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Long-Term Effectiveness of a Smartphone App and a Smart Band on Arterial Stiffness and Central Hemodynamic Parameters in a Population with Overweight and Obesity (Evident 3 Study): Randomised Controlled Trial.
Gómez-Sánchez, L, Gómez-Sánchez, M, Lugones-Sánchez, C, Rodríguez-Sánchez, E, Tamayo-Morales, O, Gonzalez-Sánchez, S, Magallón-Botaya, R, Ramirez-Manent, JI, Recio-Rodriguez, JI, Agudo-Conde, C, et al
Nutrients. 2022;(22)
Abstract
BACKGROUND mHealth technologies could help to improve cardiovascular health; however, their effect on arterial stiffness and hemodynamic parameters has not been explored to date. OBJECTIVE To evaluate the effect of a mHealth intervention, at 3 and 12 months, on arterial stiffness and central hemodynamic parameters in a sedentary population with overweight and obesity. METHODS Randomised controlled clinical trial (Evident 3 study). 253 subjects were included: 127 in the intervention group (IG) and 126 in the control group (CG). The IG subjects were briefed on the use of the Evident 3 app and a smart band (Mi Band 2, Xiaomi) for 3 months to promote healthy lifestyles. All measurements were recorded in the baseline visit and at 3 and 12 months. The carotid-femoral pulse wave velocity (cfPWV) and the central hemodynamic parameters were measured using a SphigmoCor System® device, whereas the brachial-ankle pulse wave velocity (baPWV) and the Cardio Ankle Vascular Index (CAVI) were measured using a VaSera VS-2000® device. RESULTS Of the 253 subjects who attended the initial visit, 237 (93.7%) completed the visit at 3 months of the intervention, and 217 (85.3%) completed the visit at 12 months of the intervention. At 12 months, IG showed a decrease in peripheral augmentation index (PAIx) (-3.60; 95% CI -7.22 to -0.00) and ejection duration (ED) (-0.82; 95% CI -1.36 to -0.27), and an increase in subendocardial viability ratio (SEVR) (5.31; 95% CI 1.18 to 9.44). In CG, cfPWV decreased at 3 months (-0.28 m/s; 95% CI -0.54 to -0.02) and at 12 months (-0.30 m/s, 95% CI -0.54 to -0.05), central diastolic pressure (cDBP) decreased at 12 months (-1.64 mm/Hg; 95% CI -3.19 to -0.10). When comparing the groups we found no differences between any variables analyzed. CONCLUSIONS In sedentary adults with overweight or obesity, the multicomponent intervention (Smartphone app and an activity-tracking band) for 3 months did not modify arterial stiffness or the central hemodynamic parameters, with respect to the control group. However, at 12 months, CG presented a decrease of cfPWV and cDBP, whereas IG showed a decrease of PAIx and ED and an increase of SEVR.
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Cost-effectiveness analysis of a multiple health behaviour change intervention in people aged between 45 and 75 years: a cluster randomized controlled trial in primary care (EIRA study).
Aznar-Lou, I, Zabaleta-Del-Olmo, E, Casajuana-Closas, M, Sánchez-Viñas, A, Parody-Rúa, E, Bolíbar, B, Iracheta-Todó, M, Bulilete, O, López-Jiménez, T, Pombo-Ramos, H, et al
The international journal of behavioral nutrition and physical activity. 2021;(1):88
Abstract
BACKGROUND Multiple health behaviour change (MHBC) interventions that promote healthy lifestyles may be an efficient approach in the prevention or treatment of chronic diseases in primary care. This study aims to evaluate the cost-utility and cost-effectiveness of the health promotion EIRA intervention in terms of MHBC and cardiovascular reduction. METHODS An economic evaluation alongside a 12-month cluster-randomised (1:1) controlled trial conducted between 2017 and 2018 in 25 primary healthcare centres from seven Spanish regions. The study took societal and healthcare provider perspectives. Patients included were between 45 and 75 years old and had any two of these three behaviours: smoking, insufficient physical activity or low adherence to Mediterranean dietary pattern. Intervention duration was 12 months and combined three action levels (individual, group and community). MHBC, defined as a change in at least two health risk behaviours, and cardiovascular risk (expressed in % points) were the outcomes used to calculate incremental cost-effectiveness ratios (ICER). Quality-adjusted life-years (QALYs) were estimated and used to calculate incremental cost-utility ratios (ICUR). Missing data was imputed and bootstrapping with 1000 replications was used to handle uncertainty in the modelling results. RESULTS The study included 3062 participants. Intervention costs were €295 higher than usual care costs. Five per-cent additional patients in the intervention group did a MHBC compared to usual care patients. Differences in QALYS or cardiovascular risk between-group were close to 0 (- 0.01 and 0.04 respectively). The ICER was €5598 per extra health behaviour change in one patient and €6926 per one-point reduction in cardiovascular risk from a societal perspective. The cost-utility analysis showed that the intervention increased costs and has no effect, in terms of QALYs, compared to usual care from a societal perspective. Cost-utility planes showed high uncertainty surrounding the ICUR. Sensitivity analysis showed results in line with the main analysis. CONCLUSION The efficiency of EIRA intervention cannot be fully established and its recommendation should be conditioned by results on medium-long term effects. TRIAL REGISTRATION Clinicaltrials.gov NCT03136211 . Registered 02 May 2017 - Retrospectively registered.
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Effectiveness of a Multicomponent Intervention in Primary Care That Addresses Patients with Diabetes Mellitus with Two or More Unhealthy Habits, Such as Diet, Physical Activity or Smoking: Multicenter Randomized Cluster Trial (EIRA Study).
Represas-Carrera, F, Couso-Viana, S, Méndez-López, F, Masluk, B, Magallón-Botaya, R, Recio-Rodríguez, JI, Pombo, H, Leiva-Rus, A, Gil-Girbau, M, Motrico, E, et al
International journal of environmental research and public health. 2021;18(11)
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Life habits such as smoking, physical activity, and diet affect glycaemic control. The objective of this multicentre randomised cluster trial (EIRA study) was to evaluate the effectiveness of multicomponent educational interventions on glycaemic control in Type 2 diabetic patients. Interventions in multicomponent individual, group and community settings included smoking cessation, the Mediterranean diet and physical activity, as well as an assessment of the quality of life. Participants had unhealthy lifestyles prior to the intervention. The study was conducted in 26 primary healthcare centres in seven health departments in Spain over a period of 12 months. A brief intervention aimed to change the habits of the participants, including increasing physical activity, quitting smoking and adhering to the Mediterranean diet. After 12 months of intervention, there were no statistically significant improvements in glycaemic control, physical activity, sedentary lifestyle, smoking, or quality of life. However, adherence to the Mediterranean diet was statistically significant. Further research is needed to determine the effectiveness of multicomponent interventions in improving glycaemic control. The clinical applicability of multicomponent interventions to tackle type 2 diabetes, obesity, and unhealthy lifestyles should be considered by healthcare providers.
Abstract
Introduction: We evaluated the effectiveness of an individual, group and community intervention to improve the glycemic control of patients with diabetes mellitus aged 45-75 years with two or three unhealthy life habits. As secondary endpoints, we evaluated the inverventions' effectiveness on adhering to Mediterranean diet, physical activity, sedentary lifestyle, smoking and quality of life. Method: A randomized clinical cluster (health centers) trial with two parallel groups in Spain from January 2016 to December 2019 was used. Patients with diabetes mellitus aged 45-75 years with two unhealthy life habits or more (smoking, not adhering to Mediterranean diet or little physical activity) participated. Centers were randomly assigned. The sample size was estimated to be 420 people for the main outcome variable. Educational intervention was done to improve adherence to Mediterranean diet, physical activity and smoking cessation by individual, group and community interventions for 12 months. Controls received the usual health care. The outcome variables were: HbA1c (main), the Mediterranean diet adherence score (MEDAS), the international diet quality index (DQI-I), the international physical activity questionnaire (IPAQ), sedentary lifestyle, smoking ≥1 cigarette/day and the EuroQuol questionnaire (EVA-EuroQol5D5L). Results: In total, 13 control centers (n = 356) and 12 intervention centers (n = 338) were included with similar baseline conditions. An analysis for intention-to-treat was done by applying multilevel mixed models fitted by basal values and the health center: the HbA1c adjusted mean difference = -0.09 (95% CI: -0.29-0.10), the DQI-I adjusted mean difference = 0.25 (95% CI: -0.32-0.82), the MEDAS adjusted mean difference = 0.45 (95% CI: 0.01-0.89), moderate/high physical activity OR = 1.09 (95% CI: 0.64-1.86), not living a sedentary lifestyle OR = 0.97 (95% CI: 0.55-1.73), no smoking OR = 0.61 (95% CI: 0.54-1.06), EVA adjusted mean difference = -1.26 (95% CI: -4.98-2.45). Conclusions: No statistically significant changes were found for either glycemic control or physical activity, sedentary lifestyle, smoking and quality of life. The multicomponent individual, group and community interventions only showed a statistically significant improvement in adhering to Mediterranean diet. Such innovative interventions need further research to demonstrate their effectiveness in patients with poor glycemic control.
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[Baseline characteristics and quality of life in patients with Diabetes Mellitus included in the EIRA randomized clinical trial.].
Represas-Carrera, FJ, Méndez-López, F, Couso-Viana, S, Masluk, B, Magallón-Botaya, R, Clavería, A
Revista espanola de salud publica. 2021
Abstract
OBJECTIVE The EIRA study is a randomized clinical multicenter trial that aims to evaluate the effectiveness of a complex multi-risk intervention aimed at people aged 45-75 in Primary Care. The objectives of this work were to describe the baseline characteristics of patients with Diabetes Mellitus included in phase III of the EIRA study and analyze the relationship that different independent variables may have with the quality of life. METHODS The data of all patients with Diabetes Mellitus that were included in phase III of EIRA study collected at baseline were analyzed. Patients with at least two or more of unhealthy lifestyles were selected: smoking, low adherence to the Mediterranean diet and/or low level of physical activity. The quality of life was measured with the EQ-5D-5L questionnaire. A descriptive and bivariate study was performed. The variables did not follow a normal distribution. Non-parametric statistical tests were used. For the multivariate analysis of the quality of life, automated linear regression was used with SPSS v19. RESULTS 694 were patients included with Diabetes Mellitus (356 controls, 338 in intervention, without significant differences between both groups). Control: 37.64% women, age (median) 60 years. Intervention: 37.87% women, age (median) 60 years. Most prevalent risk behaviors in descending order: low adherence to the Mediterranean diet, low level of physical activity and smoking. The variables that significantly influenced quality of life were: GAD-7, work activity, HbA1c and CIDI. CONCLUSIONS There are no significant differences motivated by the study design. The influence of mental health on the EQ-5D-5L is remarkable.
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Transcultural adaptation and validation of the Celiac Dietary Adherence Test. A simple questionnaire to measure adherence to a gluten-free diet.
Fueyo-Díaz, R, Gascón-Santos, S, Asensio-Martínez, Á, Sánchez-Calavera, MA, Magallón-Botaya, R
Revista espanola de enfermedades digestivas. 2016;(3):138-44
Abstract
BACKGROUND AND AIMS A gluten-free diet is to date the only treatment available to celiac disease sufferers. However, systematic reviews indicate that, depending on the method of evaluation used, only 42% to 91% of patients adhere to the diet strictly. Transculturally adapted tools that evaluate adherence beyond simple self-informed questions or invasive analyses are, therefore, of importance. The aim is to obtain a Spanish transcultural adaption and validation of Leffler's Celiac Dietary Adherence Test. METHODS A two-stage observational transversal study: translation and back translation by four qualified translators followed by a validation stage in which the questionnaire was administered to 306 celiac disease patients aged between 12 and 72 years and resident in Aragon. Factorial structure, criteria validity and internal consistency were evaluated. RESULTS The Spanish version maintained the 7 items in a 3-factor structure. Reliability was very high in all the questions answered and the floor and ceiling effects were very low (4.3% and 1%, respectively). The Spearman correlation with the self-efficacy and life quality scales and the self-informed question were statistically significant (p < 0.01). According to the questionnaire criteria, adherence was 72.3%. CONCLUSION The Spanish version of the Celiac Dietary Adherence Test shows appropriate psychometric properties and is, therefore, suitable for studying adherence to a gluten-free diet in clinical and research environments.
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European Code Against Cancer: what does the Spanish population know and think about its recommendations?
Pérula-de-Torres, LÁ, Marzo-Castillejo, M, Ranchal-Sánchez, A, Bartolomé-Moreno, C, Parras-Rejano, JM, Bellas-Beceiro, B, Vela-Vallespin, C, Nuin-Villanueva, MA, Melús-Palazón, E, Vilarrubí-Estrella, M, et al
European journal of cancer prevention : the official journal of the European Cancer Prevention Organisation (ECP). 2015;(2):69-75
Abstract
The aim of this study was to evaluate the Spanish population's knowledge of and beliefs regarding the European Code Against Cancer (ECAC) recommendations. This was a cross-sectional, observational, multicentric study that used self-administered surveys. Ten individuals, between the ages of 15 and 69 years old, were enrolled by each participating primary care professional in their respective surgery consultations. This study used 2058 individuals who were recruited by 205 professionals from 106 health centres. Their average age was 41.5 years (52.2% women). The majority believe that smoking [94.1%; 95% confidence interval (CI): 93.1-95.2], sun exposure (91%; 95% CI: 89.7-92.3) and alcoholism (72.1%; 95% CI: 70.1-74.1) are factors related to cancer. The least relevant are infection by the hepatitis B virus (25.7%; 95% CI: 23.8-27.7) and having multiple sexual partners (25%; 95% CI: 23.1-26.9). In all, 86.7% (95% CI: 85.2-88.2) had never heard about the ECAC. Patients adequately identify the carcinogenic effect of tobacco, alcohol or sun exposure. Moreover, they inadequately identify having hepatitis B and multiple sexual partners as being related to cancer. A large majority of individuals have not heard of the ECAC, which raises the need to conduct outreach campaigns at an institutional level and/or through scientific associations and activities promoting health education among primary care professionals.