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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity Type I and II

Intervention / Treatment
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* Device: Telemedic assistance with a technological system
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preclinical Phase: 1. 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: 1. 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional assistance<br>Usual treatment of obesity in terms of monitoring lifestyle habits | Other: Standard care<br> <br> |
| Experimental: Telemedic assistance<br>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<br> <br> * Other names: PREDIRCAM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiometabolic risk prevention | 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 | 1 year |