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

FUNDAMENTOS: La tecnología móvil, cuando se incluye dentro de las intervenciones de componentes múltiples, podría contribuir a una pérdida de peso más efectiva. El objetivo de este proyecto es evaluar el impacto de añadir el uso de la aplicación EVIDENT 3, diseñada para promover la salud a los hábitos de vida, a las estrategias de modificación tradicionales empleadas para la pérdida de peso. También se evaluarán otras conductas específicas (caminar, ingesta de calorías, tiempo sentado) y resultados (calidad de vida, marcadores inflamatorios, mediciones del envejecimiento arterial). MÉTODOS: Ensayo clínico aleatorio y multicéntrico con 2 grupos paralelos. El estudio se llevará a cabo en el ámbito de la atención primaria e incluirá 700 sujetos de 20 a 65 años, con un índice de masa corporal (27,5-40kg/m2), que están clínicamente clasificados como sedentarios. El resultado primario será la pérdida de peso. Los resultados secundarios incluirán cambios en la forma de caminar (pasos/d), el tiempo de permanencia sentado (min/sem), la ingesta calórica (kcal/d), la calidad de vida, el envejecimiento arterial (índice de aumento) y los niveles de marcadores proinflamatorios. Los resultados se medirán en la línea de base, después de 3 meses y después de 1 año. Los participantes serán asignados aleatoriamente al grupo de intervención (IG) o al grupo de control (CG). Ambos grupos recibirán el asesoramiento tradicional de estilo de vida de atención primaria antes de la asignación al azar. A los sujetos del IG se les prestará un teléfono inteligente y una banda inteligente por un período de 3 meses, correspondiente a la duración de la intervención. La aplicación del EVIDENTE 3 integra la información recogida por la banda inteligente sobre la actividad física y la información autodeclarada por los participantes sobre la ingesta diaria de alimentos. Utilizando esta información, la aplicación genera recomendaciones y objetivos personalizados para la pérdida de peso. DISCUSIÓN: Hay una gran diversidad en las aplicaciones utilizadas obteniendo diferentes resultados en la mejora del estilo de vida y la pérdida de peso. Las poblaciones estudiadas no son homogéneas y generan resultados diferentes. Los resultados de este estudio ayudarán a nuestra comprensión de la eficacia de las nuevas tecnologías, combinadas con el asesoramiento tradicional, para reducir la obesidad y permitir estilos de vida más saludables.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 (27.5–40kg/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.• Ministerio de Ciencia e Innovación y el Instituto de Salud Carlos III/Europa y Fondo de Desarrollo Regional (FEDER). Proyectos PI16/00101, PI16/00952, PI16/00765, PI16/00659, PI16/00421, PI16/00170 • Junta de Castilla y León. Ayuda GRS 1277/B/16peerReviewe

Effectiveness of a smartphone application for improving healthy lifestyles, a randomized clinical trial (EVIDENT II) : study protocol

Background: New technologies could facilitate changes in lifestyle and improve public health. However, no large randomized, controlled studies providing scientific evidence of the benefits of their use have been made. The aims of this study are to develop and validate a smartphone application, and to evaluate the effect of adding this tool to a standardized intervention designed to improve adherence to the Mediterranean diet and to physical activity. An evaluation is also made of the effect of modifying habits upon vascular structure and function, and therefore on arterial aging. Methods/Design: A randomized, double-blind, multicenter, parallel group clinical trial will be carried out. A total of 1215 subjects under 70 years of age from the EVIDENT trial will be included. Counseling common to both groups (control and intervention) will be provided on adaptation to the Mediterranean diet and on physical activity. The intervention group moreover will receive training on the use of a smartphone application designed to promote a healthy diet and increased physical activity, and will use the application for three months. The main study endpoints will be the changes in physical activity, assessed by accelerometer and the 7-day Physical Activity Recall (PAR) interview, and adaptation to the Mediterranean diet, as evaluated by an adherence questionnaire and a food frequency questionnaire (FFQ). Evaluation also will be made of vascular structure and function based on central arterial pressure, the radial augmentation index, pulse velocity, the cardio-ankle vascular index, and carotid intima-media thickness. Discussion: Confirmation that the new technologies are useful for promoting healthier lifestyles and that their effects are beneficial in terms of arterial aging will have important clinical implications, and may contribute to generalize their application in favor of improved population health. Trial registration: Clinical Trials.gov Identifier: NCT0201601

The effectiveness of a smartphone application on modifying the intakes of macro and micronutrients in primary care: a randomized controlled trial. The EVIDENT II Study

Background: This study evaluates the effectiveness of adding a diet smartphone application to standard counseling to modify dietary composition over the long term (12 months). Methods: A randomized, controlled, multicenter clinical trial was conducted involving the participation of 833 subjects from primary care clinics (415 to the intervention (counseling + application) group (IG) and 418 to the control (counseling) group (CG)). Both groups were counseled about a healthy diet and physical activity. For the 3-month intervention period, the IG was also trained to use a diet smartphone application that involved dietary self-monitoring and tailored feedback. Nutritional composition was estimated using a self-reported food frequency questionnaire. Results: An analysis of repeated measures revealed an interaction between the group and the percentages of carbohydrates (p = 0.031), fats (p = 0.015) and saturated fats (p = 0.035) consumed. Both groups decreased their energy intake (Kcal) at 12 months (IG: −114 (95% CI: −191 to −36); CG: −108 (95% CI: −184 to −31)). The IG reported a higher percentage intake of carbohydrates (1.1%; 95% CI: 0.1 to 2.0), and lower percentage intakes of fats (−1.0%; 95% CI: −1.9 to −0.1) and saturated fats (−0.4%; 95%CI: −0.8 to −0.1) when compared to the CG. Conclusions: Better results were achieved in terms of modifying usual diet composition from counseling and the diet smartphone application compared to counseling alone. This was evaluated by a self-reported questionnaire, which indicated an increased percentage intake of carbohydrates, and decreased percentage intakes of fats and saturated fatsSpanish Ministry of Science and Innovation (MICINN) and the Carlos III Health Institute/European Regional Development Fund (ERDF) (FIS: PI13/00618, PI13/01526, PI13/00058, PI13/01635, PI13/02528, PI12/01474; RETICS: RD12/0005, RD16/0007), Regional Health Management of Castilla and León (GRS 1191/B/15, GRS 909/B/14, GRS 770/B/13) and the Infosalud Foundatio

Physical exercise, fitness and dietary pattern and their relationship with circadian blood pressure pattern, augmentation index and endothelial dysfunction biological markers: EVIDENT study protocol

Background: Healthy lifestyles may help to delay arterial aging. The purpose of this study is to analyze the relationship of physical activity and dietary pattern to the circadian pattern of blood pressure, central and peripheral blood pressure, pulse wave velocity, carotid intima-media thickness and biological markers of endothelial dysfunction in active and sedentary individuals without arteriosclerotic disease. Methods/Design Design: A cross-sectional multicenter study with six research groups. Subjects: From subjects of the PEPAF project cohort, in which 1,163 who were sedentary became active, 1,942 were sedentary and 2,346 were active. By stratified random sampling, 1,500 subjects will be included, 250 in each group. Primary measurements: We will evaluate height, weight, abdominal circumference, clinical and ambulatory blood pressure with the Radial Pulse Wave Acquisition Device (BPro), central blood pressure and augmentation index with Pulse Wave Application Software (A-Pulse) and SphymgoCor System Px (Pulse Wave Analysis), pulse wave velocity (PWV) with SphymgoCor System Px (Pulse Wave Velocity), nutritional pattern with a food intake frequency questionnaire, physical activity with the 7-day PAR questionnaire and accelerometer (Actigraph GT3X), physical fitness with the cycle ergometer (PWC-170), carotid intima-media thickness by ultrasound (Micromax), and endothelial dysfunction biological markers (endoglin and osteoprotegerin). Discussion: Determining that sustained physical activity and the change from sedentary to active as well as a healthy diet improve circadian pattern, arterial elasticity and carotid intima-media thickness may help to propose lifestyle intervention programs. These interventions could improve the cardiovascular risk profile in some parameters not routinely assessed with traditional risk scales. From the results of this study, interventional approaches could be obtained to delay vascular aging that combine physical exercise and diet

Short-Term Effectiveness of a Mobile Phone App for Increasing Physical Activity and Adherence to the Mediterranean Diet in Primary Care : A Randomized Controlled Trial (EVIDENT II Study)

Altres ajuts: This study was funded by the Regional Health Management of Castilla y León (GRS 1191/B/15, GRS 909/B/14, GRS 770/B/13), and the Infosalud Foundation.The use of mobile phone apps for improving lifestyles has become generalized in the population, although little is still known about their effectiveness in improving health. We evaluate the effect of adding an app to standard counseling on increased physical activity (PA) and adherence to the Mediterranean diet, 3 months after implementation. A randomized, multicenter clinical trial was carried out. A total of 833 participants were recruited in six primary care centers in Spain through random sampling: 415 in the app+counseling group and 418 in the counseling only group. Counseling on PA and the Mediterranean diet was given to both groups. The app+counseling participants additionally received training in the use of an app designed to promote PA and the Mediterranean diet over a 3-month period. PA was measured with the 7-day Physical Activity Recall (PAR) questionnaire and an accelerometer; adherence to the Mediterranean diet was assessed using the Mediterranean Diet Adherence Screener questionnaire. Participants were predominantly female in both the app+counseling (249/415, 60.0%) and counseling only (268/418, 64.1%) groups, with a mean age of 51.4 (SD 12.1) and 52.3 (SD 12.0) years, respectively. Leisure-time moderate-to-vigorous physical activity (MVPA) by 7-day PAR increased in the app+counseling (mean 29, 95% CI 5-53 min/week; P =.02) but not in the counseling only group (mean 17.4, 95% CI -18 to 53 min/week; P =.38). No differences in increase of activity were found between the two groups. The accelerometer recorded a decrease in PA after 3 months in both groups: MVPA mean -55.3 (95% CI -75.8 to -34.9) min/week in app+counseling group and mean -30.1 (95% CI -51.8 to -8.4) min/week in counseling only group. Adherence to the Mediterranean diet increased in both groups (8.4% in app+counseling and 10.4% in counseling only group), with an increase in score of 0.42 and 0.53 points, respectively (P <.001), but no difference between groups (P =.86). Leisure-time MVPA increased more in the app+counseling than counseling only group, although no difference was found when comparing the increase between the two groups. Counseling accompanied by printed materials appears to be effective in improving adherence to the Mediterranean diet, although the app does not increase adherence. Clinicaltrials.gov NCT02016014; https://clinicaltrials.gov/ct2/show/NCT02016014 (Archived by WebCite at http://www.webcitation.org/6mnopADbf

Short-Term Effectiveness of a Mobile Phone App for Increasing Physical Activity and Adherence to the Mediterranean Diet in Primary Care : A Randomized Controlled Trial (EVIDENT II Study)

Altres ajuts: This study was funded by the Regional Health Management of Castilla y León (GRS 1191/B/15, GRS 909/B/14, GRS 770/B/13), and the Infosalud Foundation.The use of mobile phone apps for improving lifestyles has become generalized in the population, although little is still known about their effectiveness in improving health. We evaluate the effect of adding an app to standard counseling on increased physical activity (PA) and adherence to the Mediterranean diet, 3 months after implementation. A randomized, multicenter clinical trial was carried out. A total of 833 participants were recruited in six primary care centers in Spain through random sampling: 415 in the app+counseling group and 418 in the counseling only group. Counseling on PA and the Mediterranean diet was given to both groups. The app+counseling participants additionally received training in the use of an app designed to promote PA and the Mediterranean diet over a 3-month period. PA was measured with the 7-day Physical Activity Recall (PAR) questionnaire and an accelerometer; adherence to the Mediterranean diet was assessed using the Mediterranean Diet Adherence Screener questionnaire. Participants were predominantly female in both the app+counseling (249/415, 60.0%) and counseling only (268/418, 64.1%) groups, with a mean age of 51.4 (SD 12.1) and 52.3 (SD 12.0) years, respectively. Leisure-time moderate-to-vigorous physical activity (MVPA) by 7-day PAR increased in the app+counseling (mean 29, 95% CI 5-53 min/week; P =.02) but not in the counseling only group (mean 17.4, 95% CI -18 to 53 min/week; P =.38). No differences in increase of activity were found between the two groups. The accelerometer recorded a decrease in PA after 3 months in both groups: MVPA mean -55.3 (95% CI -75.8 to -34.9) min/week in app+counseling group and mean -30.1 (95% CI -51.8 to -8.4) min/week in counseling only group. Adherence to the Mediterranean diet increased in both groups (8.4% in app+counseling and 10.4% in counseling only group), with an increase in score of 0.42 and 0.53 points, respectively (P <.001), but no difference between groups (P =.86). Leisure-time MVPA increased more in the app+counseling than counseling only group, although no difference was found when comparing the increase between the two groups. Counseling accompanied by printed materials appears to be effective in improving adherence to the Mediterranean diet, although the app does not increase adherence. Clinicaltrials.gov NCT02016014; https://clinicaltrials.gov/ct2/show/NCT02016014 (Archived by WebCite at http://www.webcitation.org/6mnopADbf

Physical exercise, fitness and dietary pattern and their relationship with circadian blood pressure pattern, augmentation index and endothelial dysfunction biological markers : EVIDENT study protocol

Background: Healthy lifestyles may help to delay arterial aging. The purpose of this study is to analyze the relationship of physical activity and dietary pattern to the circadian pattern of blood pressure, central and peripheral blood pressure, pulse wave velocity, carotid intima-media thickness and biological markers of endothelial dysfunction in active and sedentary individuals without arteriosclerotic disease. Methods/Design Design: A cross-sectional multicenter study with six research groups. Subjects: From subjects of the PEPAF project cohort, in which 1,163 who were sedentary became active, 1,942 were sedentary and 2,346 were active. By stratified random sampling, 1,500 subjects will be included, 250 in each group. Primary measurements: We will evaluate height, weight, abdominal circumference, clinical and ambulatory blood pressure with the Radial Pulse Wave Acquisition Device (BPro), central blood pressure and augmentation index with Pulse Wave Application Software (A-Pulse) and SphymgoCor System Px (Pulse Wave Analysis), pulse wave velocity (PWV) with SphymgoCor System Px (Pulse Wave Velocity), nutritional pattern with a food intake frequency questionnaire, physical activity with the 7-day PAR questionnaire and accelerometer (Actigraph GT3X), physical fitness with the cycle ergometer (PWC-170), carotid intima-media thickness by ultrasound (Micromax), and endothelial dysfunction biological markers (endoglin and osteoprotegerin). Discussion: Determining that sustained physical activity and the change from sedentary to active as well as a healthy diet improve circadian pattern, arterial elasticity and carotid intima-media thickness may help to propose lifestyle intervention programs. These interventions could improve the cardiovascular risk profile in some parameters not routinely assessed with traditional risk scales. From the results of this study, interventional approaches could be obtained to delay vascular aging that combine physical exercise and diet

Effectiveness of a smartphone application for improving healthy lifestyles, a randomized clinical trial (EVIDENT II) : study protocol

Background: New technologies could facilitate changes in lifestyle and improve public health. However, no large randomized, controlled studies providing scientific evidence of the benefits of their use have been made. The aims of this study are to develop and validate a smartphone application, and to evaluate the effect of adding this tool to a standardized intervention designed to improve adherence to the Mediterranean diet and to physical activity. An evaluation is also made of the effect of modifying habits upon vascular structure and function, and therefore on arterial aging. Methods/Design: A randomized, double-blind, multicenter, parallel group clinical trial will be carried out. A total of 1215 subjects under 70 years of age from the EVIDENT trial will be included. Counseling common to both groups (control and intervention) will be provided on adaptation to the Mediterranean diet and on physical activity. The intervention group moreover will receive training on the use of a smartphone application designed to promote a healthy diet and increased physical activity, and will use the application for three months. The main study endpoints will be the changes in physical activity, assessed by accelerometer and the 7-day Physical Activity Recall (PAR) interview, and adaptation to the Mediterranean diet, as evaluated by an adherence questionnaire and a food frequency questionnaire (FFQ). Evaluation also will be made of vascular structure and function based on central arterial pressure, the radial augmentation index, pulse velocity, the cardio-ankle vascular index, and carotid intima-media thickness. Discussion: Confirmation that the new technologies are useful for promoting healthier lifestyles and that their effects are beneficial in terms of arterial aging will have important clinical implications, and may contribute to generalize their application in favor of improved population health. Trial registration: Clinical Trials.gov Identifier: NCT0201601