title: Effectiveness of a smartphone application for improving healthy lifestyles, a randomized clinical trial (EVIDENT II): study protocol.
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Clinical Trials.gov Identifier: NCT02016014.
authors.forename: José I
authors.initials: JI
authors.lastname: Recio-Rodríguez
authors.forename: Carlos
authors.initials: C
authors.lastname: Martín-Cantera
authors.forename: Natividad
authors.initials: N
authors.lastname: González-Viejo
authors.forename: Amparo
authors.initials: A
authors.lastname: Gómez-Arranz
authors.forename: Maria S
authors.initials: MS
authors.lastname: Arietaleanizbeascoa
authors.forename: Yolanda
authors.initials: Y
authors.lastname: Schmolling-Guinovart
authors.forename: Jose A
authors.initials: JA
authors.lastname: Maderuelo-Fernandez
authors.forename: Diana
authors.initials: D
authors.lastname: Pérez-Arechaederra
authors.forename: Emiliano
authors.initials: E
authors.lastname: Rodriguez-Sanchez
authors.forename: Manuel A
authors.initials: MA
authors.lastname: Gómez-Marcos
authors.affiliation: The Alamedilla Health Center, Castilla y León Health Service, USAL, IBSAL, Salamanca, Spain. Lgarciao@usal.es.
authors.forename: Luis
authors.initials: L
authors.lastname: García-Ortiz
mesh_terms: D000328:Adult; D000368:Aged; D000375:Aging; D001794:Blood Pressure; D059168:Carotid Intima-Media Thickness; D040421:Cell Phone; D038441:Diet, Mediterranean; D004311:Double-Blind Method; D015444:Exercise; D005260:Female; D015438:Health Behavior; D006293:Health Promotion / Q000379:methods*; D006339:Heart Rate; D006801:Humans; D008019:Life Style; D008297:Male; D008875:Middle Aged; D063731:Mobile Applications; D012107:Research Design; D011795:Surveys and Questionnaires