Experiences of smoking and tobacco use during pregnancy: A qualitative study protocol.

Tobacco use during pregnancy is the main avoidable cause of morbidity and mortality both for pregnant women and their offspring. Between 12 and 22% of pregnant women in industrialized countries smoke during pregnancy, and 13% are unable to stop smoking. Pregnancy is considered an ideal opportunity to intervene and control tobacco use among smokers and their families. However, pregnant women experience barriers to quitting smoking, including social stigma and fear of being judged. Thus, it is necessary to develop interventions for smoking cessation adapted for pregnant women. This paper presents a qualitative study protocol to assess the barriers and facilitators of smoking cessation during pregnancy that female smokers encounter or perceive. It consists of a series of focus groups and individual interviews with female smokers who have been pregnant within the last five years. Participants will be recruited from the Sexual and Reproductive Health Care Services of the Camp de Tarragona. A group of 5-10 women who have been pregnant and tried to quit smoking over the last 5 years will be selected. The data will be collected by means of semistructured interviews. All interviews will be transcribed verbatim, coded and synthesized into categories and main themes. Thematic analysis will be conducted employing an iterative and reflexive approach. The results of this study will offer new perspectives on smoking interventions for pregnant women and enhance our comprehension of the main barriers to and facilitators of smoking cessation during pregnancy. This will contribute to the adaptation of the Tobbstop app, originally designed for the general public, to suit the needs of pregnant women. Consequently, the creation of targeted interventions will positively influence the health outcomes of both pregnant women and newborns. Trial registration: Clinicaltrials.gov ID: NCT05222958. The trial was registered 3 February 2022, at https://clinicaltrials.gov/ct2/show/NCT05222958.

Effectiveness of the spirometry-based motivational intervention to quit smoking: RESET randomised trial.

BACKGROUND: The effectiveness of providing feedback on spirometry results for smoking cessation remains inconclusive according to the current evidence. OBJECTIVES: To assess the effectiveness of a motivational intervention based on spirometry results in achieving prolonged smoking abstinence (12 months post-intervention). DESIGN AND SETTING: A randomised, controlled, observer-blinded, multicentre clinical trial was conducted (from January 2012 to December 2015) in 20 primary healthcare centres in the Tarragona province, Spain. METHODS: Participants, active smokers aged 35-70 without known respiratory disease, were recruited from primary healthcare centres by family doctors and nurses. They were randomly assigned to either the intervention group (IG = 308) or the control group (CG = 306). Both groups received brief smoking cessation counselling. Additionally, the IG underwent spirometry and received detailed information about the results, including lung age. The primary outcome was prolonged abstinence, defined as lasting at least 12 months and validated through cotinine measurement in urine. RESULTS: The prolonged abstinence rate was 7.8% in the IG, compared to 2.6% in the CG (p = 0.004). At 12 months, in the multivariate analysis, the intervention was identified as an independent factor for smoking cessation (OR 2.8; 95%CI 1.2 to 7.7), a trend maintained throughout the follow-up (HR 2.74; 95%CI 1.13 to 6.62). Moreover, according to the Prochaska and DiClemente model, the preparation or action phase to quit was also associated with smoking cessation (HR 2.55, 95%CI 1.07 to 6.09). CONCLUSION: A primary care-delivered intervention involving brief counselling and detailed spirometry information proves effective in increasing abstinence rates among active smokers without known respiratory disease. Additionally, smoking cessation is also influenced by the individual's stage of change. TRIAL REGISTRATION: ClinicatTrials.gov NCT02153047.

Mediterranean Diet and Lung Function in Adults Current Smokers: A Cross-Sectional Analysis in the MEDISTAR Project.

BACKGROUND: Previous studies have shown that adherence to the Mediterranean Diet (MeDi) has a positive impact on lung function in subjects with lung disease. In subjects free of respiratory diseases, but at risk, this association is not yet well established. METHODS: Based on the reference data from the MEDISTAR clinical trial (Mediterranean Diet and Smoking in Tarragona and Reus; ISRCTN 03.362.372), an observational study was conducted with 403 middle-aged smokers without lung disease, treated at 20 centres of primary care in Tarragona (Catalonia, Spain). The degree of MeDi adherence was evaluated according to a 14-item questionnaire, and adherence was defined in three groups (low, medium, and high). Lung function were assessed by forced spirometry. Logistic regression and linear regression models were used to analyse the association between adherence to the MeDi and the presence of ventilatory defects. RESULTS: Globally, the pulmonary alteration prevalence (impaired FEV1 and/or FVC) was 28.8%, although it was lower in participants with medium and high adherence to the MeDi, compared to those with a low score (24.2% and 27.4% vs. 38.5%, p = 0.004). Logistic regression models showed a significant and independent association between medium and high adherence to the MeDi and the presence of altered lung patterns (OR 0.467 [95%CI 0.266, 0.820] and 0.552 [95%CI 0.313, 0.973], respectively). CONCLUSIONS: MeDi adherence is inversely associated with the risk impaired lung function. These results indicate that healthy diet behaviours can be modifiable risk factors to protect lung function and reinforce the possibility of a nutritional intervention to increase adherence to MeDi, in addition to promoting smoking cessation.

Effectiveness of an App for tobacco cessation in pregnant smokers (TOBBGEST): study protocol.

BACKGROUND: Tobacco consumption during pregnancy is one of the most modifiable causes of morbidity and mortality for both pregnant smokers and their foetus. Even though pregnant smokers are conscious about the negative effects of tobacco consumption, they also had barriers for smoking cessation and most of them continue smoking, being a major public health problem. The aim of this study is to determine the effectiveness of an application (App) for mobile devices, designed with a gamification strategy, in order to help pregnant smokers to quit smoking during pregnancy and in the long term. METHODS: This study is a multicentre randomized community intervention trial. It will recruit pregnant smokers (200 participants/group), aged more than 18 years, with sporadically or daily smoking habit in the last 30 days and who follow-up their pregnancy in the Sexual and Reproductive Health Care Services of the Camp de Tarragona and Central Catalonia Primary Care Departments. All the participants will have the usual clinical practice intervention for smoking cessation, whereas the intervention group will also have access to the App. The outcome measure will be prolonged abstinence at 12 months after the intervention, as confirmed by expired-carbon monoxide and urinary cotinine tests. Results will be analysed based on intention to treat. Prolonged abstinence rates will be compared, and the determining factors will be evaluated using multivariate statistical analysis. DISCUSSION: The results of this study will offer evidence about the effectiveness of an intervention using a mobile App in smoking cessation for pregnant smokers, to decrease comorbidity associated with long-term smoking. If this technology is proven effective, it could be readily incorporated into primary care intervention for all pregnant smokers. TRIAL REGISTRATION: Clinicaltrials.gov ID NCT05222958 . Trial registered 3 February 2022.

Susceptibility and risk of SARS-COV-2 infection among middle-aged and older adults in Tarragona area, Spain.

Objective: To analyse susceptibility/risk of suffering COVID-19 among adults with distinct underlying medical conditions. Methods: Population-based cohort study involving 79,083 individuals ≥50 years old in Tarragona (Southern Catalonia, Spain). Baseline cohort characteristics (demographic, pre-existing comorbidities, chronic medications and vaccinations history) were established at study start (01/03/2020) and primary outcome was laboratory-confirmed COVID-19 occurred among cohort members throughout 01/03/2020-30/06/2020. Risk of suffering COVID-19 was evaluated by Cox regression, estimating multivariable hazard ratios (HRs) adjusted for age/sex and pre-existing comorbidities. Results: Across study period, 536 laboratory-confirmed COVID-19 cases were observed (mean incidence: 39.5 cases per 100,000 persons-week). In multivariable-analysis, increasing age/years (HR: 1.01; 95% CI: 1.00-1.02), nursing-home (HR: 20.19; 95% CI: 15.98-25.51), neurological disease (HR: 1.35; 95% CI: 1.03-1.77), taking diuretics (HR: 1.39; 95% CI: 1.10-1.75), antiplatelet (HR: 1.36; 95% CI: 1.05-1.76) and benzodiazepines (HR: 1.24; 95% CI: 1.00-1.53) increased risk; conversely, taking angiotensin-converting-enzyme inhibitors (HR: 0.78; 95% CI: 0.61-1.00), angiotensin-receptor-blockers (HR: 0.70; 95%CI: 0.51-0.96) and statins (HR: 0.75; 95% CI: 0.58-0.96) were associated with reduced risk. Among community-dwelling individuals, pre-existing cancer, renal and cardiac disease appeared also related with an increased risk, whereas influenza vaccination was associated with reduced risk. Conclusion: In a setting with relatively low incidence of COVID-19 across the first wave of pandemic period, increasing age, nursing-home residence and multiple comorbidities appear predisposing for COVID-19 among middle-aged/older adults. Conversely, statins, angiotensin-receptor blockers/inhibitors and influenza vaccination were related with decreased risk.

Objetivo: Analizar incidencia y riesgo/susceptibilidad de sufrir la COVID-19 en adultos según distintas condiciones médicas preexistentes. Métodos: Cohorte de base poblacional que incluyó 79.083 personas ≥50 años en Tarragona. Características basales de la cohorte (edad/sexo, comorbilidades, medicaciones crónicas) se establecieron a 01-03-2020 y se registraron todos los casos de COVID-19 confirmada ocurridos en miembros de la cohorte hasta el 30-06-2020. Para estimación de riesgos se realizó regresión de Cox, con cálculo de hazard ratio (HR) ajustados por edad, sexo y comorbilidad. Resultados: Se observaron 536 casos confirmados de COVID-19 (incidencia media: 39,5 casos por 100.000 personas-semana). En análisis multivariante, edad/años (HR: 1,01; IC el 95%: 1,00-1,02; p = 0,050), estar institucionalizado/residencia (HR: 20,19; IC 95%: 15,98-25,51; p<0,001), enfermedad neurológica (HR: 1,35; IC el 95%: 1,03-1,77), diuréticos (HR: 1,39; IC 95%: 1,10-1,75), antiagregantes plaquetarios (HR: 1,36; IC 95%: 1,05-1,76) y benzodiacepinas (HR: 1,24; IC 95%: 1,00-1,53) se asociaron con un riesgo aumentado de la COVID-19 analizando la totalidad de la cohorte; contrariamente, medicación IECA (HR: 0,78; IC el 95%: 0,61-1,00), ARA-II (HR: 0,70; IC el 95%: 0,51-0,96) y estatinas (HR: 0,75; IC el 95%: 0,58-0,96) se asociaron con menor riesgo. Entre personas no institucionalizadas, cáncer, nefropatía y cardiopatía se asociaron con mayor riesgo y vacunación antigripal con menor riesgo. Conclusión: En un área con relativamente baja incidencia de COVID-19, edad, institucionalización y múltiples comorbilidades aumentaron el riesgo/susceptibilidad de sufrir la COVID-19. Contrariamente, estatinas, inhibidores del sistema renina-angiotensina y vacunación antigripal se asociaron con menor riesgo.

Susceptibility and risk of SARS-COV-2 infection among middle-aged and older adults in Tarragona area, Spain.

OBJECTIVE: To analyse susceptibility/risk of suffering COVID-19 among adults with distinct underlying medical conditions. METHODS: Population-based cohort study involving 79,083 individuals ≥50 years old in Tarragona (Southern Catalonia, Spain). Baseline cohort characteristics (demographic, pre-existing comorbidities, chronic medications and vaccinations history) were established at study start (01/03/2020) and primary outcome was laboratory-confirmed COVID-19 occurred among cohort members throughout 01/03/2020-30/06/2020. Risk of suffering COVID-19 was evaluated by Cox regression, estimating multivariable hazard ratios (HRs) adjusted for age/sex and pre-existing comorbidities. RESULTS: Across study period, 536 laboratory-confirmed COVID-19 cases were observed (mean incidence: 39.5 cases per 100,000 persons-week). In multivariable-analysis, increasing age/years (HR: 1.01; 95% CI: 1.00-1.02), nursing-home (HR: 20.19; 95% CI: 15.98-25.51), neurological disease (HR: 1.35; 95% CI: 1.03-1.77), taking diuretics (HR: 1.39; 95% CI: 1.10-1.75), antiplatelet (HR: 1.36; 95% CI: 1.05-1.76) and benzodiazepines (HR: 1.24; 95% CI: 1.00-1.53) increased risk; conversely, taking angiotensin-converting-enzyme inhibitors (HR: 0.78; 95% CI: 0.61-1.00), angiotensin-receptor-blockers (HR: 0.70; 95%CI: 0.51-0.96) and statins (HR: 0.75; 95% CI: 0.58-0.96) were associated with reduced risk. Among community-dwelling individuals, pre-existing cancer, renal and cardiac disease appeared also related with an increased risk, whereas influenza vaccination was associated with reduced risk. CONCLUSION: In a setting with relatively low incidence of COVID-19 across the first wave of pandemic period, increasing age, nursing-home residence and multiple comorbidities appear predisposing for COVID-19 among middle-aged/older adults. Conversely, statins, angiotensin-receptor blockers/inhibitors and influenza vaccination were related with decreased risk.

Effectiveness of a Motivational Nutritional Intervention through Social Networks 2.0 to Increase Adherence to the Mediterranean Diet and Improve Lung Function in Active Smokers: The DIET Study, a Randomized, Controlled and Parallel Clinical Trial in Primary Care.

BACKGROUND: Diet can help preserve lung function in smokers, as well as aid individuals who avoid smoking. This study aimed to evaluate the effectiveness of a nutritional intervention, using the Social Networks 2.0 tool, to increase adherence to the Mediterranean diet (MD) and improve lung function in smokers without prior respiratory disease. METHODS: A randomized controlled parallel design was used. The participants were assigned to either the intervention or control group. Data from representative smokers without respiratory disease (n = 77) aged 18-70 years were analyzed. The participants completed a validated semi-quantitative food-frequency questionnaire, and their adherence to the diet was evaluated by using the questionnaire called the Mediterranean Diet Adherence Score (MEDAS, with 14 items), which considers ≥9 points to indicate high adherence. The lung function was assessed by spirometry. Associations among variables were determined by logistic regression. RESULTS: A comparison of the variables at the end of the study between the control and intervention groups showed that the intervention significantly increased adherence to the MD based on the MEDAS questionnaire (0.69 (2.1) vs. 2.05 (2.03); p = 0.009). Specifically, the consumption of fruits was increased after two years in both groups; however, a more significant increase was detected in the intervention group (121 (178) vs. 12.7 (167) in the control group; p-value = 0.008). In the unadjusted analysis, the intervention only showed a statistical significant increase in the score of adherence to the MD (ß: 1.36; 95% CI 0.35; 2.3; p = 0.009), and this increase was maintained after adjusting for age and sex (ß: 1.15; 95% CI 0.05; 2.2; p = 0.040) and after adjusting for various sociodemographic, lifestyle and anthropometric variables (ß: 1.17; 95% CI 0.02; 2.31; p = 0.046). The pulmonary function parameters improved more in the intervention group; however, no significant differences were observed between the two groups. CONCLUSIONS: A nutritional intervention based on a dietetic-nutritional education program resulted in a significant increase in adherence to the MD. However, some evidence suggests that an MD dietary intervention can improve lung function, but in our study, we were not able to demonstrate this. Further research is needed to obtain more robust data and confirm a possible benefit of the program before it can be extended to general practice.

Analysis of Patient Safety Incidents in Primary Care Reported in an Electronic Registry Application.

OBJECTIVES: (1) To describe the epidemiology of patient safety (PS) incidents registered in an electronic notification system in primary care (PC) health centres; (2) to define a risk map; and (3) to identify the critical areas where intervention is needed. DESIGN: Descriptive analytical study of incidents reported from 1 January to 31 December 2018, on the TPSC Cloud™ platform (The Patient Safety Company) accessible from the corporate website (Intranet) of the regional public health service. SETTING: 24 Catalan Institute of Health PC health centres of the Tarragona region (Spain). PARTICIPANTS: Professionals from the PC health centres and a Patient Safety Functional Unit. MEASUREMENTS: Data obtained from records voluntarily submitted to an electronic, standardised and anonymised form. Data recorded: healthcare unit, notifier, type of incident, risk matrix, causal and contributing factors, preventability, level of resolution and improvement actions. RESULTS: A total of 1544 reports were reviewed and 1129 PS incidents were analysed: 25.0% of incidents did not reach the patient; 66.5% reached the patient without causing harm, and 8.5% caused adverse events. Nurses provided half of the reports (48.5%), while doctors reported more adverse events (70.8%; p < 0.01). Of the 96 adverse events, 46.9% only required observation, 34.4% caused temporary damage that required treatment, 13.5% required (or prolonged) hospitalization, and 5.2% caused severe permanent damage and/or a situation close to death. Notably, 99.2% were considered preventable. The main critical areas were: communication (27.8%), clinical-administrative management (25.1%), care delivery (23.5%) and medicines (18.4%); few incidents were related to diagnosis (3.6%). CONCLUSIONS: PS incident notification applications are adequate for reporting incidents and adverse events associated with healthcare. Approximately 75% and 10% of incidents reach the patient and cause some damage, respectively, and most cases are considered preventable. Adequate and strengthened risk management of critical areas is required to improve PS.

Effectiveness of New Tools to Define an Up-to-Date Patient Safety Risk Map: A Primary Care Study Protocol.

BACKGROUND: Reducing incidents related to health care interventions to improve patient safety is a health policy priority. To strengthen a culture of safety, reporting incidents is essential. This study aims to define a patient safety risk map using the description and analysis of incidents within a primary care region with a prior patient safety improvement strategy organisationally developed and promoted. METHODS: The study will be conducted in two phases: (1) a cross-sectional descriptive observational study to describe reported incidents; and (2) a quasi-experimental study to compare reported incidents. The study will take place in the Camp de Tarragona Primary Care Management (Catalan Institute of Health). In Phase 1, all reactive notifications collected within one year (2018) will be analysed; during Phase 2, all proactive notifications of the second and third weeks of June 2019 will be analysed. Adverse events will also be assessed. Phases 1 and 2 will use a digital platform and the proactive tool proSP to notify and analyse incidents related to patient safety. EXPECTED RESULTS: To obtain an up-to-date, primary care patient safety risk map to prioritise strategies that result in safer practices.

Effectiveness of a motivational intervention based on spirometry results to achieve smoking cessation in primary healthcare patients: randomised, parallel, controlled multicentre study.

OBJECTIVE: This 12-month study in a primary healthcare network aimed to assess the effectiveness of usual smoking cessation advice compared with personalised information about the spirometry results. DESIGN: Randomised, parallel, controlled, multicentre clinical trial. SETTING: This study involved 12 primary healthcare centres (Tarragona, Spain). PARTICIPANTS: Active smokers aged 35-70 years, without known respiratory disease. Each participant received brief smoking cessation advice along with a spirometry assessment. Participants with normal results were randomised to the intervention group (IG), including detailed spirometry information at baseline and 6-month follow-up or control group (CG), which was simply informed that their spirometry values were within normal parameters. MAIN OUTCOME: Prolonged abstinence (12 months) validated by expired-CO testing. RESULTS: Spirometry was normal in 571 patients in 571 patients (45.9% male), 286 allocated to IG and 285 to CG. Baseline characteristics were comparable between the groups. Mean age was 49.8 (SD ±7.78) years and mean cumulative smoking exposure was 29.2 (±18.7) pack-years. Prolonged abstinence was 5.6% (16/286) in the IG, compared with 2.1% (6/285) in the CG (p=0.03); the cumulative abstinence curve was favourable in the IG (HR 1.98; 95% CI 1.29 to 3.04). CONCLUSIONS: In active smokers without known respiratory disease, brief advice plus detailed spirometry information doubled prolonged abstinence rates, compared with brief advice alone, in 12-month follow-up, suggesting a more effective intervention to achieve smoking cessation in primary healthcare. TRIAL REGISTRATION NUMBER: NCT01194596.

Effects of hesperidin in orange juice on blood and pulse pressures in mildly hypertensive individuals: a randomized controlled trial (Citrus study).

PURPOSE: To assess the sustained and acute effects, as well as the influence of sustained consumption on the acute effects, of orange juice (OJ) with a natural hesperidin content and hesperidin-enriched OJ (EOJ) on blood (BP) and pulse (PP) pressures in pre- and stage-1 hypertensive individuals. METHODS: In a randomized, parallel, double-blind, placebo-controlled trial, participants (n = 159) received 500 mL/day of control drink, OJ, or EOJ for 12 weeks. Two dose-response studies were performed at baseline and after 12 weeks. RESULTS: A single EOJ dose (500 mL) reduced systolic BP (SBP) and PP, with greater changes after sustained treatment where a decrease in diastolic BP (DBP) also occurred (P < 0.05). SBP and PP decreased in a dose-dependent manner relative to the hesperidin content of the beverages throughout the 12 weeks (P < 0.05). OJ and EOJ decreased homocysteine levels at 12 weeks versus the control drink (P < 0.05). After 12 weeks of EOJ consumption, four genes related to hypertension (PTX3, NLRP3, NPSR1 and NAMPT) were differentially expressed in peripheral blood mononuclear cells (P < 0.05). CONCLUSION: Hesperidin in OJ reduces SBP and PP after sustained consumption, and after a single dose, the chronic consumption of EOJ enhances its postprandial effect. Decreases in systemic and transcriptomic biomarkers were concomitant with BP and PP changes. EOJ could be a useful co-adjuvant tool for BP and PP management in pre- and stage-1 hypertensive individuals.

A clinical trial to evaluate the effect of the Mediterranean diet on smokers lung function.

Data on the association between lung function and some dietary patterns have been published. However, it is not yet well known if whether the Mediterranean Diet (MD) pattern can preserve or improve lung function. Our purpose is to evaluate the effect of increased MD adherence on lung function in smokers. A multicenter, parallel, cluster-randomized, controlled clinical trial is proposed. A total of 566 active smokers (>10 packs-year), aged 25-75 years will be included, without previous respiratory disease and who sign an informed consent to participate. Twenty Primary Care Centres in Tarragona (Spain) will be randomly assigned to a control or an intervention group (1:1). All participants will receive advice to quit smoking, and the intervention group, a nutritional intervention (2 years) designed to increase MD adherence by: (1) annual visit to deliver personalized nutritional education, (2) annual telephone contact to reinforce the intervention, and (3) access to an online dietary blog. We will evaluate (annually for 2 years): pulmonary function by forced spirometry and MD adherence by a 14-item questionnaire and medical tests (oxidation, inflammation and consumption biomarkers). In a statistical analysis by intention-to-treat basis, with the individual smoker as unit of analysis, pulmonary function and MD adherence in both groups will be compared; logistic regression models will be applied to analyze their associations. We hope to observe an increased MD adherence that may prevent the deterioration of lung function in smokers without previous respiratory disease. This population may benefit from a dietary intervention, together with the recommendation of smoking cessation.

Adiposity markers and lung function in smokers: a cross-sectional study in a Mediterranean population.

BACKGROUND: The aim of this study was to assess the association of key adiposity markers with lung function in smokers without respiratory disease in a Mediterranean population. METHODS: We performed a cross-sectional study with baseline data from a representative sample of the ESPITAP study in Spain. Participants were 738 smokers (52.3% men) without respiratory disease, aged 35 to 70, selected from 12 primary health care centres. We assessed weight, height, body mass index (BMI), waist circumference (WC) and waist-to-height ratio (WHtR). The pulmonary functional parameters were forced vital capacity (FVC), forced expiratory volume in 1 s (FEV1) and FEV1/FVC ratio. RESULTS: In this cohort of smokers, 22.2% of individuals had central obesity. FVC% was inversely associated with all anthropometric measures (BMI, WC and WHtR) in the overall population and in men; in women, only BMI was associated with FVC%. FEV1% was inversely associated to BMI and WC in the overall population, and to all anthropometric measures in men. Furthermore, both BMI and obesity were positively associated with FEV1/FVC ratio overall and when stratified by sex; this suggests a restrictive pattern explained by the altered ventilator mechanics experienced by people with obesity. CONCLUSION: In a Mediterranean population of smokers without respiratory symptoms, abdominal obesity, evaluated not only by BMI and WC but also WHtR, is inversely associated with lung function. Fat distribution appears more strongly related to pulmonary function parameters in men than in women. In smokers with high values for WC, WHtR and BMI, assessment of lung function is recommended. TRIAL REGISTRATION: Current Controlled Trials NCT01194596 . Registered 2 September 2010.

Dietary patterns are associated with lung function among Spanish smokers without respiratory disease.

BACKGROUND: Diet can help preserve lung function in smokers, in addition to avoidance of smoking. The study aimed to evaluate associations between dietary patterns and lung function in smokers without respiratory disease. METHODS: This cross-sectional study analysed baseline data from randomised representative smokers without respiratory disease (n = 207, aged 35-70 years), selected from 20 primary health-care centres. Participants completed a validated semi-quantitative food-frequency questionnaire. Dietary patterns were identified by Principal Component Analysis (PCA). Impaired lung function was defined as FVC <80% and/or FEV1 < 80% of predicted value and/or FEV1/FVC <0.7. Associations were determined by logistic regression. RESULTS: Three major dietary patterns were identified. In multivariate-adjusted model, impaired lung function was associated with the Alcohol-consumption pattern (OR 4.56, 95% CI 1.58-13.18), especially in women (OR 11.47, 95% CI 2.25-58.47), and with the Westernised pattern in women (OR 5.62, 95% CI 1.17-27.02), whereas it not was associated with the Mediterranean-like pattern (OR 0.71, 95% CI 0.28-1.79). CONCLUSION: In smokers without respiratory disease, the Alcohol-consumption pattern and the Westernised pattern are associated with impaired lung function, especially in women. The Mediterranean-like pattern appears to be associated with preserved lung function because no statistical association is observed with impaired lung function. In addition to smoking cessation, modifying dietary patterns has possible clinical application to preserve lung function.

Multicentric randomized clinical trial to evaluate the long-term effectiveness of a motivational intervention against smoking, based on the information obtained from spirometry in primary care: the RESET study protocol.

BACKGROUND: Spirometry is the recommended method of evaluating pulmonary function when respiratory disease is suspected in smokers. Nonetheless, no evidence exists of the usefulness of information obtained from this test as a motivational strategy for smoking cessation. The primary objective of this study is to evaluate the effectiveness of a motivational intervention based on spirometry results in achieving long-term smoking cessation. METHODS/DESIGN: We propose a multicenter randomized clinical trial in the primary care setting. STUDY SUBJECTS: We will recruit active smokers of both sexes, aged 35-70 years, with a cumulated smoking habit exceeding 10 packs/year and who consult for any reason with their primary care physician in the 20 health centers in the province of Tarragona (Spain). Patients with a history of lung disease or who have undergone exploratory measures of pulmonary function in the preceding 12 months will be excluded. All patients who agree to participate will provide signed informed consent prior to their inclusion. A total of 1000 smokers will be consecutively randomized to a control or intervention group (1:1). INTERVENTION: Participants in both groups will receive brief (5-minute) health counseling, in accordance with usual clinical practice. In a consultation lasting about 15 minutes, participants in the intervention group will also receive detailed, personalized information about the results of a spirometry test and about their lung age compared with their chronological age. Both groups will be followed up for 12 months. Main variables and analysis: The main variable will be sustained smoking abstinence at 12 months after the intervention, as confirmed by CO breath testing and urine cotinine test. Results will be analyzed based on intention to treat, using the chi-square test and logistical regression if necessary to adjust for confounding variables. DISCUSSION: We expect the rate of prolonged smoking abstinence in the intervention group will be at least 5% higher than in the control group. If this strategy proves effective, it could easily be included in the health promotion activities offered in primary care settings. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02153047 . Registered on 28/05/2014.

Effects of mediterranean diet on lung function in smokers: a randomised, parallel and controlled protocol.

BACKGROUND: There is evidence of an association between pulmonary function and various nutrients, although no association has been observed in our setting between the Mediterranean Diet (MD) eating pattern and improved lung function. The objective of this study is to evaluate the effect of an intervention designed to increase MD adherence on lung function in smokers with no previous respiratory disease. METHODS/DESIGN: Randomized, controlled, parallel clinical trial. SETTING: primary health care centers in Catalonia (Spain). PARTICIPANTS: Current smokers (cumulative > 10 pack-years) aged 35-70 years, with Internet access, who provide signed informed consent to participate. INTERVENTION: A nutritionist will conduct a 2-year multicomponent intervention to increase MD adherence, based on: 1) a personalized dietary-nutritional education intervention, 2) a Web 2.0 approach, the DIET Blog of nutritional information, and 3) group sessions to increase motivation to increase MD adherence and motivation to make changes in eating habits. Annually, an office visit and one group session will reinforce the nutritional intervention. The control group will follow their usual diet, with general nutritional counselling. In both groups, a 14-item questionnaire will evaluate individual MD dietary patterns and forced spirometry will assess lung function. ANALYSIS: Intention to treat. The unit of analysis will be the individual smoker. Primary outcome is lung function indicated by spirometry, FVC, FEV1 and FEV1/FVC %. Lung function parameters in both groups will be compared by adherence to the MD pattern. DISCUSSION: The DIET study could contribute data on a protective action of the MD pattern on lung function in smokers. If so, this population may benefit from a nutritional intervention, along with the fundamental recommendation to stop smoking. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02151669 . Registered 26 May 2014.

Effectiveness of a structured motivational intervention including smoking cessation advice and spirometry information in the primary care setting: the ESPITAP study.

BACKGROUND: There is current controversy about the efficacy of smoking cessation interventions that are based on information obtained by spirometry. The objective of this study is to evaluate the effectiveness in the primary care setting of structured motivational intervention to achieve smoking cessation, compared with usual clinical practice. DESIGN: Multicentre randomized clinical trial with an intervention and a control group. SETTING: 12 primary care centres in the province of Tarragona (Spain). SUBJECTS OF STUDY: 600 current smokers aged between 35 and 70 years with a cumulative habit of more than 10 packs of cigarettes per year, attended in primary care for any reason and who did not meet any of the exclusion criteria for the study, randomly assigned to structured intervention or standard clinical attention. INTERVENTION: Usual advice to quit smoking by a general practitioner as well as a 20-minute personalized visit to provide detailed information about spirometry results, during which FEV1, FVC, FEF 25-75% and PEF measurements were discussed and interpreted in terms of theoretical values. Additional information included the lung age index (defined as the average age of a non-smoker with the same FEV1 as the study participant), comparing this with the chronological age to illustrate the pulmonary deterioration that results from smoking. MEASUREMENTS: Spirometry during the initial visit. Structured interview questionnaire administered at the primary care centre at the initial visit and at 12-month follow-up. Telephone follow-up interview at 6 months. At 12-month follow-up, expired CO was measured in patients who claimed to have quit smoking. MAIN VARIABLES: Smoking cessation at 12 months. ANALYSIS: Data will be analyzed on the basis of "intention to treat" and the unit of analysis will be the individual smoker. EXPECTED RESULTS: Among active smokers treated in primary care we anticipate significantly higher smoking cessation in the intervention group than in the control group. DISCUSSION: Application of a motivational intervention based on structured information about spirometry results, improved abstinence rates among smokers seen in actual clinical practice conditions in primary care. TRIAL REGISTRATION: ClinicalTrial.gov, number NCT01194596.