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Individualized Telemedical Assistance for Lifestyle Modification in the Treatment of Obesity and Cardiometabolic Risk Prevention

NCT01919372 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 183

Last updated 2018-03-07

No results posted yet for this study

Summary

This project is based on the contribution that could offer a technological system for a continuous monitoring, individualized treatment of obesity and prevention of cardiometabolic complications in high risk population.

The main objective of PREDIRCAM study is to evaluate the benefits obtained with the use in high cardiometabolic risk individuals of a telemedical platform integrating applications for monitoring and providing recommendations to improve lifestyle habits (diet and physical activity) in a healthier way.

The study population are obese subjects (type I or II) aged between 25 and 65 years with a 12 month follow-up. In this population it will be analysed the cost-effectiveness of a telemedic assistance with a technological system and its ability to modify lifestyle habits, reduce weight and cardiovascular risk associated parameters.

Previously to the clinical implementation, a pilot study for testing the telemedical system will be made. Efficacy and security variables will be evaluated along the study.

Conditions

  • Obesity Type I and II

Interventions

DEVICE

Telemedic assistance with a technological system

OTHER

Standard care

Sponsors & Collaborators

  • Grupo de Bioingenieria y Telemedicina -ETSI Telecomunicacion. Universidad Politecnica de Madrid

    collaborator UNKNOWN

  • Spanish Clinical Research Network - SCReN

    collaborator NETWORK

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-29
Primary Completion
2017-12-30
Completion
2018-01-25

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01919372 on ClinicalTrials.gov