Instituto Biosanitario de Salamanca. Research unit La Alamedilla
Salamanca, 37003, Spain
NCT Number: NCT02016014
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.
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Notify Me20 year–70 year
All sexes
Interventional
Not applicable
Salamanca, 37003, Spain
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Smartphone with APP (EVIDENT) for 3 months
Counseling on physical activity and mediterranean diet
Time frame: 1 year
Measurement by medierranean diet questionary from PREDIMED study
Time frame: 1 year
Measurement by accelerometer and evaluate bay counts/minute
Time frame: 1 year
Measurement by Vasera device
Instituto de Investigación Biomédica de Salamanca
Other
Effectiveness of the Use of a Mobile Tool Added to a Standard Intervention in Improving Lifestyles in Adults
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