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Clinical Trials/NCT02016014
NCT02016014
Completed
Not Applicable

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

Instituto de Investigación Biomédica de Salamanca1 site in 1 country833 target enrollmentJanuary 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy Subjects Without Cardiovascular Disease
Sponsor
Instituto de Investigación Biomédica de Salamanca
Enrollment
833
Locations
1
Primary Endpoint
Mediterranean diet compliance
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
July 2016
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Instituto de Investigación Biomédica de Salamanca
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Mediterranean diet compliance

Time Frame: 1 year

Measurement by medierranean diet questionary from PREDIMED study

Secondary Outcomes

  • Increase physical activity(1 year)

Study Sites (1)

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