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

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

Status: Completed

Conditions: Obesity Type I and II

Treatments: Device: Telemedic assistance with a technological system; Other: Standard care

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT01919372

IIBSP-MTP-2012-74

Details and patient eligibility

About

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.

Enrollment: 183 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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183 participants in 2 patient groups

Conventional assistance

Active Comparator group

Description:

Usual treatment of obesity in terms of monitoring lifestyle habits

Treatment:

Other: Standard care

Telemedic assistance

Experimental group

Description:

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

Treatment:

Device: Telemedic assistance with a technological system