Evidence map›Paper›PMID 34863136›Full record

Trial reportBMC public health2021

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.

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 and 18 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC public health, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03136211 (A Hybrid Effectiveness-Implementation Trial of a Complex Multiple Risk Intervention to Promote Healthy Behaviors in People Between 45 to 75 Years Attended in Primary Health Care), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03136211 nacompletednot on this map

A Hybrid Effectiveness-Implementation Trial of a Complex Multiple Risk Intervention to Promote Healthy Behaviors in People Between 45 to 75 Years Attended in Primary Health Care

TypeinterventionalSponsorFundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaRan2017 to 2018Enrolled3,062ConditionsHealth Behavior, Health Promotion, Primary Health Care, Implementation ResearchArmsEIRA intervention
3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Article
  7. [Who cares about prevention?]Atencion primaria · 2024
    Article
  8. Article
  9. Article
  10. [Putting prevention into practice].Atencion primaria · 2022
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

28 authors.

Edurne Zabaleta-Del-OlmoFundació 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.ORCID 0000-0002-5072-8548
Marc Casajuana-ClosasFundació 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.
Tomàs López-JiménezFundació 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.
Haizea PomboEzkerraldea-Enkarterri-Cruces Integrated Health Organisation-Biocruces Bizkaia Health Research Institute Innovation Unit, Plaza de Cruces s/n, 48903, Barakaldo, Bizkaia, Spain.
Mariona Pons-ViguésNursing Department, Nursing Faculty, Universitat de Girona, Emili Grahit 77, 17003, Girona, Spain.
Enriqueta Pujol-RiberaFundació 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.
Carmen Cabezas-PeñaDepartment of Health, Deputy Directorate of Health Promotion, Public Health Agency, Goverment of Catalonia, Roc Boronat, 81-95 (Edifici Salvany), 08005, Barcelona, Spain.
Joan LloberaUnitat de Recerca, Atenció Primaria de Mallorca, Servei de Salut de les Illes Balears, C/Escola Graduada 3, 07002, Palma, Spain.
Ruth Martí-LluchUniversitat Autònoma de Barcelona, Cerdanyola del Vallès, 08193, Bellaterra, Spain.
Caterina VicensInstitut de Investigació Sanitària de les Illes Balears (IdISBa), Carretera de Valldemossa, 79. Hospital Universitari Son Espases, Ed S., 070112, Palma, Spain.
Emma MotricoUniversidad Loyola Andalucía, Avda. de las Universidades, s/n, 41704, Dos Hermanas, Sevilla, Spain.
Irene Gómez-GómezUniversidad Loyola Andalucía, Avda. de las Universidades, s/n, 41704, Dos Hermanas, Sevilla, Spain.
José-Ángel Maderuelo-FernándezInstitute of Biomedical Research of Salamanca (IBSAL), Edificio Virgen de la Vega, 10.a planta. Paseo de San Vicente, 58-182, 37007, Salamanca, Spain.
José I Recio-RodriguezUnidad de Investigación de Atención Primaria de Salamanca (APISAL), Instituto de Investigación Biomédica de Salamanca (IBSAL), Avda. Portugal 83, 37005, Salamanca, Spain.
Barbara MaslukDepartamento de Psicología y Sociología, Universidad de Zaragoza, C/Pedro Cerbuna 12, 50009, Zaragoza, Spain.
Sara Contreras-MartosUnitat de Recerca, Atenció Primaria de Mallorca, Servei de Salut de les Illes Balears, C/Escola Graduada 3, 07002, Palma, Spain.
Constanza Jacques-AviñóFundació 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.
Ignacio Aznar-LouResearch and Development Unit, Institut de Recerca Sant Joan de Déu, C\ Doctor Antoni Pujadas 42, 08830, Sant Boi de Llobregat, Spain.
Montserrat Gil-GirbauResearch and Development Unit, Institut de Recerca Sant Joan de Déu, C\ Doctor Antoni Pujadas 42, 08830, Sant Boi de Llobregat, Spain.
Ana ClaveríaÁrea de Xestión Integrada de Vigo, Servizio Galego de Saúde, c/Rosalía Castro 21-23, 36201, Vigo, Spain.
Rosa Magallón-BotayaFacultad de Medicina, Universidad de Zaragoza, c/ Domingo Miral s/n, 50009, Zaragoza, Spain.
Juan-Ángel BellónInstituto de Investigación Biomédica de Málaga (IBIMA), Hospital Civil Pabellón 5. 2a Planta, Plaza del Hospital Civil, s/n, 29009, Málaga, Spain.
Rafel RamosUnitat 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.
Alvaro Sanchez-PerezPrimary 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.
Patricia Moreno-PeralInstituto de Investigación Biomédica de Málaga (IBIMA), Hospital Civil Pabellón 5. 2a Planta, Plaza del Hospital Civil, s/n, 29009, Málaga, Spain.
Alfonso LeivaUnitat de Recerca, Atenció Primaria de Mallorca, Servei de Salut de les Illes Balears, C/Escola Graduada 3, 07002, Palma, Spain.
Clara González-FormosoInstituto de Investigación Sanitaria Galicia Sur, Hospital Álvaro Cunqueiro, Bloque Técnico, Planta 2, Carretera Clara Campoamor n° 341, Beade, 36213, Vigo, Spain.
Bonaventura BolíbarFundació 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.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis 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.

methodsA 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.

results14.5% 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.

conclusionsCompared 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 registrationClinicalTrials.gov , NCT03136211 . Registered 2 May 2017, "retrospectively registered".

Indexed as

Diet, HealthySmoking CessationAdultAgedExerciseHealth BehaviorHealth PromotionHumansMiddle AgedPrimary Health CareHealth behaviourHealth promotionHybrid trialImplementation scienceMediterranean dietPhysical activityPrimary health careSmoking cessation

Identifiers

PMID34863136
PMCPMC8642878

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.