ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of the Use of a Mobile Tool in Improving Lifestyles

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02016014
Recruitment Status : Completed
First Posted : December 19, 2013
Last Update Posted : March 3, 2017
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Luis Garcia Ortiz, Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Brief Summary:
Objectives: To develop and validate a mobile tool for use in Smartphone supports as a first step, and to evaluate the effect of adding this new tool of information and communication technologies (ICT), to a standardized intervention to increase adherence to nutritional recommendations of the Mediterranean diet and increase physical activity as primary endpoint. Analyze adherence and intervention results from a gender perspective. Methodology: Multicenter, randomized double-blind, clinical trial with two parallel group, aimed at assessing the effects of adding an TIC tool, developed for the Smartphone application (intervention), in support of behavioral and educational recommendations (control) in the increased physical activity and adaptation to the Mediterranean dietary pattern. Population: 1215 included subjects younger than 70 years from the project EVIDENT who agree to participate. Measurement and interventions: Physical activity will be assessed with the accelerometer and the 7-PAR day and adaptation to the Mediterranean diet with a questionnaire of adherence and a food frequency survey. It will also assess vascular structure and function, central blood pressure, Augmentation index, pulse rate and of carotid intima-media thickness. The counsel to adaptation the Mediterranean diet (based on the project PREDIMED) and exercise (based on PEPAF project), will be common to both groups. The intervention group will be added training and use of an application on a Smartphone designed to promote healthy eating and increased physical activity.

Condition or disease Intervention/treatment Phase
Healthy Subjects Without Cardiovascular Disease Device: Smartphone with APP Behavioral: Counseling on lifestyles Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 833 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Effectiveness of the Use of a Mobile Tool Added to a Standard Intervention in Improving Lifestyles in Adults
Study Start Date : January 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : July 2016

Arm Intervention/treatment
Experimental: Intervention group
Lifestyle counseling in physical activity and alimentation and add for three months a smartphopne with a app (EVIDENT) to improve alimentation and physical activity
Device: Smartphone with APP
Smartphone with APP (EVIDENT) for 3 months

Behavioral: Counseling on lifestyles
Counseling on physical activity and mediterranean diet

Active Comparator: Lifestyle counseling
Lifestyle counseling in physical activity and alimentation
Behavioral: Counseling on lifestyles
Counseling on physical activity and mediterranean diet




Primary Outcome Measures :
  1. Mediterranean diet compliance [ Time Frame: 1 year ]
    Measurement by medierranean diet questionary from PREDIMED study


Secondary Outcome Measures :
  1. Increase physical activity [ Time Frame: 1 year ]
    Measurement by accelerometer and evaluate bay counts/minute


Other Outcome Measures:
  1. Cardio ankle vascular index (CAVI) [ Time Frame: 1 year ]
    Measurement by Vasera device



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects since 20 to 70 years

Exclusion Criteria:

Older than 70 years are excluded, due to difficulties in the use of ICTs and those who can not exercise or follow a diet Mediterranean diet


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02016014


Locations
Spain
Instituto Biosanitario de Salamanca. Research unit La Alamedilla
Salamanca, Spain, 37003
Sponsors and Collaborators
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Instituto de Salud Carlos III
Investigators
Principal Investigator: Luis Garcia-Ortiz, MD Instituto Biosanitario de Salamanca

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Luis Garcia Ortiz, MD.PhD, Fundacion para la Investigacion y Formacion en Ciencias de la Salud
ClinicalTrials.gov Identifier: NCT02016014     History of Changes
Other Study ID Numbers: PI13/00618
GRS 770/B/13 ( Registry Identifier: EVIDENT II )
First Posted: December 19, 2013    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: August 2016

Keywords provided by Luis Garcia Ortiz, Fundacion para la Investigacion y Formacion en Ciencias de la Salud:
Physical activity
Alimentation
Information and communication Technology
Arterial aging

Additional relevant MeSH terms:
Cardiovascular Diseases