Combined use of a healthy lifestyle smartphone application and usual primary care counseling to improve arterial stiffness, blood pressure and wave reflections: a Randomized Controlled Trial (EVIDENT II Study).

Our aim was to investigate the effects of an intervention that comprised a brief counseling session on lifestyle habits together with the use of the EVIDENT (Lifestyles and arterial aging) application on the modification of markers that indicated different hemodynamic functions, such as arterial stiffness, blood pressure or wave reflections. The EVIDENT II study (Lifestyles and arterial aging) is a randomized clinical trial with two parallel groups. Each participant had an initial visit and two follow-up visits at 3 and 12 months where the peripheral augmentation index-PAIx75 was measured by tonometry, while an oscillometric method was used for the cardio-ankle vascular index-CAVI and brachial-ankle pulse wave velocity-baPWV. Both groups (intervention-IG and control-CG) were briefly counseled on diet and exercise. The IG also received instructions on the use of the EVIDENT II application during the 3 months. The sample (N = 597; 52 ± 11 years; 64% women) was randomized into IG = 291 and CG = 306. Comparing groups, there was a decrease in the PAIx75 favorable to the IG at 3 months (-4.9%, 95% CI: -7.7 to -2.1) and 12 months (-3.9%, 95% CI: -6.8 to -1.0). There was also a nonsignificant reduction of the CAVI at 3 months in the IG. A group effect was observed in the measurement of the PAIx75 over the 12-month follow-up (p = 0.003). This interaction was only observed in women (p = 0.017). In conclusion, the use of the EVIDENT II application achieved a modification of the PAIx75, a marker of wave reflection and vascular tone, in women through lifestyle improvements (physical activity and adherence to the Mediterranean diet). No significant results were found regarding blood pressure or arterial stiffness markers.

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.

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.

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.

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.

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.

Blood pressure circadian pattern and physical exercise assessment by accelerometer and 7-day physical activity recall scale.

BACKGROUND: The relationship between regular physical activity, measured objectively and by self-report, and the circadian pattern of 24-hour ambulatory arterial blood pressure (BP) has not been clarified. METHODS: We performed a cross-sectional study in a cohort of healthy patients. We included 1,345 patients from the EVIDENT study (mean age 55 ± 14 years; 59.3% women). Physical activity was assessed using the 7-day physical activity recall (PAR) questionnaire (metabolic equivalents (MET)/hour/week) and the Actigraph GT3X accelerometer (counts/minute) for 7 days; ambulatory arterial BP was measured with a radial tonometer (B-pro device). RESULTS: The dipper-pattern patients showed a higher level of activity than nondipper patients, as assessed by accelerometer and 7-day PAR. Physical activity measures correlated positively with the percent drop in systolic BP (SBP; ρ = 0.19 to 0.11; P < 0.01) and negatively with the systolic and diastolic sleep to wake ratios (ρ = -0.10 to -0.18; P < 0.01) and heart rate (ρ = -0.13; P < 0.01). In logistic regression, considering the circadian pattern (1, dipper; 0, nondipper) as the dependent variable, the odds ratio of the third tertile of counts/minute was 1.79 (95% confidence interval [CI], 1.35-2.38; P < 0.01) and of MET/hour/week was 1.33 (95% CI, 1.01-1.75; P = 0.04) after adjustment for confounding variables. CONCLUSIONS: Physical activity, as evaluated by both the accelerometer and the 7-day PAR, was associated with a more marked nocturnal BP dip and, accordingly, a lower SBP and diastolic BP sleep to wake ratio. CLINICAL TRIAL REGISTRATION: Clinical Trials.gov Identifier: NCT01083082.

Association of television viewing time with central hemodynamic parameters and the radial augmentation index in adults.

BACKGROUND: We conducted a study to explore the relationship between television viewing time and central hemodynamic parameters and the radial augmentation index (AIx) in adults. METHODS: Random sampling was used to select 732 individuals who attended primary-care centers as subjects for the study. The self-reported time that these individuals spent in viewing television was elicited with a questionnaire and included the number of hours that they spent watching television while sitting or lying down. The subjects' physical activity was estimated through accelerometers attached to their waists. Central hemodynamic parameters and the peripheral augmentation index adjusted for a heart rate of 75 bpm (PAIx75) were measured with pulse-wave application software (A-Pulse CASP). RESULTS: The subjects' systolic blood pressure (SBP) (central and peripheral), pulse pressure, and radial AIx showed significant differences between tertiles of television viewing time, with the lowest values in the first tertile (P < 0.01). After adjustment for age and sex, a multiple linear regression analysis showed an association of television viewing time with office SBP. Although the association of television viewing time with central SBP followed the same trend as for office BP, it did not reach statistical significance. After adjustment for age, sex, waist-to-height ratio, physical activity reflected by accelerometer data (counts/min), high-density lipoprotein cholesterol, smoking, antihypertensive and antidiabetic medication, and the use of lipid-lowering drugs, an increase in PAIx75 of 0.22 was estimated for each hour of increase in television viewing time (P < 0.01). CONCLUSIONS: Television viewing time was directly correlated with PAIx75 in an adult population. This correlation was maintained even after adjustment for physical activity, age, sex, and other cardiovascular risk factors.

Physical exercise, fitness and dietary pattern and their relationship with circadian blood pressure pattern, augmentation index and endothelial dysfunction biological markers: EVIDENT study protocol.

BACKGROUND: Healthy lifestyles may help to delay arterial aging. The purpose of this study is to analyze the relationship of physical activity and dietary pattern to the circadian pattern of blood pressure, central and peripheral blood pressure, pulse wave velocity, carotid intima-media thickness and biological markers of endothelial dysfunction in active and sedentary individuals without arteriosclerotic disease. DESIGN: A cross-sectional multicenter study with six research groups. SUBJECTS: From subjects of the PEPAF project cohort, in which 1,163 who were sedentary became active, 1,942 were sedentary and 2,346 were active. By stratified random sampling, 1,500 subjects will be included, 250 in each group. PRIMARY MEASUREMENTS: We will evaluate height, weight, abdominal circumference, clinical and ambulatory blood pressure with the Radial Pulse Wave Acquisition Device (BPro), central blood pressure and augmentation index with Pulse Wave Application Software (A-Pulse) and SphymgoCor System Px (Pulse Wave Analysis), pulse wave velocity (PWV) with SphymgoCor System Px (Pulse Wave Velocity), nutritional pattern with a food intake frequency questionnaire, physical activity with the 7-day PAR questionnaire and accelerometer (Actigraph GT3X), physical fitness with the cycle ergometer (PWC-170), carotid intima-media thickness by ultrasound (Micromax), and endothelial dysfunction biological markers (endoglin and osteoprotegerin). DISCUSSION: Determining that sustained physical activity and the change from sedentary to active as well as a healthy diet improve circadian pattern, arterial elasticity and carotid intima-media thickness may help to propose lifestyle intervention programs. These interventions could improve the cardiovascular risk profile in some parameters not routinely assessed with traditional risk scales. From the results of this study, interventional approaches could be obtained to delay vascular aging that combine physical exercise and diet. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01083082.