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.

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.

Effectiveness of a Smartphone application and wearable device for weight loss in overweight or obese primary care patients: protocol for a randomised controlled trial.

BACKGROUND: To evaluate the effectiveness of an experimental intervention based on standard diet recommendations plus free Smartphone application (app) and wearable device for weight loss, compared with the standard diet intervention alone, in primary care patients aged 18 years or older who are overweight or obese. METHODS/DESIGN: Multicentre randomized, controlled clinical trial. LOCATION: Primary health care centres in the city of Tarragona and surrounding areas. SUBJECTS: 70 primary care patients, aged 18 years or older, with body mass index of 25 g/m2 or greater who wish to lose weight. Description of the intervention: 12 months of standard diet recommendations without (n = 35) or with (n = 35) assistance of a free Smartphone app that allows the participant to maintain a record of dietary intake and a bracelet monitor that records physical activity. The outcomes will be weight loss at 12 months (primary outcome), changes in physical activity and cardiometabolic risk factors, frequency of app use, and participant satisfaction after 12 months. DISCUSSION: The results of our study will offer evidence of the effectiveness of an intervention using one of the most popular free apps and wearable devices in achieving weight loss among patients who are overweight or obese. If these new technologies are proven effective in our population, they could be readily incorporated into primary care interventions promoting healthy weight. The open design and study characteristics make it impossible for the participants and researchers to be blinded to study group assignment. Researchers responsible for data analysis will be blinded to participant allocation. TRIAL REGISTRATION: Clinical Register: NCT02417623. Registered 26 March 2015.

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.