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Effectiveness of a smartphone application for improving healthy lifestyles, a randomized clinical trial (EVIDENT II): study protocol
- Published on March 14, 2014
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 (GT3X) 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: NCT02016014
- José I Recio-Rodríguez 1
- Carlos Martín-Cantera 2
- Natividad González-Viejo 3
- Amparo Gómez-Arranz 4
- Maria S Arietaleanizbeascoa 5
- Yolanda Schmolling-Guinovart 6
- Jose A Maderuelo-Fernandez 1
- Diana Pérez-Arechaederra 1
- Emiliano Rodriguez-Sanchez 1
- Manuel A Gómez-Marcos 1
- Luis García-Ortiz 1
- on behalf the EVIDENT Group 7
Primary Health care Research Unit of Barcelona, Primary Healthcare University Research Institute IDIAP-Jordi Gol, Barcelona, Spain
Torre Ramona Health Center, Aragón Health Service, Zaragoza, Spain
Casa de Barco Health Center, Castilla y León Health Service, Valladolid, Spain
Primary Care Research Unit of Bizkaia, Basque Health Service-Osakidetza, Bilbao, Spain
Río Tajo Health Center, Castilla-La Mancha Health Service, University of Castilla-La Mancha, Talavera de la Reina, Spain
EVIDENT Group. redIAPP: Red de Investigación en Actividades Preventivas y Promoción de la Salud (Research Network on Preventive Activities and Health Promotion), Salamanca, Spain
BMC Public Health