Clinical trial NCT01919372: Individualized Telemedical Assistance for Lifestyle Modification in the Treatment of Obesity and Cardiometabolic Risk Prevention
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity Type I and II
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Grupo de Bioingenieria y Telemedicina -ETSI Telecomunicacion. Universidad Politecnica de Madrid
name: Spanish Clinical Research Network - SCReN
First posted: 2013-08-09
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Weight loss
timeFrame: 1 year
Secondary outcomes:
measure: Cardiometabolic risk prevention
timeFrame: 1 year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
References: