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OpenTrials
Completed

NCT Number: NCT02016014

Effectiveness of the Use of a Mobile Tool in Improving Lifestyles

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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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Biosanitario de Salamanca. Research unit La Alamedilla

Salamanca, 37003, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smartphone with APP

Device

Smartphone with APP (EVIDENT) for 3 months

Counseling on lifestyles

Behavioral

Counseling on physical activity and mediterranean diet

Primary outcomes

  1. Mediterranean diet compliance

    Time frame: 1 year

    Measurement by medierranean diet questionary from PREDIMED study

Secondary outcomes

  1. Increase physical activity

    Time frame: 1 year

    Measurement by accelerometer and evaluate bay counts/minute

Other outcomes

  1. Cardio ankle vascular index (CAVI)

    Time frame: 1 year

    Measurement by Vasera device

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Biomédica de Salamanca

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 19, 2013
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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