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.

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".

[Sick leave due to tobacco use in workers aged 35-64. Catalonia, 2007-2016]. / La incapacidad temporal atribuible al consumo de tabaco en trabajadores de 35-64 años. Cataluña, 2007-2016.

OBJECTIVE: Few recent studies have researched into the size and trends of the impact of tobacco use on productivity losses. The objective of this work was to describe the percentage of episodes and non work-related sick leave days with a duration over 5 days due to tobacco use in Catalonia in the period 2007-2016 in relation to the total sick-leave episodes and sick leave days in patients aged 35-64. METHODS: Descriptive study of 3,627,107 episodes and 237,219,230 days in sick-leave by any cause, except those work-related, in workers aged 35-64. Population etiological fractions were used. The annual percentage of number of episodes and sick-leave days due to tobacco use in relation with total episodes and sick-leave days was calculated and a trend test was performed. RESULTS: The percentage of sick-leave episodes and days due to tobacco use was higher in men (3.9%; 5.5% respectively) than in women (2.3%; 1.5% respectively). The trend for sick-leave due to tobacco use was positive, with a maximum OR in 2013. For the number of sick-leave episodes due to tobacco use, the corrected Z was 25.3 in men (p<0.001) and 49.4 in women (p<0.001). For sick-leave days due to tobacco use, the corrected Z was 36.9 in men (p<0.001) and 250.4 in women (p< 0.001). CONCLUSIONS: About 3% of sick-leave episodes with a duration over than 5 days are due to tobacco use, with a positive trend in both sexes. It is necessary to continue reinforcing the tobacco prevention and control policies in order to improve such trends for years to come.

OBJETIVO: Pocos estudios recientes han investigado en nuestro medio la magnitud y las tendencias del impacto del consumo de tabaco en la pérdida de productividad. El objetivo de este trabajo fue describir la proporción de episodios y de días en incapacidad temporal no profesional de duración superior a 5 días y atribuible al consumo de tabaco en Cataluña en el período 2007-2016, respecto del total de incapacidad temporal en trabajadores de 35-64 años. METODOS: Estudio descriptivo de 3.627.107 episodios y 237.219.230 días de incapacidad temporal por todas las causas, excepto las de origen profesional, en trabajadores de 35-64 años. Se aplicaron las fracciones etiológicas poblacionales. Se calculó la proporción anual de episodios y de días en incapacidad temporal atribuible (ITA) respecto de la incapacidad temporal (IT) por todas las causas y se realizó un test de tendencia. RESULTADOS: El porcentaje de episodios y de días en ITA por consumo de tabaco fue superior en hombres (3,9%; 5,5% respectivamente) que en mujeres (2,3%; 1,5% respectivamente). La tendencia de la ITA fue ascendente, con un OR máximo en 2013. Para los episodios de ITA, la Z corregida fue 25,3 en hombres (p<0,001) y 49,4 en mujeres (p<0,001). Para los días en ITA, la Z corregida fue 36,9 en hombres (p<0,001) y 250,4 en mujeres (p<0,001). CONCLUSIONES: Alrededor de un 3% de los episodios de IT de 5 días o más son atribuibles al tabaco, con una tendencia ascendente en ambos sexos. Es necesario continuar reforzando las políticas de prevención y control del tabaquismo para mejorar esta tendencia.

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.

BACKGROUND: 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. METHODS: 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. DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov , NCT03136211 .Retrospectively registered on May 2, 2017.

Effectiveness of a brief primary care intervention to reduce passive smoking in babies: a cluster randomised clinical trial.

BACKGROUND: Tobacco smoke pollution (TSP) has major negative effects on infant health. Our objectives were to determine the effectiveness of a brief primary care intervention directed at parents who smoke in reducing babies' TSP exposure, and to establish variables related to greater exposure. METHOD: A multicentre, open, cluster-randomised clinical trial in Catalonia. The 83 participating primary health paediatric teams of the Catalan Health Service recruited 1101 babies whose parents were smokers. The intervention group (IG) received a brief TSP intervention; the control group (CG) received the usual care. Outcomes were measured by parents' reported strategies to avoid TSP exposure. Baseline clinical data and characteristics of each baby's TSP exposure were collected, along with infant hair samples and parents' tobacco use and related attitudes/behaviours. At 3-month and 6-month follow-up, behavioural changes to avoid TSP exposure were recorded; the association between reported parental behaviours and nicotine concentration in infant hair samples was tested in a random sample of 253 babies at baseline and 6 months. RESULTS: During follow-up, TSP-avoidance strategies improved more in the IG than in the CG: 35.4% and 26.9% ( p=0.006) at home, and 62.2% and 53.1% in cars (p=0.008). Logistic regression showed adjusted ORs for appropriate measures in the IG versus CG of 1.59 (95% CI 1.21 to 2.09) at home and 1.30 (95% CI 0.97 to 1.75) in cars. Hair samples showed that 78.7% of the babies tested were exposed. Reduced nicotine concentration was associated with improved implementation of effective strategies reported by parents at home (p=0.029) and in cars (p=0.014). CONCLUSIONS: The intervention produced behavioural changes to avoid TSP exposure in babies. The proportion of babies with nicotine (>=1ng/mg) in hair samples at baseline is a concern. TRIAL REGISTRATION NUMBER: Clinical Trials.gov Identifier: NCT00788996.

WITHDRAWN: Interventions for preventing tobacco smoking in public places.

BACKGROUND: Environmental tobacco smoke is a health hazard. Reducing exposure to tobacco smoke in public places is a widespread public health goal. There is, however, considerable variation in the extent to which this goal has been achieved in different settings and societies. There is therefore a need to identify effective strategies for reducing tobacco consumption in public places. OBJECTIVES: To evaluate the effectiveness of interventions to reduce tobacco consumption in public places. SEARCH STRATEGY: We searched the Tobacco Addiction Review Group trials register, MEDLINE and EMBASE in March 2006. We handsearched a key journal and abstracts from international conferences on tobacco. We checked the bibliographies of identified studies and reviews for additional references. SELECTION CRITERIA: We considered randomized and controlled trials, controlled and uncontrolled before-and-after studies and interrupted time series. The main outcome of interest was levels and measures of compliance with bans and restrictions. We considered strategies aimed at populations, including education campaigns, written material, non-smoking and warning signs, and comprehensive strategies. We also considered strategies aimed at individual smokers. DATA COLLECTION AND ANALYSIS: Information relating to the characteristics and content of all kinds of interventions, participants, outcomes and methods of each study was abstracted by one reviewer and checked by two others. Studies were combined using qualitative narrative synthesis. MAIN RESULTS: Twenty of 25 studies reporting information about interventions to reduce smoking in public places met all the inclusion criteria. Three were controlled before-and-after studies and 17 were uncontrolled before-and-after studies. The most effective strategies used comprehensive, multi-component approaches to implement policies banning smoking within institutions. Less comprehensive strategies, such as posted warnings and educational material, had a moderate effect. Five studies showed that prompting individual smokers had an immediate effect, but such strategies are unlikely to be acceptable as a public health intervention. AUTHORS' CONCLUSIONS: Carefully planned and resourced, multi-component strategies effectively reduced smoking within public places. Less comprehensive strategies were less effective. Most studies were done in the USA and, despite increasing evidence from Europe, there is a need to identify ways in which these strategies can be adopted and used in countries with different attitudes to tobacco use. Future studies should also consider the use of more rigorous experimental designs.