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

BMC Public Health

Barbara Masluk¹  Carmen Cabezas-Peña²  Haizea Pombo³  Rosa Magallón-Botaya⁴  Bonaventura Bolíbar⁵  Marc Casajuana-Closas⁵  Tomàs López-Jiménez⁵  Enriqueta Pujol-Ribera⁵  Edurne Zabaleta-del-Olmo⁵  Constanza Jacques-Aviñó⁵  Caterina Vicens⁶  José-Ángel Maderuelo-Fernández⁷  Patricia Moreno-Peral⁸  Juan-Ángel Bellón⁸  Clara González-Formoso⁹  Mariona Pons-Vigués^1,10  Alvaro Sanchez-Perez^1,11  Ignacio Aznar-Lou^1,12  Montserrat Gil-Girbau^1,12  José I. Recio-Rodriguez^1,13  Joan Llobera^1,14  Alfonso Leiva^1,14  Sara Contreras-Martos^1,14  Rafel Ramos^1,15  Emma Motrico^1,16  Irene Gómez-Gómez^1,16  Ruth Martí-Lluch^1,17  Ana Clavería^1,18 

[1] Departamento de Psicología y Sociología, Universidad de Zaragoza;Department of Health, Deputy Directorate of Health Promotion, Public Health Agency;Ezkerraldea-Enkarterri-Cruces Integrated Health Organisation-Biocruces Bizkaia Health Research Institute Innovation Unit;Facultad de Medicina, Universidad de Zaragoza;Fundació Institut Universitari per a la recerca a l’Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol);Institut de Investigació Sanitària de les Illes Balears (IdISBa), Carretera de Valldemossa, 79. Hospital Universitari Son Espases;Institute of Biomedical Research of Salamanca (IBSAL);Instituto de Investigación Biomédica de Málaga (IBIMA), Hospital Civil Pabellón 5. 2a Planta, Plaza del Hospital Civil;Instituto de Investigación Sanitaria Galicia Sur, Hospital Álvaro Cunqueiro, Bloque Técnico;Nursing Department, Nursing Faculty, Universitat de Girona;Primary Care Research Unit, Deputy Directorate of Healthcare Assistance- BioCruces Bizkaia Health Research Institute, Basque Healthcare Service –Osakidetza;Research and Development Unit, Institut de Recerca Sant Joan de Déu;Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Instituto de Investigación Biomédica de Salamanca (IBSAL);Unitat de Recerca, Atenció Primaria de Mallorca, Servei de Salut de les Illes Balears;Unitat de suport a la recerca de Girona. Fundació Institut Universitari per a la recerca a l’Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol);Universidad Loyola Andalucía;Universitat Autònoma de Barcelona;Área de Xestión Integrada de Vigo;

关键词: Health behaviour;    Health promotion;    Hybrid trial;    Implementation science;    Mediterranean diet;    Physical activity;   

DOI  :  10.1186/s12889-021-11982-4

来源: DOAJ

【 摘 要 】

Abstract Background This study aimed 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 Spanish Primary Health Care (PHC) centres (3062 participants): 12 centres (1481 participants) were randomised to the intervention and 13 (1581 participants) to the control group (usual care). The intervention was based on the Transtheoretical Model and focused on all target behaviours using individual, group and community approaches. PHC professionals made it during routine care. The implementation strategy was based on the Consolidated Framework for Implementation Research (CFIR). 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 14.5% of participants in the intervention group and 8.9% in the usual care group showed a positive change in two or all the target behaviours. Intervention was more effective in promoting dietary behaviour change (31.9% vs 21.4%). 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. 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 the percentage of approaches with fidelity ≥50% was 16.7%. Eight CFIR constructs distinguished between high and low implementation, five corresponding to the Inner Setting domain. Conclusions Compared to usual care, the EIRA intervention was more effective in promoting MHBC and dietary behaviour change. 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”.

【 授权许可】

Unknown