Multiple health behaviour change primary care intervention for smoking cessation, physical activity and healthy diet in adults 45 to 75 years old (EIRA study): a hybrid effectiveness-implementation cluster randomised trial

Abstract

Background This aim of this study was to evaluate the effectiveness of: a) a Multiple Health Behaviour Change (MHBC) intervention on reducing smoking, increasing physical activity and adherence to a Mediterranean dietary pattern in people aged 45-75 years compared to usual care; and b) an implementation strategy. Methods A cluster randomised effectiveness-implementation hybrid trial type 2 with two parallel groups was conducted in 25 Primary Health Care centres (3062 participants): 12 centres (1481 participants) were randomised to the intervention and 13 (1581 participants) to the control group (usual care). The intervention focused on all target behaviours and used individual, group and community approaches. The implementation strategy was based on the Consolidated Framework for Implementation Research (CFIR) and a set of discrete implementation strategies which included planning, educating, financing, restructuring and managing quality. Data were analysed using generalised linear mixed models, accounting for clustering. A mixed methods data analysis was used to evaluate implementation outcomes (adoption, acceptability, appropriateness, feasibility and fidelity) and determinants of implementation success. Results MHBC was greater in the intervention (14.5%) than in the usual care group (8.9%). The overall adoption rate by professionals was 48.7. Early and final appropriateness were perceived by professionals as moderate. Early acceptability was high, whereas final acceptability was only moderate. Initial and final acceptability as perceived by the participants was high, and appropriateness moderate, with a lower initial than final appropriateness perception. Consent and recruitment rates were 82.0% and 65.5%, respectively, intervention uptake was 89.5% and completion rate 74.7%. The global value of percentage of approaches with fidelity ≥ 50% was 16.7%. Eight CFIR constructs distinguished between high and low implementation, five of them corresponding to the Inner Setting domain. Conclusions Compared to usual care, the EIRA intervention was more effective in promoting MHBC. Implementation outcomes were satisfactory except for the fidelity to the planned intervention which was low. The organisational and structural contexts of the centres proved to be significant determinants of implementation effectiveness. Trial registration ClinicalTrials.gov, NCT03136211. Registered 2 May 2017, “retrospectively registered”: https://clinicaltrials.gov/ct2/show/NCT03136211