Complex Multiple Risk Behavior Intervention in People Between 45 to 75 Years (EIRA Study)

NCT03136211 | Completed

• 3 other identifiers: 4R15/032PI15/00114SLT002/16/00112
• Study Type: interventional
• Target: 3,062
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines the effectiveness and the costs of a complex multiple risk behavior intervention to promote healthy behaviors in people aged between 45 and 75 years attended in Primary Health Care services. This intervention aims to reduce tobacco use, to enhance adherence to the Mediterranean dietary pattern and to increase physical activity. The study also seeks to provide evidence on the strategies to integrate health promotion into the usual clinical practice of primary care providers.

Conditions

Health Behavior; Health Promotion; Primary Health Care; Implementation Research; Smoking Cessation; Mediterranean Diet; Physical Activity

Outcome Measures

Primary Outcomes (13)

• Effectiveness: Positive change in baseline eating behavior

  Adherence to the Mediterranean dietary pattern in low adherence people. For the evaluation, the 14-item Questionnaire of Mediterranean diet adherence (PREDIMED study) will be used.

  at the study entry and at 12 months

• Effectiveness: Positive change in baseline physical activity behavior

  Sufficient physical activity in insufficiently active people. For the evaluation, the "International Physical Questionnaire (IPAQ)" will be used.

  at the study entry and at 12 months

• Effectiveness: Positive change in baseline smoking behavior

  Smoking cessation in smokers. For the evaluation, the interview will be used and the cooximetry (optional).

  at the study entry and at 12 months

• Implementation: adoption

  Proportion of professionals who express their willingness to participate in the study between of total of potential professionals.

  Within 2 months prior to the start of the intervention

• Implementation: early acceptability

  They will be evaluated in professionals and participants by means of a survey.

  Within 2 months prior to the start of the intervention

• Implementation: final acceptability

  They will be evaluated in professionals and participants by means of a survey. What is more, discussion groups will be held at the end of the intervention with the professionals and participants.

  at 12 months post intervention

• Implementation: early appropriateness

  They will be evaluated in professionals and participants by means of a survey.

  Within 2 months prior to the start of the intervention

• Implementation: final appropriateness

  They will be evaluated in professionals and participants by means of a survey. What is more, discussion groups will be held at the end of the intervention with the professionals and participants.

  at 12 months post intervention

• Implementation: Cost of time invested in training and organizational meetings

  Cost of time invested in training and organizational meetings to carry out the intervention.

  at 12 months post intervention

• Implementation: feasibility

  On the basis of the calculation of participation, recruitment and retention rate.

  at 12 months post intervention

• Implementation: fidelity of the motivational interview technique

  The quality of the motivational interview will be evaluated through videotapes of visits to simulated patients through the "motivational interviewing assessment scale".

  Within 2 months prior to the start of the intervention

• Implementation: fidelity of the planned intervention

  The degree of compliance of the activities recorded in the case report form will be analyzed.

  at 12 months post intervention

• Implementation: penetration

  The proportion of professionals who have integrated the intervention into their usual clinical practice within six months of the end of intervention.

  Within six months of the end of intervention

Secondary Outcomes (4)

• Effectiveness: Beginning or making of a behavior change

  at the study entry and at 12 months

• Effectiveness: Change from baseline on arterial stiffness at 12 months

  at the study entry and at 12 months.

• Change from baseline on health-related quality of life

  at the study entry and at 12 months.

• Change from baseline on costs of number visits, diagnostic tests, community resources used and loss of productivity

  at the study entry and at 12 months.

Other Outcomes (11)

• Effectiveness: Reduction of the cardiovascular risk

  at the study entry and at 12 months

• Effectiveness: Reduction of the risk of depression

  at the study entry and at 12 months

• Effectiveness:change from baseline on body mass index

  at the study entry and at 12 months.

Study Arms (2)

EIRA intervention

EXPERIMENTAL

EIRA intervention It is based on the Transtheoretical Model (TTM) and States of Change and it is made by physicians and nurses in routine care of primary care practices according to the conceptual framework of the "5A": Ask, Advise, Assess, Assist, and Arrange. It consists of a first visit of screening ("Ask"). Subsequently, the professional develops a personalized plan that is negotiated with the participant ("Advise" and "Assess"). This plan is reviewed during successive visits and positive changes are reinforced and new objectives are negotiated ("Assist" and "Arrange"). The motivational interview is the essential tool of the intervention. The intervention is carried out to different levels: individual, group and community.

Behavioral: EIRA intervention

Usual care

NO INTERVENTION

Health providers of this group integrate in their practice the recommendations of the Program of Preventive Activities and Health Promotion (PAPPS)". These guidelines are based on systematic screening and brief advice for the prevention of cardiovascular and mental diseases and cancer as well as vaccine recommendations.

Interventions

EIRA intervention BEHAVIORAL

Individual intervention has an average intensity between 2 and 3 visits; if necessary, professionals have the freedom to make a greater number of visits. Group intervention is carried out through health education workshops. These workshops take place 15-20 days after initiating the individual intervention and they are conducted by primary care providers in the health center. A group of 12-15 people attend in each workshop. Community intervention focuses mainly on the social prescription of resources and activities that are carried out in the community where the participant person resides. In addition the intervention has the support of information and communication technologies, such as a web addressed to the participant, a mobile app or the sending personalized text messages.

EIRA intervention

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People who carry out 2 or more of the following unhealthy behaviors: tobacco consumption, low adherence to the Mediterranean dietary pattern or insufficient physical activity. In addition, they must have a professional provider of the health center assigned and voluntarily agree to participate.

You may not qualify if:

• Advanced serious illnesses
• Cognitive impairment
• Dependence in basic everyday activities
• Severe mental illness
• People included in a long term home health care program
• People in treatment for cancer
• People in end-of-life care

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Instituto de Salud Carlos III: collaborator
• Department of Health, Generalitat de Catalunya: collaborator
• Parc Sanitari Sant Joan de Déu: collaborator
• Sanidad de Castilla y León: collaborator
• Servei de Salut de les Illes Balears: collaborator
• Institut Català de la Salut: collaborator
• Servicio Aragones De Salud: collaborator
• Osakidetza: collaborator
• Andaluz Health Service: collaborator
• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: collaborator
• Servicio Gallego de Salud: collaborator

Study Sites (1)

IDIAP Jordi Gol

Barcelona, Spain

Location

Related Publications (33)

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• Ramos R, Baena-Diez JM, Quesada M, Solanas P, Subirana I, Sala J, Alzamora M, Fores R, Masia R, Elosua R, Grau M, Cordon F, Pera G, Rigo F, Marti R, Ponjoan A, Cerezo C, Brugada R, Marrugat J. Derivation and validation of REASON: a risk score identifying candidates to screen for peripheral arterial disease using ankle brachial index. Atherosclerosis. 2011 Feb;214(2):474-9. doi: 10.1016/j.atherosclerosis.2010.11.015. Epub 2010 Nov 19.

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• Rubio-Valera M, Pons-Vigues M, Martinez-Andres M, Moreno-Peral P, Berenguera A, Fernandez A. Barriers and facilitators for the implementation of primary prevention and health promotion activities in primary care: a synthesis through meta-ethnography. PLoS One. 2014 Feb 28;9(2):e89554. doi: 10.1371/journal.pone.0089554. eCollection 2014.

  PMID: 24586867 RESULT

• Zabaleta-del-Olmo E, Bolibar B, Garcia-Ortiz L, Garcia-Campayo J, Llobera J, Bellon JA, Ramos R. Building interventions in primary health care for long-term effectiveness in health promotion and disease prevention. A focus on complex and multi-risk interventions. Prev Med. 2015 Jul;76 Suppl:S1-4. doi: 10.1016/j.ypmed.2015.03.011. Epub 2015 Mar 14. No abstract available.

  PMID: 25778858 RESULT

• Fernandez A, Moreno-Peral P, Zabaleta-del-Olmo E, Bellon JA, Aranda-Regules JM, Luciano JV, Serrano-Blanco A, Rubio-Valera M. Is there a case for mental health promotion in the primary care setting? A systematic review. Prev Med. 2015 Jul;76 Suppl:S5-11. doi: 10.1016/j.ypmed.2014.11.019. Epub 2014 Dec 2.

  PMID: 25475684 RESULT

• Garcia-Campayo J, del Hoyo YL, Valero MS, Yus MC, Esteban EA, Guedea MP, Botaya RM. Primary prevention of anxiety disorders in primary care: A systematic review. Prev Med. 2015 Jul;76 Suppl:S12-5. doi: 10.1016/j.ypmed.2014.10.015. Epub 2014 Oct 16.

  PMID: 25456801 RESULT

• Gili M, Vicens C, Roca M, Andersen P, McMillan D. Interventions for preventing relapse or recurrence of depression in primary health care settings: A systematic review. Prev Med. 2015 Jul;76 Suppl:S16-21. doi: 10.1016/j.ypmed.2014.07.035. Epub 2014 Sep 3.

  PMID: 25192769 RESULT

• Bellon JA, Moreno-Peral P, Motrico E, Rodriguez-Morejon A, Fernandez A, Serrano-Blanco A, Zabaleta-del-Olmo E, Conejo-Ceron S. Effectiveness of psychological and/or educational interventions to prevent the onset of episodes of depression: A systematic review of systematic reviews and meta-analyses. Prev Med. 2015 Jul;76 Suppl:S22-32. doi: 10.1016/j.ypmed.2014.11.003. Epub 2014 Nov 20.

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• Alvarez-Bueno C, Rodriguez-Martin B, Garcia-Ortiz L, Gomez-Marcos MA, Martinez-Vizcaino V. Effectiveness of brief interventions in primary health care settings to decrease alcohol consumption by adult non-dependent drinkers: a systematic review of systematic reviews. Prev Med. 2015 Jul;76 Suppl:S33-8. doi: 10.1016/j.ypmed.2014.12.010. Epub 2014 Dec 13.

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• Maderuelo-Fernandez JA, Recio-Rodriguez JI, Patino-Alonso MC, Perez-Arechaederra D, Rodriguez-Sanchez E, Gomez-Marcos MA, Garcia-Ortiz L. Effectiveness of interventions applicable to primary health care settings to promote Mediterranean diet or healthy eating adherence in adults: A systematic review. Prev Med. 2015 Jul;76 Suppl:S39-55. doi: 10.1016/j.ypmed.2014.12.011. Epub 2014 Dec 16.

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• Sanchez A, Bully P, Martinez C, Grandes G. Effectiveness of physical activity promotion interventions in primary care: A review of reviews. Prev Med. 2015 Jul;76 Suppl:S56-67. doi: 10.1016/j.ypmed.2014.09.012. Epub 2014 Sep 26.

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• Alvarez-Bueno C, Cavero-Redondo I, Martinez-Andres M, Arias-Palencia N, Ramos-Blanes R, Salcedo-Aguilar F. Effectiveness of multifactorial interventions in primary health care settings for primary prevention of cardiovascular disease: A systematic review of systematic reviews. Prev Med. 2015 Jul;76 Suppl:S68-75. doi: 10.1016/j.ypmed.2014.11.028. Epub 2014 Dec 12.

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• Bully P, Sanchez A, Zabaleta-del-Olmo E, Pombo H, Grandes G. Evidence from interventions based on theoretical models for lifestyle modification (physical activity, diet, alcohol and tobacco use) in primary care settings: A systematic review. Prev Med. 2015 Jul;76 Suppl:S76-93. doi: 10.1016/j.ypmed.2014.12.020. Epub 2015 Jan 5.

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• March S, Torres E, Ramos M, Ripoll J, Garcia A, Bulilete O, Medina D, Vidal C, Cabeza E, Llull M, Zabaleta-del-Olmo E, Aranda JM, Sastre S, Llobera J. Adult community health-promoting interventions in primary health care: A systematic review. Prev Med. 2015 Jul;76 Suppl:S94-104. doi: 10.1016/j.ypmed.2015.01.016. Epub 2015 Jan 24.

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• Moreno-Peral P, Conejo-Ceron S, Fernandez A, Berenguera A, Martinez-Andres M, Pons-Vigues M, Motrico E, Rodriguez-Martin B, Bellon JA, Rubio-Valera M. Primary care patients' perspectives of barriers and enablers of primary prevention and health promotion-a meta-ethnographic synthesis. PLoS One. 2015 May 4;10(5):e0125004. doi: 10.1371/journal.pone.0125004. eCollection 2015.

  PMID: 25938509 RESULT

• Martin Cantera C, Puigdomenech E, Ballve JL, Arias OL, Clemente L, Casas R, Roig L, Perez-Tortosa S, Diaz-Gete L, Granollers S. Effectiveness of multicomponent interventions in primary healthcare settings to promote continuous smoking cessation in adults: a systematic review. BMJ Open. 2015 Oct 1;5(10):e008807. doi: 10.1136/bmjopen-2015-008807.

  PMID: 26428333 RESULT

• Berenguera A, Pons-Vigues M, Moreno-Peral P, March S, Ripoll J, Rubio-Valera M, Pombo-Ramos H, Asensio-Martinez A, Bolanos-Gallardo E, Martinez-Carazo C, Maderuelo-Fernandez JA, Martinez-Andres M, Pujol-Ribera E. Beyond the consultation room: Proposals to approach health promotion in primary care according to health-care users, key community informants and primary care centre workers. Health Expect. 2017 Oct;20(5):896-910. doi: 10.1111/hex.12530. Epub 2017 Jan 24.

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• Pons-Vigues M, Berenguera A, Coma-Auli N, March S, Pombo H, Masluk B, Pulido-Fuentes M, Rodriguez C, Bellon JA, Pujol-Ribera E. Qualitative evaluation of a complex intervention to implement health promotion activities according to healthcare attendees and health professionals: EIRA study (phase II). BMJ Open. 2019 Mar 23;9(3):e023872. doi: 10.1136/bmjopen-2018-023872.

  PMID: 30904842 RESULT

• Pons-Vigues M, Berenguera A, Coma-Auli N, Pombo-Ramos H, March S, Asensio-Martinez A, Moreno-Peral P, Mora-Simon S, Martinez-Andres M, Pujol-Ribera E. Health-care users, key community informants and primary health care workers' views on health, health promotion, health assets and deficits: qualitative study in seven Spanish regions. Int J Equity Health. 2017 Jun 13;16(1):99. doi: 10.1186/s12939-017-0590-2.

  PMID: 28610633 RESULT

• Zabaleta-Del-Olmo E, Pombo H, Pons-Vigues M, Casajuana-Closas M, Pujol-Ribera E, Lopez-Jimenez T, Cabezas-Pena C, Martin-Borras C, Serrano-Blanco A, Rubio-Valera M, Llobera J, Leiva A, Vicens C, Vidal C, Campinez M, Martin-Alvarez R, Maderuelo JA, Recio JI, Garcia-Ortiz L, Motrico E, Bellon JA, Moreno-Peral P, Martin-Cantera C, Claveria A, Aldecoa-Landesa S, Magallon-Botaya R, Bolibar B. 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. BMC Public Health. 2018 Jul 13;18(1):874. doi: 10.1186/s12889-018-5805-y.

  PMID: 30005705 RESULT

• Sanchez-Recio R, Olivan-Blazquez B, Mendez-Lopez F, Gascon-Santos S, Marti-Lluch R, Zabaleta-Del-Olmo E, Tamayo-Morales O, Maderuelo-Fernandez JA, Casajuana M, Lopez-Jimenez T, Motrico E, Gomez-Gomez I, Sanchez-Perez A, Rodero-Cosano ML, Llobera J, Bellon JA, Moreno-Peral P, Bolibar B, Recio-Rodriguez JI, Ramos R, Claveria A. Self-reported health and depression among EIRA cohort: a moderated mediation model of sex and perceived social support. Front Psychol. 2025 Jun 13;16:1540530. doi: 10.3389/fpsyg.2025.1540530. eCollection 2025.

  PMID: 40584072 DERIVED

• Gomez-Gomez I, Motrico E, Moreno-Peral P, Casajuana-Closas M, Lopez-Jimenez T, Zabaleta-Del-Olmo E, Claveria A, LLobera J, Marti-Lluch R, Ramos R, Maderuelo-Fernandez JA, Vicens C, Dominguez-Garcia M, Bartolome-Moreno C, Recio-Rodriguez JI, Bellon JA. A multiple health behaviour change intervention to prevent depression: A randomized controlled trial. Gen Hosp Psychiatry. 2023 May-Jun;82:86-94. doi: 10.1016/j.genhosppsych.2023.02.004. Epub 2023 Feb 22.

  PMID: 37001428 DERIVED

• Recio-Rodriguez JI, Garcia-Ortiz L, Garcia-Yu IA, Lugones-Sanchez C, Olmo EZ, Bolibar B, Casajuana-Closas M, Lopez-Jimenez T, Llobera J, Ramos R, Pombo H, Motrico E, Gil-Girbau M, Lopez-Mendez F, Represas-Carrera F, Maderuelo-Fernandez JA. Effectiveness of a multiple health-behaviour-change intervention in increasing adherence to the Mediterranean Diet in adults (EIRA study): a randomized controlled hybrid trial. BMC Public Health. 2022 Nov 19;22(1):2127. doi: 10.1186/s12889-022-14590-y.

  PMID: 36401247 DERIVED

• Zabaleta-Del-Olmo E, Casajuana-Closas M, Lopez-Jimenez T, Pombo H, Pons-Vigues M, Pujol-Ribera E, Cabezas-Pena C, Llobera J, Marti-Lluch R, Vicens C, Motrico E, Gomez-Gomez I, Maderuelo-Fernandez JA, Recio-Rodriguez JI, Masluk B, Contreras-Martos S, Jacques-Avino C, Aznar-Lou I, Gil-Girbau M, Claveria A, Magallon-Botaya R, Bellon JA, Ramos R, Sanchez-Perez A, Moreno-Peral P, Leiva A, Gonzalez-Formoso C, Bolibar B. 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. BMC Public Health. 2021 Dec 4;21(1):2208. doi: 10.1186/s12889-021-11982-4.

  PMID: 34863136 DERIVED

• Aznar-Lou I, Zabaleta-Del-Olmo E, Casajuana-Closas M, Sanchez-Vinas A, Parody-Rua E, Bolibar B, Iracheta-Todo M, Bulilete O, Lopez-Jimenez T, Pombo-Ramos H, Martin Miguel MV, Magallon-Botaya R, Maderuelo-Fernandez JA, Motrico E, Bellon J, Marti-Lluch R, Rubio-Valera M, Serrano-Blanco A. Cost-effectiveness analysis of a multiple health behaviour change intervention in people aged between 45 and 75 years: a cluster randomized controlled trial in primary care (EIRA study). Int J Behav Nutr Phys Act. 2021 Jul 2;18(1):88. doi: 10.1186/s12966-021-01144-5.

  PMID: 34215275 DERIVED

MeSH Terms

Conditions

Health Behavior; Smoking Cessation; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Bonaventura Bolibar-Ribas, MD MSc

  Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: redIAPP Coordinator

Model Details: Cluster randomized controlled trial

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: May 2, 2017
• Study Start: January 15, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)