RT Journal Article
T1 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
A1 Zabaleta-del-Olmo, Edurne
A1 Casajuana-Closas, Marc
A1 Lopez-Jimenez, Tomas
A1 Pombo, Haizea
A1 Pons-Vigues, Mariona
A1 Pujol-Ribera, Enriqueta
A1 Cabezas-Pena, Carmen
A1 Llobera, Joan
A1 Marti-Lluch, Ruth
A1 Vicens, Caterina
A1 Motrico, Emma
A1 Gomez-Gomez, Irene
A1 Maderuelo-Fernandez, Jose-Angel
A1 Recio-Rodriguez, Jose, I
A1 Masluk, Barbara
A1 Contreras-Martos, Sara
A1 Jacques-Avino, Constanza
A1 Aznar-Lou, Ignacio
A1 Gil-Girbau, Montserrat
A1 Claveria, Ana
A1 Magallon-Botaya, Rosa
A1 Bellon, Juan-Angel
A1 Ramos, Rafel
A1 Sanchez-Perez, Alvaro
A1 Moreno-Peral, Patricia
A1 Leiva, Alfonso
A1 Gonzalez-Formoso, Clara
A1 Bolibar, Bonaventura
K1 Health behaviour
K1 Health promotion
K1 Hybrid trial
K1 Implementation science
K1 Mediterranean diet
K1 Physical activity
K1 Primary health care
K1 Smoking cessation
K1 Mediterranean diet
K1 Clinical-trials
K1 Promotion
K1 Settings
K1 Complex
K1 Prescription
K1 Innovations
K1 Adherence
K1 Lessons
K1 Design
AB 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.
PB Bmc
YR 2021
FD 2021-12-04
LK https://hdl.handle.net/10668/24553
UL https://hdl.handle.net/10668/24553
LA en
DS RISalud
RD Apr 10, 2025