Long-Term Effectiveness of a Smartphone App and a Smart Band on Arterial Stiffness and Central Hemodynamic Parameters in a Population with Overweight and Obesity (Evident 3 Study): Randomised Controlled Trial.

BACKGROUND: mHealth technologies could help to improve cardiovascular health; however, their effect on arterial stiffness and hemodynamic parameters has not been explored to date. OBJECTIVE: To evaluate the effect of a mHealth intervention, at 3 and 12 months, on arterial stiffness and central hemodynamic parameters in a sedentary population with overweight and obesity. METHODS: Randomised controlled clinical trial (Evident 3 study). 253 subjects were included: 127 in the intervention group (IG) and 126 in the control group (CG). The IG subjects were briefed on the use of the Evident 3 app and a smart band (Mi Band 2, Xiaomi) for 3 months to promote healthy lifestyles. All measurements were recorded in the baseline visit and at 3 and 12 months. The carotid-femoral pulse wave velocity (cfPWV) and the central hemodynamic parameters were measured using a SphigmoCor System® device, whereas the brachial-ankle pulse wave velocity (baPWV) and the Cardio Ankle Vascular Index (CAVI) were measured using a VaSera VS-2000® device. RESULTS: Of the 253 subjects who attended the initial visit, 237 (93.7%) completed the visit at 3 months of the intervention, and 217 (85.3%) completed the visit at 12 months of the intervention. At 12 months, IG showed a decrease in peripheral augmentation index (PAIx) (-3.60; 95% CI -7.22 to -0.00) and ejection duration (ED) (-0.82; 95% CI -1.36 to -0.27), and an increase in subendocardial viability ratio (SEVR) (5.31; 95% CI 1.18 to 9.44). In CG, cfPWV decreased at 3 months (-0.28 m/s; 95% CI -0.54 to -0.02) and at 12 months (-0.30 m/s, 95% CI -0.54 to -0.05), central diastolic pressure (cDBP) decreased at 12 months (-1.64 mm/Hg; 95% CI -3.19 to -0.10). When comparing the groups we found no differences between any variables analyzed. CONCLUSIONS: In sedentary adults with overweight or obesity, the multicomponent intervention (Smartphone app and an activity-tracking band) for 3 months did not modify arterial stiffness or the central hemodynamic parameters, with respect to the control group. However, at 12 months, CG presented a decrease of cfPWV and cDBP, whereas IG showed a decrease of PAIx and ED and an increase of SEVR.

Long-term Effectiveness of a Smartphone App Combined With a Smart Band on Weight Loss, Physical Activity, and Caloric Intake in a Population With Overweight and Obesity (Evident 3 Study): Randomized Controlled Trial.

BACKGROUND: Multicomponent mobile health approaches can improve lifestyle intervention results, although little is known about their long-term effectiveness. OBJECTIVE: This study aims to evaluate the long-term effectiveness (12 months) of a multicomponent mobile health intervention-combining a smartphone app, an activity tracker wristband, and brief counseling, compared with a brief counseling group only-on weight loss and improving body composition, physical activity, and caloric intake in Spanish sedentary adults with overweight or obesity. METHODS: We conducted a randomized controlled, multicenter clinical trial (Evident 3). A total of 650 participants were recruited from 5 primary care centers, with 318 participants in the intervention group (IG) and 332 in the control group (CG). All participants were briefly counseled about a healthy diet and physical activity at the baseline visit. For the 3-month intervention period, the IG received training to use the app to promote healthy lifestyles and the smart band (Mi Band 2, Xiaomi). All measurements were performed at baseline and at 3 and 12 months. Physical activity was measured using the International Physical Activity Questionnaire-Short Form. Nutritional habits were assessed using the Food Frequency Questionnaire and Adherence to Mediterranean diet questionnaire. RESULTS: Of the 650 participants included, 563 (86.6%) completed the 3-month visit and 443 (68.2%) completed the 12-month visit. After 12 months, the IG showed net differences in weight (-0.26, 95% CI -1.21 to 0.70 kg; P=.02), BMI (-0.06, 95% CI -0.41 to 0.28 points; P=.01), waist-height ratio (-0.25, 95% CI -0.94 to 0.44; P=.03), body adiposity index (-0.33, 95% CI -0.77 to 0.11; P=.03), waist circumference (-0.48, 95% CI -1.62 to 0.66 cm, P=.04) and hip circumference (-0.69, 95% CI -1.62 to 0.25 cm; P=.03). Both groups lowered daily caloric intake and increased adherence to the Mediterranean diet, with no differences between the groups. The IG increased light physical activity time (32.6, 95% CI -30.3 to 95.04 min/week; P=.02) compared with the CG. Analyses by subgroup showed changes in body composition variables in women, people aged >50 years, and married people. CONCLUSIONS: The low-intensity intervention of the Evident 3 study showed, in the IG, benefits in weight loss, some body composition variables, and time spent in light physical activity compared with the CG at 3 months, but once the devices were collected, the downward trend was not maintained at the 12-month follow-up. No differences in nutritional outcomes were observed between the groups. TRIAL REGISTRATION: ClinicalTrials.gov NCT03175614; https://clinicaltrials.gov/ct2/show/NCT03175614. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1097/MD.0000000000009633.

Retinal blood vessel calibre and vascular ageing in a general Spanish population: A EVA study.

INTRODUCTION: The aim of this work was to analyse the association of the retinal arteriolar calibre and the arteriole/venule index (AV index) with vascular ageing in a general population without previous cardiovascular disease. MATERIALS AND METHODS: Descriptive cross-sectional study. A total of 482 individuals without cardiovascular disease (mean age: 55.6 ± 14.2 years) were selected by random sampling, stratified by age and sex. The retinal arteriolar calibre was measured using digital fundus images of the back of the eye captured with a validated, semiautomatized and computer-assisted software (Index calculator). Vascular ageing was defined using three criteria based on the values of: (1) Carotid-femoral Pulse Wave Velocity (cfPWV), (2) Brachial-ankle Pulse Wave Velocity (baPWV) and (3) Carotid Intima-Media Thickness. RESULTS: The AV index and arteriolar calibre show a negative correlation with age, arterial pressure, cardiovascular risk and parameters of vascular structure and function (p < 0.001 in all cases). We found lower mean values of the AV index and arteriolar calibre in the individuals with early vascular ageing compared to those with healthy vascular ageing. AV index was negatively correlated with cfPWV ((ß=-2.9; 95% CI (-4.7; -1.1)), baPWV ((ß=-3.2; 95% CI (-5.4; -0.9)) and vascular ageing index ((ß=-1.7; 95% CI (-2.7; -0.7)). Arteriolar calibre showed a negative correlation with baPWV (ß=-0.1; 95% CI (-0.2; -0.1)). In the logistic regression analysis, lower values of AV index ((OR=0.01; 95% CI (0.01-0.10), OR=0.03; 95% CI (0.01-0.11) and OR=0.09; 95% CI (0.01-0.67)) were associated with EVA defined with cfPWV, baPWV and vascular ageing index respectively, and lower values of arteriolar calibre ((OR=0.71; 95% CI (0.55-0.91)) were associated with EVA defined with vascular ageing index. CONCLUSIONS: Lower values of AV index and retinal arteriolar calibre were associated with vascular ageing in a general Spanish population without previous cardiovascular disease.

Association between measurements of arterial stiffness and target organ damage in a general Spanish population.

INTRODUCTION: Little is known about the relationship between arterial stiffness and cardiovascular target organ damage (TOD) in the general population. The aim was to analyse the relationship between different measurements of arterial stiffness and TOD, in a general Spanish population without a history of cardiovascular event. MATERIALS AND METHODS: Transversal descriptive study. Through stratified random sampling, a total of 501 individuals were included. Carotid-femoral pulse wave velocity (cf-PWV) was measured using a SphygmoCor System®, the cardio-ankle vascular index (CAVI) was determined with aVasera VS-1500® and brachial-ankle pulse wave velocity (ba-PWV)was calculated through a validated equation. RESULTS: The average age was 55.84 ± 14.26.The percentage of vascular TOD, left ventricular hypertrophy (LVH) and renal TOD was higher in men (p < .001). A positive correlation was obtained between carotid intima-media thickness (c-IMT) and the measurements of vascular function. In the model 1 of the logistic regression analysis, cf-PWV was associated with vascular TOD (OR = 1.15, p = .040), ba-PWV was associated with vascular TOD (OR = 1.20, p = .010) and LVH (OR = 1.12, p = .047). CONCLUSIONS: The different measurements of arterial stiffness are highly associated with each other. Moreover, cf-PWV and ba-PWV were associated with vascular TOD, and ba-PWV with LVH, although they disappear when adjusting for cardiovascular risk factors. Key Messages There is a strong correlation between the different measurements of vascular structure and function. Carotid-femoral and brachial-ankle pulse wave velocity were positively associated with vascular target organ damage, the latter was also positively associated with left ventricular hypertrophy. This associations disappear when adjusting for cardiovascular risk factors.

Gut microbiota composition and arterial stiffness measured by pulse wave velocity: case-control study protocol (MIVAS study).

INTRODUCTION: Intestinal microbiota is arising as a new element in the physiopathology of cardiovascular diseases. A healthy microbiota includes a balanced representation of bacteria with health promotion functions (symbiotes). The aim of this study is to analyse the relationship between intestinal microbiota composition and arterial stiffness. METHODS AND ANALYSIS: An observational case-control study will be developed. Cases will be defined by the presence of at least one of the following: carotid-femoral pulse wave velocity (cf-PWV), Cardio-Ankle Vascular Index (CAVI), brachial ankle pulse wave velocity (ba or ba-PWV) above the 90th percentile, for age and sex, of the reference population. Controls will be selected from the same population as cases. The study will be developed in Primary Healthcare Centres. We will select 500 subjects (250 cases and 250 controls), between 45 and 74 years of age. Cases will be selected from a database that combines data from EVA study (Spain) and Guimarães/Vizela study (Portugal). MEASUREMENTS: cf-PWV will be measured using the SphygmoCor system, CAVI, ba-PWV and Ankle-Brachial Index will be determined using VaSera device. Gut microbiome composition in faecal samples will be determined by 16S ribosomal RNA sequencing. Lifestyle will be assessed by food frequency questionnaire, adherence to the Mediterranean diet and IPAQ (International Physical Activity Questionnaire). Body composition will be evaluated by bioimpedance. ETHICS AND DISSEMINATION: The study has been approved by 'Committee of ethics of research with medicines of the health area of Salamanca' on 14 December 2018 (cod. 2018-11-136) and the 'Ethics committee for health of Guimaraes' (Portugal) on 15 October 2019 (ref: 67/2019). All study participants will sign an informed consent form agreeing to participate in the study, in compliance with the Declaration of Helsinki and the WHO standards for observational studies. The results of this study will allow a better description of gut microbiota in patients with arterial stiffness. TRIAL REGISTRATION DETAILS: ClinicalTrials.gov, identifier NCT03900338.

Effectiveness of an mHealth Intervention Combining a Smartphone App and Smart Band on Body Composition in an Overweight and Obese Population: Randomized Controlled Trial (EVIDENT 3 Study).

BACKGROUND: Mobile health (mHealth) is currently among the supporting elements that may contribute to an improvement in health markers by helping people adopt healthier lifestyles. mHealth interventions have been widely reported to achieve greater weight loss than other approaches, but their effect on body composition remains unclear. OBJECTIVE: This study aimed to assess the short-term (3 months) effectiveness of a mobile app and a smart band for losing weight and changing body composition in sedentary Spanish adults who are overweight or obese. METHODS: A randomized controlled, multicenter clinical trial was conducted involving the participation of 440 subjects from primary care centers, with 231 subjects in the intervention group (IG; counselling with smartphone app and smart band) and 209 in the control group (CG; counselling only). Both groups were counselled about healthy diet and physical activity. For the 3-month intervention period, the IG was trained to use a smartphone app that involved self-monitoring and tailored feedback, as well as a smart band that recorded daily physical activity (Mi Band 2, Xiaomi). Body composition was measured using the InBody 230 bioimpedance device (InBody Co., Ltd), and physical activity was measured using the International Physical Activity Questionnaire. RESULTS: The mHealth intervention produced a greater loss of body weight (-1.97 kg, 95% CI -2.39 to -1.54) relative to standard counselling at 3 months (-1.13 kg, 95% CI -1.56 to -0.69). Comparing groups, the IG achieved a weight loss of 0.84 kg more than the CG at 3 months. The IG showed a decrease in body fat mass (BFM; -1.84 kg, 95% CI -2.48 to -1.20), percentage of body fat (PBF; -1.22%, 95% CI -1.82% to 0.62%), and BMI (-0.77 kg/m2, 95% CI -0.96 to 0.57). No significant changes were observed in any of these parameters in men; among women, there was a significant decrease in BMI in the IG compared with the CG. When subjects were grouped according to baseline BMI, the overweight group experienced a change in BFM of -1.18 kg (95% CI -2.30 to -0.06) and BMI of -0.47 kg/m2 (95% CI -0.80 to -0.13), whereas the obese group only experienced a change in BMI of -0.53 kg/m2 (95% CI -0.86 to -0.19). When the data were analyzed according to physical activity, the moderate-vigorous physical activity group showed significant changes in BFM of -1.03 kg (95% CI -1.74 to -0.33), PBF of -0.76% (95% CI -1.32% to -0.20%), and BMI of -0.5 kg/m2 (95% CI -0.83 to -0.19). CONCLUSIONS: The results from this multicenter, randomized controlled clinical trial study show that compared with standard counselling alone, adding a self-reported app and a smart band obtained beneficial results in terms of weight loss and a reduction in BFM and PBF in female subjects with a BMI less than 30 kg/m2 and a moderate-vigorous physical activity level. Nevertheless, further studies are needed to ensure that this profile benefits more than others from this intervention and to investigate modifications of this intervention to achieve a global effect. TRIAL REGISTRATION: Clinicaltrials.gov NCT03175614; https://clinicaltrials.gov/ct2/show/NCT03175614. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1097/MD.0000000000009633.

Effects of Cocoa-Rich Chocolate on Blood Pressure, Cardiovascular Risk Factors, and Arterial Stiffness in Postmenopausal Women: A Randomized Clinical Trial.

This study aimed to evaluate the effects of the intake of 10 g of cocoa-rich chocolate on blood pressure, other cardiovascular risk factors, and vascular structure and function in postmenopausal women. A total of 140 postmenopausal women participated in this randomized and controlled parallel clinical trial. For six months, the intervention group (IG; n = 73) consumed daily 10 g of chocolate (99% cocoa) added to their usual food intake, whereas the control group (CG; n = 67) did not receive any intervention. Blood pressure, pulse pressure (PP), cardio-ankle vascular index (CAVI), ankle-brachial index (ABI), brachial-ankle pulse wave velocity (baPWV), augmentation index, and laboratory variables were measured at baseline and six months. ANCOVA analyses adjusted for baseline values revealed no significant differences for systolic blood pressure (-1.45 mm Hg; 95% confidence interval (CI): -4.79, 1.88; p = 0.391) or baPWV (0.18 m/s; 95% CI: -0.14, 0.50; p = 0.263) between groups. A decrease in PP was observed in the IG compared to the CG (-2.05 mm Hg; 95% CI: -4.08, -0.02; p = 0.048). The rest of the vascular structure and function parameters and other measured variables remained unchanged. The daily intake of 10 g of cocoa-rich chocolate seems to provide little improvement to cardiovascular health, but neither does it cause any adverse effects on the parameters evaluated in postmenopausal women in the long term.

Metabolic Syndrome Including Glycated Hemoglobin A1c in Adults: Is It Time to Change?

(1) Background: To assess the suitability of replacing conventional markers used for insulin resistance and dysglycemia by HbA1c in both the quantitative and qualitative metabolic syndrome (MetS) definition criteria; (2) Methods: Confirmatory factorial analysis was used to compare three quantitative definitions of MetS that consisted of many single-factor models, one of which included HbA1c as the dysglycemia indicator. After that, the model with the better goodness-of-fit was selected. Furthermore, a new MetS qualitative definition was proposed by replacing fasting plasma glucose with HbA1c > 5.7% in the International Diabetes Federation (IDF) definition. The clinical performance of these two MetS criteria (IDF and IDF-modified including HbA1c as the dysglycemia indicator) to predict vascular damage (pulse wave velocity [PWv], intima media thickness [IMT] and albumin-to-creatinine ratio [ACR]) was estimated; (3) Results: The single-factor model including HbA1c showed the better goodness-of-fit (χ2 = 2.45, df = 2, p = 0.293, CFI = 0.999, SRMR = 0.010). Additionally, the IDF-modified criteria gained in clinical performance to predict vascular damage (diagnostic Odds Ratio: 6.94, 1.34 and 1.90) for pulse wave velocity (PWv), intima media thickness (IMT) and albumin-to-creatinine ratio (ACR), respectively; and (4) Conclusions: These data suggest that HbA1c could be considered as a useful component to be included in the MetS definition.

Relationship between the presence of insomnia and walking physical activity and diet quality: A cross-sectional study in a sample of Spanish adults / Relación entre la presencia de insomnio y la actividad física caminando y la calidad de la dieta: un estudio transversal en una muestra de adultos españoles

Introduction and objectives: Certain lifestyle habits may influence aspects of sleep quality, such as insomnia. The main objective of the present study was to analyze the relationship of the presence of insomnia, with walking physical activity and diet quality in an adult population. Patients and methods: A cross-sectional descriptive study was performed (subanalysis of the TRIPLE A study) between January of 2014 to June of 2015. A total of 454 subjects were selected by consecutive sampling. Insomnia was evaluated with the Atenas scale, diet quality using the diet quality index (DQI) questionnaire, and physical activity using pedometers for seven days, evaluating the total number of steps, aerobic steps, and energy expended. Results: Of all patients, 26.8% presented with insomnia (33.8% in women and 17.5% in men). In a adjusted model, the mean differences of total steps/day, aerobic steps/day, and kilocalories/day spent in performing physical activity, between no insomnia group and insomnia group were: 1022.5 (95% CI: 177.9-1867.0), 743.9 (95% CI: 68.3-1419.4) and 39.8 (95% CI: 5.7-73.9), respectively. We did not find an association between the diet quality index (DQI) and insomnia. Conclusions: The findings suggest that completing daily a greater total number of steps, aerobic steps, and energy expended by walking, could be correlated with less insomnia, independent of age, sex, and other confounding variables. However, no relationship was observed between diet quality and insomnia

Introducción y objetivo: Ciertos hábitos y estilos de vida pueden influir en algunos aspectos de la calidad del sueño, como el insomnio. El objetivo principal del presente estudio fue analizar la relación de la presencia de insomnio, con la actividad física caminando y la calidad de la dieta en una población adulta. Pacientes y métodos: Se realizó un estudio descriptivo transversal (subanálisis del estudio TRIPLE A) desde enero de 2014 a junio de 2015. Se seleccionó una muestra de 454 sujetos mediante muestreo consecutivo. El insomnio fue evaluado con la escala Atenas, la calidad de la dieta mediante el cuestionario del índice de calidad de la dieta (DQI) y la actividad física mediante podómetros durante 7 días, evaluando el número de pasos totales, pasos aeróbicos y gasto energético. Resultados: Presentaron insomnio el 26,8% (el 33,8% en mujeres y el 17,5% en varones). Las diferencias de media de los pasos totales/día, pasos aeróbicos/día y las kilocalorías/día gastadas en la realización de la actividad física, entre el grupo de sujetos sin insomnio y el grupo de sujetos con insomnio fueron: 1.022,5 (IC 95%: 177,9-1.867,0), 743,9 (IC 95%: 68,3-1.419,4) y 39,8 (IC 95%: 5,7-73,9),respectivamente. No hemos encontrado asociación entre el DQI y el insomnio. Conclusiones: Un mayor número total de pasos, pasos aeróbicos y gasto energético gastado, realizando actividad física caminando, podría estar relacionado con menor presencia de insomnio, independientemente de la edad, sexo y otras variables de confusión. Sin embargo no se ha encontrado relación entre la calidad de la dieta y el insomnio

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.

Capacity adiposity indices to identify metabolic syndrome in subjects with intermediate cardiovascular risk (MARK study).

BACKGROUND: Obesity increases mortality, and is linked to cardiovascular diseases and metabolic syndrome (MetS). Therefore, the purpose of this study was to analyze the ability of different adiposity indices to identify subjects with MetS among people with intermediate cariovascular risk. MATERIALS AND METHODS: The cross-sectional study involved 2478 subjects, recruited by the MARK study. Adiposity measures: general adiposity by body mass index (BMI), central adiposity by waist-to-height ratio (WHtR), fat mass percent by the Clínica Universidad de Navarra-body adiposity estimator (CUN-BAE), percentage of body fat and of visceral adipose tissue by body roundness index (BRI) and visceral obesity and general adiposity with body shape index (ABSI). The diagnosis of MetS was made in accordance with the criteria established in the international consensus of the Joint Scientific Statement National Cholesterol Education Program III. RESULTS: The highest correlation coefficients were obtained by the glycemic components (HbA1c and FPG) of the MetS and ranged from 0.155 to 0.320. The exception was ABSI, which showed lower values in the global analysis and in the males. Values of the area under the ROC curve with the adiposity indices ranged from 0.773 with the BMI in males to 0.567 with ABSI in males. In the logistic regression analysis, all adiposity factors, except ABSI, showed similar OR values of MetS after adjusting for possible confounding factors. In the global analysis, the adiposity index that showed a highest OR of MetS was CUN-BAE (OR 5.50; 95% CI 4.27-7.09). In the analysis by gender, the highest ORs were BMI in males (OR 5.98; 95% CI 4.70-7.60) and both WHtR and BRI in females (OR 4.15; 95% CI 3.09-5.58). CONCLUSION: All adiposity indices, except for ABSI, show an association with MetS and similar ability to detect subjects with MetS among people with intermediate cariovascular risk.

Relationship between the presence of insomnia and walking physical activity and diet quality: A cross-sectional study in a sample of Spanish adults.

INTRODUCTION AND OBJECTIVES: Certain lifestyle habits may influence aspects of sleep quality, such as insomnia. The main objective of the present study was to analyze the relationship of the presence of insomnia, with walking physical activity and diet quality in an adult population. PATIENTS AND METHODS: A cross-sectional descriptive study was performed (subanalysis of the TRIPLE A study) between January of 2014 to June of 2015. A total of 454 subjects were selected by consecutive sampling. Insomnia was evaluated with the Atenas scale, diet quality using the diet quality index (DQI) questionnaire, and physical activity using pedometers for seven days, evaluating the total number of steps, aerobic steps, and energy expended. RESULTS: Of all patients, 26.8% presented with insomnia (33.8% in women and 17.5% in men). In a adjusted model, the mean differences of total steps/day, aerobic steps/day, and kilocalories/day spent in performing physical activity, between no insomnia group and insomnia group were: 1022.5 (95% CI: 177.9-1867.0), 743.9 (95% CI: 68.3-1419.4) and 39.8 (95% CI: 5.7-73.9), respectively. We did not find an association between the diet quality index (DQI) and insomnia. CONCLUSIONS: The findings suggest that completing daily a greater total number of steps, aerobic steps, and energy expended by walking, could be correlated with less insomnia, independent of age, sex, and other confounding variables. However, no relationship was observed between diet quality and insomnia.

A body shape index and vascular structure and function in Spanish adults (MARK study): A cross-sectional study.

A body shape index (ABSI) has been introduced as a marker of the relationship between body composition and all-cause mortality. However, until now, the relationships between ABSI and vascular structure and function have not been evaluated. The aim of this study was to investigate the association of ABSI with vascular structure and function in Spanish adults with intermediate cardiovascular risk. This cross-sectional study analyzed the data of 2354 subjects [age, 35-74 years (median, 62.0 years [range, 56.0-67.0 years]), 61.9% men] enrolled into the MediAte Risk management (MARK) study. ABSI was calculated by using the following formula: ABSI = waist circumference (m)/[body mass index × height (m))]. Vascular function was assessed by measuring cardio-ankle vascular index (CAVI) with the VaSera device and brachial ankle pulse wave velocity (baPWV) by using a validated equation. Vascular structure was assessed by measuring carotid intima-media thickness (IMT) by ultrasonography. Median value of ABSI was 0.083 (range, 0.081-0.090), mean CAVI was (8.5 ±â€Š1.2), and median IMT was 0.727 (range, 0.672-0.799). The values of ABSI and CAVI were higher in men. After adjusting for confounders, ABSI was positively associated with CAVI, baPWV, and average mean IMT. Thus, for each unit increase in ABSI, CAVI increased by 0.16 units, baPWV by 0.25 m/s, and IMT by 0.033 mm. In the logistic regression analysis, the odds ratio of ABSI was > 1 for high CAVI ≥ 9, baPWV ≥ 15 m/s, and IMT ≥ 0.90 mm in the overall subject group, and in the sex- and age-specific (> 62 years, ≤ 62 years) subgroups, after adjusting for confounders. The area under the receiver-operating characteristic curve of the ABSI was 0.631 (95% confidence interval [CI], 0.608-0.654) for CAVI ≥ 9, and 0.617 (95% CI, 0.593-0.641) for high baPWV ≥ 15 m/s. ABSI showed a positive association with vascular structure and function, independent of other confounders that might influence weight and fat mass distribution in Spanish subjects at intermediate cardiovascular risk.Trial Registration: ClinicalTrials.gov Identifier: NCT01428934 (registered: September 2, 2011; last updated: September 8, 2016).

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.

Corrigendum: Association of VAV2 and VAV3 polymorphisms with cardiovascular risk factors.

This corrects the article DOI: 10.1038/srep41875.

Noninvasive validation of central and peripheral augmentation index estimated by a novel wrist-worn tonometer.

BACKGROUND: The validation of new blood pressure devices with easier use and more rapid data collection may facilitate the incorporation of these measures into clinical practice. We analyze the reliability and validity of Pulse Wave Analysis as reported by a novel wrist-worn device, easy and quick to use, comparing central and peripheral augmentation index (AIx) with the same measures from the SphygmoCor. Additionally, we analyzed clinical relevance through the association of the Pulse Wave Analysis, as reported by a novel wrist-worn device, with other cardiovascular parameters. METHODS: Cross-sectional study including 254 participants. Mean age was 51.9 ±â€Š13.4 years and 53% were women. MEASUREMENTS: peripheral AIx (PAIx) and central AIx (CAIx) by the wrist-worn device and SphygmoCor (MM3); carotid-femoral (cf) pulse wave velocity (PWV) by SphygmoCor (MM3); cardioankle-vascular index (CAVI), ankle-brachial index (ABI) and brachial-ankle (ba) PWV by the Vasera device and carotid-intima media thickness (IMT) by ultrasonography. RESULTS: Intra-observer intra-class correlation coefficient (ICC) for PAIx was 0.886 (95% CI 0.803-0.934) and for CAIx 0.943 (95% CI 0.901-0.968) with Bland Altman limits of agreement -0.75 (-23.8 to 21.8) and 0.08 (-15.7 to 15.9), respectively. Inter-observer ICC for PAIx was 0.952 (95% CI 0.915-0.972) and CAIx 0.893 (95% CI 0.811-0.939) with limits of agreement -0.45 (-13.7 to 12.8) and 0.43 (-17.7 to 18.5), respectively. Comparing the wrist-worn device with SphygmoCor, the ICC was 0.849 (95% CI 0.798-0.887) for PAIx, and 0.783 (95% CI 0.711-0.838) for CAIx. In Bland-Altman, limits of agreement for PAIx 1.03 (-20.67 to 22.73), and for CAIx -2.14 (-24.79 to 20.50). PAIx and CAIx, from the wrist-worn device, correlated with age, CAVI, ABI, baPWV, cfPWV, IMT, glomerular filtration and cardiovascular risk. CONCLUSION: AIx measurements by wrist-worn device shows a good intra-observer and inter-observer reliability, inter-device noninvasive reliability and validity when compared with SphygmoCor, and clinical relevance by association with measures of vascular structure and function, end-organ damage and cardiovascular risk. TRIAL REGISTRATION: Clinicaltrials.gov NCT02623894; https://clinicaltrials.gov/ct2/show/NCT02623894.

Long-Term Effectiveness of a Smartphone App for Improving Healthy Lifestyles in General Population in Primary Care: Randomized Controlled Trial (Evident II Study).

BACKGROUND: Information and communication technologies are currently among the supporting elements that may contribute to improving health and changing lifestyles. OBJECTIVE: The aim of this study was to evaluate the long-term effectiveness of adding an app to standardized counseling in order to increase physical activity (PA) and adherence to the Mediterranean diet and to analyze the effects of app adherence in lifestyle changes. METHODS: A randomized, multicenter clinical trial with a 12 month-follow up was conducted, involving 833 participants recruited by random sampling in 6 primary Spanish care centers (415 vs 418). Counseling on PA and the Mediterranean diet was given to both groups by a research nurse; however, the counseling + app group (intervention group) received additional training in the use of an app that was designed to promote the Mediterranean diet and PA over a 3-month period. Main outcomes and measures included PA by accelerometer and the 7-day Physical Activity Recall (PAR) questionnaire and adherence to the Mediterranean diet by an adherence screener questionnaire. We considered adherence to the app to be high when it was used for more than 60 days. RESULTS: The mean age was 51 years (SD 12) in the intervention group and 52.3 years (SD 12.0) in the counseling-only group; females predominated in both groups (60.0%, 249/415 and 64.1%, 268/418, respectively). PA by accelerometer declined in both groups at 12 months (P value for tendency in moderate to vigorous PA, [MVPA]=.15). The intervention subgroup with high app adherence had better behavior than the low adherence subgroup (P value for tendency in MVPA=.001). PA analyzed by 7-day PAR did not show changes at 12 months in any of the groups (P value for tendency=.25). In the Mediterranean diet, an increase in adherence was observed in both groups at 12 months with no differences between them (P value for tendency=.46). In these two cases, the group with high app adherence also had better behavior, although without reaching significance for the tendency (P>.05). CONCLUSIONS: The participants with strongest app adherence showed better outcomes in terms of maintenance of healthy lifestyles at 12 months than those with weaker adherence. Overall, however, we found no differences between intervention group and counseling-only group in PA increase and adherence to the Mediterranean diet in the long term.

Short- and long-term effectiveness of a smartphone application for improving measures of adiposity: A randomised clinical trial - EVIDENT II study.

BACKGROUND: Evidence on the efficacy of smartphone applications (apps) for reducing body weight and other measurements of adiposity sustainably is not conclusive. OBJECTIVE: To evaluate the effect of adding an app for 3 months to traditional counselling on physical activity (PA) and a heart-healthy diet for the modification of measurements of adiposity at 3 and 12 months after intervention. METHODS: This randomised clinical trial included 833 subjects. The counselling and app group (IG) had 415 subjects, while 418 were included in the counselling only group (CG). The primary outcome was adiposity measurements at 3 and 12 months after intervention. The secondary outcome was the effect of the intervention by sex. INTERVENTION: Counselling on a heart-healthy diet and PA was given to both groups. The IG also received training in the use of a smartphone app designed to promote a heart-healthy diet and PA, and this group was given access to this application for 3 months. Outcome measurements included waist circumference (WC), body mass index (BMI) and Clínica Universidad de Navarra - body adiposity estimator (CUN-BAE). RESULTS: In the IG at 12 months, the following decreased: WC -0.72 cm (95% confidence interval [CI]: -2.35 to -0.02) and CUN-BAE -0.35 (95% CI: -0.63 to -0.06). These decreases were only observed in women. After baseline adjustment, the beneficial effect was maintained in the IG compared to the CG at 12 months in terms of WC (-0.67; 95% CI: -0.29 to -0.02) and CUN-BAE (-0.57; 95% CI: -1.10 to -0.04), but only in women. CONCLUSIONS: An intervention of nutritional counselling and PA plus the smartphone app with personalised recommendations compared to CG showed beneficial results in terms of reduction of abdominal obesity and the percentage of body fat in women, but not in men.

EVIDENT 3 Study: A randomized, controlled clinical trial to reduce inactivity and caloric intake in sedentary and overweight or obese people using a smartphone application: Study protocol.

INTRODUCTION: Mobile technology, when included within multicomponent interventions, could contribute to more effective weight loss. The objective of this project is to assess the impact of adding the use of the EVIDENT 3 application, designed to promote healthy living habits, to traditional modification strategies employed for weight loss. Other targeted behaviors (walking, caloric-intake, sitting time) and outcomes (quality of life, inflammatory markers, measurements of arterial aging) will also be evaluated. METHODS: Randomized, multicentre clinical trial with 2 parallel groups. The study will be conducted in the primary care setting and will include 700 subjects 20 to 65 years, with a body mass index (27.5-40 kg/m), who are clinically classified as sedentary. The primary outcome will be weight loss. Secondary outcomes will include change in walking (steps/d), sitting time (min/wk), caloric intake (kcal/d), quality of life, arterial aging (augmentation index), and pro-inflammatory marker levels. Outcomes will be measured at baseline, after 3 months, and after 1 year. Participants will be randomly assigned to either the intervention group (IG) or the control group (CG). Both groups will receive the traditional primary care lifestyle counseling prior to randomization. The subjects in the IG will be lent a smartphone and a smartband for a 3-month period, corresponding to the length of the intervention. The EVIDENT 3 application integrates the information collected by the smartband on physical activity and the self-reported information by participants on daily food intake. Using this information, the application generates recommendations and personalized goals for weight loss. DISCUSSION: There is a great diversity in the applications used obtaining different results on lifestyle improvement and weight loss. The populations studied are not homogeneous and generate different results. The results of this study will help our understanding of the efficacy of new technologies, combined with traditional counseling, towards reducing obesity and enabling healthier lifestyles. ETHICS AND DISSEMINATION: The study was approved by the Clinical Research Ethics Committee of the Health Area of Salamanca ("CREC of Health Area of Salamanca") on April 2016. A SPIRIT checklist is available for this protocol. The trial was registered in ClinicalTrials.gov provided by the US National Library of Medicine-number NCT03175614.

Adiposity measures and arterial stiffness in primary care: the MARK prospective observational study.

BACKGROUND: The cardiovascular risk of obesity is potentially increased by arterial stiffness. OBJECTIVE: To assess the relationship of adiposity measures with arterial stiffness in Caucasian adults with intermediate cardiovascular risk. SETTING: Six Spanish health centres. PARTICIPANTS: We enrolled 2354 adults (age range, 35-74 years; mean age, 61.4±7.7 years, 61.9% male). METHODS: This is a cross-sectional study that analyses data from the baseline visit of the improving interMediAte RisK management (MARK) study. The main outcome variables were body mass index (BMI), waist-to-height ratio (WHtR), Clínica Universidad de Navarra-body adiposity estimation (CUN-BAE) body fat percentage and body roundness index (BRI). Vascular function was assessed by the cardio-ankle vascular index (CAVI) with the VaSera device; brachial-ankle pulse wave velocity (baPWV) was determined using a validated equation. RESULTS: The mean adiposity measures were a BMI of 29.2±4.4, WHtR of 0.61±0.07, CUN-BAE of 35.7±1.7 and BRI of 5.8±1.7. The mean stiffness measures were a CAVI of 8.8±1.2 and baPWV of 14.9±2.5. In multiple linear regression analyses, all adiposity measures were negatively associated with CAVI and baPWV (p<0.01 for all) after adjustment for possible factors of confusion. The proportion of CAVI variability via the adiposity measures were 5.5% for BMI, 5.8% for CUN-BAE, 3.8% for WHtR and 3.7% for BRI. These were higher among diabetic, obese, younger (≤62 years) and non-hypertensive subjects who had similar activity and sedentary profiles. CONCLUSIONS: Adiposity measures are negatively associated with arterial stiffness measures. The percentage of variation in CAVI explained by its relation to the different measures of adiposity ranges from 5.8% (CUN-BAE) to 3.7% (BRI). In the case of baPWV, it oscillates between 0.7% (CUN-BAE and BMI) and 0.1% (WHtR). TRIAL REGISTRATION NUMBER: NCT01428934.