This study aimed to examine plasma melatonin levels, seasonal variation, and their association with sleep quality in adults aged 25-65 years using both the Pittsburgh Sleep Quality Index and actigraphy. A cross-sectional study was conducted in a stratified random sample of 500 adults from Salamanca and Ávila (Spain). Plasma melatonin was quantified by HPLC-DAD-MS/MS, and sleep quality was assessed using the Pittsburgh Sleep Quality Index and a 5-day wrist actigraphy protocol (ActiGraph GT3X+). Participants were stratified by age and sex, and seasonal variation was evaluated. Multivariable analyses were adjusted for relevant confounders. A total of 334 participants with valid melatonin measurements were included (mean age 43 years). Mean plasma melatonin concentration was 14.5 ± 15.9 pg/mL, with higher levels observed in men than women and a decreasing trend with age. A trend toward higher melatonin levels during winter was observed, although the differences were not statistically significant. No significant association was found between plasma melatonin levels and Pittsburgh Sleep Quality Index scores. However, higher melatonin levels were associated with slightly greater sleep efficiency measured by actigraphy. Participants reporting melatonin supplement use showed higher Pittsburgh Sleep Quality Index scores and lower total sleep time compared with non-users. Overall, plasma melatonin levels varied by sex, age, and season but showed no association with subjective sleep quality, while a modest relationship was observed with objective sleep efficiency, suggesting that melatonin alone is not a strong determinant of perceived sleep quality and highlighting the multifactorial nature of sleep regulation in adults.

Abstract Poor sleep quality is associated with obesity, cardiovascular disease, cognitive impairment, increased hospitalization and mortality. Combining actigraphy with questionnaires effectively evaluates sleep. Age and sex shape both subjective sleep quality and objective actigraphic metrics; however, stratified estimates combining both approaches in Spanish adults are scarce. The aim of this study was to analyse the role of age and sex on sleep quality, in an age–sex stratified random sample of the general Spanish population. For this, it was carried out a cross-sectional descriptive study carried out in Salamanca and Ávila (Spain). The study population included a sample of 500 people aged 25–65 years selected by stratified random sampling by age and sex. Sleep quality was analysed using actigraphy and the Pittsburgh Sleep Quality Index-PSQI. Sociodemographic and clinical variables were also studied. The results were that men obtained a lower mean PSQI score than women. By age group, the poorer subjective sleep quality corresponded to the 25-years group, whereas the 45-year group had the lowest PSQI scores. Actigraphy showed higher efficiency in women. Men had more WASO, more awakenings and higher fragmentation. Midlife groups (35–45 years) showed lower efficiency and higher WASO. Trial registration number: NCT05324267.

BackgroundThe positive relationship between health and good perceived social support has been widely demonstrated in the scientific literature. It is known that having a good social support influences the proper maintenance of health even as a protective factor, besides being a good predictor in the recovery of health during a disease process, influencing differently men and women.AimThis project aims to study the moderating effects of perceived social support in the relationship between depression and self-perceived health according to gender, after a complex multiple-risk intervention was carried out in patients of primary health care with low social support.MethodsA cluster randomized clinical trial was developed in the subgroup of patients included in phase 3 of the EIRA project. CONSORT recommendations were followed to present the results. To determine the mediating effect between social support and self-perceived health, three regression analyses were carried out using the procedure designed by Hayes through the PROCESS macro for SPSS.Results3,062 people (54.9% women) participated in the study. Men reported experiencing more social support and self-perceived health (p < 0.001) than women at the beginning of the study, but women reported higher social support at post-intervention. Moderation analyses showed that, post-intervention, those women (bsimple = −2.9867, p < 0.001) and males (bsimple = −1.4337, p < 0.001) who scored lower in depression reported higher social support.ConclusionIn primary care, it is necessary to encourage intervention strategies that promote social networks as a key element of positive action aimed at maintaining and improving the population’s health, especially in adults and more specifically in women.Clinical trial registrationClinicalTrials.gov, identifier NCT03136211.

BACKGROUND:Postpartum is a critical phase for women's health, characterized by physical, psychological, and social changes. Social networks have emerged as a predominant communication channel, offering support and quick access to information about motherhood. However, their use can also negatively influence body image and dietary behavior, especially in a context of pro-slimness beauty standards. Postpartum women are particularly vulnerable to body dissatisfaction, but there are still few studies that specifically analyze the impact of social networks at this stage. This scoping review aims to map and describe the available evidence on how the possible influence of exposure to social media content on body image perception and the adoption of eating and exercise-related habits in women during the postpartum period has been investigated. METHODS:This scoping review was conducted following the PRISMA-ScR (Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews) guidelines, adapted for exploratory reviews. We searched for studies published in the last 10-years in databases such as PubMed, Scopus, Web of Science, CINAHL, and BVS, using terms related to social networks, body image, diet, exercise, and the postpartum period. Eight studies were included after applying eligibility criteria based on the PIO framework. An assessment of the quality of methodological reporting was performed using best practice guidelines such as SRQR, STROBE, CONSORT, and PRISMA, for descriptive purposes. RESULTS:We analyzed 8 studies suggesting that social networks may negatively influence the body image, eating and exercise habits of postpartum women. The publications represent unrealistic aesthetic standards, associated with body dissatisfaction, restrictive diets, and intensive exercise, with prevalent nutritional misinformation. Although positive messages of body acceptance were identified, they were scarce, suggesting the need for regulation and media education. CONCLUSIONS:Social networks could exert a relevant influence on women's body image and self-care habits in the postpartum period, promoting unrealistic aesthetic standards that could have a negative impact on their physical and emotional well-being. It is essential to implement media literacy strategies, promote inclusive content, and regulate misinformation on these platforms to mitigate their adverse effects and promote a healthy and sustainable recovery.

BackgroundThe positive relationship between health and good perceived social support has been widely demonstrated in the scientific literature. It is known that having a good social support influences the proper maintenance of health even as a protective factor, besides being a good predictor in the recovery of health during a disease process, influencing differently men and women.AimThis project aims to study the moderating effects of perceived social support in the relationship between depression and self-perceived health according to gender, after a complex multiple-risk intervention was carried out in patients of primary health care with low social support.MethodsA cluster randomized clinical trial was developed in the subgroup of patients included in phase 3 of the EIRA project. CONSORT recommendations were followed to present the results. To determine the mediating effect between social support and self-perceived health, three regression analyses were carried out using the procedure designed by Hayes through the PROCESS macro for SPSS.Results3,062 people (54.9% women) participated in the study. Men reported experiencing more social support and self-perceived health (p < 0.001) than women at the beginning of the study, but women reported higher social support at post-intervention. Moderation analyses showed that, post-intervention, those women (bsimple = −2.9867, p < 0.001) and males (bsimple = −1.4337, p < 0.001) who scored lower in depression reported higher social support.ConclusionIn primary care, it is necessary to encourage intervention strategies that promote social networks as a key element of positive action aimed at maintaining and improving the population’s health, especially in adults and more specifically in women.Clinical trial registrationClinicalTrials.gov, identifier NCT03136211.

OBJECTIVE:To identify sex-specific patterns based on determinants related to sleep quality, using a representative sample of the Spanish adult population. DESIGN:Cross-sectional, age-stratified and sex-stratified study. SETTING:Community-based assessments in two Spanish provinces (Salamanca and Ávila). PARTICIPANTS:Adults aged 25-65 years (n=500), equally distributed by sex and five age strata, selected from the regional health-card database. PRIMARY AND SECONDARY OUTCOME MEASURES:Objective sleep metrics from wrist actigraphy (time in bed, total sleep time (TST), sleep efficiency, wake after sleep onset, number/duration of awakenings, fragmentation/movement indices) and self-reported sleep quality (Pittsburgh Sleep Quality Index). METHODS:Standardised baseline assessments collected sociodemographic, clinical, mental-health and lifestyle variables using validated instruments. Actigraphy (ActiGraph GT3X+) recorded triaxial acceleration at 30 Hz over 5 days; data were aggregated in 60 s epochs (ActiLife). Sleep/wake was classified with Cole-Kripke and nocturnal episodes identified with Tudor-Locke before deriving sleep indices. Two-step cluster analysis was applied separately by sex. RESULTS:Three clusters were identified for each sex, with age and educational level being the most influential factors. In men, the 65-year-old cluster with university education and lower anxious-depressive load showed the highest sleep efficiency (91.8±3.8%) and the lowest TST (351.7±74.8 min). In contrast, the 35-year-old cluster with middle or high school presented the lowest efficiency (88.3±10.0%) and higher TST (368.1±83.8 min). In women, the 55-year-old cluster with middle or high school and low emotional load showed the highest efficiency (93.6±2.8%), despite a reduced TST (352.0±79.7 min), while the 35-year-old cluster, with middle or high school and high levels of anxiety and depression, showed the worst efficiency metrics (89.5±3.9%) and a higher TST (394.8±67.3 min). CONCLUSION:Sleep quality in Spanish adults is heterogeneous across sex-specific clusters shaped by age, education and mental-health burden. Cluster-based characterisation may support tailored public-health interventions. TRIAL REGISTRATION NUMBER:NCT05324267.

BACKGROUND AND AIM:Despite advances in research on training and nutritional supplementation, it is largely unknown how micronutrient intake modulates the response to training in older adults. This study investigates the relationship between nutrient intake and response to training in older women at risk of sarcopenia. METHODS:A randomized clinical trial with two parallel groups (high-speed resistance training (H-RT) and multicomponent training (MT)) was conducted over a 32-week intervention involving 80 older women at risk of sarcopenia (mean age: 77.36 ± 6.71 years). A food frequency questionnaire was administered to assess whether nutrient intake influenced strength outcomes measured by the Five Times Sit-to-Stand Test (5STS) and other functional variables. RESULTS:Significant improvements in the five times sit to stand test (5STS) were observed in both groups post-intervention (p < 0.001), with no significant differences between them (p = 0.127), suggesting comparable effectiveness. In both groups, lower levels of vitamin B12 (H-RT: rp = -0.52; MT: rp = -0.50) and vitamin D (H-RT: rp = -0.55; MT: rp = -0.69) were associated with worse 5STS performance. Additionally, in the H-RT group, lower levels of vitamin E (rp = -0.36), magnesium (rp = -0.48), iron (rp = -0.43), and potassium (rp = -0.47) were also correlated with poorer performance. CONCLUSIONS:The results indicate that improvements in strength are related to micronutrient sufficiency rather than macronutrient sufficiency. Deficiencies in vitamin D and B12 negatively impacted muscle strength gains in both H-RT and MT, while vitamin E, potassium, magnesium, and iron influenced H-RT outcomes. The lesser effect of micronutrient deficiencies on MT suggests it may be more suitable for individuals with mild deficiencies, as it requires fewer specific nutrients for muscle strength. REGISTRATION:The study is registered at ClinicalTrials.gov under the identifier NCT05870046.

Objectives: To describe, understand, and correlate willingness to forgive with self-perceived health-related quality of life, including the components of quality of physical health and mental health. Methods: Conducted with 30 older individuals, ≥65 years old, with preserved cognitive abilities, literacy ≥ four years of education, living in Portugal and Spain. The 12-Item Short-Form Health Survey (SF-12) was used to assess self-perceived health-related quality of life, and the Heartland Forgiveness Scale (HFS) was used to measure willingness to forgive. Results: There was a direct positive correlation between willingness to forgive and perception of health-related quality of life, especially for the mental health component, educational level, cohabitation, and work activity. Conclusions: Forgiveness could play a significant role in the emotional health and quality of life of the elderly. Strategies to develop forgiveness can benefit the active aging process, contributing to improved health-related quality of life in older individuals.

Background: Some social networks, such as Twitter (now known as X), have proven to be very useful for sharing and discussing multiple aspects related to the healthcare field. However, the use of Twitter as a method of communication and knowledge transfer to nursing students has been limited. Objectives: To evaluate the usability and effect of an educational intervention for monitoring additional content, through the social network Twitter, of various subjects of nursing studies (clinical nursing, community nursing, and nursing fundamentals). Design: An exploratory experimental study was carried out through an educational intervention during the 2020-2021 and 2021-2022 academic years. Settings: Faculty of Nursing at the University of Salamanca, Spain. Participants were 308 students. Methods: Students used Twitter to receive tweets about news or links to subject -related content. They also completed a pre -post questionnaire. Results: A high degree of visualization and interaction of the study's Twitter account stands out, mainly in the subject clinical nursing. In relation to usability, the participants stated that they strongly agreed with aspects such as "thinking that it was easy to use the account" (59.4 %) as well as "imagining that the majority of colleagues would learn very quickly to use said account" (46.5 %). Students who used the account at least once a day obtained higher scores on the post -study knowledge questionnaire than those who used it less than once a day (p < 0.05), or those who used it 2 or 3 times during the study (p = 0.010). Conclusions: The group of participants who used the Twitter account at least once a day stated that using the account was easy and that they would like to use it more frequently. Likewise, greater use of this tool was associated with a better score on a post -study knowledge questionnaire.

The prevalence of sarcopenia depends on the diagnostic criteria and updates used. There are few studies investigating the relationship between the European Working Group on Sarcopenia in Older People (EWGSOP2) criteria and risk factors in active community-dwelling older adults. In this cross-sectional study, a total of 533 community-dwelling active older adults were assessed. 3.75 % were diagnosed with confirmed sarcopenia and 15.86 % with probable sarcopenia. The risk of sarcopenia was found to increase with age, taking more than four tablets a day and having a low level of education. There is a possible association between smoking and living alone. In contrast, active older adults had a lower prevalence of sarcopenia compared to the European and global populations, suggesting a protective effect of physical activity adherence against sarcopenia. Further studies in this population are needed to increase the sample size and to better understand the development and factors associated with sarcopenia.

OBJECTIVE:To examine the effectiveness of a 12-month MHBC intervention in the prevention of onset depression in primary health care (PHC). METHODS:Twenty-two PHC centres took part in the cluster-randomized controlled trial. Patients were randomized to receive either usual care or an MHBC intervention. The endpoints were onset of major depression and reduction of depressive symptoms in participants without baseline depression at a 12-month follow-up. RESULTS:2531 patients agreed and were eligible to participate. At baseline, around 43% were smokers, 82% were non-adherent to the Mediterranean diet and 55% did not perform enough physical activity. The intervention group exhibited a greater positive change in two or more behaviours (OR 1.75 [95%CI: 1.17 to 2.62]; p = 0.006); any behaviour (OR 1.58 [95%CI: 1.13 to 2.20]; p = 0.007); and adherence to the Mediterranean diet (OR 1.94 [95%CI: 1.29 to 2.94]; p = 0.002), while this increase was not statistically significant for smoking and physical activity. The intervention was not effective in preventing major depression (OR 1.17; [95% CI 0.53 to 2.59)]; p = 0.690) or reducing depressive symptoms (Mean difference: 0.30; [95% CI -0.77 to 1.36]; p = 0.726) during follow-up. CONCLUSIONS:As compared to usual care, the MHBC intervention provided a non-significant reduction in the incidence of major depression. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03136211.

The increase in life expectancy and survival time implies an increase in the possible side-effects of pharmacological treatments in patients. Cancer-related fatigue is one of these side-effects. The main objective of this study was to evaluate the effects of a multimodal program of physical exercise and functional rehabilitation on asthenia, pain, functional capacity, and quality of life in cancer patients with cancer-related fatigue.METHODS:This was a randomized, parallel-controlled clinical trial, with two arms (experimental and control group), and it was conducted over the course of a year in the Oncology Hospitalization Unit at the University Hospital of Salamanca, Spain. Participants (n = 48) were assessed at three points during the study. The first assessment was prior to hospital discharge, the second assessment was after 15 days, and the final assessment was at one month post-hospital follow-up. The intervention lasted one month. The main variables studied were the dependency levels (Barthel), cancer-related fatigue (FACT-An), health-related quality of life (EuroQoL-5D), functional capacity (SPPB), and kinesiophobia (TSK-F).RESULTS:Sample size (n = 44). Mean age 63.46 ± 12.36 years. Significant differences between control and experimental group participants in Barthel, FACT-An, TSK-F, and SPPB scores at follow-up and final assessment.CONCLUSIONS:There are beneficial effects of a multimodal physical exercise and functional rehabilitation program in improving the autonomy of cancer-related fatigue patients.

Abstract Background Polyphenols have been shown to be effective against many chronic diseases, including neurodegenerative diseases. Specifically, the consumption of raisins, being a food rich in polyphenols, has been attributed with neuroprotective benefits. Therefore, our main objective is to evaluate the effect of including 50 g of raisins in the diet daily for 6 months, on the improvement of cognitive performance, cardiovascular risk factors and markers of inflammation in a population of older adults without cognitive impairment. Methods Design and intervention: This study will be a randomized controlled clinical trial of two parallel groups. Each subject included in the study will be randomly assigned to one of two study groups: control group (no supplement), intervention group (50 g of raisins daily during 6 months). Study population: The participants will be selected by consecutive sampling in the Primary Care consultations of urban health centers in Salamanca and Zamora (Spain), taking into account the selection criteria. Study variables: Two visits will be made, baseline and at 6 months. Cognitive performance will be evaluated (Mini-Mental State Examination test, Rey Auditory Verbal Learning Test, verbal fluency and montreal cognitive assessment (Moca)). It will also be analyzed the level of physical activity, quality of life, activities of daily living, energy and nutritional composition of the diet, body composition, blood pressure, heart rate, markers of inflammation and other laboratory tests of clinical relevance (glycaemia, total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides). In addition, sociodemographic data, personal and family history, medication use and alcohol and tobacco consumption will be collected. Discussion In this project, it is intended to contribute to minimize the problems derived from cognitive deterioration in older people. Trial registration ClincalTrials.gov Identifier: NCT04966455 Registration date: July 1, 2021.

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.

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 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

Background The aim of this study was to assess the efficacy of the combined use of smartphone and smartband technology for 3-months alongside brief lifestyle counselling, versus counselling alone, in increasing physical activity. As secondary objectives, the effects of the intervention on dietary habits, body composition, quality of life, level of functionality and cognitive performance were assessed. Methods This study employed a randomized clinical trial of two-parallel groups design – control group (CG) and intervention group (IG). The study was conducted in 3 Spanish health-centres between October 2018-February 2020. Eligible participants were people of both sexes and aged between 65–80 years attending the health-centres with a score ≥ 24 points on the Mini-Mental State Examination. Key variables included physical activity, dietary pattern, body composition, cognitive performance, level of functionality and quality of life. All variables were measured at baseline and after 3-months. Both groups received a brief nutritional and physical activity advice. Intervention group participants were 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. Results The study population comprised 160 participants (IG = 81, CG = 79), with a mean age of 70.8 ± 4.0 years (61.3% women). No difference was found in the primary and secondary outcomes analyzed (physical activity (steps/min -0.4 (-1.0 to 0.2) p = 0.174), and dietary habits (Mediterranean diet score 0.0 (-0.6 to 0.6) p = 0.956) that could be attributed to either group after an ANCOVA test. A difference attributable to the intervention was observed in the total Clock test score (0.7 (0.1 to 1.2) p = 0.018. Conclusions In a sample of people over 65 years of age, the combined use of the EVIDENT 3 smartphone app and an activity tracking bracelet for 3-months did not result in lifestyles changes related to the amount and level of physical activity or the eating habits, compared to brief lifestyle advice. Other clinical parameters were not changed either, although at the cognitive level, a slight improvement was observed in the score on the Clock test assessing a variety of cognitive functions such as memory. Trial registration The study was registered in ClinicalTrials.gov Identifier: NCT03574480. Date of trial Registration 02/07/2018.

A balanced diet can help in the prevention of chronic diseases. The aim of this study was to evaluate the effect of an mHealth intervention on the distribution of macronutrients and the intake of food groups. A total of 650 participants were included in this multi-center, clinical, randomized, controlled trial (Evident 3 study). All participants were given brief advice about diet and exercise. The intervention group received, in addition, an app (Evident 3) for the self-recording of their diet and an activity tracker wristband for 3 months. Follow-up visits were performed at 3 and 12 months to collect the diet composition using the Food Frequency Questionnaire. There were decreases in the intake of total calories, fat, protein and carbohydrates in both groups throughout the study, without significant differences between them. The intervention group reduced the intake of cholesterol (−30.8; 95% CI −59.9, −1.7) and full-fat dairies (−23.3; 95% CI −42.8, −3.8) and increased the intake of wholemeal bread (3.3; 95% CI −6.7, 13.3) and whole-grain cereals (3.4; 95% CI −6.8, 13.7) with respect to the control group. No differences were found in the rest of the nutritional parameters. The brief advice is useful to promote a healthier diet, and the app can be a support tool to obtain changes in relevant foods, such as integral foods, and the intake of cholesterol. Trial registration: ClinicalTrials.gov with identifier NCT03175614.

Background This study aimed to evaluate the effectiveness of a) a Multiple Health Behaviour Change (MHBC) intervention on reducing smoking, increasing physical activity and adherence to a Mediterranean dietary pattern in people aged 45–75 years compared to usual care; and b) an implementation strategy. Methods A cluster randomised effectiveness-implementation hybrid trial-type 2 with two parallel groups was conducted in 25 Spanish Primary Health Care (PHC) centres (3062 participants): 12 centres (1481 participants) were randomised to the intervention and 13 (1581 participants) to the control group (usual care). The intervention was based on the Transtheoretical Model and focused on all target behaviours using individual, group and community approaches. PHC professionals made it during routine care. The implementation strategy was based on the Consolidated Framework for Implementation Research (CFIR). Data were analysed using generalised linear mixed models, accounting for clustering. A mixed-methods data analysis was used to evaluate implementation outcomes (adoption, acceptability, appropriateness, feasibility and fidelity) and determinants of implementation success. Results 14.5% of participants in the intervention group and 8.9% in the usual care group showed a positive change in two or all the target behaviours. Intervention was more effective in promoting dietary behaviour change (31.9% vs 21.4%). The overall adoption rate by professionals was 48.7%. Early and final appropriateness were perceived by professionals as moderate. Early acceptability was high, whereas final acceptability was only moderate. Initial and final acceptability as perceived by the participants was high, and appropriateness moderate. Consent and recruitment rates were 82.0% and 65.5%, respectively, intervention uptake was 89.5% and completion rate 74.7%. The global value of the percentage of approaches with fidelity ≥50% was 16.7%. Eight CFIR constructs distinguished between high and low implementation, five corresponding to the Inner Setting domain. Conclusions Compared to usual care, the EIRA intervention was more effective in promoting MHBC and dietary behaviour change. Implementation outcomes were satisfactory except for the fidelity to the planned intervention, which was low. The organisational and structural contexts of the centres proved to be significant determinants of implementation effectiveness. Trial registration ClinicalTrials.gov , NCT03136211 . Registered 2 May 2017, “retrospectively registered”.

Objectives: Central blood pressure (BP) predicts mortality independent of office brachial BP. The aim was to describe reference values for central blood pressure and pulsatile hemodynamic parameters, and their relationship with cardiovascular risk factors in an adult Spanish population without cardiovascular disease. Methods: Cross-sectional study. We included 501 participants stratified by age and sex by random sampling, with a mean age of 56 years (50.3% women). The SphygmoCor System device's pulse wave analysis software was used to perform the measurements. Results: The following values were obtained: central blood pressure median (109/76 mmHg), central pulse pressure (33 mmHg), pulse pressure amplification (8.5 mmHg), ejection duration (130 ms) and subendocardial viability ratio (163%). All parameters were greater in men, except heart rate and ejection duration. In the logistic regression analysis, controlled for age, sex and taking antihypertensive drugs, being hypertensive was associated with cSBP (OR = 1.265), cDBP (OR = 1.307), cPP (OR = 1.067), pulse wave amplification (OR = 1.034) and SEVR (OR = 0.982); being diabetic was associated with SEVR (OR = 0.982); being obese was associated with cSBP (OR = 1.028) and cDBP (OR = 1.058) and being a smoker was associated with ejection duration (OR = 0.980) and SEVR (OR = 0.984). Conclusion: This study provides reference values for central blood pressure and parameters derived from the pulse wave analysis in a random sample of the Spanish population. The only risk factor that is not associated with any of the parameters analysed is dyslipidaemia. Trial registration number: https://clinicaltrials.gov/ct2/show/NCT02623894