19 research outputs found

    Dietary glycemic index and retinal microvasculature in adults: a cross-sectional study

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    [EN] Objective: To analyze the relationship between dietary glycemic index (GI) and retinal microvasculature in adults. Methods: This was a cross-sectional study of 300 subjects from the EVIDENT II study. Dietary GI was calculated using a validated, semi-quantitative food frequency questionnaire. Retinal photographs were digitized, temporal vessels were measured in an area 0.5–1 disc diameter from the optic disc and arteriolar-venular index (AVI) was estimated with semi-automated software. Results: AVI showed a significant difference between the tertiles of GI, after adjusting for potential confounders. The lowest AVI values were observed among subjects in the highest tertile of GI, whereas the greatest were found among those in the lowest tertile (estimated marginal mean of 0.738 vs. 0.768, p = 0.014). Conclusions: In adults, high dietary GI implies lowering AVI values regardless of age, gender and other confounding variables. Trial registration: Clinical Trials.gov Identifier: NCT02016014. Registered 9 December 2013

    Effectiveness of a universal personalized intervention for the prevention of anxiety disorders: Protocol of a randomized controlled trial (the prevANS project)

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    Background: To date, all preventive anxiety disorders interventions are one-fit-all and none of them are based on individual level and risk profile. The aim of this project is to design, develop and evaluate an online personalized intervention based on a risk algorithm for the universal prevention of anxiety disorders in the general population. Methods: A randomized controlled trial (RCT) with two parallel arms (prevANS vs usual care) and 1-year follow- up including 2000 participants without anxiety disorders from Spain and Portugal will be conducted. The prevANS intervention will be self-guided and can be implemented from the prevANS web or from the participants' Smartphone (through an App). The prevANS intervention will have different intensities depending on the risk level of the population, evaluated from the risk algorithm for anxiety: predictA. Both low and moderate-high risk participants will receive information on their level and profile (risk factors) of anxiety disorders, will have access to stress management tools and psychoeducational information periodically. In addition, participants with a moderate-high risk of anxiety disorders will also have access to cognitive-behavioral training (problem-solving, decision-making, communication skills, and working with thoughts). The control group will not receive any intervention, but they will fill out the same questionnaires as the intervention group. Assessments will be completed at baseline, 6 and 12-month follow-up. The primary outcome is the cumulative incidence of anxiety disorders. Secondary outcomes include depressive and anxiety symptoms, risk probability of anxiety disorders (predictA algorithm) and depression (predictD algorithm), improvement in physical and mental quality of life, and acceptability and satisfaction with the intervention. In addition, cost-effectiveness and cost-utility analyses will also be carried out from two perspectives, societal and health system, and analyses of mediators and moderators will also be performedSpanish Ministry of Health, the Institute of Health Carlos III, co-funded by the European Social Fund “Investing in your future” (grant references: CP19/00056), and the Chronicity, Primary Care and Health Promotion Research Network ‘RICAPPS’ (RD21/0016/0012); and Spanish Ministry of Science and Innovation, the State Investigation Agency (PID2020-119652RA-l00). These funding sources had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit resultsS

    Postprandial Effects of Breakfast Glycemic Index on Vascular Function among Young Healthy Adults: A Crossover Clinical Trial

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    This study aimed to evaluate the postprandial effects of high and low glycemic index (GI) breakfasts on vascular function. It was a crossover trial that included 40 young healthy adults (50% women), aged 20–40 years, who were recruited at primary care settings. They consumed three experimental breakfasts in randomized order, each one separated by a 1-week washout period: (1) control conditions (only water); (2) low GI (LGI) breakfast (29.4 GI and 1489 KJ energy); and (3) high GI (HGI) breakfast (64.0 GI and 1318 KJ energy). Blood samples were collected at 60 and 120 min after each breakfast to determine glucose and insulin levels. Vascular parameters were measured at 15 min intervals. Augmentation index (AIx) was studied as a primary outcome. Secondary outcomes comprised glucose, insulin, heart rate (HR) and pulse pressures (PPs). We found a trend toward increased AIx, HR and PPs for the HGI versus the LGI breakfast. A significant interaction between the type of breakfast consumed and all measured parameters was identified (p < 0.05) except for central PP. Stratifying data by sex, this interaction remained significant for AIx and augmentation pressure only in males (p < 0.05). In conclusion, breakfast GI could affect postprandial vascular responses in young healthy adults

    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

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    [eng] Metrics Abstract 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/m2), 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

    Analysis of the determinants of sleep quality in a Spanish population: a study protocol for a cross-sectional study

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    Introduction Sleep problems are a growing public health concern being related, among others, to an increased risk of cardiovascular diseases or worse cognitive functioning. In addition, they can affect aspects related to personal motivation and quality of life. However, very few studies have analysed the possible determinants of sleep quality in the adult population as a whole, establishing patterns based on these determinants.The objectives are to evaluate the determinants of sleep quality in a representative sample of the general adult population between 25 and 65 years old, and to establish patterns of sleep quality based on lifestyles, psychological factors, morbidities, sociodemographic variables, biological markers and other possible determinants.Methods and analysis Descriptive observational cross-sectional study. The study population will include a representative sample of 500 people between 25 and 65 years old from the cities of Salamanca and Ávila (Spain) selected by random sampling stratified by age groups and sex. A 90-minute visit will be performed, during which sleep quality will be assessed. The variables collected will be: morbidity, lifestyles (physical activity, diet, toxic habits), psychological factors (depression, stress, occupational stress and anxiety), socioeconomic and work-related variables, habitability conditions of the habitual residence and rest area, screen time, relaxation techniques and melatonin as a biological marker related to sleep quality.Discussion With the results of this work, improved interventions for behaviour modification could be designed, as well as intervention and education programmes or other research aimed at improving sleep quality.Ethics and dissemination This study has a favourable opinion from the Ethics Committee for Drug Research of the Health Areas of Salamanca and Ávila (CEim Code: PI 2021 07 815). The results of this study will be published in international impact journals of different specialties.Trial registration number NCT05324267
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