Objective: The aim of this paper is to describe the protocol of pilot cluster randomized controlled trial (RCT) that will evaluate the effects of a lifestyle-based intervention. The Archena Infancia Saludable project will have several objectives. The primary objective of this project is to determine the 6-month effects of a lifestyle-based intervention on adherence to 24-h movement behaviors and Mediterranean diet (MedDiet) in schoolchildren. The secondary objective of this project is to test the intervention effects of this lifestyle-based intervention on a relevant set of health-related outcomes (i.e., anthropometric measurements, blood pressure, perceived physical fitness, sleep habits, and academic performance). The tertiary objective is to investigate this intervention's halo effect on parents'/guardians' 24-h movement behaviors and adherence to the MedDiet. Methods: The Archena Infancia Saludable trial will be a cluster RCT submitted to the Clinical Trials Registry. The protocol will be developed according to SPIRIT guidelines for RCTs and CONSORT statement extension for cluster RCTs. A total of 153 eligible parents/guardians with schoolchildren aged 6-13 years will be randomized into an intervention group or a control group. This project focuses on two fundamental pillars: 24-h movement behaviors and MedDiet. It will mainly focus on the relationship between parents/guardians and their children. Behavior change strategies for dietary and 24-h movement behaviors in schoolchildren will be based on healthy lifestyle education for parents/guardians through infographics, video recipes, brief video clips, and videos. Conclusions: Most of the current knowledge on 24-h movement behaviors and adherence to the MedDiet is based on cross-sectional or longitudinal cohort studies, warranting a need to design and conduct RCTs to obtain more robust evidence on the effect of a healthy lifestyle program to increase 24-h movement behaviors and to improve adherence to the MedDiet in schoolchildren.

BackgroundSARS-CoV-2 is the causative agent of COVID-19 identified in December 2019, an acute infectious respiratory disease that can cause persistent neurological and musculoskeletal symptoms such as headache, fatigue, myalgias difficulty concentrating, among others including acute cerebrovascular disease with a prevalence of 1-35%. The aim of this study is to evaluate the impact of COVID-19 in undergraduate students on their academic performance as an indicator of their intellectual ability and performance in a university that maintained 100% face-to-face teaching during the 2020-2021 academic year.MethodsA total of 7,039 undergraduate students were analyzed in a prospective cohort study at the University of Navarra. A questionnaire including sociodemographic and behavioral questions was sent. PCRs were performed throughout the academic year for the diagnosis of SARS-CoV-2 infection and students' academic results were provided by the academic center, adjusted descriptive and multivariate models were performed to assess the association.ResultsA total of 658 (9.3%) participants were diagnosed with COVID-19, almost 4.0% of them achieved outstanding academic results, while uninfected students did so in 7.3%. SARS-CoV-2 infection was associated with a significant decrease in having outstanding academic results (OR = 0.57; 95% CI: 0.38-0.86).ConclusionHaving COVID-19 disease, decreased academic performance in undergraduate students. Therefore, it is necessary to prevent infection even in the youngest sections of the population.

The aim of this study was to analyze the life habits and personal factors associated with increased severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) risk in a university environment with in-person lectures during the coronavirus disease 2019 (COVID-19) pandemic. To our knowledge, there are no previous longitudinal studies that have analyzed associations of behavioral and personal factors with the risk of SARS-CoV-2 infection on an entire university population. A cohort study was conducted in the 3 campuses of the University of Navarra between August 24, 2020, and May 30, 2021, including 14,496 students and employees; the final sample included 10,959. Descriptive and multivariate-adjusted models were fitted using Cox regression. A total of 1,032 (9.4%) participants were diagnosed with COVID-19 (879 students and 153 employees), almost 50% living with their families. COVID-19 was associated with living in college or residence (hazard ratio (HR) = 1.96, 95% CI: 1.45, 2.64), motor transportation (HR = 1.35, 95% CI: 1.14, 1.61), South American origin (HR = 1.43, 95% CI: 1.20, 1.72), and belonging to Madrid's campus (HR = 3.11, 95% CI: 2.47, 3.92). International students, especially from Latin America, mostly lived in university apartments or shared flats and cohabited with 4-11 people. Living in a big city (Madrid), was a significant risk factor.

Objective: To assess whether breastfeeding during the first months of life is associated with adherence to the Mediterranean dietary (MedDiet) pattern in preschool children. Design: The Seguimiento del Nino para un Desarrollo & Oacute; ptimo (SENDO) project is an ongoing pediatric cohort with open recruitment, started in 2015 in Spain. Participants, recruited when they are 4 to 5 years old at their primary local health center or school, are followed annually through online questionnaires. For this study, 941 SENDO participants with full data on study variables were included. Breastfeeding history was collected retrospectively at baseline. Adherence to the Mediterranean diet was assessed with the KIDMED index (range -3 to 12). Results: After accounting for multiple sociodemographic and lifestyle confounders, including parental attitudes and knowledge about dietary recommendations for children, breastfeeding was independently associated with a higher adherence to the MedDiet. Compared with children who were never breastfed, children breastfed for >= 6 months had a one-point increase on their mean KIDMED score (Mean difference +0.93, 95%confidence interval [CI]. 0.52-1.34, p for trend <0.001). The odds ratio of high adherence to the MedDiet (KIDMED index >= 8) was 2.94 (95%CI 1.50-5.36) in children who were breastfed for at least 6 months, as compared to their peers who were never breastfeed. Children who were breastfed for less than 6 months exhibited intermediate levels of adherence (p for trend <0.01). Conclusion: Breastfeeding for 6 months or longer is associated with a higher adherence to the Mediterranean diet during the preschool years.

(1) Background: Metabolic Syndrome (MetS) affects over a third of the United States population, and has similar prevalence in Europe. Dietary approaches to prevention are important. Coffee consumption has been inversely associated with mortality and chronic disease; however, its relation to the risk of MetS is unclear. We aimed to investigate the association between coffee consumption and incident MetS in the 'Seguimiento Universidad de Navarra' cohort. (2) Methods: From the SUN project, we included 10,253 participants initially free of MetS. Coffee consumption was assessed at baseline, and the development of MetS was assessed after 6 years of follow-up. All data were self-reported by participants. MetS was defined according to the Harmonizing Definition. We used multivariable logistic regression models to estimate odds ratios and 95% confidence intervals for incident MetS according to four categories of coffee consumption: <1 cup/month; >= 1 cup/month to <1 cup/day; >= 1 cup/day to <4 cups/day; >= 4 cups/day. (3) Results: 398 participants developed MetS. Coffee consumption of >= 1 to <4 cups/day was associated with significantly lower odds of developing MetS (multivariable adjusted OR = 0.71, 95% CI (0.50-0.99)) as compared to consumption of <1 cup/month. (4) Conclusions: In a Mediterranean cohort, moderate coffee consumption may be associated with a lower risk of MetS.

Importance: US firefighters are a working population at risk of chronic diseases, including obesity, cardiovascular disease, and cancer. This risk may be mitigated by a healthy diet. Objective: To evaluate the effect of a Mediterranean nutrition intervention using a behavioral/environmental approach (firefighter/fire station/home) at the individual participant level. Design, setting, and participants: This 12-month cluster randomized clinical trial included US career firefighters from fire stations and homes within 2 Indiana fire departments. Participants were randomized by fire station to either Mediterranean diet or control (usual care). The study was conducted from October 2016 to December 2019, and data were analyzed in November 2022. Intervention: For the first 12 months of the study, firefighters located at fire stations randomized to the intervention group were provided with access to supermarket discounts and free samples of Mediterranean diet foods, online nutrition education platforms, email announcements and reminders, family and peer education and support, and chef demonstrations. Firefighters in fire stations allocated to the control group received no intervention and were instructed to follow their usual diet. Main outcomes and measures: Change in dietary habits at 12 months as measured by a modified Mediterranean diet score (range, 0 to 51 points) at baseline and 6-month and 12-month follow-up. Cardiometabolic parameters were secondary outcomes. Results: Of 485 included firefighters, 458 (94.4%) were male, and the mean (SD) age was 47 (7.5) years. A total of 241 firefighters (27 fire stations) were randomized to the Mediterranean nutrition intervention, and 244 (25 fire stations) were randomized to usual diet. Outcomes were analyzed using generalized linear mixed models for modified Mediterranean diet score at 6 months (n = 336) and 12 months (n = 260), adjusting for baseline age, sex, race and ethnicity, fire department, physical activity, and waist circumference. In the intervention group compared with the control group, the modified Mediterranean diet score significantly increased by 2.01 points (95% CI, 0.62-3.40; P = .005) at 6 months and by 2.67 points (95% CI, 1.14-4.20; P = .001) at 12 months. Among secondary outcomes, changes in cardiometabolic risk factors were not statistically significant at 1 year. Results from analyses with multilevel multiple imputation for missingness were similar. Conclusions and relevance: In this Mediterranean nutrition intervention of multicomponent behavioral/environmental changes, career firefighters had increased adherence to a Mediterranean diet. Trial registration: ClinicalTrials.gov Identifier: NCT02941757.

Background: Metabolic syndrome (MetS), prediabetes (PreDM) and metabolic-associated fatty liver disease (MAFLD) share pathophysiological pathways concerning type 2 diabetes mellitus (T2DM) onset. The non-invasive assessment of MAFLD combined with PreDM and MetS features might provide further accuracy in predicting hyperglucaemic status with the description of singular clinical phenotypes.Methods: A retrospective cohort study was performed on 2799 patients recruited in the Vascular-Metabolic CUN cohort. The main outcome was the incidence of T2DM according to ADA criteria. MetS and PreDM were defined according to ATP III and ADA criteria, respectively. Hepatic steatosis index (HSI) was used to detect patients with MAFLD.Results: MetS and PreDM were more common in patients with MAFLD (35% vs. 8% and 34% vs. 18%, respectively). MAFLD showed clinical interaction with MetS and PreDM in the prediction of T2DM [MAFLD-MetS interaction HR= 4.48 (3.37-5.97) and MAFLD-PreDM interaction HR = 6.34 (4.67-8.62)]. These findings supported the description of five different liver status-linked phenotypes with increasing risk of T2DM: Metabolically healthy patients (1,5% of T2DM incidence), MAFLD (4,4% of T2DM incidence), MAFLD and MetS (10,6% of T2DM incidence), PreDM (11,1% of T2DM incidence) and MAFLD and PreDM (28,2% of T2DM incidence). These phenotypes provided independent capacity of prediction of T2DM incidence after adjustment for age, sex, tobacco and alcohol consumption, obesity and number of SMet features with a c-Harrell=0.84.Conclusions: MAFLD interplay with MetS and PreDM might help to discriminate patient risk of T2DM in the clinical setting through metabolic remodelling-based phenotypes.

Background: The main objective was to evaluate the efficacy of intranasal photodynamic therapy (PDT) in SARS-CoV-2 mildly symptomatic carriers on decreasing the infectivity period. SARS-CoV-2-specific immune-stimulating effects and safety were also analysed. Methods: We performed a randomized, placebo-controlled, clinical trial in a tertiary hospital (NCT05184205). Patients with a positive SARS-CoV-2 PCR in the last 48 hours were recruited and aleatorily assigned to PDT or placebo. Patients with pneumonia were excluded. Participants and investigators were masked to group assignment. The primary outcome was the reduction in in vitro infectivity of nasopharyngeal samples at days 3 and 7. Additional outcomes included safety assessment and quantification of humoral and T-cell immune-responses. Findings: Patients were recruited between December 2021 and February 2022. Most were previously healthy adults vaccinated against COVID-19 and most carried Omicron variant. 38 patients were assigned to placebo and 37 to PDT. Intranasal PDT reduced infectivity at day 3 post-treatment when compared to placebo with a ß-coefficient of -812.2 (CI95%= -478660 ¿ -1.3, p<0.05) infectivity arbitrary units. The probability of becoming PCR negative (ct>34) at day 7 was higher on the PDT-group, with an OR of 0.15 (CI95%=0.04-0.58). There was a decay in anti-Spike titre and specific SARS-CoV-2 T cell immunity in the placebo group 10 and 20 weeks after infection, but not in the PDT-group. No serious adverse events were reported. Interpretation: Intranasal-PDT is safe in pauci-symptomatic COVID-19 patients, it reduces SARS-CoV-2 infectivity and decelerates the decline SARS-CoV-2 specific immune-responses.

Purpose: To study the association between ultrasound cortical thickness in reactive post-vaccination lymph nodes and the elicited humoral response and to evaluate the performance of cortical thickness as a predictor of vaccine effectiveness in patients with and without a previous history of COVID-19 infection. Methods: A total of 156 healthy volunteers were recruited and followed prospectively after receiving two COVID-19 vaccination doses using different protocols. Within a week after receiving the second dose, an axillary ultrasound of the ipsilateral vaccinated arm was performed, and serial post-vaccination serologic tests (PVST) were collected. Maximum cortical thickness was chosen as a nodal feature to analyze association with humoral immunity. Total antibodies quantified during consecutive PVST in previously-infected patients and in coronavirus-naïve volunteers were compared (Mann-Whitney U test). The association between hyperplastic-reactive lymph nodes and effective humoral response was studied (odds ratio). The performance of cortical thickness in detecting vaccination effectiveness was evaluated (area under the ROC curve). Results: Significantly higher values for total antibodies were observed in volunteers with a previous history of COVID-19 infection (p < 0.001). The odds ratio associating immunized coronavirus-naïve volunteers after 90 and 180 days of the second dose with a cortical thickness ¿ 3 mm was statistically significant (95% CI 1.52-6.97 and 95% CI 1.47-7.29, respectively). The best AUC result was obtained comparing antibody secretion of coronavirus-naïve volunteers at 180 days (0.738). Conclusions: Ultrasound cortical thickness of reactive lymph nodes in coronavirus-naïve patients may reflect antibody production and a long-term effective humoral response elicited by vaccination. Clinical relevance statement: In coronavirus-naïve patients, ultrasound cortical thickness of post-vaccination reactive lymphadenopathy shows a positive association with protective antibody titers against SARS-CoV-2, especially in the long term, providing new insights into previous publications. Key points: ¿ Hyperplastic lymphadenopathy was frequently observed after COVID-19 vaccination. ¿ Ultrasound cortical thickness of reactive post-vaccine lymph nodes may reflect a long-term effective humoral response in coronavirus-naïve patients.

AimsThe association between body mass index (BMI) fluctuation and BMI fluctuation rate with cardiovascular stress morbidities in a Caucasian European cohort was evaluated to ascertain the impact of weight cycling. MethodsA total of 4,312 patients of the Vascular-Metabolic CUN cohort (VMCUN cohort) were examined and followed up during 9.35 years ( +/- 4.39). Cox proportional hazard ratio analyses were performed to assess the risk of developing cardiovascular stress-related diseases (CVDs) across quartiles of BMI fluctuation, measured as the average successive variability (ASV) (ASV = |BMIt0 - BMIt1| + |BMIt1 - BMIt2| + |BMIt2-BMIt3| + horizontal ellipsis + |BMItn - 1 - BMItn|/n - 1), and quartiles of BMI fluctuation rate (ASV/year). ResultsThere were 436 incident cases of CVD-associated events involving 40,323.32 person-years of follow-up. A progressively increased risk of CVD in subjects with greater ASV levels was found. Also, a higher level of ASV/year was significantly associated with an increased risk of developing CVD stress independent of confounding factors with a value of 3.71 (95% CI: 2.71-5.07) for those in the highest quartile and 1.82 (95% CI: 1.33-2.50) for those in the third quartile. ConclusionsThe BMI fluctuation rate seems to be a better predictor than BMI fluctuation of the potential development of cardiovascular stress morbidities. The time-rated weight fluctuations are apparently more determinant in increasing the risk of a CVD than the weight fluctuation itself, which is remarkable in subjects under yo-yo weight patterns for precision medicine.