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

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

(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.

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. 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. 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. ClinicalTrials.gov Identifier: NCT03574480 . Date of trial Registration July 2, 2018.

The objective of this study is to analyze the influence of adherence to the Mediterranean diet (MDA) and its components on early vascular aging (EVA) in a Spanish population sample free of cardiovascular disease and to analyze the differences by sex. Methods: We recruited 501 individuals aged 35–75 without cardiovascular disease by random sampling (55.90 ± 14.24 years, 49.70% men). EVA was defined in two steps: Step 1: subjects with vascular damage in carotid arteries or peripheral artery disease were classified as EVA. Step 2: subjects at the percentile of the combined Vascular Aging Index (VAI) were classified; ≥ p90 was considered EVA and < p90 was considered normal vascular aging (NVA), estimated using the following formula (VAI = (log (1.09) × 10 cIMT + log (1.14) cfPWV) × 39.1 + 4.76 by age and sex. Carotid-femoral pulse wave velocity (cfPWV) was measured by SphigmoCor System^® and carotid intima-media thickness by Sonosite Micromax^® ultrasound and classified thus: values ≥ Percentile 90 were considered EVA and those < Percentile 90 as NVA, with population percentiles analyzed. The principal result variable was assessed using the 14-item MEDAS questionnaire, developed and validated by the PREDIMED group, comprising 12 questions about the frequency of food consumption and two questions regarding the Spanish population’s typical eating habits. Results: MDA was observed by 25% (17% men and 34% women). EVA was present in 17% (29% men and 4% women). The adjusted logistic regression models showed that an increase in MDA decreases the probability of EVA in the global analysis (OR = 0.36; 95% CI: 0.16–0.82). In the analysis by sex, this association was only seen in men (OR = 0.33; 95% CI: 0.12–0.86), but not in women (OR = 0.31; 95% CI: 0.04–2.50). Conclusion: The results of this study suggest that a greater adherence to the Mediterranean diet decreases the probability of presenting EVA. In the analysis by sex, this association applies only to men.

Background: Studying the adherence of the population to the Atlantic Diet (AD) could be simplified by an easy and quickly applied dietary index. The aim of this study is to analyse the relationship of an index measuring compliance with recommendations regarding the Atlantic diet and physical activity with cardiovascular disease risk factors, cardiovascular risk factors, obesity indexes and arterial stiffness markers. Methods: We included 791 individuals from the EVIDENT study (lifestyles and arterial ageing), (52.3 ± 12 years, 61.7% women) without cardiovascular disease. Compliance with recommendations on AD was collected through the responses to a food frequency questionnaire, while physical activity was measured by accelerometer. The number of recommendations being met was estimated using a global scale between 0 and 14 points (a higher score representing greater adherence). Blood pressure, plasma lipid and glucose values and obesity rates were measured. Cardiovascular risk was estimated with the Framingham equation. Results: In the overall sample, 184 individuals (23.3%) scored between 0–3 on the 14-point index we created, 308 (38.9%) between 4 and 5 points, and 299 (37.8%) 6 or more points. The results of multivariate analysis yield a common tendency in which the group with an adherence score of at least 6 points shows lower figures for total cholesterol (p = 0.007) and triglycerides (p = 0.002). Similarly, overall cardiovascular risk in this group is the lowest (p < 0.001), as is pulse wave velocity (p = 0.050) and the mean values of the obesity indexes studied (p < 0.05 in all cases). Conclusion: The rate of compliance with the Atlantic diet and physical activity shows that greater adherence to these recommendations is linked to lower cardiovascular risk, lower total cholesterol and triglycerides, lower rates of obesity and lower pulse wave velocity values.