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

Intensificación y monitorización telemática Personalizada de la modificación Del Estilo de Vida en el Tratamiento de la Obesidad y la prevención Del Riesgo cardiometabólico

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01919372

Acronym

PREDIRCAM 2

Enrollment

183

Registered

2013-08-09

Start date

2015-10-29

Completion date

2018-01-25

Last updated

2018-03-07

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

Conditions

Obesity Type I and II

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.

Interventions

DEVICETelemedic assistance with a technological system

OTHERStandard care

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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: 1. Grade I or II without sleep apnea syndrome and ischemic heart disease 2. Absence of metabolic processes (dyslipidemia) or associated hypertension requiring drug treatment at the time of inclusion in the study. 3. 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

Design outcomes

Primary

Measure	Time frame
Weight loss	1 year

Secondary

Measure	Time frame	Description
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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026