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Effectiveness of the Use of a Mobile Tool in Improving Lifestyles

I

Instituto de Investigación Biomédica de Salamanca

Status

Completed

Conditions

Healthy Subjects Without Cardiovascular Disease

Treatments

Behavioral: Counseling on lifestyles
Device: Smartphone with APP

Study type

Interventional

Funder types

Other

Identifiers

NCT02016014
GRS 770/B/13 (Registry Identifier)
PI13/00618

Details and patient eligibility

About

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.

Enrollment

833 patients

Sex

All

Ages

20 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

833 participants in 2 patient groups

Intervention group
Experimental group
Description:
Lifestyle counseling in physical activity and alimentation and add for three months a smartphopne with a app (EVIDENT) to improve alimentation and physical activity
Treatment:
Device: Smartphone with APP
Behavioral: Counseling on lifestyles
Lifestyle counseling
Active Comparator group
Description:
Lifestyle counseling in physical activity and alimentation
Treatment:
Behavioral: Counseling on lifestyles

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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