RT Journal Article T1 Complex multiple risk intervention to promote healthy behaviours in people between 45 to 75 years attended in primary health care (EIRA study): study protocol for a hybrid trial. A1 Zabaleta-Del-Olmo, Edurne A1 Pombo, Haizea A1 Pons-Vigués, Mariona A1 Casajuana-Closas, Marc A1 Pujol-Ribera, Enriqueta A1 López-Jiménez, Tomás A1 Cabezas-Peña, Carmen A1 Martín-Borràs, Carme A1 Serrano-Blanco, Antoni A1 Rubio-Valera, Maria A1 Llobera, Joan A1 Leiva, Alfonso A1 Vicens, Caterina A1 Vidal, Clara A1 Campiñez, Manuel A1 Martín-Álvarez, Remedios A1 Maderuelo, José-Ángel A1 Recio, José-Ignacio A1 García-Ortiz, Luis A1 Motrico, Emma A1 Bellón, Juan-Ángel A1 Moreno-Peral, Patricia A1 Martín-Cantera, Carlos A1 Clavería, Ana A1 Aldecoa-Landesa, Susana A1 Magallón-Botaya, Rosa A1 Bolíbar, Bonaventura K1 Complex interventions K1 Cost-effectiveness analysis K1 Health behaviour K1 Health promotion K1 Hybrid trial K1 Implementation research K1 Mediterranean diet K1 Physical activity K1 Primary health care K1 Smoking AB Health promotion is a key process of current health systems. Primary Health Care (PHC) is the ideal setting for health promotion but multifaceted barriers make its integration difficult in the usual care. The majority of the adult population engages two or more risk behaviours, that is why a multiple intervention might be more effective and efficient. The primary objectives are to evaluate the effectiveness, the cost-effectiveness and an implementation strategy of a complex multiple risk intervention to promote healthy behaviours in people between 45 to 75 years attended in PHC. This study is a cluster randomised controlled hybrid type 2 trial with two parallel groups comparing a complex multiple risk behaviour intervention with usual care. It will be carried out in 26 PHC centres in Spain. The study focuses on people between 45 and 75 years who carry out two or more of the following unhealthy behaviours: tobacco use, low adherence to the Mediterranean dietary pattern or insufficient physical activity level. The intervention is based on the Transtheoretical Model and it will be made by physicians and nurses in the routine care of PHC practices according to the conceptual framework of the "5A's". It will have a maximum duration of 12 months and it will be carried out to three different levels (individual, group and community). Incremental cost per quality-adjusted life year gained measured by the tariffs of the EuroQol-5D questionnaire will be estimated. The implementation strategy is based on the "Consolidated Framework for Implementation Research", a set of discrete implementation strategies and an evaluation framework. EIRA study will determine the effectiveness and cost-effectiveness of a complex multiple risk intervention and will provide a better understanding of implementation processes of health promotion interventions in PHC setting. It may contribute to increase knowledge about the individual and structural barriers that affect implementation of these interventions and to quantify the contextual factors that moderate the effectiveness of implementation. ClinicalTrials.gov , NCT03136211 .Retrospectively registered on May 2, 2017. YR 2018 FD 2018-07-13 LK http://hdl.handle.net/10668/12707 UL http://hdl.handle.net/10668/12707 LA en DS RISalud RD Mar 18, 2025