This study cross-sectionally examines in the elderly population: (a) the association of type 2 diabetes with executive function (EF); (b) the effect of BMI on both type 2 diabetes and EF; (c) the ...association between glycaemia control and EF in type 2 diabetes. 6823 older individuals with overweight/obesity and metabolic syndrome participating in the PREDIMED-PLUS study, were assessed with a battery of cognitive tests and a medical interview. ANOVA showed a significantly worse performance on EF in type 2 diabetes vs. non-diabetic individuals. Two complementary models were displayed: (1) in the whole sample, the presence of type 2 diabetes, depressive symptoms and BMI had a direct negative effect on EF, while apnoea had an indirect negative effect; (2) in the diabetes subsample, higher illness duration was associated with worse performance in EF. Participants with type 2 diabetes and HbA1c<53 mmol/mol displayed better cognitive performance when compared to those with HbA1c≥53 mmol/mol. Our results provide a controlled comprehensive model that integrates relevant neuropsychological and physical variables in type 2 diabetes. The model suggests that, to improve treatment adherence and quality of life once diabetes has been diagnosed, cognitive decline prevention strategies need to be implemented while monitoring depressive symptoms, BMI and glycaemia control.
Tobacco smoking is a major preventable cause of death, and a significant public health problem worldwide. Most smokers begin in adolescence, age at which they are more susceptible to nicotine ...addiction. The prevalence of smoking in adolescence is considerable. Therefore, it would be convenient to incorporate smoking prevention programs in the school environment. It is necessary to provide evidence of its effectiveness. The primary objective of the study was to evaluate the effectiveness of a teacher-delivered school-based intervention on the initiation of smoking in adolescents (ITACA smoking prevention education program).
A multi-center cluster randomized trial was designed. Twenty-two secondary schools from Spain were enrolled in 2 successive cohorts, from 2010 to 2011. The intervention consisted in the application of the ITACA smoking prevention education program. A 4-year cognitive-behavioral intervention that is based on the social-influences model and is integrated into schools' regular curricular activities. A total of 1055 students were surveyed before the intervention (age: 12–13 years-old), and at the third year of the intervention (age: 14–15 years-old) of a 4-year education program. The outcome measures were daily and weekly use of cigarettes, and initiation of smoking.
There was no evidence that the intervention impacted the incidence of regular smoking (OR = 1.08; 95% CI: 0.50–2.33) or the initiation of smoking (OR = 1.09; 95% CI: 0.56–1.72).
This trial provides evidence supporting the non-effectiveness of a complex educational smoking prevention program at 3 years after the intervention.
Trial registration number: Current Controlled Trials: NCT01602796.
•A smoking prevention program (families, teachers and schools) had no effect among adolescents.•Two study groups had no significant difference in the incidence of students who ever smoke.•There were no significant differences in regular smoking in the intervention and control groups.
•Prediabetes subjects with visceral obesity and eGFR ≥ 60 ml/min are at increased risk of MAFLD.•In these subjects MAFLD is associated with glomerular hyperfiltration.•Presence of MAFLD could ...potentiate the age-related eGFR decline.•The liver health assessment should be included in the conventional screening approach.
To investigate the prevalence of metabolic dysfunction-associated fatty liver disease (MAFLD) in prediabetes, visceral obesity, and preserved kidney function, and explore whether MAFLD is associated with hyperfiltration.
We analyzed data from 6697 Spanish civil servants, aged 18–65 years, with fasting plasma glucose ≥ 100 and ≤ 125 mg/dL (prediabetes, ADA), waist circumference ≥ 94 cm in men and ≥ 80 cm in women (visceral obesity, IDF) and de-indexed estimated glomerular filtration rate (eGFR) ≥ 60 ml/min, collected during occupational health visits. The association between MAFLD and hyperfiltration (eGFR > age- and sex-specific 95th percentile) was tested by multivariable logistic regression analyses.
Overall, 4213 patients (62.9%) had MAFLD, and 330 (4.9%) were hyperfiltering. MAFLD was more frequent in hyperfiltering than in non-hyperfiltering subjects (86.4% vs 61.7%, P < 0.001). BMI, waist circumference, systolic, diastolic, mean arterial pressure, and prevalence of hypertension were higher in hyperfiltering than in non-hyperfiltering subjects (P < 0.05). MAFLD was independently associated with hyperfiltration, even after adjusting for common confounders OR (95% CI): 3.36 (2.33–4.84), P < 0.001. In stratified analyses MAFLD potentiated age-related eGFR decline vs. non-MAFLD (P < 0.001).
More than half of subjects with prediabetes, visceral obesity and eGFR ≥ 60 ml/min presented MAFLD that was associated with hyperfiltration and potentiated the age-related eGFR decline.
Abstract
Background
In the last years, evidence that dietary vitamin K could have a role in the cognitive domain has increased. However, data from large trials are limited. The objective of this ...study was to assess the association of 2 year changes in the dietary intake of vitamin K with cognitive function measured through neuropsychological performance tests.
Methods
In 5,533 participants of the multicentre PREDIMED-Plus study (48.1% women, age 65.1 ± 4.9 years with overweight/obesity and metabolic syndrome), we assessed the adjusted odds ratios of cognitive function decline according to 2 year changes in vitamin K intake. Participants answered a battery of cognitive function tests and Food Frequency Questionnaires (FFQs) in order to estimate the vitamin K dietary intake.
Results
After adjusting for potential cofounders, the highest tertile of change of dietary vitamin K intake (median IQR; 194.4 μg/d 120.9, 373.1) was inversely associated with a Mini-Mental State Examination (MMSE) score ≤24 (OR 95% CI; 0.53 0.35, 0.79 P for trend = 0.002) compared with a decrease in the intake of vitamin K (median IQR; −97.8 μg/d −292.8, −51.5). A significant positive association between changes in dietary vitamin K intake and the semantic verbal fluency test scores (OR 95% CI; 0.69 0.51, 0.94 P for trend = 0.019) was found.
Conclusions
An increase of the intake of dietary vitamin K was associated with better cognitive function scores, independently of recognised risk factors for cognitive decline, in an older adult Mediterranean population with high cardiovascular risk.
During the SARS-CoV-2 pandemic, nurses of primary health care has been an important role in Spain. Even so, the data obtained in the tracing have been scarcely used to investigate the possible ...mechanisms of transmission. Few studies focused on community transmission, evaluating the effectiveness of individual protective measures and exposure environment. The main aim of the study was to evaluate the association between individual protective measures and SARS-CoV-2 transmission in the community and to compare secondary attack rates in different exposure settings.
A case-control study from contact tracing of SARS-CoV-2 index patients. COVID-19 contact tracing was led by nurses at the COVID-19 Coordinating Centre in Majorca (Spain). During the systematic tracing, additional information for this study was collected from the index patient (social-demographic variables, symptoms, the number of close contacts). And also, the following variables from their close contacts: contact place, ventilation characteristics mask-wearing, type of mask, duration of contact, shortest distance, case-contact relationship, household members, and handwashing, the test result for SARS-CoV-2 diagnostic. Close contacts with a positive test for SARS-CoV-2 were classified as "cases" and those negative as "controls."
A total of 1,778 close contacts from 463 index patients were identified. No significant differences were observed between the sexes but between age groups. Overall Secondary Attack Rate (SAR) was 24.0% (95% CI: 22.0-26.0%), 36.9% (95% CI: 33.2-40.6%) in closed spaces without ventilation and 50.7% (95% CI: 45.6-55.8%) in exposure time > 24 h. A total of 49.2% of infections occurred among household members. Multivariate logistic regression analysis showed that open-air setting (OR 0.43, 95% CI: 0.27-0.71), exposure for less than 1 h (OR 0.19, 95% CI: 0.11-0.32), and wearing a mask (OR 0.49, 95% CI: 0.28-0.85) had a protective effect transmission of SARS-CoV-2 in the community.
Ventilation of the space, mask-wearing and shorter exposure time were associated with a lower risk of transmission in the community. The data obtained allowed an assessment of community transmission mechanisms and could have helped to improve and streamline tracing by identifying close contacts at higher risk.
Type 2 diabetes mellitus (T2DM) is a highly prevalent disease associated with an increased risk of comorbidities, premature death, and health costs. Prediabetes is a stage of glucose alteration ...previous to T2DM, that can be reversed. The aim of the study is to develop and evaluate a low-intensity, multifaceted, digital intervention to prevent T2DM. The intervention comprises: (1) the use of mobile health technology to send tailored text messages promoting lifestyle changes to people at risk of T2DM and (2) the provision of online education to primary healthcare physicians and nurses about management of prediabetes.
In stages 1-4 we will design, develop and pilot-test the intervention. In Stage 5 we will conduct a phase II, six-month, three-arm, cluster randomized, clinical trial with 42 primary care professionals and 420 patients at risk of T2DM. Patients will be allocated to a control group (usual care), intervention A (patient messaging intervention), or intervention B (patient messaging intervention plus online education to their primary healthcare professionals). The primary outcome will be glycated haemoglobin. All the procedures obtained ethical approval in June 2021 (CEI-IB Ref No: IB4495/21PI).
Digital health interventions can effectively prevent T2DM and reduce important T2DM risk factors such as overweight or hypertension. In Spain, this type of intervention is understudied. Moreover, there is controversy regarding the type of digital health interventions that are more effective. Findings from this study may contribute to address T2DM prevention, through a low-cost and easily implementable intervention.
Trapeziometacarpal (TMC) osteoarthritis (OA) is a common cause of pain and weakness during thumb pinch leading to disability. There is no consensus about the best surgical treatment in unresponsive ...cases. The treatment is associated with costs and the recovery may take up to 1 year after surgery depending on the procedure. No randomized controlled trials have been conducted comparing ball and socket TMC prosthesis to trapeziectomy with ligament reconstruction.
A randomized, blinded, parallel-group superiority clinical trial comparing trapeziectomy with abductor pollicis longus (APL) arthroplasty and prosthetic replacement with Maïa® prosthesis. Patients, 18 years old and older, with a clinical diagnosis of unilateral or bilateral TMC OA who fulfill the trial's eligibility criteria will be invited to participate. The diagnosis will be made by experienced hand surgeons based on symptoms, clinical history, physical examination, and complementary imaging tests. A total of 106 patients who provide informed consent will be randomly assigned to treatment with APL arthroplasty and prosthetic replacement with Maïa® prosthesis. The participants will complete different questionnaires including EuroQuol 5D-5L (EQ-5D-5L), the Quick DASH, and the Patient Rated Wrist Evaluation (PRWE) at baseline, at 6 weeks, and 3, 6, 12, 24, 36, 48, and 60 months after surgical treatment. The participants will undergo physical examination, range of motion assessment, and strength measure every appointment. The trial's primary outcome variable is the change in the visual analog scale (VAS) from baseline to 12 months. A long-term follow-up analysis will be performed every year for 5 years to assess chronic changes and prosthesis survival rate. The costs will be calculated from the provider's and society perspective using direct and indirect medical costs.
This is the first randomized study that investigates the effectiveness and cost-utility of trapeziectomy and ligament reconstruction arthroplasty and Maïa prosthesis. We expect the findings from this trial to lead to new insights into the surgical approach to TMC OA.
ClinicalTrials.gov NCT04562753. Registered on June 15, 2020.
Treatment-resistant depression (TRD) has a high prevalence and can be exacerbated by poor physical health and economic hardships, which have become common stressors during the current COVID-19 ...pandemic. The therapeutic approaches used to treat these patients are not always available, may be not be accepted by some patients, and often require face-to-face interactions.
The main aim of this study will be to evaluate the effectiveness of an Internet-based adjuvant lifestyle-based intervention for patients with TRD.
This will be a parallel, randomized, and controlled clinical trial. A total of 180 patients with TRD will be randomly allocated (1:1:1) to 1 of 3 groups: treatment prescribed by the mental health team and written suggestions for lifestyle changes (placebo control group); treatment prescribed by the mental health team, written suggestions for lifestyle changes, and an 8-week mindfulness-based cognitive therapy program (active control group); or treatment prescribed by the mental health team, written suggestions for lifestyle changes, and an 8-week lifestyle change promotion program (intervention group). We will perform this study during the COVID-19 pandemic, and will administer interventions by teletherapy, and contact participants by telephone calls, text messages, and/or teleconferences. We will collect patient data using questionnaires administered at baseline, immediately after the intervention, and after 6 and 12 months. The primary outcome will be score on the Beck Depression Inventory-II. The secondary outcomes will be score on the Clinical Global Impressions Scale (used to quantify and track patient progress and treatment response over time) and health-related quality of life measured using the European Quality of Life-5 Dimensions Questionnaire.
Patients with TRD are especially vulnerable when face-to-face psychotherapy is unavailable. The main strength of the proposed study is the novelty of the intervention to be used as an adjuvant therapy. Our results may provide guidance for treatment of patients with TRD in future situations that require lockdown measures.
NCT04428099.
Summary Background Obstructive Sleep Apnoea (OSA) is associated with increased oxidative stress. NADPH oxidases are the main source of Reactive Oxygen Species (ROS) in the vasculature. Several ...polymorphisms related to NADPH oxidase expression or activity have been identified. We compared the distribution of the allelic frequencies of A-930G and C242T polymorphisms and their possible relationship with the levels of 8-isoprostanes as a marker of oxidative stress in patients with OSA and in a control group without OSA. Methods This is a case-control study. We determined the A-930G and C242T p22phox genotypes in 427 patients with OSA and in 139 healthy subjects recruited from the Sleep Unit of Son Dureta University Hospital, (Palma de Mallorca, Spain). 8-Isoprostane was measured as an oxidative stress marker. Results The distribution of the p22phox genotypes in OSA and in control subjects was different. The risk of OSA was associated with the presence of the G allele in the A-930G p22phox independently of age, gender, Body Mass Index (BMI), hypertension, dyslipemia and diabetes, but no association was found with the C242T polymorphism. The median level of 8-isoprostane was significantly higher in OSA patients. Synergic effect in 8-Isoprostane levels was observed when these two polymorphisms were analysed together. Conclusion the A-930G polymorphism of the p22phox gene may play an important role in genetic susceptibility to OSA. Furthermore, the C242T and A-930G polymorphisms of the p22phox gene have a synergic effect on the 8-isoprostane levels, suggesting that they may be involved in the development of oxidative stress in these patients.
The global health emergency generated by the COVID-19 pandemic is posing an unprecedented challenge to health care workers, who are facing heavy workloads under psychologically difficult situations. ...Mental mobile Health (mHealth) interventions are now being widely deployed due to their attractive implementation features, despite the lack of evidence about their efficacy in this specific population and context.
The aim of this trial is to evaluate the effectiveness of a psychoeducational, mindfulness-based mHealth intervention to reduce mental health problems in health care workers during the COVID-19 pandemic.
We conducted a blinded, parallel-group, controlled trial in Spain. Health care workers providing face-to-face health care to patients with COVID-19 were randomly assigned (1:1) to receive the PsyCovidApp intervention (an app targeting emotional skills, healthy lifestyle behavior, burnout, and social support) or a control app (general recommendations about mental health care) for 2 weeks. The participants were blinded to their group allocation. Data were collected telephonically at baseline and after 2 weeks by trained health psychologists. The primary outcome was a composite of depression, anxiety, and stress (overall score on the Depression Anxiety Stress Scale-21 DASS-21). Secondary outcomes were insomnia (Insomnia Severity Index), burnout (Maslach Burnout Inventory Human Services Survey), posttraumatic stress (Davidson Trauma Scale), self-efficacy (General Self-Efficacy Scale), and DASS-21 individual scale scores. Differences between groups were analyzed using general linear modeling according to an intention-to-treat protocol. Additionally, we measured the usability of the PsyCovidApp (System Usability Scale). The outcome data collectors and trial statisticians were unaware of the treatment allocation.
Between May 14 and July 25, 2020, 482 health care workers were recruited and randomly assigned to PsyCovidApp (n=248) or the control app (n=234). At 2 weeks, complete outcome data were available for 436/482 participants (90.5%). No significant differences were observed between the groups at 2 weeks in the primary outcome (standardized mean difference -0.04; 95% CI -0.11 to 0.04; P=.15) or in the other outcomes. In our prespecified subgroup analyses, we observed significant improvements among health care workers consuming psychotropic medications (n=79) in the primary outcome (-0.29; 95% CI -0.48 to -0.09; P=.004), and in posttraumatic stress, insomnia, anxiety, and stress. Similarly, among health care workers receiving psychotherapy (n=43), we observed improvements in the primary outcome (-0.25; 95% CI -0.49 to -0.02; P=.02), and in insomnia, anxiety, and stress. The mean usability score of PsyCovidApp was high (87.21/100, SD 12.65). After the trial, 208/221 participants in the intervention group (94.1%) asked to regain access to PsyCovidApp, indicating high acceptability.
In health care workers assisting patients with COVID-19 in Spain, PsyCovidApp, compared with a control app, reduced mental health problems at 2 weeks only among health care workers receiving psychotherapy or psychotropic medications.
ClinicalTrials.gov NCT04393818; https://clinicaltrials.gov/ct2/show/NCT04393818.
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