Effectiveness of a multiple health-behaviour-change intervention in increasing adherence to the Mediterranean Diet in adults (EIRA study): a randomized controlled hybrid trial.

BACKGROUND: The present study describes the effectiveness of a complex intervention that addresses multiple lifestyles to promote healthy behaviours in increasing adherence to the Mediterranean diet (MD).  METHODS: Cluster-randomised, hybrid clinical trial controlled with two parallel groups. The study was carried out in 26 primary Spanish healthcare centres. People aged 45-75 years who presented at least two of the following criteria were included: smoker, low adherence to the MD or insufficient level of physical activity. The intervention group (IG) had three different levels of action: individual, group, and community, with the aim of acting on the behaviours related to smoking, diet and physical activity at the same time. The individual intervention included personalised recommendations and agreements on the objectives to attain. Group sessions were adapted to the context of each healthcare centre. The community intervention was focused on the social prescription of resources and activities performed in the environment of the community of each healthcare centre. Control group (CG) received brief advice given in the usual visits to the doctor's office. The primary outcome was the change, after 12 months, in the number of participants in each group with good adherence to the MD pattern. Secondary outcomes included the change in the total score of the MD adherence score (MEDAS) and the change in some cardiovascular risk factors. RESULTS: Three thousand sixty-two participants were included (IG = 1,481, CG = 1,581). Low adherence to the MD was present in 1,384 (93.5%) participants, of whom 1,233 initiated the intervention and conducted at least one individual visit with a healthcare professional. A greater increase (13.7%; 95% CI, 9.9-17.5; p < 0.001) was obtained by IG in the number of participants who reached 9 points or more (good adherence) in the MEDAS at the final visit. Moreover, the effect attributable to the intervention obtained a greater increase (0.50 points; 95% CI, 0.35 to 0.66; p < 0.001) in IG. CONCLUSIONS: A complex intervention modelled and carried out by primary healthcare professionals, within a real clinical healthcare context, achieved a global increase in the adherence to the MD compared to the brief advice. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03136211. Retrospectively registered on 02/05/2017 https://clinicaltrials.gov/ct2/show/NCT03136211.

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".

Effectiveness of a Multicomponent Intervention in Primary Care That Addresses Patients with Diabetes Mellitus with Two or More Unhealthy Habits, Such as Diet, Physical Activity or Smoking: Multicenter Randomized Cluster Trial (EIRA Study).

Introduction: We evaluated the effectiveness of an individual, group and community intervention to improve the glycemic control of patients with diabetes mellitus aged 45-75 years with two or three unhealthy life habits. As secondary endpoints, we evaluated the inverventions' effectiveness on adhering to Mediterranean diet, physical activity, sedentary lifestyle, smoking and quality of life. Method: A randomized clinical cluster (health centers) trial with two parallel groups in Spain from January 2016 to December 2019 was used. Patients with diabetes mellitus aged 45-75 years with two unhealthy life habits or more (smoking, not adhering to Mediterranean diet or little physical activity) participated. Centers were randomly assigned. The sample size was estimated to be 420 people for the main outcome variable. Educational intervention was done to improve adherence to Mediterranean diet, physical activity and smoking cessation by individual, group and community interventions for 12 months. Controls received the usual health care. The outcome variables were: HbA1c (main), the Mediterranean diet adherence score (MEDAS), the international diet quality index (DQI-I), the international physical activity questionnaire (IPAQ), sedentary lifestyle, smoking ≥1 cigarette/day and the EuroQuol questionnaire (EVA-EuroQol5D5L). Results: In total, 13 control centers (n = 356) and 12 intervention centers (n = 338) were included with similar baseline conditions. An analysis for intention-to-treat was done by applying multilevel mixed models fitted by basal values and the health center: the HbA1c adjusted mean difference = -0.09 (95% CI: -0.29-0.10), the DQI-I adjusted mean difference = 0.25 (95% CI: -0.32-0.82), the MEDAS adjusted mean difference = 0.45 (95% CI: 0.01-0.89), moderate/high physical activity OR = 1.09 (95% CI: 0.64-1.86), not living a sedentary lifestyle OR = 0.97 (95% CI: 0.55-1.73), no smoking OR = 0.61 (95% CI: 0.54-1.06), EVA adjusted mean difference = -1.26 (95% CI: -4.98-2.45). Conclusions: No statistically significant changes were found for either glycemic control or physical activity, sedentary lifestyle, smoking and quality of life. The multicomponent individual, group and community interventions only showed a statistically significant improvement in adhering to Mediterranean diet. Such innovative interventions need further research to demonstrate their effectiveness in patients with poor glycemic control.

Qualitative evaluation of a complex intervention to implement health promotion activities according to healthcare attendees and health professionals: EIRA study (phase II).

OBJECTIVE: To evaluate the implementation and development of a complex intervention on health promotion and changes in health-promoting behaviours in primary healthcare according to healthcare attendees and health professionals. DESIGN: Descriptive qualitative evaluation research conducted with 94 informants. Data collection techniques consisted of 14 semistructured individual interviews, 9 discussion groups, 1 triangular group and 6 documents. Three analysts carried out a thematic content analysis with the support of Atlas.ti software. This evaluation was modelled on Proctor and colleagues' concept of outcomes for implementation research. SETTING: 7 primary care centres from seven Spanish regions: Andalusia, Aragon, Balearic Islands, Basque Country, Castilla-La Mancha, Castilla-Leon and Catalonia. PARTICIPANTS: The study population were healthcare attendees (theoretical sampling) and health professionals (opportunistic sampling) who had participated in the exploratory trial of the EIRA intervention (2015). RESULTS: Healthcare attendees and professionals had a positive perception of the study. Healthcare attendees even reported that they would recommend participation to family and friends. Health professionals became aware of the significance of the motivational interview, especially for health promotion, and emphasised social prescribing of physical activity. They also put forward recommendations to improve recruitment, screening and retention of participants. Healthcare attendees modified behaviours and health professionals modified working practices. To achieve sustainability, health professionals believe that it is crucial to adapt agendas and involve all the staff. CONCLUSIONS: The discourses of all stakeholders on the intervention must be taken into consideration for the successful, setting-specific implementation of adequate, acceptable, equitable and sustainable strategies aimed at health promotion and well-being.

Correction to: 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.

It has been highlighted the original article (1) contained a typesetting mistake in the authorship, and that author Caterine Vicens was omitted.

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.

Collaborative modeling of an implementation strategy: a case study to integrate health promotion in primary and community care.

BACKGROUND: Evidence-based interventions are more likely to be adopted if practitioners collaborate with researchers to develop an implementation strategy. This paper describes the steps to plan and execute a strategy, including the development of structure and supports needed for implementing proven health promotion interventions in primary and community care. RESULTS: Between 10 and 13 discussion and consensus sessions were performed in four highly-motivated primary health care centers involving 80% of the primary care staff and 21 community-based organizations. All four centers chose to address physical activity, diet, and smoking. They selected the 5 A's evidence-based clinical intervention to be adapted to the context of the health centers. The planned implementation strategy worked at multiple levels: bottom-up primary care organizational change, top-down support from managers, community involvement, and the development of innovative e-health information and communication tools. Shared decision making and practice facilitation were perceived as the most positive aspects of the collaborative modeling process, which took more time than expected, especially the development of the new e-health tools integrated into electronic health records. CONCLUSIONS: Collaborative modeling of an implementation strategy for the integration of health promotion in primary and community care was feasible in motivated centers. However, it was difficult, being hindered by the heavy workload in primary care and generating uncertainty inherent to a bottom-up decision making processes. Lessons from this experience could be useful in diverse settings and for other clinical interventions. Two companion papers report the evaluation of its feasibility and assess quantitatively and qualitatively the implementation process.

Efficiency of "Prescribe Vida Saludable", a health promotion innovation. Pilot phase / Eficiencia de «Prescribe Vida Saludable», una innovación de promoción de la salud. Fase piloto

Objective: "Prescribe Vida Saludable" (PVS) is an organisational innovation designed to optimise the promotion of multiple healthy habits in primary healthcare. It aims to estimate the cost effectiveness and cost-utility of prescribing physical activity in the pilot phase of the PVS programme, compared to the routine clinical practice of promoting physical activity in primary healthcare. Methods: An economic evaluation of the quasi-experimental pilot phase of PVS was carried out. In the four control centres, a systematic sample was selected of 194 patients who visited the centre in a single year and who did not comply with physical activity recommendations. In the four intervention centres, 122 patients who received their first physical activity prescription were consecutively enrolled. The costs were evaluated from the perspective of the PVS programme using bottom-up methodology. The effectiveness (proportion of patients who changed their physical activity) as well as the utility were evaluated at baseline and after 3 months. The incremental cost-utility ratio (ICUR) and the incremental cost-effectiveness ratio (ICER) were calculated and a sensitivity analysis was performed with bootstrapping and 1,000 replications. Results: Information was obtained from 35% of control cases and 62% of intervention cases. The ICUR was Euros1,234.66/Quality Adjusted Life Years (QALY) and the ICER was Euros4.12. In 98.3% of the simulations, the ICUR was below the Euros30,000/QALY threshold. Conclusions: The prescription of physical activity was demonstrably within acceptable cost-utility limits in the pilot PVS phase, even from a conservative perspective (AU)

Objetivo: Prescribe Vida Saludable (PVS) es una innovación organizativa para optimizar la promoción de múltiples hábitos saludables en atención primaria. El objetivo es estimar el coste-efectividad y el coste-utilidad de la prescripción de actividad física en el pilotaje del programa PVS, respecto a la práctica clínica habitual de promoción de la actividad física en atención primaria. Métodos: Se llevó a cabo una evaluación económica del pilotaje cuasi experimental PVS. En los cuatro centros de control se seleccionó una muestra sistemática de 194 pacientes que visitaron el centro durante 1 año y que no cumplían las recomendaciones de actividad física. En los cuatro centros de intervención se captaron consecutivamente 122 pacientes que recibieron la primera prescripción de actividad física. Los costes se evaluaron desde la perspectiva del programa PVS con la metodología bottom-up. Tanto la efectividad (proporción de pacientes que modificaron su actividad física) como la utilidad fueron evaluadas basalmente y a los 3 meses. Se calcularon la razón de coste-utilidad incremental (RCUI) y la razón de coste-efectividad incremental (RCEI), y se realizó el análisis de sensibilidad con bootstrapping con 1000 repeticiones. Resultados: Se obtuvo información de un 35% de los casos control y de un 62% de los casos con intervención. La RCUI fue de 1234,66 Euros por año de vida ajustado por calidad (AVAC) y la RCEI fue de 4,12 Euros. En un 98,3% de las simulaciones el RCUI estuvo por debajo del umbral de 30.000 Euros/AVAC. Conclusiones: La prescripción de actividad física se muestra en unos límites aceptables de coste-utilidad en el pilotaje de PVS, incluso desde una perspectiva conservadora (AU)

Efficiency of "Prescribe Vida Saludable", a health promotion innovation. Pilot phase.

OBJECTIVE: "Prescribe Vida Saludable" (PVS) is an organisational innovation designed to optimise the promotion of multiple healthy habits in primary healthcare. It aims to estimate the cost effectiveness and cost-utility of prescribing physical activity in the pilot phase of the PVS programme, compared to the routine clinical practice of promoting physical activity in primary healthcare. METHODS: An economic evaluation of the quasi-experimental pilot phase of PVS was carried out. In the four control centres, a systematic sample was selected of 194 patients who visited the centre in a single year and who did not comply with physical activity recommendations. In the four intervention centres, 122 patients who received their first physical activity prescription were consecutively enrolled. The costs were evaluated from the perspective of the PVS programme using bottom-up methodology. The effectiveness (proportion of patients who changed their physical activity) as well as the utility were evaluated at baseline and after 3 months. The incremental cost-utility ratio (ICUR) and the incremental cost-effectiveness ratio (ICER) were calculated and a sensitivity analysis was performed with bootstrapping and 1,000 replications. RESULTS: Information was obtained from 35% of control cases and 62% of intervention cases. The ICUR was €1,234.66/Quality Adjusted Life Years (QALY) and the ICER was €4.12. In 98.3% of the simulations, the ICUR was below the €30,000/QALY threshold. CONCLUSIONS: The prescription of physical activity was demonstrably within acceptable cost-utility limits in the pilot PVS phase, even from a conservative perspective.

The implementation of health promotion in primary and community care: a qualitative analysis of the 'Prescribe Vida Saludable' strategy.

BACKGROUND: The impact of lifestyle on health is undeniable and effective healthy lifestyle promotion interventions do exist. However, this is not a fundamental part of routine primary care clinical practice. We describe factors that determine changes in performance of primary health care centers involved in piloting the health promotion innovation 'Prescribe Vida Saludable' (PVS) phase II. METHODS: We engaged four primary health care centers of the Basque Healthcare Service in an action research project aimed at changing preventive health practices. Prescribe Healthy Life (PVS from the Spanish "Prescribe Vida Saludable) is focused on designing, planning, implementing and evaluating innovative programs to promote multiple healthy habits, feasible to be performed in routine primary health care conditions. After 2 years of piloting, centers were categorized as having high, medium, or low implementation effectiveness. We completed qualitative inductive and deductive analysis of five focus groups with the staff of the centers. Themes generated through consensual grounded qualitative analysis were compared between centers to identify the dimensions that explain the variation in actual implementation of PVS, and retrospectively organized and assessed against the Consolidated Framework for Implementation Research (CFIR). RESULTS: Of the 36 CFIR constructs, 11 were directly related to the level of implementation performance: intervention source, evidence strength and quality, adaptability, design quality and packaging, tension for change, learning climate, self-efficacy, planning, champions, executing, and reflecting and evaluating, with -organizational tracking added as a new sub-construct. Additionally, another seven constructs emerged in the participants' discourse but were not related to center performance: relative advantage, complexity, patients' needs and resources, external policy and incentives, structural characteristics, available resources, and formally appointed internal implementation leaders. Our findings indicate that the success of the implementation seems to be associated with the following components: the context, the implementation process, and the collaborative modelling. CONCLUSIONS: Identifying barriers and enablers is useful for designing implementation strategies for health promotion in primary health care centers that are essential for innovation success. An implementation model is proposed to highlight the relationships between the CFIR constructs in the context of health promotion in primary care.

Feasibility of an implementation strategy for the integration of health promotion in routine primary care: a quantitative process evaluation.

BACKGROUND: Process evaluation is recommended to improve the understanding of underlying mechanisms related to clinicians, patients, context and intervention delivery that may impact on trial or program results, feasibility and transferability to practice. The aim of this study was to assess the feasibility of the Prescribe Healthy Life (PVS from the Spanish "Prescribe Vida Saludable") implementation strategy for enhancing the adoption and implementation of an evidence-based health promotion intervention in primary health care. METHODS: A descriptive study of 2-year implementation indicators for the PVS clinical intervention was conducted in four primary health care centers. A multifaceted collaborative modeling implementation strategy was developed to enhance the integration of a clinical intervention to promote healthy lifestyles into clinical practice. Process indicators were assessed for intervention reach, adoption, implementation, sustainability and their variability at center, practice, and patient levels. RESULTS: Mean rates of adoption by means of active collaboration among the three main professional categories (family physicians, nurses and administrative personnel) were 75% in all centers. Just over half of the patients that attended (n = 11650; 51.9%) were reached in terms of having their lifestyle habits assessed, while more than a third (33.7%; n = 7433) and almost 10% (n = 2175) received advice or a printed prescription for at least one lifestyle change, respectively. Only 3.7% of the target population received a repeat prescription. These process indicators significantly (p < 0.001) varied by center, lifestyle habit and patient characteristics. Sustainability of intervention components changed thorough the implementation period within centers. CONCLUSIONS: The implementation strategy used showed moderate-to-good performance on process indicators related to adoption, reach, and implementation of the evidence-based healthy lifestyle promotion intervention in the context of routine primary care. Sources of heterogeneity and instability in these indicators may improve our understanding of factors required to attain adequate program adoption and implementation through improved implementation strategies.

Metric properties of the "prescribe healthy life" screening questionnaire to detect healthy behaviors: a cross-sectional pilot study.

BACKGROUND: Feasible and valid assessment of healthy behaviors is the first step for integrating health promotion in routine primary care. Therefore, the aim of this study was to develop and evaluate the validity and reliability of the "prescribe healthy life" screening questionnaire, a brief tool for detecting physical activity levels, consumption of fruit and vegetables, tobacco use and patients' compliance with minimal recommendations. METHODS: An observational cross-sectional study to determine the reliability and validity of this questionnaire by means of mixed (qualitative and quantitative) methods. Thirteen healthcare professionals designed the questionnaire. One hundred and twenty-six patients from three primary care health centers within Osakidetza (Basque Health Service, Spain) filled in the "Prescribe Healthy Life" Screening Questionnaire and completed an accelerometry record, the PREDIMED Food Frequency Questionnaire and a co-oximetry as gold standards for physical activity, dietary intake and tobacco use, respectively. Correlations, sensitivities, specificities, likelihood ratios and test-retest reliability were calculated. Additionally, the feasibility and utility of the questionnaire were evaluated. RESULTS: Both reliability and concurrent validity for the consumption of fruit and vegetables (rspearman = 0.59, rspearman = 0.50) and tobacco use (rspearman = 0.76, r = 0.69) as their overall performance in the detection of unhealthy diet (accuracy = 76.8%, LR + = 3.1 and LR- = 0.31) and smokers (accuracy = 86.8%, LR + = 6.1 and LR- = 0.05) were good. Meanwhile, the reproducibility (0.38), the correlation between the minutes of physical activity (0.34) and LR+ (1.00) for detection of physical activity were low. On average the questionnaire was considered by patients easy to understand, easy to fill in, short (5-6 min) and useful. CONCLUSION: The "Prescribe Healthy Life" Screening Questionnaire, PVS-SQ, has proved to be a simple and practical tool for use in the actual context of primary care, with guarantees of validity and reliability for the diet and tobacco scales. However, the physical activity scale show unsatisfactory results, and alternative questions ought to be tested.

Evidence from interventions based on theoretical models for lifestyle modification (physical activity, diet, alcohol and tobacco use) in primary care settings: A systematic review.

OBJECTIVE: To determine the effectiveness of health promotion interventions based on theoretical models of behavioral change to modify the main lifestyle factors (physical activity, diet, alcohol and tobacco) in adults receiving primary health care (PHC). METHODS: We searched the MEDLINE and Cochrane Database of Systematic Reviews from January 2000 to December 2012. Two reviewers independently performed the first screening of titles and abstracts, the methodological quality assessment using the lecturacritica.com tool, and the extraction of necessary data to systematize the available information. RESULTS: Only few studies met the inclusion criteria (17 studies from 30 articles). Thirteen were randomized controlled trials, three systematic reviews, and one observational study. The transtheoretical model was the most frequent (13 studies), and obtained strong evidence of its effectiveness for dietary interventions in the short-term and for smoking cessation interventions in the long-term as compared to usual PHC practice. Limited evidence was found for smoking cessation interventions based in the social cognitive theory. CONCLUSION: There are few studies that explicitly link intervention strategies and theories of behavioral change. A rigorous evaluation of the theoretical principles could help researchers and practitioners to understand how and why interventions succeed or fail.

Effectiveness of "primary bereavement care" for widows: a cluster randomized controlled trial involving family physicians.

Thirty-one family physicians, from 19 primary care teams in Biscay (Spain), were randomly assigned to intervention or control group. The 75 intervention family physicians, after training in primary bereavement care, saw 43 widows for 7 sessions, from the 4th to 13th month after their loss. The 16 control family physicians, without primary bereavement care training, saw 44 widows for 7 ordinary appointments, with the same schedule. Outcome measures were collected at 4, 10, 16, and 24 months after the loss. A linear mixed model was used. No significant differences were found in favor of the intervention group on grief and indeed control group widows experienced more improvement in somatisation, general health, and general emotional outcomes.

Modelling innovative interventions for optimising healthy lifestyle promotion in primary health care: "prescribe Vida Saludable" phase I research protocol.

BACKGROUND: The adoption of a healthy lifestyle, including physical activity, a balanced diet, a moderate alcohol consumption and abstinence from smoking, are associated with large decreases in the incidence and mortality rates for the most common chronic diseases. That is why primary health care (PHC) services are trying, so far with less success than desirable, to promote healthy lifestyles among patients. The objective of this study is to design and model, under a participative collaboration framework between clinicians and researchers, interventions that are feasible and sustainable for the promotion of healthy lifestyles in PHC. METHODS AND DESIGN: Phase I formative research and a quasi-experimental evaluation of the modelling and planning process will be undertaken in eight primary care centres (PCCs) of the Basque Health Service--OSAKIDETZA, of which four centres will be assigned for convenience to the Intervention Group (the others being Controls). Twelve structured study, discussion and consensus sessions supported by reviews of the literature and relevant documents, will be undertaken throughout 12 months. The first four sessions, including a descriptive strategic needs assessment, will lead to the prioritisation of a health promotion aim in each centre. In the remaining eight sessions, collaborative design of intervention strategies, on the basis of a planning process and pilot trials, will be carried out. The impact of the formative process on the practice of healthy lifestyle promotion, attitude towards health promotion and other factors associated with the optimisation of preventive clinical practice will be assessed, through pre- and post-programme evaluations and comparisons of the indicators measured in professionals from the centres assigned to the Intervention or Control Groups. DISCUSSION: There are four necessary factors for the outcome to be successful and result in important changes: (1) the commitment of professional and community partners who are involved; (2) their competence for change; (3) the active cooperation and participation of the interdisciplinary partners involved throughout the process of change; and (4) the availability of resources necessary to facilitate the change.