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Effectiveness of the Use of a Mobile Tool in Improving Lifestyles

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02016014
Enrollment
833
Registered
2013-12-19
Start date
2014-01-31
Completion date
2016-07-31
Last updated
2024-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects Without Cardiovascular Disease

Keywords

Physical activity, Alimentation, Information and communication Technology, Arterial aging

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.

Interventions

DEVICESmartphone with APP

Smartphone with APP (EVIDENT) for 3 months

BEHAVIORALCounseling on lifestyles

Counseling on physical activity and mediterranean diet

Sponsors

Instituto de Salud Carlos III
CollaboratorOTHER_GOV
Instituto de Investigación Biomédica de Salamanca
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Mediterranean diet compliance1 yearMeasurement by medierranean diet questionary from PREDIMED study

Secondary

MeasureTime frameDescription
Increase physical activity1 yearMeasurement by accelerometer and evaluate bay counts/minute

Other

MeasureTime frameDescription
Cardio ankle vascular index (CAVI)1 yearMeasurement by Vasera device

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026