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PREDIRCAM 2: Individualized Telemedical Assistance for Lifestyle Modification in the Treatment of Obesity and Cardiometabolic Risk Prevention

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)
Overall Status
Completed
CT.gov ID
NCT01919372
Collaborator
Grupo de Bioingenieria y Telemedicina -ETSI Telecomunicacion. Universidad Politecnica de Madrid (Other), Spanish Clinical Research Network - SCReN (Other)
183
Enrollment
1
Location
2
Arms
26.9
Actual Duration (Months)
6.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Telemedic assistance with a technological system
  • Other: Standard care
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
183 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Intensificación y monitorización telemática Personalizada de la modificación Del Estilo de Vida en el Tratamiento de la Obesidad y la prevención Del Riesgo cardiometabólico
Actual Study Start Date :
Oct 29, 2015
Actual Primary Completion Date :
Dec 30, 2017
Actual Study Completion Date :
Jan 25, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Conventional assistance

Usual treatment of obesity in terms of monitoring lifestyle habits

Other: Standard care
Experimental: Telemedic assistance

telemedical assistance with a technological system to provide a continuous monitoring of lifestyle habits and individualized treatment of obesity

Device: Telemedic assistance with a technological system
Other Names:
  • PREDIRCAM

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Weight loss [1 year]

    Secondary Outcome Measures

    1. Cardiometabolic risk prevention [1 year]

      We will measure different parameters related to cardiovascular risk, such as adiponectine, tumour necrosis factor, Homeostasis Model Assessment, etc.at the beginning and at the end of the study

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    Preclinical Phase:
    1. People over 18 years with or without obesity and with ability for technology management
    Clinical Phase:

    1. People between 18 and 65 years.

    2. Obesity defined as a body mass index (BMI) greater than or equal to 30 kg/m2:

    3. Grade I or II without sleep apnea syndrome and ischemic heart disease

    4. Absence of metabolic processes (dyslipidemia) or associated hypertension requiring drug treatment at the time of inclusion in the study.

    5. People with ability for technology management

    Exclusion Criteria:
    Preclinical Phase:
    1. Serious illness and / or disabling
    Clinical Phase:

    1. Diabetes defining according to American Diabetes Association (ADA) criteria.

    2. Subjects with moderate to severe active disease at the time of inclusion in the study protocol

    3. Impaired glucose metabolism related diseases associated with diabetes mellitus or drugs interfering carbohydrate metabolism.

    4. Cardiovascular disease

    5. Dyslipidemia or hypertension requiring drug treatment.

    6. Alcohol consumption

    7. Pregnancy

    8. Serious illness and / or disabling

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital de la Santa Creu i Sant Pau Barcelona Spain 08025

    Sponsors and Collaborators

    • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
    • Grupo de Bioingenieria y Telemedicina -ETSI Telecomunicacion. Universidad Politecnica de Madrid
    • Spanish Clinical Research Network - SCReN

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
    ClinicalTrials.gov Identifier:
    NCT01919372
    Other Study ID Numbers:
    • IIBSP-MTP-2012-74
    First Posted:
    Aug 9, 2013
    Last Update Posted:
    Mar 7, 2018
    Last Verified:
    Mar 1, 2018
    Additional relevant MeSH terms:
    Obesity

    Study Results

    No Results Posted as of Mar 7, 2018