[Impact of gender violence on girls and adolescents]. / Impacto de la violencia de género en las niñas y las adolescentes.

Gender is an important determinant of health. Its relationship with inequality and violence allows us to consider being a woman as a risk factor for health. Girls and teenager girls are not exempt from this circumstance, which conditions their lives from before birth and can determine their health status throughout life. It can vary according to social contexts, as various factors intersect with gender, adding risk and vulnerability to being a woman. Gender-based violence is often identified as a problem for adult women; however, the experience of discriminatory gender-based violence is constructed throughout women's lives, producing serious individual and social consequences from childhood. Accepting this violence as a «private or domestic matter¼ often prevents seeing the true dimension of the problem, its consequences, and the need to address it as a global issue.

Body mass index interacts with a genetic-risk score for depression increasing the risk of the disease in high-susceptibility individuals.

Depression is strongly associated with obesity among other chronic physical diseases. The latest mega- and meta-analysis of genome-wide association studies have identified multiple risk loci robustly associated with depression. In this study, we aimed to investigate whether a genetic-risk score (GRS) combining multiple depression risk single nucleotide polymorphisms (SNPs) might have utility in the prediction of this disorder in individuals with obesity. A total of 30 depression-associated SNPs were included in a GRS to predict the risk of depression in a large case-control sample from the Spanish PredictD-CCRT study, a national multicentre, randomized controlled trial, which included 104 cases of depression and 1546 controls. An unweighted GRS was calculated as a summation of the number of risk alleles for depression and incorporated into several logistic regression models with depression status as the main outcome. Constructed models were trained and evaluated in the whole recruited sample. Non-genetic-risk factors were combined with the GRS in several ways across the five predictive models in order to improve predictive ability. An enrichment functional analysis was finally conducted with the aim of providing a general understanding of the biological pathways mapped by analyzed SNPs. We found that an unweighted GRS based on 30 risk loci was significantly associated with a higher risk of depression. Although the GRS itself explained a small amount of variance of depression, we found a significant improvement in the prediction of depression after including some non-genetic-risk factors into the models. The highest predictive ability for depression was achieved when the model included an interaction term between the GRS and the body mass index (BMI), apart from the inclusion of classical demographic information as marginal terms (AUC = 0.71, 95% CI = [0.65, 0.76]). Functional analyses on the 30 SNPs composing the GRS revealed an over-representation of the mapped genes in signaling pathways involved in processes such as extracellular remodeling, proinflammatory regulatory mechanisms, and circadian rhythm alterations. Although the GRS on its own explained a small amount of variance of depression, a significant novel feature of this study is that including non-genetic-risk factors such as BMI together with a GRS came close to the conventional threshold for clinical utility used in ROC analysis and improves the prediction of depression. In this study, the highest predictive ability was achieved by the model combining the GRS and the BMI under an interaction term. Particularly, BMI was identified as a trigger-like risk factor for depression acting in a concerted way with the GRS component. This is an interesting finding since it suggests the existence of a risk overlap between both diseases, and the need for individual depression genetics-risk evaluation in subjects with obesity. This research has therefore potential clinical implications and set the basis for future research directions in exploring the link between depression and obesity-associated disorders. While it is likely that future genome-wide studies with large samples will detect novel genetic variants associated with depression, it seems clear that a combination of genetics and non-genetic information (such is the case of obesity status and other depression comorbidities) will still be needed for the optimization prediction of depression in high-susceptibility individuals.

Use of a personalised depression intervention in primary care to prevent anxiety: a secondary study of a cluster randomised trial.

BACKGROUND: In the predictD-intervention, GPs used a personalised biopsychosocial programme to prevent depression. This reduced the incidence of major depression by 21.0%, although the results were not statistically significant. AIM: To determine whether the predictD-intervention is effective at preventing anxiety in primary care patients without depression or anxiety. DESIGN AND SETTING: Secondary study of a cluster randomised trial with practices randomly assigned to either the predictD-intervention or usual care. This study was conducted in seven Spanish cities from October 2010 to July 2012. METHOD: In each city, 10 practices and two GPs per practice, as well as four to six patients every recruiting day, were randomly selected until there were 26-27 eligible patients for each GP. The endpoint was cumulative incidence of anxiety as measured by the PRIME-MD screening tool over 18 months. RESULTS: A total of 3326 patients without depression and 140 GPs from 70 practices consented and were eligible to participate; 328 of these patients were removed because they had an anxiety syndrome at baseline. Of the 2998 valid patients, 2597 (86.6%) were evaluated at the end of the study. At 18 months, 10.4% (95% CI = 8.7% to 12.1%) of the patients in the predictD-intervention group developed anxiety compared with 13.1% (95% CI = 11.4% to 14.8%) in the usual-care group (absolute difference = -2.7% [95% CI = -5.1% to -0.3%]; P = 0.029). CONCLUSION: A personalised intervention delivered by GPs for the prevention of depression provided a modest but statistically significant reduction in the incidence of anxiety.

A mindfulness and compassion-based program applied to pregnant women and their partners to decrease depression symptoms during pregnancy and postpartum: study protocol for a randomized controlled trial.

BACKGROUND: Pregnancy and the postpartum period are times of great change for women and their partners, often bringing substantial challenges and stress. Approximately 10%-20% of women suffer from mood disorders such as depression in the perinatal period. There are risks involved in using psychopharmacological interventions to treat perinatal depression. Mindfulness and compassion-based educational programs could be efficacious and cost-effective options for the prevention and treatment of perinatal mood disorders. The aim of this study is to assess the efficacy of an adapted Mindfulness-Based Childbirth and Parenting (MBCP) program that includes compassion training for pregnant women in primary care (PC) settings in the Spanish National Health System to decrease perinatal depression. METHODS: A multicenter randomized controlled trial (RCT) will be conducted. Participants will be pregnant women (n = 122) and their partners who wish to participate. They will be enrolled and assessed in PC settings and randomly assigned to either: (1) an adapted MBCP educational program tailored to the Spanish National Health System + treatment as usual (TAU); or (2) TAU only. The main outcome to be assessed will be depression, evaluated with the Edinburgh Postnatal Depression Scale (EPDS). Secondary outcomes will include self-reported measures of perceived stress, affects, mindfulness, self-compassion, maternal self-efficacy, and use of health and social services. Patients will be assessed at four timepoints: baseline; post-treatment; and at three and six months after childbirth. Intention-to-treat and per-protocol analyses will be carried out using linear regression mixed models. Effect sizes will be estimated using Cohen's d. DISCUSSION: Perinatal depression is a significant health problem. An effective and low-cost childbirth education program that incorporates mindfulness and compassion practices may be a beneficial preventive complementary healthcare modality for expectant women and their partners. This study will be the first multicenter RCT in Spanish PC settings using adapted MBCP and compassion practices to reduce symptoms of depression during pregnancy and the postpartum period. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03247491. Registered on 31 July 2017.

Family physicians' views on participating in prevention of major depression. The predictD-EVAL qualitative study.

BACKGROUND: The predictD intervention, a multicomponent intervention delivered by family physicians (FPs), reduced the incidence of major depression by 21% versus the control group and was cost-effective. A qualitative methodology was proposed to identify the mechanisms of action of these complex interventions. PURPOSE: To seek the opinions of these FPs on the potential successful components of the predictD intervention for the primary prevention of depression in primary care and to identify areas for improvement. METHOD: Qualitative study with FPs who delivered the predictD intervention at 35 urban primary care centres in seven Spanish cities. Face-to-face semi-structured interviews adopting a phenomenological approach. The data was triangulated by three investigators using thematic analysis and respondent validation was carried out. RESULTS: Sixty-seven FPs were interviewed and they indicated strategies used to perform the predictD intervention, including specific communication skills such as empathy and the activation of patient resources. They perceived barriers such as lack of time and facilitators such as prior acquaintance with patients. FPs recognized the positive consequences of the intervention for FPs, patients and the doctor-patient relationship. They also identified strategies for future versions and implementations of the predictD intervention. CONCLUSIONS: The FPs who carried out the predictD intervention identified factors potentially associated with successful prevention using this program and others that could be improved. Their opinions about the predictD intervention will enable development of a more effective and acceptable version and its implementation in different primary health care settings.

Aunando esfuerzos en Prevención y Promoción de la Salud con el PAPPS / Joining efforts in prevention and health promotion with the PAPPS

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EVIDENT Smartphone App, a New Method for the Dietary Record: Comparison With a Food Frequency Questionnaire.

BACKGROUND: More alternatives are needed for recording people's normal diet in different populations, especially adults or the elderly, as part of the investigation into the effects of nutrition on health. OBJECTIVE: The aim of this study was to compare the estimated values of energy intake, macro- and micronutrient, and alcohol consumption gathered using the EVIDENT II smartphone app against the data estimated with a food frequency questionnaire (FFQ) in an adult population aged 18 to 70 years. METHODS: We included 362 individuals (mean age 52 years, SD 12; 214/362, 59.1% women) who were part of the EVIDENT II study. The participants registered their food intake using the EVIDENT app during a period of 3 months and through an FFQ. Both methods estimate the average nutritional composition, including energy intake, macro- and micronutrients, and alcohol. Through the app, the values of the first week of food recording, the first month, and the entire 3-month period were estimated. The FFQ gathers data regarding the food intake of the year before the moment of interview. RESULTS: The intraclass correlation for the estimation of energy intake with the FFQ and the app shows significant results, with the highest values returned when analyzing the app's data for the full 3-month period (.304, 95% CI 0.144-0.434; P<.001). For this period, the correlation coefficient for energy intake is .233 (P<.001). The highest value corresponds to alcohol consumption and the lowest to the intake of polyunsaturated fatty acids (r=.676 and r=.155; P<.001), respectively. The estimation of daily intake of energy, macronutrients, and alcohol presents higher values in the FFQ compared with the EVIDENT app data. Considering the values recorded during the 3-month period, the FFQ for energy intake estimation (Kcal) was higher than that of the app (a difference of 408.7, 95% CI 322.7-494.8; P<.001). The same is true for the other macronutrients, with the exception g/day of saturated fatty acids (.4, 95% CI -1.2 to 2.0; P=.62). CONCLUSIONS: The EVIDENT app is significantly correlated to FFQ in the estimation of energy intake, macro- and micronutrients, and alcohol consumption. This correlation increases with longer app recording periods. The EVIDENT app can be a good alternative for recording food intake in the context of longitudinal or intervention studies. TRIAL REGISTRATION: ClinicalTrials.gov NCT02016014; http://clinicaltrials.gov/ct2/show/NCT02016014 (Archived by WebCite at http://www.webcitation.org/760i8EL8Q).

Combined use of smartphone and smartband technology in the improvement of lifestyles in the adult population over 65 years: study protocol for a randomized clinical trial (EVIDENT-Age study).

BACKGROUND: The increasing use of smartphones by older adults also increases their potential for improving different aspects of health in this population. Some studies have shown promising results in the improvement of cognitive performance through lifestyle modification. All this may have a broad impact on the quality of life and carrying out daily living activities. The objective of this study is to evaluate the effectiveness of combining the use of smartphone and smartband technology for 3 months with brief counseling on life habits, as opposed to providing counseling only, in increasing physical activity and improving adherence to the Mediterranean diet. Secondary objectives are to assess the effect of the intervention on body composition, quality of life, independence in daily living activities and cognitive performance. METHODS: This study is a two-arm cluster-randomized trial that will be carried out in urban health centers in Spain. We will recruit 160 people aged between 65 and 80 without cardiovascular disease or cognitive impairment (score in the Mini-mental State Examination ≥24). On a visit to their center, intervention group participants will be instructed to use a smartphone application for a period of 3 months. This application integrates information on physical activity received from a fitness bracelet and self-reported information on the patient's daily nutritional composition. The primary outcome will be the change in the number of steps measured by accelerometer. Secondary variables will be adherence to the Mediterranean diet, sitting time, body composition, quality of life, independence in daily living activities and cognitive performance. All variables will be measured at baseline and on the assessment visit after 3 months. A telephone follow-up will be carried out at 6 months to collect self-reported data regarding physical activity and adherence to the Mediterranean diet. DISCUSSION: Preventive healthy aging programs should include health education with training in nutrition and lifestyles, while stressing the importance of and enhancing physical activity; the inclusion of new technologies can facilitate these goals. The EVIDENT-AGE study will incorporate a simple, accessible intervention with potential implementation in the care of older adults. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03574480 . Date of trial Registration July 2, 2018.

The Effectiveness of a Smartphone Application on Modifying the Intakes of Macro and Micronutrients in Primary Care: A Randomized Controlled Trial. The EVIDENT II Study.

BACKGROUND: This study evaluates the effectiveness of adding a diet smartphone application to standard counseling to modify dietary composition over the long term (12 months). METHODS: A randomized, controlled, multicenter clinical trial was conducted involving the participation of 833 subjects from primary care clinics (415 to the intervention (counseling + application) group (IG) and 418 to the control (counseling) group (CG)). Both groups were counseled about a healthy diet and physical activity. For the 3-month intervention period, the IG was also trained to use a diet smartphone application that involved dietary self-monitoring and tailored feedback. Nutritional composition was estimated using a self-reported food frequency questionnaire. RESULTS: An analysis of repeated measures revealed an interaction between the group and the percentages of carbohydrates (p = 0.031), fats (p = 0.015) and saturated fats (p = 0.035) consumed. Both groups decreased their energy intake (Kcal) at 12 months (IG: -114 (95% CI: -191 to -36); CG: -108 (95% CI: -184 to -31)). The IG reported a higher percentage intake of carbohydrates (1.1%; 95% CI: 0.1 to 2.0), and lower percentage intakes of fats (-1.0%; 95% CI: -1.9 to -0.1) and saturated fats (-0.4%; 95%CI: -0.8 to -0.1) when compared to the CG. CONCLUSIONS: Better results were achieved in terms of modifying usual diet composition from counseling and the diet smartphone application compared to counseling alone. This was evaluated by a self-reported questionnaire, which indicated an increased percentage intake of carbohydrates, and decreased percentage intakes of fats and saturated fats.

Self-sustained enzymatic cascade for the production of 2,5-furandicarboxylic acid from 5-methoxymethylfurfural.

BACKGROUND: 2,5-Furandicarboxylic acid is a renewable building block for the production of polyfurandicarboxylates, which are biodegradable polyesters expected to substitute their classical counterparts derived from fossil resources. It may be produced from bio-based 5-hydroxymethylfurfural or 5-methoxymethylfurfural, both obtained by the acidic dehydration of biomass-derived fructose. 5-Methoxymethylfurfural, which is produced in the presence of methanol, generates less by-products and exhibits better storage stability than 5-hydroxymethylfurfural being, therefore, the industrial substrate of choice. RESULTS: In this work, an enzymatic cascade involving three fungal oxidoreductases has been developed for the production of 2,5-furandicarboxylic acid from 5-methoxymethylfurfural. Aryl-alcohol oxidase and unspecific peroxygenase act on 5-methoxymethylfurfural and its partially oxidized derivatives yielding 2,5-furandicarboxylic acid, as well as methanol as a by-product. Methanol oxidase takes advantage of the methanol released for in situ producing H2O2 that, along with that produced by aryl-alcohol oxidase, fuels the peroxygenase reactions. In this way, the enzymatic cascade proceeds independently, with the only input of atmospheric O2, to attain a 70% conversion of initial 5-methoxymethylfurfural. The addition of some exogenous methanol to the reaction further improves the yield to attain an almost complete conversion of 5-methoxymethylfurfural into 2,5-furandicarboxylic acid. CONCLUSIONS: The synergistic action of aryl-alcohol oxidase and unspecific peroxygenase in the presence of 5-methoxymethylfurfural and O2 is sufficient for the production of 2,5-furandicarboxylic acid. The addition of methanol oxidase to the enzymatic cascade increases the 2,5-furandicarboxylic acid yields by oxidizing a reaction by-product to fuel the peroxygenase reactions.

A personalized intervention to prevent depression in primary care: cost-effectiveness study nested into a clustered randomized trial.

BACKGROUND: Depression is viewed as a major and increasing public health issue, as it causes high distress in the people experiencing it and considerable financial costs to society. Efforts are being made to reduce this burden by preventing depression. A critical component of this strategy is the ability to assess the individual level and profile of risk for the development of major depression. This paper presents the cost-effectiveness of a personalized intervention based on the risk of developing depression carried out in primary care, compared with usual care. METHODS: Cost-effectiveness analyses are nested within a multicentre, clustered, randomized controlled trial of a personalized intervention to prevent depression. The study was carried out in 70 primary care centres from seven cities in Spain. Two general practitioners (GPs) were randomly sampled from those prepared to participate in each centre (i.e. 140 GPs), and 3326 participants consented and were eligible to participate. The intervention included the GP communicating to the patient his/her individual risk for depression and personal risk factors and the construction by both GPs and patients of a psychosocial programme tailored to prevent depression. In addition, GPs carried out measures to activate and empower the patients, who also received a leaflet about preventing depression. GPs were trained in a 10- to 15-h workshop. Costs were measured from a societal and National Health care perspective. Qualityadjustedlife years were assessed using the EuroQOL five dimensions questionnaire. The time horizon was 18 months. RESULTS: With a willingness-to-pay threshold of €10,000 (£8568) the probability of cost-effectiveness oscillated from 83% (societal perspective) to 89% (health perspective). If the threshold was increased to €30,000 (£25,704), the probability of being considered cost-effective was 94% (societal perspective) and 96%, respectively (health perspective). The sensitivity analysis confirmed these results. CONCLUSIONS: Compared with usual care, an intervention based on personal predictors of risk of depression implemented by GPs is a cost-effective strategy to prevent depression. This type of personalized intervention in primary care should be further developed and evaluated. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01151982. Registered on June 29, 2010.

Intervention to Prevent Major Depression in Primary Care: A Cluster Randomized Trial.

BACKGROUND: Not enough is known about universal prevention of depression in adults. OBJECTIVE: To evaluate the effectiveness of an intervention to prevent major depression. DESIGN: Multicenter, cluster randomized trial with sites randomly assigned to usual care or an intervention. (ClinicalTrials.gov: NCT01151982). SETTING: 10 primary care centers in each of 7 cities in Spain. PARTICIPANTS: Two primary care physicians (PCPs) and 5236 nondepressed adult patients were randomly sampled from each center; 3326 patients consented and were eligible to participate. INTERVENTION: For each patient, PCPs communicated individual risk for depression and personal predictors of risk and developed a psychosocial program tailored to prevent depression. MEASUREMENTS: New cases of major depression, assessed every 6 months for 18 months. RESULTS: At 18 months, 7.39% of patients in the intervention group (95% CI, 5.85% to 8.95%) developed major depression compared with 9.40% in the control (usual care) group (CI, 7.89% to 10.92%) (absolute difference, -2.01 percentage points [CI, -4.18 to 0.16 percentage points]; P = 0.070). Depression incidence was lower in the intervention centers in 5 cities and similar between intervention and control centers in 2 cities. LIMITATION: Potential self-selection bias due to nonconsenting patients. CONCLUSION: Compared with usual care, an intervention based on personal predictors of risk for depression implemented by PCPs provided a modest but nonsignificant reduction in the incidence of major depression. Additional study of this approach may be warranted. PRIMARY FUNDING SOURCE: Institute of Health Carlos III.

Clustering of lifestyle characteristics and their association with cardio-metabolic health: the Lifestyles and Endothelial Dysfunction (EVIDENT) study.

Little is known about the clustering patterns of lifestyle behaviours in adult populations. We explored clusters in multiple lifestyle behaviours including physical activity (PA), smoking, alcohol use and eating habits in a sample of adult population. A cross-sectional and multi-centre study was performed with six participating groups distributed throughout Spain. Participants (n 1327) were part of the Lifestyles and Endothelial Dysfunction (EVIDENT) study and were aged between 20 and 80 years. The lifestyle and cardiovascular risk (CVR) factors were analysed using a clustering method based on the HJ-biplot coordinates to understand the variables underlying these groupings. The following three clusters were identified. Cluster 1: unhealthy, 677 subjects (51%), with a slight majority of men (58.7%), who were more sedentary and smokers with higher consumption of whole-fat dairy products, bigger waist circumference as well as higher TAG levels, systolic blood pressure (SBP) and CVR. Cluster 2: healthy/PA, 265 subjects (20%), including 24.0% of males with high PA. Cluster 3: healthy/diet, including 29% of the participants, with a higher consumption of olive oil, fish, fruits, nuts, vegetables and lower alcohol consumption. Using the unhealthy cluster as a reference, and after adjusting for age and sex, the multiple regression analysis showed that belonging to the healthy/PA cluster was associated with a lower waist circumference, body fat percentage, SBP and CVR. In summary, the three clusters were identified according to lifestyles. The 'unhealthy' cluster had the least favourable clinical parameters, the 'healthy/PA' cluster had good HDL-cholesterol levels and low SBP and the 'healthy/diet' cluster had lower LDL-cholesterol levels and clinical blood pressure.

Patients' opinions about knowing their risk for depression and what to do about it. The predictD-qualitative study.

BACKGROUND: The predictD study developed and validated a risk algorithm for predicting the onset of major depression in primary care. We aimed to explore the opinion of patients about knowing their risk for depression and the values and criteria upon which these opinions are based. METHODS: A maximum variation sample of patients was taken, stratified by city, age, gender, immigrant status, socio-economic status and lifetime depression. The study participants were 52 patients belonging to 13 urban health centres in seven different cities around Spain. Seven Focus Groups (FGs) were given held with primary care patients, one for each of the seven participating cities. RESULTS: The results showed that patients generally welcomed knowing their risk for depression. Furthermore, in light of available evidence several patients proposed potential changes in their lifestyles to prevent depression. Patients generally preferred to ask their General Practitioners (GPs) for advice, though mental health specialists were also mentioned. They suggested that GPs undertake interventions tailored to each patient, from a "patient-centred" approach, with certain communication skills, and giving advice to help patients cope with the knowledge that they are at risk of becoming depressed. CONCLUSIONS: Patients are pleased to be informed about their risk for depression. We detected certain beliefs, attitudes, values, expectations and behaviour among the patients that were potentially useful for future primary prevention programmes on depression.

Relationship between objectively measured physical activity and cardiovascular aging in the general population--the EVIDENT trial.

BACKGROUND: Aging has been associated with an increase in arterial stiffness. We analyzed the relationship between regular physical activity and cardiovascular aging evaluated by the radial augmentation index (rAIx), ambulatory arterial stiffness index (AASI), pulse pressure (PP) and heart age in subjects without atherosclerotic disease. METHODS: A cross-sectional study was performed including 1365 subjects from the EVIDENT trial (mean age 54.9±13.7 years; 60.3% women). As a measure of total volume of physical activity we used counts/minute recorded in an accelerometer (Actigraph GT3X) that participants wore for seven days, collecting data in 60-sec epochs, and respondents with ≥4 valid days were retained for the analysis. Arterial stiffness was evaluated using measures of rAIx, AASI, and central and peripheral PP on the B-pro device. rAIx was adjusted to 75 heart rate(rAIx75). Cardiovascular risk and heart age was estimated by the Framingham Risk Score. RESULTS: The median (IQR) of counts/min was 236.9 (176.3-307.8), rAIx75 90 (77-100), sleep PP 40 mmHg (33-47), central PP 39 mmHg (32-47) and heart age 57 years (45-73) and the mean±SD of the ASSI was 0.44±0.07. We found an inverse correlation between counts/minute and rAIx75 (r=-0.086; p<0.01), AASI (r=-0.146; p<0.001), heart age (r=-0.163; p<0.001) and peripherals PP. These associations were remained after controlling for potential confounders, except for rAIx75. In the multiple regression analysis, after adjustment, an inverse association persisted between counts/minute and AASI, sleep PP and heart age, but not with rAIx75. Accordingly, for every 100 higher counts/minute of accelerometer measures, both AASI and sleep PP would be lower by one measurement unit (beta=-0.979 and -1.031 respectively, p<0.001) and the estimated heart age by half year (beta=-0.525, p=0.023). CONCLUSIONS: Regular physical activity was inversely associated with parameters related to advanced cardiovascular aging after adjustment for potentially influencing variables. TRIAL REGISTRATION: Clinical Trials.gov Identifier: NCT01083082.

Electrocardiographic left ventricular hypertrophy criteria and ambulatory blood pressure monitoring parameters in adults.

BACKGROUND: To examine the relationship between ambulatory blood pressure monitoring parameters (ABPM) and electrocardiographic criteria for left-ventricular hypertrophy (LVH) in adults. METHODS: This study analyzed 1,544 subjects from the EVIDENT study (mean age = 55 ± 14 years; 61% women). A standard electrocardiograph (ECG) and 10 criteria were used to detect LVH. Office and ABPM were performed, and we analyzed 24-hour systolic blood pressure (SBP) and diastolic blood pressure (DBP), percentage of time awake with SBP ≥135 mm Hg, percentage of time asleep with SBP ≥120 mm Hg, and central aortic blood pressure. RESULTS: LVH according to some electrocardiographic criteria was found in 11.30% of the patients (16.60% of men and 7.70% of women). The patients with LVH were older; had higher values for office, 24-hour and, central aortic blood pressure; were more likely to be men; and had a higher prevalence of obesity, diabetes, and antihypertensive or lipid-lowering drug use. In the logistic regression analysis, the association between the parameters of ABPM and LVH, after adjusting for age, sex, body mass index, and heart rate, remained statistically significant. CONCLUSIONS: Twenty-four hour blood pressure, the percentage of time with elevated awake and asleep SBPs, and the central systolic blood pressure are related to the presence of LVH as determined by ECG in adults. These results indicate the potential importance of the monitoring and control of different 24-hour parameters of blood pressure in addition to the standard clinic blood pressure with respect to the development of LVH. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT01325064.

Preventing the onset of major depression based on the level and profile of risk of primary care attendees: protocol of a cluster randomised trial (the predictD-CCRT study).

BACKGROUND: The 'predictD algorithm' provides an estimate of the level and profile of risk of the onset of major depression in primary care attendees. This gives us the opportunity to develop interventions to prevent depression in a personalized way. We aim to evaluate the effectiveness, cost-effectiveness and cost-utility of a new intervention, personalized and implemented by family physicians (FPs), to prevent the onset of episodes of major depression. METHODS/DESIGN: This is a multicenter randomized controlled trial (RCT), with cluster assignment by health center and two parallel arms. Two interventions will be applied by FPs, usual care versus the new intervention predictD-CCRT. The latter has four components: a training workshop for FPs; communicating the level and profile of risk of depression; building up a tailored bio-psycho-family-social intervention by FPs to prevent depression; offering a booklet to prevent depression; and activating and empowering patients. We will recruit a systematic random sample of 3286 non-depressed adult patients (1643 in each trial arm), nested in 140 FPs and 70 health centers from 7 Spanish cities. All patients will be evaluated at baseline, 6, 12 and 18 months. The level and profile of risk of depression will be communicated to patients by the FPs in the intervention practices at baseline, 6 and 12 months. Our primary outcome will be the cumulative incidence of major depression (measured by CIDI each 6 months) over 18 months of follow-up. Secondary outcomes will be health-related quality of life (SF-12 and EuroQol), and measurements of cost-effectiveness and cost-utility. The inferences will be made at patient level. We shall undertake an intention-to-treat effectiveness analysis and will handle missing data using multiple imputations. We will perform multi-level logistic regressions and will adjust for the probability of the onset of major depression at 12 months measured at baseline as well as for unbalanced variables if appropriate. The economic evaluation will be approached from two perspectives, societal and health system. DISCUSSION: To our knowledge, this will be the first RCT of universal primary prevention for depression in adults and the first to test a personalized intervention implemented by FPs. We discuss possible biases as well as other limitations. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01151982.

Confirmatory factor analysis to assess the measure of adiposity that best fits the diagnosis of metabolic syndrome and relationship to physical activity in adults.

PURPOSE: The objective of the study is to assess the goodness of fit for the diagnosis of metabolic syndrome in adults of four models with different measures of adiposity using confirmatory factor analysis, to develop a cardio metabolic risk index and to analyze its relationship to physical activity. METHODS: Cross-sectional descriptive multicenter study including 636 patients from the EVIDENT study. Considering as fixed variables, triglycerides/HDL-C ratio, HOMA-IR index and mean arterial pressure, we will compare which single-factor model of metabolic syndrome shows better goodness of fit. The models only differ by the measure of adiposity used: waist circumference, waist circumference/height, body mass index or adiposity index. With the factorial weights obtained, we created a quantitative metabolic index and analyzed its relationship to physical activity, quantified with the accelerometer for 1 week and measured at counts/min. RESULTS: The single-factor model including waist circumference in women and body mass index in men were those that were better indicators of goodness of fit. The estimated quantitative metabolic index shows a mean value in men of -0.022 ± 1.29 with a range of values between -3.36 and 4.57 and in women of 0.0001 ± 1.53 with a range of values between -3.17 and 5.55. The quantitative index shows an inverse relationship to physical activity. CONCLUSIONS: Waist circumference in women and body mass index in men are the measures of adiposity that were better indicators goodness of fit. This quantitative index may be useful to quantify the risk of metabolic syndrome in clinical practice.

The role of gender in a smoking cessation intervention: a cluster randomized clinical trial.

BACKGROUND: The prevalence of smoking in Spain is high in both men and women. The aim of our study was to evaluate the role of gender in the effectiveness of a specific smoking cessation intervention conducted in Spain. METHODS: This study was a secondary analysis of a cluster randomized clinical trial in which the randomization unit was the Basic Care Unit (family physician and nurse who care for the same group of patients). The intervention consisted of a six-month period of implementing the recommendations of a Clinical Practice Guideline. A total of 2,937 current smokers at 82 Primary Care Centers in 13 different regions of Spain were included (2003-2005). The success rate was measured by a six-month continued abstinence rate at the one-year follow-up. A logistic mixed-effects regression model, taking Basic Care Units as random-effect parameter, was performed in order to analyze gender as a predictor of smoking cessation. RESULTS: At the one-year follow-up, the six-month continuous abstinence quit rate was 9.4% in men and 8.5% in women (p = 0.400). The logistic mixed-effects regression model showed that women did not have a higher odds of being an ex-smoker than men after the analysis was adjusted for confounders (OR adjusted = 0.9, 95% CI = 0.7-1.2). CONCLUSIONS: Gender does not appear to be a predictor of smoking cessation at the one-year follow-up in individuals presenting at Primary Care Centers. CLINICALTRIALS.GOV IDENTIFIER: NCT00125905.