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.

Effects of cocoa-rich chocolate on cognitive performance in postmenopausal women. A randomised clinical trial.

OBJECTIVES: The aim of this research was to evaluate the effects of adding 10 g of cocoa-rich chocolate (99%) to the habitual diet on cognitive performance in postmenopausal women. METHODS: Following a randomised controlled parallel clinical trial, a total of 140 postmenopausal women aged 50-64 were recruited. The intervention group (n = 73) consumed daily 10 g of chocolate (99% cocoa) in addition to their usual food intake for 6 months, whereas the control group (n = 67) did not receive any intervention. Attention and executive functions, verbal memory, working memory, phonological fluency, category fluency and clinical variables were assessed at baseline and 6 months. RESULTS: Trail Making Test B execution time showed a decreased of -12.08 s (95% CI: -23.99, -0.18; p = 0.047) in the intervention group compared to the control group, after adjusting for age, educational level, time elapsed from the beginning of menopause and daily energy consumption (Cohen's d = -0.343). Attention, immediate or delayed verbal memory, phonological or category fluency, and working memory remained unchanged. CONCLUSIONS: The consumption of cocoa-rich (99%) chocolate in addition to the habitual diet could be related to a slight improvement in cognitive performance regarding cognitive flexibility and processing speed in postmenopausal women, with no changes in the rest of the cognitive performance variables evaluated.Trial registration: This clinical trial has been registered at clinicaltrials.gov as NCT03492983.

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

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

Cocoa-rich chocolate and body composition in postmenopausal women: a randomised clinical trial.

During menopause, women undergo a series of physiological changes that include a redistribution of fat tissue. This study was designed to investigate the effect of adding 10 g of cocoa-rich chocolate to the habitual diet of postmenopausal women daily on body composition. We conducted a 6-month, two-arm randomised, controlled trial. Postmenopausal women (57·2 (sd 3·6) years, n 132) were recruited in primary care clinics. Participants in the control group (CG) did not receive any intervention. Those of the intervention group (IG) received 10 g daily of 99 % cocoa chocolate in addition to their habitual diet for 6 months. This quantity comprises 247 kJ (59 kcal) and 65·4 mg of polyphenols. The primary outcomes were the between-group differences in body composition variables, measured by impendancemetry at the end of the study. The main effect of the intervention showed a favourable reduction in the IG with respect to the CG in body fat mass (-0·63 kg (95 % CI -1·15, -0·11), P = 0·019; Cohen's d = -0·450) and body fat percentage (-0·79 % (95 % CI -1·31, -0·26), P = 0·004; Cohen's d = -0·539). A non-significant decrease was also observed in BMI (-0·20 kg/m2 (95 % CI -0·44, 0·03), P = 0·092; Cohen's d = -0·345). Both the body fat mass and the body fat percentage showed a decrease in the IG for the three body segments analysed (trunk, arms and legs). Daily addition of 10 g of cocoa-rich chocolate to the habitual diet of postmenopausal women reduces their body fat mass and body fat percentage without modifying their weight.

The Relationship Between Alcohol Consumption With Vascular Structure and Arterial Stiffness in the Spanish Population: EVA Study.

BACKGROUND: Controversy exists regarding the way alcohol use is associated with vascular structure and arterial stiffness parameters. The purpose of this study is to evaluate the association between alcohol consumption with vascular structure and arterial stiffness in an adult population. METHODS: We conducted a cross-sectional study. Five hundred and one participants were recruited by random sampling from an urban population of 43,946 individuals aged 35 to 75 years, assigned from 5 healthcare centers located in Salamanca, Spain. This was a subanalysis of the EVA study. Arterial stiffness was assessed by measuring cardio-ankle vascular index (CAVI) and brachial-ankle pulse wave velocity (ba-PWV) with the VaSera VS-1500® device, and carotid-femoral pulse wave velocity (cf-PWV) with the Sphygmocor® . Vascular structure was evaluated by measuring the carotid intima-media thickness (c-IMT) with a Sonosite Micromax® ultrasound. Alcohol consumption was calculated using a standardized questionnaire and quantified in g/wk. RESULTS: In the multiple regression analysis adjusted for sex, age, smoking status, and systolic blood pressure, the c-IMT and cf-PWV values of individuals drinking > 70 g/wk were higher than those of the reference group (nondrinkers) by 0.02 mm (p = 0.030) and 0.42 m/s (p = 0.021), respectively. The association between alcohol consumption with vascular structure and arterial stiffness only attains statistical significance for cf-PWV (p = 0.039) and c-IMT (p = 0.019), showing an association which suggests a J-shaped association. This association was not statistically significant for ba-PWV and CAVI (p = 0.446 and p = 0.141, respectively), although a similar trend was observed with ba-PWV. CONCLUSIONS: The results of this study suggest that heavy alcohol consumption (>70 g/wk) is associated with increased c-IMT and cf-PWV. Moreover, we found a J-shaped association between alcohol consumption and c-IMT and cf-PWV values as markers of vascular structure and arterial stiffness, with no association with ba-PWV and CAVI being observed.

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 EVIDENT diet quality index is associated with cardiovascular risk and arterial stiffness in adults.

BACKGROUND: We aimed to simplify information from food frequency questionnaires (FFQs) in a single parameter that allows for rapid identification of quality of patient diet and its relationship to cardiovascular risk and pulse wave velocity (PWV). METHODS: The sample from the EVIDENT study, consisting of 1553 subjects (aged 20-80 years) with no cardiovascular disease selected by random sampling among those attending primary care clinics, was used. The EVIDENT diet index (range 0-100) was calculated based on the results of a FFQ. Evaluation of dietary habits also included adherence to the Mediterranean diet (MD). Cardiovascular risk was estimated, and carotid-femoral pulse wave velocity was measured. RESULTS: Mean subject age was 54.9 ± 13.8 years, and 60.3% of subjects were female. The mean value of the EVIDENT diet index was 52.1 ± 3.2 points. Subjects in the third tertile (the highest score) had the greatest adherence to MD and the highest energy intake, with greater amounts of carbohydrates, protein, and fiber. The best cut-off point of the EVIDENT diet index for predicting good adherence to the MD is 52.3 (0.71 sensitivity, 0.61 specificity). In a multiple regression analysis, after a complete adjustment, it was estimated that for each one-point increase in the EVIDENT diet index, cardiovascular risk (CVR), blood-pressure, waist circumference, and PWV decreased by 0.14, 0.43, 0.24, and 0.09 respectively (p < 0.05, all). CONCLUSIONS: The diet quality index developed is associated to CVR and its components, and also with arterial stiffness, as measured with PWV. This index is also a good predictor of adherence to MD.

Physical Activity and Adiposity Among Older Adults of the EVIDENT Study.

This study determined the relationship between self-reported and objective measurements of physical activity with adiposity markers in a random sample of community-dwelling older adults. The sample included 439 individuals over 65 years (age 71.1 ± 7.8; 54.2% women). Regular physical activity information was collected using self-reported (questionnaire, 7-day-PAR) and objective measurements (accelerometer ActiGraph GT3X) over 7 days. Anthropometric parameters included body mass index, body fat percentage, and waist circumference. The number of patients considered active was 28% according to the results of 7-day PAR, and 69% according to objective measures of accelerometry. With every daily increase of 10 min of sedentary activity, the BMI, body fat percentage, and waist circumference values increased by 0.04 units, 0.14%, and 0.14 cm, respectively. According to the accelerometry data, being active was a protective factor for presenting obesity criteria (OR = 0.34, CI 95% 0.19-0.59). Objective but non self-reported physical activity was associated with adiposity markers in older adults.

Association of metabolic syndrome and its components with arterial stiffness in Caucasian subjects of the MARK study: a cross-sectional trial.

BACKGROUND: The cardio-ankle vascular index (CAVI) and brachial-ankle pulse wave velocity (baPWV) can reflect both central and peripheral arterial stiffness. Metabolic syndrome (MetS) and its components may increase arterial stiffness and the risk of cardiovascular diseases. However, the correlation of MetS and its components with arterial stiffness is still not clear. The primary aim of this study is thus the relationship using baPWV and CAVI in Caucasian adults with intermediate cardiovascular risk. The secondary aim is to analyze sex differences. METHODS: This study analyzed 2351 subjects aged 35-74 years (mean, 61.4 ± 7.7 years) comprising 61.7 % males and enrolled in the improving interMediAte Risk management (MARK) study. CAVI was measured using a VaSera VS-1500 ® device, and baPWV was calculated using a validated equation. MetS was defined based on the Joint Scientific Statement National Cholesterol Education Program III. Waist circumference, blood pressure, fasting plasma glucose, and lipid profile were measured. RESULTS: MetS was found in 51.9 % of the subjects. All MetS components except reduced HDL-cholesterol (p = 0.578) were associated with CAVI. High density lipoprotein cholesterol (p = 0.075) and waist circumference (p = 0.315) were associated with baPWV. The different MetS components that assess dyslipidemia using the stiffness measures show different associations according to patient sex. The high blood pressure component had a greater odds ratio (OR) for both baPWV ≥ 17.5 m/sec (OR = 6.90, 95 % CI 3.52-13.519) and CAVI ≥ 9 (OR = 2.20, 95 % CI 1.63-1.90). CONCLUSIONS: MetS and all its components (except HDL-cholesterol with baPWV and CAVI and WC with baPWV) were associated with baPWV and CAVI. However, there were sex differences in the association of MetS and its components with baPWV and CAVI. Data from this study suggest a greater association of CAVI and baPWV values with MetS components in males than in females and indicate greater arterial stiffness in the event of simultaneously elevated blood pressure, fasting plasma glucose, and waist circumference. Trial Registration Clinical Trials.gov Identifier: https://clinicaltrials.gov/ct2/show/ NCT01428934. Registered 2 September 2011. Last updated September 8, 2016.

Diet and physical activity in people with intermediate cardiovascular risk and their relationship with the health-related quality of life: results from the MARK study.

BACKGROUND: To analyze the interplay between diet, physical activity and health-related quality of life in a Spanish randomly selected sample of individuals attended in general practitioners offices with intermediate cardiovascular risk. METHODS: This study analyzed 314 subjects, aged 35-74 years (50.6% women), from the MARK study, conducted in Spain. Health related quality of life was measured by the SF-12 questionnaire. The assessment of the lifestyles included the diet quality index, the adherence to the Mediterranean diet and the leisure time physical activity practice. RESULTS: The highest values of health related quality of life were obtained in the area of vitality (51.05 ± 11.13), while the lowest were found in the general health (39.89 ± 8.85). In the multiple linear regression analysis, after adjustment for age, gender and other confounders, for each point of increase in the Mediterranean diet adherence score, there was an increase of 1.177 points in the mental component value (p < 0.01). Similarly, for each point of increase in the Diet Quality Index Score, there was an increase in the mental component of 0.553 (p < 0.05). Likewise, the physical activity was positively associated with the physical function and vitality (ß = 0.090 and 0.087, (p < 0.01 and p < 0.05), respectively). CONCLUSIONS: In people with intermediate cardiovascular risk, better food habits and greater adherence to the Mediterranean diet are associated with higher scores on the mental component of quality of life. Likewise, increased physical activity is related with positive scores on the physical function.

Vascular structure and function and their relationship with health-related quality of life in the MARK study.

BACKGROUND: There is limited evidence concerning the relationship between vascular disease and health-related quality of life (HRQL). We investigated the relationship between vascular structure and function with health-related quality of life in a population with intermediate cardiovascular risk. METHODS: This study analyzed 303 subjects with ankle-brachial index (ABI) values ranging from 0.9 to 1.4 who were included in the MARK study (age 35 to 74 years; mean:60.5 ± 8.5), of which 50.2 % were women. Measurements included: ABI, brachial-ankle pulse wave velocity (ba-PWV), and cardio-ankle vascular index (CAVI), all measured using the VaSera device. The central augmentation index was adjusted to 75 lpm (AIx_75) using the Mobil-O-Graph device. HRQL was assessed by the Spanish version of the SF-12, version2. The highest obtained CAVI and ba-PWV values and the lowest ABI values were considered for the study. RESULTS: The cohort was composed of21 % smokers, 76 % hypertensive patients, and 24 % diabetic patients. The ABI mean was 1.09 ± 0.07,the ba-PWV mean was 14.64 ± 2.55 m/s with a 12.9 % of subjects higher than 17.5 m/s, AIx_75 26.46 ± 14.05, and CAVI 8.61 ± 1.08 with a 36.6 % of subjects higher than 9. Men scored higher than women in the HRQL measurements for physical (PSC-12; 49.9 vs. 46.9, p = 0.004) and mental (MSC-12) domains (51.2 vs. 47.7, p = 0.003). Age was positively correlated with CAVI (r = 0.547), ba-PWV (r = 0.469), AIx_75 (r = 0.255, p < 0.01), and the MSC-12 (r = 0.147, p < 0.05), but not the PSC-12. In the adjusted multiple linear regression analysis, the positive association of ABI and CAVI with the PSC-12 was maintained. CONCLUSIONS: The ABI in the normal range has a positive association with the PSC-12 of HRQL evaluated with the SF-12. The CAVI also showed a positive association with the PSC-12 of HRQL. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01428934 .

Association between markers of glycemia and carotid intima-media thickness: the MARK study.

BACKGROUND: Carotid intima-media thickness (C-IMT) is a reliable predictor of cardiovascular events. We Investigated the relationship between markers of glycemia and C-IMT in intermediate-risk cardiovascular patients. METHODS: This study analyzed 427 subjects, aged 35 to 74 years (mean, 60.3 ± 8.5 years), 55 % women, enrolled into the MARK study. Including 231 subjects defined as normal glucose, 104 subjects classified as prediabetes and 92 with type 2 diabetes mellitus. Carotid ultrasound was used to measure C-IMT and the presence of plaques. Fasting plasma glucose (mg/dl) and glycated hemoglobin (%) (HbA1c) were measured using standard enzymatic automated methods. Postprandial glucose (mg/dl) was self-measured by patients at home 2 h after meals (breakfast, lunch and dinner) for 1 day. RESULTS: The C-IMT shows a positive correlation with fasting plasma glucose, postprandial glucose and HbA1c. Multiple linear regression analysis showed a positive association between HbA1c and C-IMT, with a 0.016 mm and 0.019 mm increase in mean and maximum C-IMT per 1 % increase in HbA1c. In addition, an association between fasting plasma glucose and C-IMT was found with an increase of 0.004 and 0.005 mm in mean and maximum C-IMT per 10 mg/dl in fasting plasma glucose. We also observed a graded association between fasting plasma glucose, postprandial glucose and HbA1c and the presence of carotid target organ damage (TOD), with an odds ratio of 1.013, 1.010 and 1.425, respectively. CONCLUSION: The results of this study suggest that the fasting plasma glucose and HbA1c, but not postprandial glucose, are associated with C-IMT media and maximum. The patients who present with a metabolic glucose alteration have more risk of developing carotid TOD. TRIAL REGISTRATION: ClinicalTrials.gov; Identifier: NCT01428934 .

Effectiveness of interventions applicable to primary health care settings to promote Mediterranean diet or healthy eating adherence in adults: A systematic review.

OBJECTIVE: To evaluate the effects on healthy eating or the Mediterranean diet adherence achieved by interventions suitable for implementation in primary care settings. METHODS: Medline (PubMed) and The Cochrane Library bibliographic searches retrieved randomized controlled trials published in English or Spanish, January 1990-January 2013. The inclusion criteria were adult population, >3 months follow-up, and interventions suitable for primary care settings. Exclusion resulted if studies focused exclusively on weight loss or did not analyze food intake (fats, fruits and vegetables--F&V, fiber) or Mediterranean diet adherence. Validity (risk of bias) was independently evaluated by two researchers; discrepancies were reviewed until a consensus was reached. RESULTS: Of the 15 included articles (14 studies), only 3 studies surpassed 12-months follow-up. Ten interventions emphasized healthy nutrition (n = 9948); 4 added activity levels (n = 3816). Six trials included participants with cardiovascular risk; 7 were community-based; 1 focused on women with cancer. Eleven studies showed 9.7% to 59.3% increased F&V intake with counseling interventions, compared to baseline (-13.3% to 27.8% in controls). Seven studies reported significant differences between intervention and control groups. CONCLUSION: Nutritional counseling moderately improves nutrition, increases intake of fiber, F&V, reduces dietary saturated fats, and increases physical activity. Studies with longer follow-up are needed to determine long-term effects, cardiovascular morbidity, and mortality.

Effects of kiwi consumption on plasma lipids, fibrinogen and insulin resistance in the context of a normal diet.

BACKGROUND AND AIMS: Among fruits, kiwi is one of the richest in vitamins and polyphenols and has strong anti-oxidant effects. We aimed to analyze the relationship between the consumption of kiwi and plasma lipid values, fibrinogen, and insulin resistance in adults within the context of a normal diet and physical-activity. METHODS: Cross-sectional study. Participants (N = 1469), who were free of cardiovascular diseases, completed a visit, which included the collection of information concerning the participant's usual diet and kiwi consumption using a previously validated, semi-quantitative, 137-item food-frequency-questionnaire. Fasting laboratory determinations included plasma lipids, fibrinogen and insulin resistance. Regular physical-activity was determined using accelerometry. RESULTS: Consumers of at least 1 kiwi/week presented higher plasma values of HDL-cholesterol (mean difference 4.50 [95% CI: 2.63 to 6.36]) and lower triglyceride values (mean difference -20.03 [95% CI: -6.77 to -33.29]), fibrinogen values (mean difference -13.22 [95% CI: -2.18 to -24.26]) and HOMAir values (mean difference -0.30 [95% CI: -0.09 to -0.50]) (p < 0.05, for all comparisons) than those who consumed less than 1 kiwi per week. In an adjusted logistic regression analysis, this group had a lower odds-ratio for presenting plasmatic fibrinogen concentrations above 400 mg/dL (OR = 0.68, 95% CI 0.49 to 0.95), HDL-Cholesterol plasma values below 45 mg/dL (OR = 0.57, 95% CI 0.36 to 0.91) and a HOMAir above 3 (OR = 0.61, 95% CI 0.37 to 1.00). CONCLUSIONS: Consumption of at least one kiwi/week is associated with lower plasma concentrations of fibrinogen and improved plasma lipid profile in the context of a normal diet and regular exercise.

Physical activity program for patients with dementia and their relative caregivers: randomized clinical trial in Primary Health Care (AFISDEMyF study).

BACKGROUND: The aging of the population has led to the increase of chronic diseases, especially dementia and cardiovascular diseases, and it has become necessary for their relatives to dedicate more time in caregiving.The objective in the first phase of this study is to evaluate the effectiveness of a Primary Health Care procedure to increase the physical activity of people with dementia and their relative caregivers. Also the effect on the cognitive state and cardiovascular risk will be assessed. DESIGN: Clinical, multicentric and randomized trial. A simple random sampling to select 134 patients diagnosed with dementia will be carried out. After contacting their relatives, his/her participation in the trial will be requested. A basal assessment will be made and the participants will be asigned to control or intervention group (1:1). VARIABLES: The main measure will be the assessment of physical activity (podometer and 7-PAR) in patients and caregivers. In patients with dementia: ADAS-cog, functional degree and cardiovascular risk. In caregivers: cardiovascular risk, general health and quality of life. INTERVENTION: For 3 months, participants will receive instructions to do physical activity with an adapted program. This program will be designed and applied by Primary Health Care professionals in patients with dementia and their caregivers. The control group will receive regular care. ANALYSIS: An intention-to-treat analysis will be carried out by comparing the observed differences between basal, 6 and 12 months measures. Change in the mean of daily steps assessed with the podometer and 7-PAR will be the main result. DISCUSSION: If the main hypothesis is confirmed, it could be useful to improve the cognitive state of patients with dementia, as well as the cardiovascular risk of all of them. The results can be good to improve technical features of the devices that register the physical activity in the patients with dementia, and it could facilitate its commercialization. TRIAL REGISTRATION: Clinical Trials.gov Identifier: NCT02044887.

Association between fat amount of dairy products with pulse wave velocity and carotid intima-media thickness in adults.

BACKGROUND: Examine the relation between consumption of low-fat vs. whole-fat dairy products with the carotid intima-media thickness and pulse wave velocity. METHODS: Cross-sectional and multi-center study. A total of 265 subjects were selected by stratified random sampling. MEASUREMENTS: Information about dairy products was assessed using a semi-quantitative food-frequency questionnaire. Carotid intima-media thickness (IMT) was measured by carotid ultrasonography. Pulse wave velocity (PWV) was measured using the SphygmoCor-System. RESULTS: Subjects (age 55.8 ± 12.2) had mean values of IMT 0.68 ± 0.10 mm and PWV 7.60 ± 2.0 m/sec. The relationship between PWV and IMT with whole-fat and low-fat dairy intake groups, adjusted for age, sex, energy intake and other confounders revealed lower values of PWV in subjects with a consumption higher than 125 g/day of low-fat dairy and in those who did not intake whole-fat dairy. In a risk-factor adjusted regression model, an increase in PWV of 0.109 m/sec (95% CI: 0.006 -0.213) was estimated for every 100 g/day increase in whole-fat dairy intake. Similarly, a decrease in PWV of 0.101 m/sec (95% CI: -0.178 -0.023) was estimated for every 100 g/day increase in low-fat dairy intake, (p = 0.038 and p = 0.011 respectively). While for every 100 g/day increase in low-fat dairy intake, the estimate decrease of IMT was 0.005 mm (95% CI: -0.010 -0.001), p = 0.011. CONCLUSIONS: PWV and IMT showed an inverse association with the intake of low-fat dairy and a positive association with the intake of whole-fat dairy, so the amount of fat in dairy products can play an important role in arterial stiffness and subclinical atherosclerosis.

Effectiveness of a smartphone application for improving healthy lifestyles, a randomized clinical trial (EVIDENT II): study protocol.

BACKGROUND: New technologies could facilitate changes in lifestyle and improve public health. However, no large randomized, controlled studies providing scientific evidence of the benefits of their use have been made. The aims of this study are to develop and validate a smartphone application, and to evaluate the effect of adding this tool to a standardized intervention designed to improve adherence to the Mediterranean diet and to physical activity. An evaluation is also made of the effect of modifying habits upon vascular structure and function, and therefore on arterial aging. METHODS/DESIGN: A randomized, double-blind, multicenter, parallel group clinical trial will be carried out. A total of 1215 subjects under 70 years of age from the EVIDENT trial will be included. Counseling common to both groups (control and intervention) will be provided on adaptation to the Mediterranean diet and on physical activity. The intervention group moreover will receive training on the use of a smartphone application designed to promote a healthy diet and increased physical activity, and will use the application for three months. The main study endpoints will be the changes in physical activity, assessed by accelerometer and the 7-day Physical Activity Recall (PAR) interview, and adaptation to the Mediterranean diet, as evaluated by an adherence questionnaire and a food frequency questionnaire (FFQ). Evaluation also will be made of vascular structure and function based on central arterial pressure, the radial augmentation index, pulse velocity, the cardio-ankle vascular index, and carotid intima-media thickness. DISCUSSION: Confirmation that the new technologies are useful for promoting healthier lifestyles and that their effects are beneficial in terms of arterial aging will have important clinical implications, and may contribute to generalize their application in favor of improved population health. TRIAL REGISTRATION: Clinical Trials.gov Identifier: NCT02016014.

Evaluation of SINERGIAPS, an intervention to improve patient safety in primary healthcare centers in Spain based on patients' perceptions and experiences: a protocol for a hybrid type I randomized clinical trial.

Background: Adverse events in the primary care setting result in a direct cost equivalent to at least 2.5% of total healthcare spending. Across OECD countries, they lead to more than seven million avoidable hospital admissions annually. In this manuscript, we describe the protocol of a trial aimed at evaluating the effectiveness of SinergiAPS (a patient-centered audit and feedback intervention) in reducing avoidable hospital admission and explore the factors that may affect its implementation. Methods: We will conduct a 24-month, parallel, open-label, multicenter, pragmatic, hybrid type 1 randomized clinical trial. 118 primary healthcare centers with wide geographical distribution in Spain will be randomly assigned (ratio 1:1) to two groups. The intervention group will receive two audits (baseline and intermediate at 12 months) based on information collected through the administration of the PREOS-PC questionnaire (a measure of patient-reported patient safety) to a convenience sample of 100 patients per center. The intervention group will receive reports on the results of both audits, along with educational resources aimed at facilitating the design and implementation of safety improvement plans. The control group will receive care as usual. The primary outcome will be the rate of avoidable hospitalizations (administrative data). Secondary outcomes: patient-reported patient safety experiences and outcomes (PREOS-PC questionnaire); patient safety culture as perceived by professionals (MOSPSC questionnaire); adverse events reported by healthcare professionals (ad hoc questionnaire); the number of safety improvement actions which the re has implemented (ad hoc questionnaire). Outcome data will be collected at baseline and 24 months follow-up. For the evaluation of the implementation of the SinergiAPS intervention, we will draw on the Consolidated Framework for Implementation Research (CFIR). We will collect and analyze qualitative and quantitative data (30 individual interviews, implementation logbooks; questionnaires for professionals from intervention centers, and level of use of the SinergiAPS web tool). Discussion: This study will expand the scarce body of evidence existing regarding the effects and implementation of interventions aimed at promoting patient and family engagement in primary healthcare, specifically for enhancing patient safety. The study has the potential to produce an impact on clinical practice, healthcare systems, and population health.Clinical Trial Registration: https://clinicaltrials.gov/study/NCT05958108?term=sinergiAPS&rank=1 (NCT05958108).

Examining the influence of mental health and structural determinants of health on the stage of motivational readiness for health behaviour changes: A path analysis study.

This study explores the influence of mental health and structural determinants of health on motivational readiness for health behaviour change in 1462 Spanish primary healthcare users. Chi-square test and structural equation modelling were performed. Results showed that depression and anxiety were negatively associated with being in the action stages of motivational readiness for a healthy diet and physical activity. This association was statistically significant only for motivational readiness for a healthy diet and depression (ß=-0.076;p=0.046). Furthermore, women and workers were more likely to be in the action stages of motivational readiness for a healthy diet while older adults and adults with higher health-related quality of life were more likely to be in the action stages of motivational readiness for physical activity. The present study suggests that structural (being older, being a woman and being employed) and intermediary (suffering from depression and higher health-related quality of life) determinants of health influence motivational readiness for health behaviour changes.

Role of personal aptitudes as determinants of incident morbidity, lifestyles, quality of life, use of health services, and mortality (DESVELA cohort): quantitative study protocol for a prospective cohort study in a hybrid analysis.

Introduction: The healthcare and well-being of the population depend on multiple factors and should adapt to societal changes. The opposite is also occurring; society has evolved concerning the individuals' approach to their care, which includes participation in decision-making processes. In this scenario, health promotion and prevention become crucial to provide an integrated perspective in the organization and management of the health systems.Health status and well-being depend on many aspects, determinants of health, which in turn may be modulated by individual behavior. Certain models and frameworks try to study the determinants of health and individual human behaviors, separately. However, the interrelation between these two aspects has not been examined in our population.Our main objective is to analyze whether personal aptitudes related to behaviors are independently associated with the incidence of morbidity. A secondary objective will enquire whether these personal aptitudes are independently associated with lower all-cause mortality, enhanced adoption of healthy lifestyles, higher quality of life, and lower utilization of health services during follow-up. Methods: This protocol addresses the quantitative branch of a multicenter project (10 teams) for the creation of a cohort of at least 3,083 persons aged 35 to 74 years from 9 Autonomous Communities (AACC). The personal variables to evaluate are self-efficacy, activation, health literacy, resilience, locus of control, and personality traits. Socio-demographic covariates and social capital will be recorded. A physical examination, blood analysis, and cognitive evaluation will be carried out.Several sets of six Cox models (one for each independent variable) will analyze the incidence of morbidity (objective 1); all-cause mortality and the rest of the dependent variables (objective 2). The models will be adjusted for the indicated covariates, and random effects will estimate Potential heterogeneity between AACC. Discussion: The analysis of the association of certain behavioral patterns and determinants of health is essential and will contribute to improving health promotion and prevention strategies. The description of the individual elements and interrelated aspects that modulate the onset and persistence of diseases will allow the evaluation of their role as prognostic factors and contribute to the development of patient-tailored preventive measures and healthcare.Clinical Trial Registration: ClinicalTrials.gov, NCT04386135. Registered on April 30, 2020.