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 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 implementati...
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2021
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oai:doaj.org-article:d1121f389af142d485825a4a1ce73bdd2021-12-05T12:09:34ZMultiple 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 trial10.1186/s12889-021-11982-41471-2458https://doaj.org/article/d1121f389af142d485825a4a1ce73bdd2021-12-01T00:00:00Zhttps://doi.org/10.1186/s12889-021-11982-4https://doaj.org/toc/1471-2458Abstract 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”.Edurne Zabaleta-del-OlmoMarc Casajuana-ClosasTomàs López-JiménezHaizea PomboMariona Pons-ViguésEnriqueta Pujol-RiberaCarmen Cabezas-PeñaJoan LloberaRuth Martí-LluchCaterina VicensEmma MotricoIrene Gómez-GómezJosé-Ángel Maderuelo-FernándezJosé I. Recio-RodriguezBarbara MaslukSara Contreras-MartosConstanza Jacques-AviñóIgnacio Aznar-LouMontserrat Gil-GirbauAna ClaveríaRosa Magallón-BotayaJuan-Ángel BellónRafel RamosAlvaro Sanchez-PerezPatricia Moreno-PeralAlfonso LeivaClara González-FormosoBonaventura BolíbarBMCarticleHealth behaviourHealth promotionHybrid trialImplementation scienceMediterranean dietPhysical activityPublic aspects of medicineRA1-1270ENBMC Public Health, Vol 21, Iss 1, Pp 1-22 (2021) |
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DOAJ |
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EN |
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Health behaviour Health promotion Hybrid trial Implementation science Mediterranean diet Physical activity Public aspects of medicine RA1-1270 |
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Health behaviour Health promotion Hybrid trial Implementation science Mediterranean diet Physical activity Public aspects of medicine RA1-1270 Edurne Zabaleta-del-Olmo Marc Casajuana-Closas Tomàs López-Jiménez Haizea Pombo Mariona Pons-Vigués Enriqueta Pujol-Ribera Carmen Cabezas-Peña Joan Llobera Ruth Martí-Lluch Caterina Vicens Emma Motrico Irene Gómez-Gómez José-Ángel Maderuelo-Fernández José I. Recio-Rodriguez Barbara Masluk Sara Contreras-Martos Constanza Jacques-Aviñó Ignacio Aznar-Lou Montserrat Gil-Girbau Ana Clavería Rosa Magallón-Botaya Juan-Ángel Bellón Rafel Ramos Alvaro Sanchez-Perez Patricia Moreno-Peral Alfonso Leiva Clara González-Formoso Bonaventura Bolíbar 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 |
| description |
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”. |
| format |
article |
| author |
Edurne Zabaleta-del-Olmo Marc Casajuana-Closas Tomàs López-Jiménez Haizea Pombo Mariona Pons-Vigués Enriqueta Pujol-Ribera Carmen Cabezas-Peña Joan Llobera Ruth Martí-Lluch Caterina Vicens Emma Motrico Irene Gómez-Gómez José-Ángel Maderuelo-Fernández José I. Recio-Rodriguez Barbara Masluk Sara Contreras-Martos Constanza Jacques-Aviñó Ignacio Aznar-Lou Montserrat Gil-Girbau Ana Clavería Rosa Magallón-Botaya Juan-Ángel Bellón Rafel Ramos Alvaro Sanchez-Perez Patricia Moreno-Peral Alfonso Leiva Clara González-Formoso Bonaventura Bolíbar |
| author_facet |
Edurne Zabaleta-del-Olmo Marc Casajuana-Closas Tomàs López-Jiménez Haizea Pombo Mariona Pons-Vigués Enriqueta Pujol-Ribera Carmen Cabezas-Peña Joan Llobera Ruth Martí-Lluch Caterina Vicens Emma Motrico Irene Gómez-Gómez José-Ángel Maderuelo-Fernández José I. Recio-Rodriguez Barbara Masluk Sara Contreras-Martos Constanza Jacques-Aviñó Ignacio Aznar-Lou Montserrat Gil-Girbau Ana Clavería Rosa Magallón-Botaya Juan-Ángel Bellón Rafel Ramos Alvaro Sanchez-Perez Patricia Moreno-Peral Alfonso Leiva Clara González-Formoso Bonaventura Bolíbar |
| author_sort |
Edurne Zabaleta-del-Olmo |
| title |
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 |
| title_short |
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 |
| title_full |
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 |
| title_fullStr |
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 |
| title_full_unstemmed |
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 |
| title_sort |
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 |
| publisher |
BMC |
| publishDate |
2021 |
| url |
https://doaj.org/article/d1121f389af142d485825a4a1ce73bdd |
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