Effectiveness of the Use of a Mobile Tool in Improving Lifestyles

Not Applicable

Completed

• Conditions: Healthy Subjects Without Cardiovascular Disease
• Interventions: Device: Smartphone with APP; Behavioral: Counseling on lifestyles

• Registration Number: NCT02016014
• Lead Sponsor: Instituto de Investigación Biomédica de Salamanca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-09
• Study First Submitted QC: 2013-12-13
• Study First Posted: 2013-12-19
• Study Start: 2014-01
• Primary Completion: 2016-06
• Study Completion: 2016-07
• Status Verified: 2016-08
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 833

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Smartphone with APP	Lifestyle counseling in physical activity and alimentation and add for three months a smartphopne with a app (EVIDENT) to improve alimentation and physical activity
Intervention group	Counseling on lifestyles	Lifestyle counseling in physical activity and alimentation and add for three months a smartphopne with a app (EVIDENT) to improve alimentation and physical activity
Lifestyle counseling	Counseling on lifestyles	Lifestyle counseling in physical activity and alimentation

Primary Outcome Measures

Name	Time	Method
Mediterranean diet compliance	1 year	Measurement by medierranean diet questionary from PREDIMED study

Secondary Outcome Measures

Name	Time	Method
Increase physical activity	1 year	Measurement by accelerometer and evaluate bay counts/minute

Trial Locations

Locations (1)

Instituto Biosanitario de Salamanca. Research unit La Alamedilla; 🇪🇸 Salamanca, Spain