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

Zabaleta‐del‐Olmo, Edurne; Pombo, Haizea; Pons‐Vigués, Mariona; Casajuana-Closas, Marc; Pujol‐Ribera, Enriqueta; López-Jiménez, Tomás; Cabezas, Carmen; Martín-Borràs, Carme; Serrano‐Blanco, Antoni; Rubio-Valera, María; Llobera, Joan; Leiva, Alfonso; Vicens, Catalina; Vidal, Clara; Campiñez, Manuel; Martín-Álvarez, Remedios; Maderuelo, José-Ángel; Recio, José-Ignacio; Motrico, Emma; Bellón, Juan-Ángel; Moreno-Peral, Patrícia; Martín-Cantera, Carlos; Fontán, Antonio; Aldecoa-Landesa, Susana; Magallón-Botaya, Rosa; Bolíbar, Bonaventura

doi:10.1186/s12889-018-5805-y

Cited by 16 publications

(29 citation statements)

References 70 publications

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“…A statistical analysis plan was established before data were available [30] All data were analysed on an intention-to-treat basis. We compared cluster and participant characteristics for all variables of interest by group allocation, using either means (standard deviations) or medians (interquartile ranges) for continuous variables, and numbers (percentages) for categorical variables.…”

Section: Discussionmentioning

confidence: 99%

“…Study was a cluster randomised effectiveness-implementation hybrid trial type 2 with two parallel groups and its protocol has been previously published [30]. It is reported according to the Standards for Reporting Implementation Studies (StaRI) and Consolidated Standards of Reporting Trials (CONSORT) extension for cluster trials (Additional le 1).…”

Section: Study Design and Participantsmentioning

confidence: 99%

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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

Zabaleta‐del‐Olmo¹,

Casajuana-Closas²,

López-Jiménez³

et al. 2020

Preprint

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Background This aim of this study was 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 Primary Health Care centres (3062 participants): 12 centres (1481 participants) were randomised to the intervention and 13 (1581 participants) to the control group (usual care). The intervention focused on all target behaviours and used individual, group and community approaches. The implementation strategy was based on the Consolidated Framework for Implementation Research (CFIR) and a set of discrete implementation strategies which included planning, educating, financing, restructuring and managing quality. 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 MHBC was greater in the intervention (14.5%) than in the usual care group (8.9%). 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, with a lower initial than final appropriateness perception. 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 percentage of approaches with fidelity ≥ 50% was 16.7%. Eight CFIR constructs distinguished between high and low implementation, five of them corresponding to the Inner Setting domain. Conclusions Compared to usual care, the EIRA intervention was more effective in promoting MHBC. 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”: https://clinicaltrials.gov/ct2/show/NCT03136211

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Section: Discussionmentioning

confidence: 99%

Section: Study Design and Participantsmentioning

confidence: 99%

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

Zabaleta‐del‐Olmo¹,

Casajuana-Closas²,

López-Jiménez³

et al. 2020

Preprint

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“…It was conducted between 2014-2015 and 2016-2018 by the Primary Care Prevention and Health Promotion Network (RedIAPP) in 38 primary care centers in the Spanish provinces of Barcelona, Girona, the Balearic Islands, Malaga, Seville, Salamanca, Soria, Toledo, Vigo, Vizcaya, and Zaragoza. The trial protocol has already been published [21].…”

Section: Methodsmentioning

confidence: 99%

Health status, lifestyle habits, and perceived social support in long-term cancer survivors: a cross-sectional study

León-Salas

Zabaleta‐del‐Olmo

Llobera

et al. 2020

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Background: The purpose of this study was to compare health status, lifestyle habits, and perceived social support between cancer survivors and people who have never had cancer. Methods: Descriptive, cross-sectional multicenter study nested in phases II and III of the cluster randomized clinical trial ERIA, designed to analyze the effects of a complex primary care intervention compared with care as usual on smoking cessation, improved adherence to the Mediterranean diet, and increased physical activity. For the cross-sectional study, patients were divided into two groups: cancer survivors and people who had never had cancer (controls). Thirty eight Primary care centers Spanish provinces of Barcelona, Girona, Balearic Islands, Malaga, Seville, Salamanca, Soria, Toledo, Vigo, Vizcaya, and Zaragoza. Adults aged between 45 and 75 years with at least two risk behaviors. Patients being treated for active cancer or in end-of-life care were excluded.Primary outcomes: Sociodemographic variables, diet, physical activity, smoking, body mass index, Charlson Comorbidity Index, and self-perceived health and social support.Results: Of the 4259 people included, 190 (4.46%) were cancer survivors. Their mean±SD age was 62.8±7 years versus 58.7±8 years (P<0.01) for people who had never had cancer. Long-term sick leave was also more common in this group (11.9% vs 3.5%, P<0.001). No between-group differences were observed for smoking, adherence to the Mediterranean diet, physical activity, obesity, or perceived social support. Cancer survivors reported worse health (OR 1.82; IC95% 1.02–2.75) and were more likely to have two or more comorbid conditions (OR 1.68; 95% CI 1.18–2.39), chronic pulmonary obstructive disease (OR 2.17; 95% CI 1.25–3.78), and depression (OR 1.65; 95% CI 1.06–2.57). In the multiple regression analysis, older age and worse self-perceived health continued to be significantly associated with having survived cancer.Conclusions: Cancer survivors have more chronic diseases, a greater likelihood of being on long-term sick leave, and worse self-perceived health than people without a history of cancer, regardless of age. The two groups perceived similar levels of social support.

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“…In most studies, lifestyle interventions for the prevention of depression are only focused on a specific healthy habit 17–26. Nevertheless, unhealthy lifestyle factors tend to co-occur; it has been reported that 31%–40% of the population has at least two risk factors 14 27.…”

Section: Introductionmentioning

confidence: 99%

“…The expected results will have multiple implications, since complex multiple-risk lifestyle interventions prevent other non-communicable diseases,32 reduce medical costs33 and improve self-efficacy in patients 34. Furthermore, complex multiple-risk lifestyle interventions respond accurately to clustering of unhealthy lifestyle factors14 27 and can easily be implemented in different settings 26 32 35 36…”

Section: Introductionmentioning

confidence: 99%

Effectiveness of complex multiple-risk lifestyle interventions in reducing symptoms of depression: a study protocol for a systematic review and meta-analysis of randomised controlled trials

et al. 2019

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IntroductionMany studies have explored the impact of lifestyle interventions on depression. However, little is known about the effectiveness of complex multiple-risk lifestyle interventions in reducing symptoms of depression. Our objective is to assess the effectiveness of complex multiple-risk lifestyle interventions in reducing depressive symptoms in the adult population by the acquisition of at least two healthy habits—healthy diet, physical activity and/or smoking cessation. For such purpose, a systematic review and meta-analysis of randomised controlled trials will be conducted.Method and analysisMEDLINE (through Ovid and PubMed), Scopus, Cochrane Central Register of Controlled Trials, Web of Science, PsycINFO, OpenGrey Register (System for Information on Grey Literature in Europe) and the International Clinical Trials Registry Platform will be searched for relevant articles. Additionally, a supplementary manual search will be performed using lists of references, references to expert authors and other systematic reviews and/or meta-analyses. Study selection, data extraction (target habits, country, target populations, conditions and statistical data to name a few) and assessment of the risk of bias will be performed separately by two independent researchers. The primary outcome measure will be the reduction of depression symptoms, as measured by validated instruments. We will calculate pooled standardised mean differences and 95% CIs using random-effect models. Heterogeneity, sensitivity and publication bias will be assessed, and sub-group analysis will be performed. Heterogeneity will be explored by random-effects meta-regression analysis.Ethics and disseminationEthical approval is not required for this study. The results of this systematic review and meta-analysis will be presented in relevant conferences and published in a peer-review journal. The findings of this study could have important clinical and scientific implications for the improvement of symptoms of depression.PROSPERO registration numberCRD42018100253; Pre-results.

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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

Cited by 16 publications

References 70 publications

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

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

Health status, lifestyle habits, and perceived social support in long-term cancer survivors: a cross-sectional study

Effectiveness of complex multiple-risk lifestyle interventions in reducing symptoms of depression: a study protocol for a systematic review and meta-analysis of randomised controlled trials

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