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

IntroductionThe 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.MethodsThis 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.DiscussionThe 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

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

IntroductionThe 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.MethodsThis 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.DiscussionThe 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

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.This study was supported in part by grants funded by the Instituto de Salud Carlos III, Institute of Biomedical Research of Salamanca (IBSAL)-IBY17/00003, and the Spanish Research Network for Preventive Activities and Health Promotion in Primary Care (REDIAPP)-RD16/0007

Vascular and cognitive effects of cocoa-rich chocolate in postmenopausal women: a study protocol for a randomised clinical trial

Introduction The intake of polyphenols has certain health benefits. This study will aim to assess the effect of adding a daily amount of chocolate high in cocoa content and polyphenols to the normal diet on blood pressure, vascular function, cognitive performance, quality of life and body composition in postmenopausal women. Methods and analysis Here we plan a randomised clinical trial with two parallel groups involving a total of 140 women between 50 and 64 years in the postmenopausal period, defined by amenorrhoea of at least 12 consecutive months. The main variable will be the change in blood pressure. Secondary variables will be changes in vascular function, quality of life, cognitive performance and body composition. The intervention group will be given chocolate containing 99% cocoa, with instructions to add 10 g daily to their normal diet for 6 months. The daily nutritional contribution of this amount of chocolate is 59 kcal and 65.4 mg of polyphenols. There will be no intervention in the control group. All variables will be measured at the baseline visit and 3 and 6 months after randomisation, except cognitive performance and quality of life, which will only be assessed at baseline and at 6 months. Recruitment is scheduled to begin on 1 June 2018, and the study will continue until 31 May 2019. Ethics and dissemination This study was approved by the Clinical Research Ethics Committee of the Health Area of Salamanca, Spain (‘CREC of Health Area of Salamanca’), in February 2018. A SPIRIT checklist is available for this protocol. The clinical trial has been registered at ClinicalTrials. gov provided by the US National Library of Medicine, number NCT03492983. The results will be disseminated through open access peer-reviewed journals, conference presentations, broadcast media and a presentation to stakeholders.Gerencia Regional de Castilla y León (GRS 1583/B/1

EVIDENT smartphone app, a new method for the dietary record: comparison with a food frequency questionnaire

Background: More alternatives are needed for recording people’s normal diet in different populations, especially adults or the elderly, as part of the investigation into the effects of nutrition on health. Objective: The aim of this study was to compare the estimated values of energy intake, macro- and micronutrient, and alcohol consumption gathered using the EVIDENT II smartphone app against the data estimated with a food frequency questionnaire (FFQ) in an adult population aged 18 to 70 years. Methods: We included 362 individuals (mean age 52 years, SD 12; 214/362, 59.1% women) who were part of the EVIDENT II study. The participants registered their food intake using the EVIDENT app during a period of 3 months and through an FFQ. Both methods estimate the average nutritional composition, including energy intake, macro- and micronutrients, and alcohol. Through the app, the values of the first week of food recording, the first month, and the entire 3-month period were estimated. The FFQ gathers data regarding the food intake of the year before the moment of interview. Results: The intraclass correlation for the estimation of energy intake with the FFQ and the app shows significant results, with the highest values returned when analyzing the app’s data for the full 3-month period (.304, 95% CI 0.144-0.434; P<.001). For this period, the correlation coefficient for energy intake is .233 (P<.001). The highest value corresponds to alcohol consumption and the lowest to the intake of polyunsaturated fatty acids (r=.676 and r=.155; P<.001), respectively. The estimation of daily intake of energy, macronutrients, and alcohol presents higher values in the FFQ compared with the EVIDENT app data. Considering the values recorded during the 3-month period, the FFQ for energy intake estimation (Kcal) was higher than that of the app (a difference of 408.7, 95% CI 322.7-494.8; P<.001). The same is true for the other macronutrients, with the exception g/day of saturated fatty acids (.4, 95% CI −1.2 to 2.0; P=.62). Conclusions: The EVIDENT app is significantly correlated to FFQ in the estimation of energy intake, macro- and micronutrients, and alcohol consumption. This correlation increases with longer app recording periods. The EVIDENT app can be a good alternative for recording food intake in the context of longitudinal or intervention studies. Trial Registration: ClinicalTrials.gov NCT02016014; http://clinicaltrials.gov/ct2/show/NCT02016014 (Archived by WebCite at http://www.webcitation.org/760i8EL8Q).Spanish Ministry of Science and Innovation and Carlos III Health Institute/European Regional Development Fund (FIS: PI13/00618, PI13/01526, PI13/00058, PI13/01635, PI13/02528, PI12/01474; RETICS: RD12/0005, RD16/0007), Regional Health Management of Castilla and León (GRS 1191/B/15, GRS 909/B/14, GRS 770/B/13), and the Infosalud Foundatio

Glycemic markers and relation with arterial stiffness in Caucasian subjects of the MARK study

[EN]BACKGROUND: Effect of prediabetes and normal glucose on arterial stiffness remains controversial. The primary aim of this study was to investigate the relationship of fasting plasma glucose (FPG), postprandial glucose (PG) and glycosylated haemoglobin (HbA1c) with brachial-ankle pulse wave velocity (baPWV) and cardio-ankle vascular index (CAVI) in Caucasian adults. The secondary aim was to analyse this relationship by glycaemic status. METHODS: Cross-sectional study. Setting: Primary care. Participants: 2,233 subjects, 35-74 years. Measures: FPG (mg/dL) and HbA1c (%) of all subjects were measured using standard automated enzymatic methods. PG (mg/dL) was self-measured at home two hours after meals (breakfast, lunch and dinner) for one day using an Accu-chek ® glucometer. CAVI was measured using a VaSera VS-1500® device (Fukuda Denshi), and baPWV was calculated using a validated equation. RESULTS: CAVI and baPWV values were significantly higher in subjects with diabetes mellitus than in glucose normal and prediabetes groups (p<0.001). FPG, PG and HbA1c were positively associated with CAVI and baPWV. The β regression coefficient for: HbA1c was 0.112 (CI 95% 0.068 to 0.155) with CAVI, 0.266 (CI 95% 0.172 to 0.359) with baPWV; for PG was 0.006 (CI 95% 0.004 to 0.009 and for FPG was 0.005 (CI 95% 0.002 to 0.008) with baPWV; and for PG was 0.002 (CI 95% 0.001 to 0.003) and 0.003 (CI 95% 0.002 to 0.004) with CAVI (p<0.01 in all cases). When analysing by hyperglycaemic status, FPG, PG and HbA1c were positively associated with CAVI and baPWV in subjects with type 2 diabetes mellitus. CONCLUSION: FPG, PG and HbA1c show a positive association with CAVI and baPWV, in Caucasian adults with intermediate cardiovascular risk factors. When analysing by hyperglycaemic status, the association is only maintained in subjects with type 2 diabetes mellitus

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 efectiveness 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 crite‑ ria were included: smoker, low adherence to the MD or insufcient level of physical activity. The intervention group (IG) had three diferent 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 ofce. 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 fnal visit. Moreover, the efect 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

A multiple health behaviour change intervention to prevent depression: A randomized controlled trial

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 clusterrandomized 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

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 fatsSpanish Ministry of Science and Innovation (MICINN) and the Carlos III Health Institute/European Regional Development Fund (ERDF) (FIS: PI13/00618, PI13/01526, PI13/00058, PI13/01635, PI13/02528, PI12/01474; RETICS: RD12/0005, RD16/0007), Regional Health Management of Castilla and León (GRS 1191/B/15, GRS 909/B/14, GRS 770/B/13) and the Infosalud Foundatio

Validation of the automatic image analyser to assess retinal vessel calibre (ALTAIR): a prospective study protocol

Introduction. The fundus examination is a non-invasive evaluation of the microcirculation of the retina. The aim of the present study is to develop and validate (reliability and validity) the ALTAIR software platform (Automatic image analyser to assess retinal vessel calibre) in order to analyse its utility in different clinical environments. Methods and analysis. A cross-sectional study in the first phase and a prospective observational study in the second with 4 years of follow-up. The study will be performed in a primary care centre and will include 386 participants. The main measurements will include carotid intima-media thickness, pulse wave velocity by Sphygmocor, cardio-ankle vascular index through the VASERA VS-1500, cardiac evaluation by a digital ECG and renal injury by microalbuminuria and glomerular filtration. The retinal vascular evaluation will be performed using a TOPCON TRCNW200 non-mydriatic retinal camera to obtain digital images of the retina, and the developed software (ALTAIR) will be used to automatically calculate the calibre of the retinal vessels, the vascularised area and the branching pattern. For software validation, the intraobserver and interobserver reliability, the concurrent validity of the vascular structure and function, as well as the association between the estimated retinal parameters and the evolution or onset of new lesions in the target organs or cardiovascular diseases will be examined. Ethics and dissemination The study has been approved by the clinical research ethics committee of the healthcare area of Salamanca. All study participants will sign an informed consent to agree to participate in the study in compliance with the Declaration of Helsinki and the WHO standards for observational studies. Validation of this tool will provide greater reliability to the analysis of retinal vessels by decreasing the intervention of the observer and will result in increased validity through the use of additional information, especially in the areas of vascularisation and vessel branching patterns