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OpenTrials
Completed

NCT Number: NCT01919372

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

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.

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Key information

Conditions

Obesity Type I and II

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Preclinical Phase:

  • People over 18 years with or without obesity and with ability for technology management

Clinical Phase:

  • People between 18 and 65 years.
  • Obesity defined as a body mass index (BMI) greater than or equal to 30 kg/m2:
  • Grade I or II without sleep apnea syndrome and ischemic heart disease
  • Absence of metabolic processes (dyslipidemia) or associated hypertension requiring drug treatment at the time of inclusion in the study.
  • People with ability for technology management

Exclusion criteria

Preclinical Phase:

  • Serious illness and / or disabling

Clinical Phase:

  • Diabetes defining according to American Diabetes Association (ADA) criteria.
  • Subjects with moderate to severe active disease at the time of inclusion in the study protocol
  • Impaired glucose metabolism related diseases associated with diabetes mellitus or drugs interfering carbohydrate metabolism.
  • Cardiovascular disease
  • Dyslipidemia or hypertension requiring drug treatment.
  • Alcohol consumption
  • Pregnancy
  • Serious illness and / or disabling

Treatment and study plan

Telemedic assistance with a technological system

Device

Other names: PREDIRCAM

Standard care

Other

Primary outcomes

  1. Weight loss

    Time frame: 1 year

Secondary outcomes

  1. Cardiometabolic risk prevention

    Time frame: 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

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Grupo de Bioingenieria y Telemedicina -ETSI Telecomunicacion. Universidad Politecnica de Madrid
  • Spanish Clinical Research Network - SCReN

Registry information

Official study 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

Acronym: PREDIRCAM 2

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Aug 9, 2013
Registry last updated
Mar 7, 2018

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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