Effectiveness of the Use of a Mobile Tool in Improving Lifestyles

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of the Use of a Mobile Tool Added to a Standard Intervention in Improving Lifestyles in Adults

Conditions
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Healthy Subjects Without Cardiovascular Disease

Intervention / Treatment
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* Device: Smartphone with APP
* Behavioral: Counseling on lifestyles


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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<br>* Smartphone with APP (EVIDENT) for 3 months<br>Behavioral: Counseling on lifestyles<br>* Counseling on physical activity and mediterranean diet<br>|
| Active Comparator: Lifestyle counseling<br>Lifestyle counseling in physical activity and alimentation | Behavioral: Counseling on lifestyles<br>* Counseling on physical activity and mediterranean diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mediterranean diet compliance | Measurement by medierranean diet questionary from PREDIMED study | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase physical activity | Measurement by accelerometer and evaluate bay counts/minute | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical activity, Alimentation, Information and communication Technology, Arterial aging