Aim
To evaluate the effectiveness of a nurse‐led personalized telephone lifestyle intervention versus automated SMSs in the reduction of fasting plasma glucose in adults with prediabetes.
Design
The ...PREDIPHONE is a randomized controlled, parallel, two arms, superiority trial with 15 months of follow‐up. Participants will be randomized to either the intervention group (teleconsultations) or the active control group (SMSs).
Methods
A total of 428 participants will be randomized in a 1:1 ratio to one of the two arms and followed up during 9 months. The teleconsultations group will receive nurse‐led personalized advice, while the SMSs group will receive 4–5 brief SMSs a week. Participants in both groups will receive evidence‐based recommendations for diet and physical activity (PA). Outcome measures will be collected at baseline, months 4 and 9 and at month 15, to evaluate post‐intervention effects.
Discussion
Prevention of diabetes through the implementation of lifestyle interventions remains an important priority. The current pandemic situation has magnified its urgency as it heavily affected the functionality of the healthcare system. Moreover, it created the need of remotely delivering preventative interventions. This study will provide insights on the effectiveness and feasibility of a telephone‐based intervention led by nurses in the amelioration of risk factors associated with diabetes.
Impact
Findings from this study will offer health services decision‐makers sound evidence regarding an alternative method to face‐to‐face consultations that could be practical, acceptable and inexpensive, and that concretely answers the need for easily implementable prevention strategies.
Trial Registration
NCT04735640 (ClinicalTrials.gov identifier).
Protocol version
V1.0, 18/02/2021.
Physical activity (PA) has been hypothesized to be effective to maintaining cognitive function and delay cognitive decline in the elderly, but physical fitness (PF) could be a better predictor of ...cognitive function. We aimed to study the association between PA and PF with cognitive function and quality of life using cross-sectional data from 6874 participants of the PREDIMED-Plus trial (64.9 ± 4.9 years, 48.5% female). PF and PA were measured with a Chair Stand Test, the REGICOR and Rapid Assessment Physical Activity questionnaires. Cognitive function was measured with Mini-mental State Examination, Control Oral Word Association Test, Trail Making Test and Digit Span tests; whereas health-related quality of life was assessed with the SF36-HRQL test. Cognitive and quality of life scores were compared among PF quartiles and PA levels (low, moderate and high) with ANCOVA and with Chair Stand repetitions and energy expenditure from total PA with multivariable linear regression adjusted for confounding factors. PF associated with higher scores in phonemic and semantic verbal fluency tests and with lower TMT A time. However, PA was not associated with the neurocognitive parameters evaluated. Both PF and PA levels were strongly associated with a better quality of life. We concluded that PF, but not PA, is associated with a better cognitive function. This trial was retrospectively registered at the International Standard Randomized Controlled Trial (ISRCTN89898870, https://www.isrctn.com/ISRCTN89898870?q=ISRCTN89898870&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10&searchType=basic-search) on 07/24/2014.
To assess the efficacy of different modalities and frequencies of physical exercise on glycaemic control in adults with prediabetes. A two-phase, parallel, randomised, controlled clinical trial will ...be carried out, in 210 participants. In phase 1, 120 participants will be randomized into four arms: (1) aerobic exercise, (2) aerobic exercise combined with resistance, (3) high-intensity intervallic exercise and (4) control group. In phase 2, 90 new participants will be randomized into three arms, using the exercise modality that showed the best glycaemic control in phase 1 in the following manner: (1) frequency of 5 days/week, (2) frequency of 3 days/week and (3) frequency of 2 days/week. The control group (n = 30) will be included in phase 1 to evaluate the effect of any type of intervention versus no intervention. Data collection will be performed at baseline and after 15 weeks of follow up. Sociodemographic data, medication, comorbidity, blood biochemical parameters, blood pressure, anthropometric measurements, body composition, physical activity, sedentary lifestyle, diet, smoking, alcohol consumption, quality of life and sleep questionnaires will be collected. Physical activity, sedentary behaviour and sleep will be further determined with an accelerometer, and continuous glycaemia will be determined with a glycaemic monitor, both during seven days, at two time points. The main dependent variable will be the reduction in the mean amplitude of glycaemic excursions. The impact of these interventions on health will also be evaluated through gene expression analysis in peripheral blood cells. The results of this study will contribute to a better understanding of the mechanisms behind the glucose response to physical exercise in a population with prediabetes as well as improve physical exercise prescriptions for diabetes prevention. Increasing glycaemic control in people with prediabetes through physical exercise offers an opportunity to prevent diabetes and reduce associated comorbidities and health costs.
Background: Physical activity health benefits are widely known. However, the association between physical activity, physical fitness, executive function, and academic performance need further ...investigation. Additionally, one of the literature gaps reveals scarce and mixed findings on what mediators of physical activity may affect academic achievement. Purpose: This investigation aims to provide knowledge about the mediation role of physical fitness and executive function in the association of physical activity with academic achievement in a cohort of Spanish schoolchildren using a structural equation modelling approach. Methods: The data for this cross-sectional study were collected from a convenience sample of children from Spain (Balearic Islands) aged between 9 and 13 years. Physical activity levels were self-reported with the Physical Activity Questionnaire for Children; physical fitness was assessed using the International Fitness Scale; executive function was assessed with the Trail Making Test, and children’s achievements were collected from the school records. Structural equation modelling was used to explore the relationship between physical activity, physical fitness, executive function, and academic achievement. Findings: Statistically significant positive direct associations were observed between physical activity and physical fitness (β = 0.46, 95% CI 0.29, 0.64), physical fitness and executive function (β = 0.28, 95% CI 0.04, 0.52), and executive function and academic achievement (β = 0.46, 95% CI 0.28, 0.65), while adjusting for the confounding effects of sex and body mass index. Furthermore, indirect associations were observed between physical activity and executive function mediated by physical fitness (β = 0.13, bias-corrected 95% CI 0.02, 0.31) and between physical fitness and academic achievement through executive function (β = 0.13, bias-corrected 95% CI 0.03, 0.32). Conclusions: This investigation adds to the literature with evidence supporting the idea that regular PA leads to improvements in physical fitness and may support cognitive skills and academic performance in children.
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.
Importance
Strategies targeting body composition may help prevent chronic diseases in persons with excess weight, but randomized clinical trials evaluating lifestyle interventions have rarely ...reported effects on directly quantified body composition.
Objective
To evaluate the effects of a lifestyle weight-loss intervention on changes in overall and regional body composition.
Design, Setting, and Participants
The ongoing Prevención con Dieta Mediterránea-Plus (PREDIMED-Plus) randomized clinical trial is designed to test the effect of the intervention on cardiovascular disease prevention after 8 years of follow-up. The trial is being conducted in 23 Spanish research centers and includes men and women (age 55-75 years) with body mass index between 27 and 40 and metabolic syndrome. The trial reported herein is an interim subgroup analysis of the intermediate outcome body composition after 3-year follow-up, and data analysis was conducted from February 1 to November 30, 2022. Of 6874 total PREDIMED-Plus participants, a subsample of 1521 individuals, coming from centers with access to a dual energy x-ray absorptiometry device, underwent body composition measurements at 3 time points.
Intervention
Participants were randomly allocated to a multifactorial intervention based on an energy-reduced Mediterranean diet (MedDiet) and increased physical activity (PA) or to a control group based on usual care, with advice to follow an ad libitum MedDiet, but no physical activity promotion.
Main Outcomes and Measures
The outcomes (continuous) were 3-year changes in total fat and lean mass (expressed as percentages of body mass) and visceral fat (in grams), tested using multivariable linear mixed-effects models. Clinical relevance of changes in body components (dichotomous) was assessed based on 5% or more improvements in baseline values, using logistic regression. Main analyses were performed in the evaluable population (completers only) and in sensitivity analyses, multiple imputation was performed to include data of participants lost to follow-up (intention-to-treat analyses).
Results
A total of 1521 individuals were included (mean SD age, 65.3 5.0 years; 52.1% men). In comparison with the control group (n=761), participants in the intervention arm (n=760) showed greater reductions in the percentage of total fat (between group differences after 1-year, −0.94% 95% CI, −1.19 to −0.69; 3 years, −0.38% 95% CI, −0.64 to −0.12 and visceral fat storage after 1 year, -126 g 95% CI, −179 to −73.3 g; 3 years, −70.4 g 95% CI, −126 to −15.2 g and greater increases in the percentage of total lean mass at 1 year, 0.88% 95% CI, 0.63%-1.12%; 3-years 0.34% 95% CI, 0.09%-0.60%). The intervention group was more likely to show improvements of 5% or more in baseline body components (absolute risk reduction after 1 year, 13% for total fat mass, 11% for total lean mass, and 14% for visceral fat mass; after 3-years: 6% for total fat mass, 6% for total lean mass, and 8% for visceral fat mass). The number of participants needed to treat was between 12 and 17 to attain at least 1 individual with possibly clinically meaningful improvements in body composition.
Conclusions and Relevance
The findings of this trial suggest a weight-loss lifestyle intervention based on an energy-reduced MedDiet and physical activity significantly reduced total and visceral fat and attenuated age-related losses of lean mass in older adults with overweight or obesity and metabolic syndrome. Continued follow-up is warranted to confirm the long-term consequences of these changes on cardiovascular clinical end points.
Trial Registration
isrctn.org Identifier:
ISRCTN89898870
Coronavirus disease 19 (COVID-19) is a persistent global pandemic with a very heterogeneous disease presentation ranging from a mild disease to dismal prognosis. Early detection of sensitivity and ...severity of COVID-19 is essential for the development of new treatments. In the present study, we measured the levels of circulating growth differentiation factor 15 (GDF15) and angiotensin-converting enzyme 2 (ACE2) in plasma of severity-stratified COVID-19 patients and uninfected control patients and characterized the
in vitro
effects and cohort frequency of ACE2 SNPs. Our results show that while circulating GDF15 and ACE2 stratify COVID-19 patients according to disease severity, ACE2 missense SNPs constitute a risk factor linked to infection susceptibility.
Background: Recent studies have shown that the lifetime prevalence of low back pain (LBP) in schoolchildren aged 10–12 years is 73.6%, and that it appears to have an impact on people’s quality of ...life. A wide range of risk factors associated with LBP have been studied. However, inconsistent results have been reported. In recent decades, the physical fitness level of children and adolescents has worsened, and the current data on the relationship between muscular fitness and musculoskeletal pain are ambiguous. The purpose of the present study was to analyze the relationship between physical fitness and the occurrence and intensity of LBP. Methods: This cross-sectional study assessed 849 students, aged 10–12 years, from 10 primary schools (fifth and sixth grades) from Majorca (Spain). It was based on two different structured and self-administered questionnaires and a fitness test battery validated for child populations. Results: The results showed that higher levels of VO2Max correspond to less LBP intensity. Additionally, LBP was less prevalent among participants who self-reported more physical activity, and higher VO2Max and higher levels of flexibility were associated with the absence of LBP in bed. Conclusion: These results are of particular importance, as cardiorespiratory fitness is the parameter most closely related to health, and it seems to also be related to LBP-prevention.
Objective
The hypertriglyceridemic waist (HTGW) phenotype is characterized by abdominal obesity and high levels of triglycerides. In a cross‐sectional assessment of PREDIMED‐Plus trial participants ...at baseline, HTGW phenotype prevalence was evaluated, associated risk factors were analyzed, and the lifestyle of individuals with metabolic syndrome and HTGW was examined.
Methods
A total of 6,874 individuals aged 55 to 75 with BMI ≥ 27 and < 40 kg/m2 were included and classified by presence (HTGW+) or absence (HTGW−) of HTGW (waist circumference: men ≥ 102 cm, women ≥ 88 cm; fasting plasma triglycerides ≥ 150 mg/dL). Analytical parameters and lifestyle (energy intake and expenditure) were analyzed.
Results
A total of 38.2% of the sample met HTGW+ criteria. HTGW+ individuals tended to be younger, have a greater degree of obesity, be sedentary, and be tobacco users. They had higher peripheral glucose, total cholesterol, and low‐density lipoprotein cholesterol levels; had lower high‐density lipoprotein cholesterol levels; and had increased prevalence of type 2 diabetes mellitus. Mediterranean diet (MedDiet) adherence and physical activity were greater in HTGW− patients. Age, BMI, tobacco use, total energy expenditure, hypertension, type 2 diabetes mellitus, and MedDiet adherence were associated with HTGW+.
Conclusions
HTGW is a highly prevalent phenotype in this population associated with younger age, higher BMI, tobacco use, and decreased MedDiet adherence. HTGW− individuals were more physically active with greater total physical activity, and fewer had hypertension.
This study explored the association between inactive time and measures of adiposity, clinical parameters, obesity, type 2 diabetes and metabolic syndrome components. It further examined the impact of ...reallocating inactive time to time in bed, light physical activity (LPA) or moderate-to-vigorous physical activity (MVPA) on cardio-metabolic risk factors, including measures of adiposity and body composition, biochemical parameters and blood pressure in older adults.
This is a cross-sectional analysis of baseline data from 2189 Caucasian men and women (age 55-75 years, BMI 27-40 Kg/m
) from the PREDIMED-Plus study (http://www.predimedplus.com/). All participants had ≥3 components of the metabolic syndrome. Inactive time, physical activity and time in bed were objectively determined using triaxial accelerometers GENEActiv during 7 days (ActivInsights Ltd., Kimbolton, United Kingdom). Multiple adjusted linear and logistic regression models were used. Isotemporal substitution regression modelling was performed to assess the relationship of replacing the amount of time spent in one activity for another, on each outcome, including measures of adiposity and body composition, biochemical parameters and blood pressure in older adults.
Inactive time was associated with indicators of obesity and the metabolic syndrome. Reallocating 30 min per day of inactive time to 30 min per day of time in bed was associated with lower BMI, waist circumference and glycated hemoglobin (HbA1c) (all p-values < 0.05). Reallocating 30 min per day of inactive time with 30 min per day of LPA or MVPA was associated with lower BMI, waist circumference, total fat, visceral adipose tissue, HbA1c, glucose, triglycerides, and higher body muscle mass and HDL cholesterol (all p-values < 0.05).
Inactive time was associated with a poor cardio-metabolic profile. Isotemporal substitution of inactive time with MVPA and LPA or time in bed could have beneficial impact on cardio-metabolic health.
The trial was registered at the International Standard Randomized Controlled Trial (ISRCTN: http://www.isrctn.com/ISRCTN89898870) with number 89898870 and registration date of 24 July 2014, retrospectively registered.
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