered in shorter, convenient sessions. Intervention delivery was affected by contextual challenges, including COVID-19 disruptions that limited in-field recruitment and group activities.
Process evaluation can strengthen community-based interventions by identifying mechanisms and contextual factors that shape implementation and engagement. Partnering with social and faith-based organisations may be an effective approach to disseminating educational programmes such as life-saving skills to lay communities. Minimising research burden and ensuring organisational leadership support may improve participation while brief, practical and culturally tailored training may enhance engagement.
ACTRN12621000367842.
Women who develop gestational diabetes mellitus (GDM) have a 60% lifetime risk of developing type 2 diabetes mellitus (T2D), which is already elevated within the first decade following childbirth. Despite the impact of lifestyle interventions to reduce long-term T2D risk in women with previous GDM, successful implementation of lifestyle interventions remains a barrier. Metformin is recommended for adults at increased risk of developing T2D; however, there is limited evidence of tolerability in the early postpartum period. Glucagon-like peptide 1 receptor agonists (GLP-1 RA) are effective at improving glycaemic status and body weight. However, GLP-1 RA have not been evaluated in the postpartum population. Finally, physical activity monitors may support behaviour changes related to physical activity to reduce long-term risk of T2D but are yet to be studied following GDM.
This will be a multicentre, randomised, open-label interventional pilot study. Using a 2x2 factorial design, we will examine the feasibility and acceptability of a pharmacotherapy intervention and a physical activity intervention in women with previous GDM at increased risk of developing T2D. Participants will be recruited from tertiary referral hospitals in Australia and will be randomised to receive either metformin alone or in combination with a GLP-1 RA and subsequently randomised to either a physical activity intervention involving activity monitor use, or usual care for 6 months, followed by a 6-month follow-up period. Primary feasibility outcomes include the acceptability and safety of the metformin and GLP-1 RA as measured through pill and injection counts, acceptability questionnaire and adverse events.
This trial is registered with the Australian and New Zealand Clinical Trials Registry (Registration Number: ACTRN12624001253594). This trial has received ethics approval from the South Eastern Sydney Local Health District Human Research Ethics Committee (Approval Number: 2024/ETH00042, protocol version v1.1, 28/02/2025).
Australian and New Zealand Clinical Trials Registry, Registration Number: ACTRN12624001253594.