000109684 001__ 109684 000109684 005__ 20230519145544.0 000109684 0247_ $$2doi$$a10.1186/s12889-021-11982-4 000109684 0248_ $$2sideral$$a126508 000109684 037__ $$aART-2021-126508 000109684 041__ $$aeng 000109684 100__ $$aZabaleta-del-Olmo E. 000109684 245__ $$aMultiple 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 000109684 260__ $$c2021 000109684 5060_ $$aAccess copy available to the general public$$fUnrestricted 000109684 5203_ $$aBackground: 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”. © 2021, The Author(s). 000109684 536__ $$9info:eu-repo/grantAgreement/ES/ISCIII-MINECO/PI15/00114$$9info:eu-repo/grantAgreement/ES/ISCIII-MINECO/PI15/00519$$9info:eu-repo/grantAgreement/ES/ISCIII-MINECO/PI15/00565$$9info:eu-repo/grantAgreement/ES/ISCIII-MINECO/PI15/00762$$9info:eu-repo/grantAgreement/ES/ISCIII-MINECO/PI15/00896$$9info:eu-repo/grantAgreement/ES/ISCIII-MINECO/PI15/01072$$9info:eu-repo/grantAgreement/ES/ISCIII-MINECO/PI15/01133$$9info:eu-repo/grantAgreement/ES/ISCIII-MINECO/PI15/01151$$9info:eu-repo/grantAgreement/ES/ISCIII-MINECO/PI15/01412 000109684 540__ $$9info:eu-repo/semantics/openAccess$$aby$$uhttp://creativecommons.org/licenses/by/3.0/es/ 000109684 590__ $$a4.135$$b2021 000109684 592__ $$a1.156$$b2021 000109684 594__ $$a4.9$$b2021 000109684 591__ $$aPUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH$$b83 / 210 = 0.395$$c2021$$dQ2$$eT2 000109684 593__ $$aPublic Health, Environmental and Occupational Health$$c2021$$dQ1 000109684 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion 000109684 700__ $$aCasajuana-Closas M. 000109684 700__ $$aLópez-Jiménez T. 000109684 700__ $$aPombo H. 000109684 700__ $$aPons-Vigués M. 000109684 700__ $$aPujol-Ribera E. 000109684 700__ $$aCabezas-Peña C. 000109684 700__ $$aLlobera J. 000109684 700__ $$aMartí-Lluch R. 000109684 700__ $$aVicens C. 000109684 700__ $$aMotrico E. 000109684 700__ $$aGómez-Gómez I. 000109684 700__ $$aMaderuelo-Fernández J.-Á. 000109684 700__ $$aRecio-Rodriguez J.I. 000109684 700__ $$0(orcid)0000-0001-9887-2250$$aMasluk B.$$uUniversidad de Zaragoza 000109684 700__ $$aContreras-Martos S. 000109684 700__ $$aJacques-Aviñó C. 000109684 700__ $$aAznar-Lou I. 000109684 700__ $$aGil-Girbau M. 000109684 700__ $$aClavería A. 000109684 700__ $$0(orcid)0000-0002-5494-6550$$aMagallón-Botaya R.$$uUniversidad de Zaragoza 000109684 700__ $$aBellón J.-Á. 000109684 700__ $$aRamos R. 000109684 700__ $$aSanchez-Perez A. 000109684 700__ $$aMoreno-Peral P. 000109684 700__ $$aLeiva A. 000109684 700__ $$aGonzález-Formoso C. 000109684 700__ $$aBolíbar B. 000109684 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Medicina 000109684 7102_ $$14009$$2735$$aUniversidad de Zaragoza$$bDpto. Psicología y Sociología$$cÁrea Psicolog.Evolut.Educac 000109684 773__ $$g21, 1 (2021), 2208 [22 pp]$$pBMC Public Health$$tBMC PUBLIC HEALTH$$x1471-2458 000109684 8564_ $$s1684045$$uhttps://zaguan.unizar.es/record/109684/files/texto_completo.pdf$$yVersión publicada 000109684 8564_ $$s1688540$$uhttps://zaguan.unizar.es/record/109684/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada 000109684 909CO $$ooai:zaguan.unizar.es:109684$$particulos$$pdriver 000109684 951__ $$a2023-05-18-15:42:13 000109684 980__ $$aARTICLE