Edurne Zabaleta-Del-Olmo1,2,3,4, Marc Casajuana-Closas1,4, Tomàs López-Jiménez1, Haizea Pombo5,6, Mariona Pons-Vigués3,7, Enriqueta Pujol-Ribera1,3,4, Carmen Cabezas-Peña8, Joan Llobera9,10, Ruth Martí-Lluch4,11,12, Caterina Vicens10,13,14, Emma Motrico15, Irene Gómez-Gómez15, José-Ángel Maderuelo-Fernández16,17,18, José I Recio-Rodriguez17,19, Barbara Masluk20,21, Sara Contreras-Martos9,10, Constanza Jacques-Aviñó1,4, Ignacio Aznar-Lou22,23, Montserrat Gil-Girbau22, Ana Clavería24,25, Rosa Magallón-Botaya26,27,28, Juan-Ángel Bellón29,30,31, Rafel Ramos11,12,32, Alvaro Sanchez-Perez33, Patricia Moreno-Peral29, Alfonso Leiva9,10, Clara González-Formoso25,34, Bonaventura Bolíbar1,4. 1. Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Gran Via de les Corts Catalanes 587, 08007, Barcelona, Spain. 2. Gerència Territorial de Barcelona, Institut Català de la Salut, Balmes 22, 08007, Barcelona, Spain. 3. Nursing Department, Nursing Faculty, Universitat de Girona, Emili Grahit 77, 17003, Girona, Spain. 4. Universitat Autònoma de Barcelona, Cerdanyola del Vallès, 08193, Bellaterra, Spain. 5. Ezkerraldea-Enkarterri-Cruces Integrated Health Organisation-Biocruces Bizkaia Health Research Institute Innovation Unit, Plaza de Cruces s/n, 48903, Barakaldo, Bizkaia, Spain. 6. Deputy Directorate of Healthcare Assistance, Osakidetza-Servicio Vasco de Salud, C/ Araba 45, 01006, Vitoria, Araba, Spain. 7. Àrea Assistencial. Servei Català de la Salut (CatSalut), Travessera de les Corts 131-159, Edifici Olímpia, 08228, Barcelona, Spain. 8. Department of Health, Deputy Directorate of Health Promotion, Public Health Agency, Goverment of Catalonia, Roc Boronat, 81-95 (Edifici Salvany), 08005, Barcelona, Spain. 9. Unitat de Recerca, Atenció Primaria de Mallorca, Servei de Salut de les Illes Balears, C/Escola Graduada 3, 07002, Palma, Spain. 10. Institut de Investigació Sanitària de les Illes Balears (IdISBa), Carretera de Valldemossa, 79. Hospital Universitari Son Espases, Ed S., 070112, Palma, Spain. 11. 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), Carrer Maluquer Salvador 11, 17002, Girona, Spain. 12. Group of research in Vascular Health, Girona Biomedical Research Institute (IdibGi), Parc Hospitalari Martí Julià - Edifici M2, Carrer del Dr. Castany, s/n, 17190, Salt, Spain. 13. Centro de Salud Son Serra-La Vileta (Ibsalut), Masanella 22, 07013, Palma, Balearic Islands, Spain. 14. Facultat de Medicina. Universitat de les Illes Balears, Carretera de Valldemossa, km 7.5, 07122, Palma, Balearic Islands, Spain. 15. Universidad Loyola Andalucía, Avda. de las Universidades, s/n, 41704, Dos Hermanas, Sevilla, Spain. 16. Institute of Biomedical Research of Salamanca (IBSAL), Edificio Virgen de la Vega, 10.a planta. Paseo de San Vicente, 58-182, 37007, Salamanca, Spain. 17. Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Instituto de Investigación Biomédica de Salamanca (IBSAL), Avda. Portugal 83, 37005, Salamanca, Spain. 18. Health Service of Castilla y León (SACyL), C/ Arapiles, 25 - 33, 37007, Salamanca, Spain. 19. Departamento de Enfermería y Fisioterapia, Universidad de Salamanca, Calle Donantes de Sangre, s/n, 37007, Salamanca, Spain. 20. Departamento de Psicología y Sociología, Universidad de Zaragoza, C/Pedro Cerbuna 12, 50009, Zaragoza, Spain. 21. Grupo Aragonés de Investigación en Atención Primaria (GAIAP), Instituto de Investigación Sanitaria, Avda. San Juan Bosco 13, 50009, Zaragoza, Spain. 22. Research and Development Unit, Institut de Recerca Sant Joan de Déu, C\ Doctor Antoni Pujadas 42, 08830, Sant Boi de Llobregat, Spain. 23. Consortium for Biomedical Research in Epidemiology & Public Health (CIBER en Epidemiología y Salud Pública-CIBERESP), 28029, Madrid, Spain. 24. Área de Xestión Integrada de Vigo, Servizio Galego de Saúde, c/Rosalía Castro 21-23, 36201, Vigo, Spain. 25. Instituto de Investigación Sanitaria Galicia Sur, Hospital Álvaro Cunqueiro, Bloque Técnico, Planta 2, Carretera Clara Campoamor n° 341, Beade, 36213, Vigo, Spain. 26. Facultad de Medicina, Universidad de Zaragoza, c/ Domingo Miral s/n, 50009, Zaragoza, Spain. 27. Arrabal Health Centre, Servicio Aragonés de Salud, Andador Aragüés del Puerto 3, 50015, Zaragoza, Spain. 28. Institute of health research of Aragon (IIS Aragón), Avda. San Juan Bosco, 13, 50009, Zaragoza, Spain. 29. Instituto de Investigación Biomédica de Málaga (IBIMA), Hospital Civil Pabellón 5. 2a Planta, Plaza del Hospital Civil, s/n, 29009, Málaga, Spain. 30. El Palo Health Centre', Andalusian Health Service (SAS), Avenida Salvador Allende 159, 29018, Málaga, Spain. 31. Department of Public Health and Psychiatry, Facultad de Medicina, University of Málaga (UMA), Campus de Teatinos, 29071, Málaga, Spain. 32. Department of Medical Sciences, School of Medicine, Campus Salut, Universitat de Girona, Emili Grahit 77, 17003, Girona, Spain. 33. Primary Care Research Unit, Deputy Directorate of Healthcare Assistance- BioCruces Bizkaia Health Research Institute, Basque Healthcare Service -Osakidetza, Plaza Cruces s/n, E-48903, Barakaldo, Spain. 34. Unidade de Calidade de Coidados, Área sanitaria de Vigo. Hospital Álvaro Cunqueiro, Estrada Clara Campoamor n° 341, 36312, Vigo, Spain.
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".
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".
Authors: Marci Kramish Campbell; Carol Carr; Brenda Devellis; Boyd Switzer; Andrea Biddle; M Ahinee Amamoo; Joan Walsh; Bingqing Zhou; Robert Sandler Journal: Ann Behav Med Date: 2009-10
Authors: Hilary Pinnock; Melanie Barwick; Christopher R Carpenter; Sandra Eldridge; Gonzalo Grandes; Chris J Griffiths; Jo Rycroft-Malone; Paul Meissner; Elizabeth Murray; Anita Patel; Aziz Sheikh; Stephanie J C Taylor Journal: BMJ Date: 2017-03-06
Authors: Maria Rubio-Valera; Antoni Serrano-Blanco; Ignacio Aznar-Lou; Edurne Zabaleta-Del-Olmo; Marc Casajuana-Closas; Alba Sánchez-Viñas; Elizabeth Parody-Rúa; Bonaventura Bolíbar; Montserrat Iracheta-Todó; Oana Bulilete; Tomàs López-Jiménez; Haizea Pombo-Ramos; María Victoria Martín Miguel; Rosa Magallón-Botaya; Jose Ángel Maderuelo-Fernández; Emma Motrico; Juan Bellón; Ruth Martí-Lluch Journal: Int J Behav Nutr Phys Act Date: 2021-07-02 Impact factor: 6.457
Authors: Kay-Tee Khaw; Nicholas Wareham; Sheila Bingham; Ailsa Welch; Robert Luben; Nicholas Day Journal: PLoS Med Date: 2008-01-08 Impact factor: 11.069
Authors: Maria Rubio-Valera; Mariona Pons-Vigués; María Martínez-Andrés; Patricia Moreno-Peral; Anna Berenguera; Ana Fernández Journal: PLoS One Date: 2014-02-28 Impact factor: 3.240